Impact of Accreditation to ISO/IEC 17025 in Accredited

Testing Laboratories in Mauritius

Bibi Farzeena Shehroze Ramjun

Masters in Business Administration (General)

University of Mauritius

Faculty of Law & Management

September 2009

ii

Table of Contents

Contents Page No.

List of Tables vii

List of Figures viii

Acknowledgements ix

Project/Dissertation Declaration Form x

Abstract xi

Abbreviations xii

Chapter 1-Introduction

1.1 Introduction 2

1.2 Background 2

1.3 Problem Statement 3

1.4 Objectives of the Study 4

1.5 Research Questions 4

1.6 Aim of the Study 4

1.7 Significance of the Study 5

1.8 Phases of the Dissertation 5

1.9 Conclusion 5

Chapter 2-Literature Review

2.1 Introduction 7

2.2 Accreditation 7

iii

2.2.1 Definition of Accreditation 7

2.2.2 Laboratory Accreditation to ISO/IEC 17025 8

2.2.3 Brief History of Laboratory Accreditation 9

2.2.4 Importance of Accreditation 10

2.2.5 Advantages of Accreditation to ISO/IEC 17025 11

2.2.5.1 A recognition of Testing Competence 12

2.2.5.2 A Marketing Advantage 12

2.2.5.3 A Benchmark for Performance 12

2.2.5.4 Avoid Retesting 13

2.2.5.5 Enhance Customer’s Confidence & Satisfaction 13

2.2.5.6 International Recognition 14

2.2.5.7 Government 14

2.3 ISO & IEC 15

2.4 Reducing Trade Barriers through Conformity Assessment 16

2.4.1 Conformity Assessment 16

2.4.2 Conformity Assessment Procedures 17

2.4.3 Technical Barriers to Trade 17

2.5 ISO/IEC 17025 and its Underlying Principles 18

2.5.1 Capacity 18

2.5.1.1 People 18

2.5.1.2 Environment 19

2.5.1.3 Quality Control 19

2.5.1.4 Procedures 20

iv

2.5.2 Exercise of Responsibility 20

2.5.3 Scientific Method 21

2.5.4 Objectivity of Results 21

2.5.5 Impartiality of Conduct 22

2.5.6 Traceability of Measurement 22

2.5.7 Repeatability of Test 22

2.5.8 Transparency of Process 22

2.6 Roadmap to Accreditation in Mauritius 23

2.6.1 MAURITAS 23

2.6.2 Accreditation by MAURITAS to ISO/IEC 17025 23

2.6.3 Accreditation in Mauritius 24

2.6.4 Implementation of ISO/IEC 17025 in Laboratories 24

2.6.5 Cost of Accreditation 27

2.7 Conclusion 28

Chapter 3-Research Methodology

3.1 Introduction 30

3.2 Research Questions 30

3.3 Research Design 30

3.3.1 Research Approach 30

3.3.2 Testing Hypothesis 30

3.3.3 Research Method 31

3.3.4 Research Strategy 31

3.3.5 Target Population 32

v

3.3.6 Research Instruments 32

3.3.7 Questionnaire Construction 33

3.3.8 Questionnaire Items 34

3.3.9 Pilot Study 35

3.4 The Research Process 35

3.4.1 Administration of the Questionnaire 35

3.4.2 Data Collection 35

3.4.3 Data Analysis 36

3.4.4 Reliability and Validity of Findings 37

3.5 Ethical Considerations 37

3.6 Limitations of the Study 38

3.7 Conclusion 38

Chapter 4-Analysis of Findings & Presentation of Results

4.1 Introduction 40

4.2 Section A- Background Information 40

4.2.1 Laboratories’ Profile (Survey1) 40

4.2.2 Employees’ Profile (Survey2) 43

4.3 Section B- Descriptive Statistics 45

4.3.1 Survey1- Part B: Potential Obstacles during Implementation of ISO/IEC 17025 45

4.3.2 Survey1- Part C: Impact of Accreditation on Testing Laboratories 49

4.3.2.1 Performance 49

4.3.2.2 Employees Performing Test 50

vi

4.3.2.3 Suppliers 51

4.3.2.4 Cost of Maintaining Accreditation 52

4.3.2.5 Drawbacks 53

4.3.2.6 Customer Focus 54

4.3.3 Part C: Section 3- Overall Satisfaction of Organisation 58

4.3.4 Survey 2: Employee Satisfaction 60

4.4 Section C: Hypothesis Testing 62

4.5 Conclusion 65

Chapter 5-Conclusion & Recommendation

5.1 Introduction 67

5.2 Conclusion 67

5.3 Recommendations 68

5.4 Future Work 70

Bibliography 72

Appendix 1-Clauses of ISO/IEC 17025 81

Appendix 2-Clauses of ISO/IEC 17025 Requiring Procedures 82

Appendix 3-Accreditation Services offered by MAURITAS 83

Appendix 4-Survey 1 84

Appendix 5-Survey 2 91

Appendix 6-Frequency Table of Impact of Accreditation on the Performance of Laboratory 93

vii

Figure No.

3.1

3.2

4.1

4.2

4.3

4.4

4.5

4.6

4.7

4.8

4.9

4.10

4.11

4.12

4.13

LIST OF TABLES

Title

Response rate of survey

Reliability statistics

Profile of laboratories

Reasons for seeking accreditation

Number of employee nature of laboratory

Years of service by nature of laboratory

Level of education by nature of laboratory

Potential barriers during implementation of ISO/IEC 17025

Performance of laboratory

Means of measuring customer satisfaction

Cross tabulation: Nature of laboratory and impact of accreditation

Chi square tests: Nature of laboratory and impact of accreditation

Cross tabulation: Impact of accreditation and level of employee satisfaction

Chi square tests: Impact of accreditation and level of employee satisfaction

Symmetric measures: Impact of accreditation and level of employee satisfaction

Page

36

37

40

42

43

43

44

45

49

56

62

63 64 64 65

viii

Figure No.

4.1

4.2

4.3

4.4

4.5

4.6

4.7

4.8

4.9

4.10

4.11

4.12

LIST OF FIGURES

Title

Nature of laboratories

Reasons for seeking accreditation

Potential barriers during implementation of ISO/IEC 17025

Impact of accreditation on employees performing tests

Supplier and laboratory accreditation

Additional costs related to accreditation

Drawbacks of accreditation to ISO/IEC 17025

Impact of accreditation on customer satisfaction

Percentage of customers requiring accredited test results

Additional services offered by respondents

Opinion on overall satisfaction of respondents on accreditation

Employees’ opinion on accreditation

Page

41

42

46

50

51

52

53

54

55

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58

59

ix

ACKNOWLEDGEMENT

The writing of this dissertation has been one of the most significant academic

challenges I ever had to face. Without the support, patience and guidance of the

following people, this study would not have been completed. It is to them that I owe

my deepest gratitude:

Mr L.Vencataya, my supervisor for his suggestions and advice despite his

many other academic and professional commitments.

Dr K. Sukon who spared his invaluable time helping me in doing the

statistical analysis.

All the head of departments, Quality Managers and employees of the

accredited laboratories who participated in this research project.

Mr Joolia, Mr Gopee, my colleagues, and my friends, Sharmeen, Vikram,

Pascal, Zyaad, Ridwaan, Varun and Sneid for their valuable suggestions and

help in shaping this project; and not to forget Andy and Vishal for their

infinite kindness and magnanimity.

My parents, sister, brother in law and Aliza, my niece, who have always

encouraged and believed in me in all my endeavours.

Indeed to Fayiz, my angel, for making things easy to me. I confess that

without his understanding, co-operation and support, I might never have

completed this work.

This dissertation is dedicated to Fayiz

x

UNIVERSITY OF MAURITIUS

PROJECT/DISSERTATION DECLARATION FORM

Name:

Student ID:

Programme of Studies:

Module Code/Name:

Title of Project/Dissertation:

Name of Supervisor(s):

Declaration: In accordance with the appropriate regulations, I hereby submit the above dissertation for examination and I declare that: (i) I have read and understood the sections on Plagiarism and Fabrication and Falsification of Results found in the University’s “General Information to Students” Handbook (20…./20….) and certify that the dissertation embodies the results of my own work. (ii) I have adhered to the ‘Harvard system of referencing’ or a system acceptable as per “The University of Mauritius Referencing Guide” for referencing, quotations and citations in my dissertation. Each contribution to, and quotation in my dissertation from the work of other people has been attributed, and has been cited and referenced. (iii) I have not allowed and will not allow, anyone to copy my work with the intention of passing it off as his or her own work. (iv) I am aware that I may have to forfeit the certificate/diploma/degree in the event that plagiarism has been detected after the award. (v) Notwithstanding the supervision provided to me by the University of Mauritius, I warrant that any alleged act(s) of plagiarism during my stay as registered student of the University of Mauritius is entirely my own responsibility and the University of Mauritius and/or its employees shall under no circumstances whatsoever be under any liability of any kind in respect of the aforesaid act(s) of plagiarism. Signature: Date:

xi

ABSTRACT

This study aimed at assessing the impact of accreditation to ISO/IEC 17025 in

accredited testing laboratories in Mauritius. Both secondary and primary data

were used in this research paper. Secondary data was generated through a

literature search on accreditation. The approach used to gather primary data was

both qualitative and quantitative. Two survey questionnaires were designed to

meet the research objectives. Data was collected among eight accredited

laboratories, five public and three private, and their employees performing tests.

Based on the results, it was found that 75% of the accredited laboratories sought

accreditation to obtain formal recognition of testing competence. Findings also

showed that although accreditation was a lengthy process, bureaucratic, as well as

involving substantial investment, all respondents valued accreditation since it

helped them to improve their laboratory operations and fulfil their customers’

expectations. Major obstacles encountered, during implementation and

maintenance of accreditation, by the laboratories were: lack of suppliers of

calibrated equipment, non-existence of accredited metrology laboratories for

calibration of equipment, and unavailability of proficiency testing providers.

Moreover, despite more responsibilities, employees claimed that accreditation did

not benefit them financially. In addition, the majority agreed that there was a lack

of communication from management. But yet they were satisfied to work in an

accredited laboratory. Using chi square test, the study further revealed that

irrespective of the nature of laboratories, whether public or private, accreditation

has had a positive impact on laboratory processes and has improved the level of

employees satisfaction.

Feasible recommendations were made to address the potential barriers to

accreditation. The most pressing ones being that calibration laboratories should

be accredited to ISO/IEC 17025 at the earliest as well as driven campaigns by

MAURITAS to boost national awareness on the economic and social benefits of

accreditation.

xii

ABBREVIATIONS

1. A2LA American Association of Laboratory Accreditation

2. CAEAL Canadian Association for Environmental Analytical Laboratories

3. EA European co-operation for Accreditation

4. EU European Union

5. FAO Food and Agricultural Organisation

6. GATT General Agreement on Tariffs and Trade

7. IAF International Accreditation Forum

8. IEC International Electrotechnical Commission

9. ILAC International Laboratory Accreditation Corporation

10. ISO International Organisation for Standardisation

11. MAURITAS Mauritius Accreditation Service

12. MRAs Mutual Recognition Arrangements

13. MSB Mauritius Standard Bureau

14. NA Norwegian Accreditation

15. NATA National Association Testing Authorities

16. PRB Pay Research Bureau

17. SAC-SINGLAS Singapore Laboratory Accreditation Scheme

18. SANAS South African National Accreditation System

19. SWEDAC Swedish Board for Accreditation and Conformity Assessment

20. TAEC Technical Assistance to Enhance Competitiveness

21. TELARC Testing Laboratory Registration Council

22. TBT Agreement Agreement on Technical Barriers to Trade

23. WHO World Health Organisation

24. WTO World Trade Organisation

CHAPTER 1

INTRODUCTION

2

1.1 Introduction

This chapter gives an overview of the importance of accreditation to ISO/IEC

17025 and explains the need to implement a management system according to the

ISO/IEC 17025 standard in organisations. The aim and objectives of the study

have been defined, as well as the structure of the remaining chapters.

1.2 Background

With the advent of globalisation, domestic and export trade have become vital to

the development of a country’s economy. There is a need to lower and/or

eliminate barriers to trade in order to facilitate trade amongst nations. Barriers to

free trade can be in the form of technical regulations and standards, usually

referred to as technical barriers, as established by countries. A General

Agreement on Tariffs and Trade (GATT) working group, set up to evaluate the

impact of non-tariff barriers in international trade in the 1970s, concluded that

technical barriers were the largest category of non-tariff measures faced by

exporters (WTO, n.d). The lowering of technical barriers to trade can be achieved

by harmonising technical regulations, standards and conformity assessment

procedures as laid down in the Agreement on Technical Barriers to Trade (TBT

Agreement) of the World Trade Organization (WTO). The TBT Agreement is an

integral part of the WTO Agreement, which now extends to 148 countries

(Guasch et al, 2007).

Accreditation is one of the tools available to lower such barriers. It creates

confidence in the work carried out by certification and inspection bodies, as well

as testing and calibration laboratories, located anywhere in the world. Without

accreditation, tests carried out in the exporting country would have to be repeated

by a recognised laboratory in the importing country and an adverse test report

could result in the rejection of the finished goods (UNIDO, 2003). Usually there

is an increase in cost in producing the required goods. While international trade is

fundamentally linked to supply capacity and cost, laboratory accreditation and the

recognition of test results is a final determinant as to whether the goods produced

by the exporter are acceptable in other countries (UNIDO, 2003).

3

The International Laboratory Accreditation Cooperation, (ILAC), is the principal

forum at international level for laboratory accreditation. ILAC fosters multilateral

recognition among members for the enhancement and facilitation of acceptance

of test and calibration data. This approach allows countries with similar

accreditation systems to establish agreements among themselves. These

agreements, called mutual recognition arrangements (MRAs), include mutual

evaluation and acceptance of each other’s accreditation systems as equivalent.

MRAs enable accredited laboratories to achieve a form of international

recognition, thereby allowing test data accompanying exported goods to be more

readily accepted. This will lead towards achieving the free-trade goal of a

“product tested once and accepted everywhere” (Unger, 2009).

The International Organization for Standardization (ISO) and the International

Electrotechnical Commission (IEC) are two standard setting bodies working

together to develop international standards. ISO/IEC 17025, General

Requirements for the Competence of Testing and Calibration Laboratories, is one

among the standards developed jointly by these institutions applicable only to

testing and calibration laboratories, to assess their competence.

1.3 Problem Statement

It is the obligation of any government to protect human safety and health, and the

environment. Widespread complaints from the public in Mauritius show the

general dissatisfaction expressed towards the services offered by government

institutions. The Pay Research Bureau (PRB) report 2003 stipulated that it would

be in the interest of the public sector organisations to implement ISO principles to

provide a quality service to the society (PRB, 2003). Thus, to improve on service

delivery, government institutions have been adopting ISO 9001 quality

management system for their operation since the last five years. In addition, since

the Mauritius Accreditation Service (MAURITAS) started providing

accreditation services in 2005, government laboratories have been implementing

a quality management system in line with the requirements of ISO/IEC 17025.

The private sector is also wholly concerned with the development and

establishment of working tools that promote the quality of products and/or

4

services as well as shortening the lead time for supply inspection and acceptance,

to be successful in the marketplace. Quality improvement has become a key

national and international business strategy. Testing laboratories play an

important role in the quality systems of organisations. Several organisations have

already implemented ISO/IEC 17025 to improve existing processes. In addition,

customers have asked private laboratories to have a quality management system

in accordance to ISO/IEC 17025 for their products to be readily acceptable on the

market.

1.4 Objectives of the Study

The specific objectives of the study are as follows:

To assess the impact of accreditation to ISO/IEC 17025 in testing

accredited laboratories, both private and public, in Mauritius.

To investigate whether accreditation to ISO/IEC 17025 has improved

employees’ satisfaction in accredited testing laboratories

To identify reasons for seeking accreditation to ISO/IEC 17025.

To investigate potential barriers faced during implementation of ISO/IEC

17025 in testing laboratories.

1.5 Research Questions

What are the impacts of accreditation to ISO/IEC 17025 in accredited

testing laboratories in Mauritius?

How accreditation to ISO/IEC 17025 has improved employees’

satisfaction in accredited testing laboratories?

Why have laboratories sought accreditation to ISO/IEC 17025?

What are the potential barriers faced during implementation of ISO/IEC

17025?

1.6 Aim of the Study

The major aim of this research paper is to assess the impact of accreditation to

ISO/IEC 17025 in accredited testing laboratories in Mauritius.

5

1.7 Significance of the Study

This research project will be beneficial to the laboratory community and its

customers as this study enhances the importance of accreditation to ISO/IEC

17025 for the economic and social development of the country.

This study will also be helpful to assess the views of employees involved in the

management system based on ISO/IEC 17025. Therefore, findings are expected

to contribute towards improving staff motivation and the management system.

Furthermore, this research will identify potential obstacles to the implementation

and maintenance of accreditation to ISO/IEC 17025. Recommendations will be

proposed to address these constraints.

1.8 Phases of the Dissertation

Chapter 1 provides a brief introduction of the subject matter of the dissertation.

Chapter 2 explains the history, importance, benefits and concept of accreditation

to ISO/IEC 17025.

Chapter 3 outlines the methodology used for the purpose of the study.

Data presentation and analysis of the study are presented in Chapter 4.

Chapter 5 provides conclusions and recommendations of the study.

1.9 Conclusion

This chapter has introduced the subject of accreditation. The significance of the

study and the research questions have been outlined. The next chapter will

address an in-depth research on relevant literatures on accreditation to ISO/IEC

17025.

CHAPTER 2

LITERATURE REVIEW

7

2.1 Introduction

This chapter begins with a definition of accreditation as well as a brief history.

The importance of accreditation to ISO/IEC 17025 in the global economy and its

benefits have been outlined. It further lays emphasis on the role of ISO and IEC

to develop international standards and the use of accreditation as a tool to reduce

technical barriers to trade. The concept behind the international standard ISO/IEC

17025 has also been elaborated. Finally, accreditation in Mauritius is explained.

2.2 Accreditation

2.2.1 Definition of Accreditation

ISO/IEC 17000:2004 defines accreditation as the “third-party attestation related

to a conformity assessment body conveying formal demonstration of its

competence to carry out specific conformity assessment tasks”.

Attestation is “issue of a statement, based on a decision following review, that

fulfilment of specified requirements has been demonstrated” (Szewieczeka,

Karkoszkaa, & Zającb, 2009).

According to ISO/IEC 17000 (2004), a conformity assessment body can be a

calibration laboratory or a testing laboratory or an inspection body or a product

certification body or a system certification body or personnel certification body.

Conformity assessment tasks can be categorised into the following (Productivity

Commission, 2006):

Calibration- checking the accuracy of measuring devices and equipment.

Testing- determining the properties of products or materials. The equipment

used in these tests will often need to be calibrated.

Inspection- judging or grading the quality of products or services.

Certification- giving an assurance that a product, process or service

conforms to specified requirements. There are three main types of

certification:

8

Product certification checks that a specific product has passed relevant

tests and meets packaging or labelling requirements.

Systems certification certifies that a management system meets a

particular standard. An example is the ISO 9001:2000 standard for

quality management systems, which is designed to ensure that a business

is achieving a consistent level of quality across all of its output.

Personnel certification assesses the qualifications of auditors and certifies

that they are competent to undertake product or systems audits.

2.2.2 Laboratory Accreditation to ISO/IEC 17025

Laboratory accreditation ensures that a laboratory is competent to perform

specified tests or measurement and has management policies and practices that

are likely to produce reliable test data each time a test is performed.

According to Robinson & Valentine (2001), competency is defined as having all

the necessary components such that the test can be carried out correctly. These

components include

Trained and qualified staff

Properly functioned equipment

Standardised methods

Proper environmental conditions

Procedures for feedback and corrective action

Quality control system

A testing laboratory is defined by ISO as a body disposing of the necessary

measuring and test equipment and of appropriately qualified persons whose main

function is to measure, examine, test or otherwise determine the composition,

characteristics or performance of product, materials, components, assemblies or

structures (Stanger, 1989).

Any laboratory seeking accreditation needs to have necessary resources to

undertake all tests or group of tests correctly and consistently as defined under its

9

scope of accreditation. The competence of a laboratory is evaluated against

ISO/IEC 17025.

2.2.3 Brief History of Laboratory Accreditation

History indicates that testing laboratories emerged in the second half of the

nineteenth century (Stanger, 1989). The testing laboratories provided specialised

services which included approval and quality assurance programs to specific

industries such as the automotive manufacturers and the military.

The history of laboratory accreditation is summarised below (Garside & Gilmour,

1983; NATA, 2009):

1920s- First proposal to establish a national laboratory approval system,

Australia.

Early 1940s- Approved Wartime Test House Scheme by Australian

Government whereby both government and private laboratories

performed routine testing of raw materials.

1947- The success of the above scheme led to the creation of the National

Association Testing Authorities (NATA) in Australia, the first national

laboratory accreditation system in the world.

1972- New Zealand adopted the second national accreditation system with

the setting up of Testing Laboratory Registration Council (TELARC).

1973- Denmark was next to establish a national accreditation scheme.

With only very few accreditation bodies in the early 1980s, by the year 1987,

there were 21 such accreditation bodies worldwide mostly in Europe, Asia and

the Americas (NATA, 2009). The first accreditation body in Africa is the South

African National Accreditation System (SANAS) which has been set up in 1996

(UNIDO, 2003). The second accreditation body set up in the African region was

MAURITAS in 1998.

NATA was the pioneer in the field of laboratory accreditation in the world

exhibiting new features as listed below (Garside & Gilmour, 1983):

10

to provide a national testing service for government, industry and

commerce,

to operate a uniform system throughout Australia, and

to use a unique method of assessment of the competence of laboratories by

independent experts.

The growing interest in laboratory accreditation led to the first ILAC conference

in Copenhagen in 1977 (NATA, 2009). ILAC produced a document for

laboratory accreditation which was adopted as ISO Guide 25: 1978 (Squirrell,

2008). This standard was revised in 1990 and another revision led to ISO/IEC

17025 in 1999. The latest standard published in 2005 incorporates quality

management elements of ISO 9001 (Squirrell, 2008).

According to ILAC (2009), there are almost 29000 laboratories accredited

worldwide in 2007, representing a growth of over 30% since 2004.

2.2.4 Importance of Accreditation

Without accreditation, buyers of commodities or products would solely rely on

the seller’s assurance about the quality or safety of a product or their own

inspections. Assurance from sellers can be unsatisfactory since they have

incentives to overstate quality of product and consumers are often deprived of

information. For instance, in September 2008, the world was taken aback by the

problem of melamine in Chinese baby milk and related dairy products. It was

found that factories producing milk added melamine to boost the apparent level

of protein. The Codex Alimentarius, the international reference for development

of food standards, jointly published by the Food and Agricultural Organization

(FAO) and World Health Organization (WHO), does not recognise melamine as a

food additive (WHO, 2009). Manufacturers bypassed the Codex guidelines and

released their melamine enriched milk products on the market. This led to the

hospitalization of more than 50 000 infants and young children, and six deaths in

China (WHO, 2009). Many countries importing dairy products from China had to

carry out massive product recalls from market shelves and domestic outlets.

11

It is worth noting that once a defective product enters the marketplace, it is unsafe

for consumers. Recalls are never 100% effective and are a tremendous waste to

distributors and a nuisance, if not threat, to consumers. The cost associated with

accreditation of a laboratory is far less than the costs and public scrutiny

associated with recalls.

2.2.5 Advantages of Accreditation to ISO/IEC 17025

A study carried out by Hacham and Sheinman (2003) pointed out the benefits of

accreditation to ISO/IEC 17025 with respect to improved quality customer

service and handling customer's complaints, establishing multi-channel

communication, enhanced inter-laboratory collaboration and coordination.

Another study carried out by Vlachos et al. (2002), in the General Chemical State

Laboratory of Greece, on the implementation and the maintenance of the

ISO/IEC 17025, found that despite drawbacks of developing and maintaining an

efficient management system such as time-consuming efforts, increase expenses

and bureaucratic procedures, the whole process is quite rewarding and fruitful.

Accreditation provides extensive training to both management and laboratory

employees. There is evidence of a strong relationship between laboratory

accreditation and employee satisfaction (Verstraete et al., 1998). Laboratory

accreditation leads to the overall traceability of laboratory work, better

knowledge of the methods and equipment, a more systematic and empowering

approach to laboratory management, improvement in personnel professionalism

and skills, better working instructions, increased level of responsibilities, and

fewer errors from employees (Verstraete et al., 1998; Siloaho and Puhakainen,

2000). Access to information and data from internal and external sources to

perform corrective and preventive activities improves organisational learning

(Halevy, 2003). Laboratory accreditation further enhances the performance of the

organisation through better control of laboratory operations and feedback from

customers. This will result in potential increase in business due to enhanced

customer satisfaction (NABL, n.d).

12

According to Wiegers (2002), accreditation leads to an increase in productivity,

morale of staff and ability to stay abreast of developments in requirements for

competence and testing.

Mukhopadhyay (2004) and ILAC (n.d., 2001, 2008) highlight the following

benefits of laboratory accreditation.

2.2.5.1 A recognition of Testing Competence

Laboratory accreditation provides formal recognition of competence to

laboratories, thus raising the efficiency and effectiveness of laboratory operation.

It allows customers to select appropriate testing services and minimises the risk

of unreliable results. Laboratories are regularly assessed by the accreditation

body to ensure continual compliance with requirements.

Laboratories are also required to participate in relevant proficiency testing

programs between reassessments, as a further demonstration of technical

competence. A study carried out from 1997 to 2000, by the Canadian Association

for Environmental Analytical Laboratories (CAEAL), revealed that accredited

laboratories outperformed non-accredited laboratories when performing the same

proficiency testing programme. Following this study, in 2001, over 33 % of non-

accredited laboratories sought accreditation (CAEAL, 2002).

2.2.5.2 A Marketing Advantage

Accreditation is an effective marketing tool for testing, calibration and

measurement organisations, and a passport to submit tenders to contractors that

require independently verified laboratories. Users of accredited laboratories will

enjoy greater access for their products, in both domestic and international

markets.

2.2.5.3 A Benchmark for Performance

Laboratory accreditation ensures that laboratories perform their work correctly

and to appropriate standards. It provides them with a benchmark for maintaining

that competence. In addition to commercial testing and calibration services,

13

manufacturing organisations may use laboratory accreditation to ensure the

testing of their products by their own in-house laboratories is being done

correctly.

2.2.5.4 Avoid Retesting

Testing of products and materials can be expensive and time consuming, even

when they are done correctly the first time. If not done correctly, then the cost

and time involved in re-testing can be even higher if the product has failed to

meet specifications or expectations. Not only costs go up, but reputation as a

supplier or manufacturer can go down. Thus, a product tested in a particular

country by an accredited laboratory minimises the chances of retesting and

reducing chances of additional financial burden and time delays.

2.2.5.5 Enhance Customer Confidence and Satisfaction

Confidence in a product is enhanced if customers know it has been thoroughly

evaluated by an independent, competent testing facility, that is, an accredited

laboratory. Increasingly, customers are relying on independent evidence, rather

than simply accepting a supplier's word that the product is “fit for purpose”.

A survey conducted by the Swedish National Testing and Research Institute in

2001-2002 concluded that 81 % of its customers valued the importance of an

accredited test result and 12 % found irrelevant the use of accredited test result

(Holmgren, 2003).

In addition, another survey was carried out in an accredited Polish laboratory in

2006 on the level of satisfaction on services provided by the laboratory. Results

showed that 41% of questionnaired were very satisfied, 53% were satisfied and

the remaining 6% were moderately satisfied with the services (Szewieczeka,

Karkoszkaa, & Zajacb, 2009).

14

2.2.5.6 International Recognition

Laboratory accreditation ensures international acceptability of test data and

facilitates trade among countries. This reduces cost for exporters and duplication

of test in the importing countries.

Accreditation is gaining due recognition on the international level, the latest

being the setting up of a legal framework for accreditation in Europe as it is

found that accreditation plays an important role in the European Union’s

economic infrastructure. On 9 July 2008, Regulation (EC) 765/2008, Setting out

the requirements for accreditation and market surveillance relating to the

marketing of products, was adopted by the European Parliament and the Council

of the European Union (EC, 2008).

The Regulation sets out a legal framework for accreditation in the European

Union (EU) thus enhancing confidence in conformity assessment of products by

strengthening the role of accreditation for testing, certification and inspection

bodies. It also reinforces Market Surveillance structures to protect citizens from

unsafe products (including those from outside the EU) and level the playing field

for compliant business, by removing those products from the market.

A major policy intention of this Regulation is to reduce duplication and remove

the need to hold multiple accreditation certificates. This will facilitate mutual

recognition and promote the overall acceptance of accreditation certificates and

conformity assessment results across the European Economic Area, irrespective

of the issuing European Union country of origin. Hence, conformity assessment

bodies will require only one accreditation throughout the European Economic

Area. The Regulation (EC) 765/2008 will come into force on 1 January 2010.

2.2.5.7 Government

Governments are using accreditation through regulations to reduce uncertainties

associated with decisions that affect the protection of human health and the

environment, and meet their responsibilities and safeguard the public.

15

2.3 ISO & IEC

ISO is a network of national standards institutes from 162 countries and is the

world’s largest developer of internationally harmonised standards (ISO, 2009).

IEC is the global organization that prepares and publishes International Standards

for all electrical, electronic and related technologies (IEC, 2004).

ISO and IEC form a specialised system for worldwide standardization. National

bodies that are members of ISO or IEC participate in the development of ISO

standards through their technical committees, and ISO and IEC committees

collaborate. Both ISO and IEC produce around 85% of all international standards

(Productivity Commission, 2006).

The use of standards is of paramount importance as:

they play a pivotal role in facilitating market exchange and they reduce

transaction costs: distant parties unknown to each other are able to share

expectations on the qualities of products and processes, and ensure

compatibility

they reduce costs by delivering economies of scale

they facilitate international trade, global transport, communication and

technological innovation

they provide consumers with greater certainty about the quality and safety

of products

they are increasingly used by governments to address concerns about social

issues and the environment

they facilitate the diffusion of technology

they provide regulators with an additional tool to meet policy objectives

(Productivity Commission, 2006).

Without international standards, technical barriers to trade would result in

increased costs for importers and consumers, reduced competition and different

standards of a product or service.

16

2.4 Reducing Trade Barriers through Conformity Assessment

2.4.1 Conformity Assessment

Conformity assessment according to the definition in ISO/IEC 17000 (2004) is

the demonstration that specified requirements relating to the product, process,

system, person or body are fulfilled.

Conformity assessment provides a user or purchaser or regulator with the needed

confidence that a product, service, process, system or person meets relevant

requirement.

There are three types of conformity assessment namely:

First Party or Supplier’s Declaration of Conformity

This implies that the responsibility rests on the supplier for testing to

demonstrate the conformance of a product to its specification, i.e, a self-

declaration from the supplier. The declaration may be in the form of a

certificate, brochure, manual or product or packaging markings (IEC,

2008).

Second Party or Buyer Declaration of Conformity

This implies a person or organisation that has a user interest in the

product. The purchaser does his/her own testing. For example, a consumer

checks an appliance upon purchase to ensure that it conforms to its

specification (IEC, 2008).

Third Party

This implies a person or an independent body performs the verification

that product’s specification is being met. Example of third party

conformity assessment includes: testing, inspection, certification and

accreditation (Unger, 2008).

17

Third party assessment provides benefits to everyone in the supply chain from the

supplier to the consumer. It also involves governmental bodies putting in place

conformity assessment infrastructure to ensure that health, safety and

environmental conditions are met.

Besides providing confidence and trust to consumers and purchasers, conformity

assessment also helps to facilitate the free flow of goods and services on the

international level.

2.4.2 Conformity Assessment Procedures

According to IEC (2008), technical and regulatory infrastructure of a country

must have certain characteristics before one may expect to derive maximum

benefit from international standards and conformity assessment:

Established metrology infrastructure, both in legal metrology and facilities

for traceable calibration of laboratory equipment

Competent product test laboratories, whether government or private, with

up-to-date equipment

Trained personnel, both for laboratories and for government agencies (e.g.

regulators)

A stable, well-publicised regulatory regime, clearly organised at national

level and determining the roles of government agencies and certification

bodies

These conformity assessment procedures are technical procedures which

confirmed that products fulfil the requirements laid down in regulations and

standards.

2.4.3 Technical Barriers to Trade

In 1947, members of the United Nations gathered in Geneva for the first round to

discuss international trade. Provisions of GATT only make reference to technical

regulations and standards. In the second round of negotiation, the Tokyo round,

in the 1970s, it was found that technical barriers to trade were the major problem

faced by exporters. In 1995, WTO was set up to continue the work of GATT.

18

WTO´s TBT Agreement was established to prohibit the use of technical

regulations, product standards and conformity assessment as unnecessary

obstacles to international trade (Guasch et al, 2007). The agreement:

requires national technical regulations to be transparent, justifiable and non-

discriminatory based on international standards,

encourages members to sign mutual recognition agreements on conformity

assessment, and

encourages the development of harmonised international conformity

assessment systems.

2.5 ISO/IEC 17025 and its Underlying Principles

ISO/IEC 17025 is divided into two sections, management and technical

requirements, comprising of 15 and 10 clauses respectively, as shown in

Appendix 1.

The management system includes the quality policy statement and the quality

objectives to be met by the laboratory. These should be communicated to all staff

in the performance of their duties.

According to Gravel (2006), ISO/IEC 17025 is based on eight principles, as

explained below.

2.5.1 Capacity

This implies that a laboratory has the appropriate resources to perform test and/or

calibration, to produce reliable results. Resources include people with required

skills and knowledge, the appropriate environment with required facilities and

equipment, the quality control and the procedures.

2.5.1.1 People

All personnel who have a direct effect on the validity of the test results should

demonstrate their competence to perform specific tasks. Personnel records for

education, training, technical knowledge and experience should indicate that the

19

person is competent, as defined in their job descriptions. The laboratory should

evaluate the competence of all personnel and ensure that training is kept up-to-

date. Personnel are also required to contribute to meet the quality policy

statement and the quality objectives of the management system.

2.5.1.2 Environment

The laboratory may perform work in permanent or mobile facilities, where

environmental conditions are met. These facilities should be furnished with

appropriate equipment.

For each area that requires a controlled environment, the laboratory should

document the conditions that they are controlling and parameters that affect the

test should be monitored appropriately. Records should indicate that all

environmental conditions that may affect the validity of data have been identified.

The laboratory should take necessary actions when environmental conditions are

outside the acceptable range. Access to controlled areas should be identified and

controlled to the extent necessary to protect the controlled environment. Good

laboratory practice is encouraged.

The laboratory is responsible for making sure that its equipment meets the test

specifications. This is a critical component of the evaluation of the laboratory’s

competence. The equipment must be capable of giving a valid test result based on

the requirements of the specification. This factor must be taken into consideration

when purchasing equipment and maintaining older equipment. The laboratory

must ensure that equipment is capable to perform the test. This can be found in

the manufacturer’s specifications or manual. Equipment must be calibrated or

checked to assure that it meets the specifications prior to use.

For unforeseen reason, when a laboratory subcontracts test, the laboratory should

ensure the sub-contractor also complies with requirement of ISO/IEC 17025.

2.5.1.3 Quality Control

Quality control is of paramount importance in laboratory accreditation. It gives

confidence in the work performed by the laboratory. The validity of results

20

should be rigorously monitored through quality control checks, which may be

internal or external. Internal quality control usually is done using statistical

techniques to detect trend in the results. External quality control is done either

through proficiency testing programme or inter-laboratory comparison to

compare results obtained by the laboratory.

According to ILAC-P9 (2005), proficiency testing and inter-laboratory

comparison are defined as:

Proficiency testing is the determination of the calibration or testing performance

of a laboratory or the testing performance of an inspection body by means of

inter-laboratory comparison.

Inter-laboratory comparison is the organization, performance and evaluation of

calibrations/tests on the same or similar calibrations/tests items by two or more

laboratories in accordance with predetermined conditions.

2.5.1.4 Procedures

The laboratory should have procedures in place that are understood by staff

involved in laboratory work as well as to meet the management requirements of

ISO/IEC 17025. Staff should be trained to use these procedures.

ISO/IEC 17025 procedures should be established for 16 clauses as shown in

Appendix 2.

2.5.2 Exercise of Responsibility

As per the requirements of ISO/IEC 17025, responsibilities shall be assigned to

persons with specific tasks.

There should be a Quality Manager who has overall responsibility of the quality

management system, including implementation and monitoring. He should have

access to the highest level of authority for decision making concerning the

laboratory in the organisation.

21

There should be a person who is familiar with the methods and procedures, the

objective, and assessment of results of the tests or calibrations performed. He is

responsible for the smooth running of the laboratory and that the laboratory has

the necessary resources to ensure the required quality of the laboratory

operations.

The technical staff should perform tests and/or calibrations according to standard

operating procedures with support personnel for assistance.

The authority and responsibility of the above personnel having an influence on

the validity of the test result are best described in a Job Description.

The laboratory or the organisation of which it is part should be legally

responsible for all work undertaken by the laboratory under its scope of

accreditation. The laboratory or organisation may be incorporated as a company

or formed through partnership agreement or is established by an act of

Parliament.

2.5.3 Scientific Method

Tests carried out by a laboratory under its scope of accreditation should be in line

with international recognised scientific methods and any deviation of the test

method should be validated before use to ensure that the method is still fit for its

purpose. It is preferable to use test methods designed by ISO or any international

bodies that have expertise in their relevant field.

2.5.4 Objectivity of Results

Test results are based on a recognised system of measurement traceable to the

internationally recognised system of measurement, the SI Unit. For qualitative

results, such as in analytical chemistry, all instrumentation used to produce the

results should be traceable in order for the measurement to be considered

traceable.

22

2.5.5 Impartiality of Conduct

It is of vital importance that officers performing test follow standard operating

procedures with no conflict of interest in their work. In any circumstances

influences should not be permitted to take precedence. Usually, staff is required

to sign a confidentiality document which restricts them from divulging

information gained in the course of their duties. Additionally, to avoid conflict of

interest, pressure or any undue influences, staff should follow standards of ethical

conduct governing the laboratory or organisation.

2.5.6 Traceability of Measurement

Results produced within the scope of work of a laboratory, is based on the SI

Unit.

Traceability of measurement is also related to equipment used for testing.

Standards used to calibrate equipment should be traceable to national and

international standards.

2.5.7 Repeatability of Test

This is a concept that the test which produced the objective results will produce

the same results, within accepted deviations during subsequent testing, and within

the constraints of using the same procedures, equipment and persons used during

a previous execution of the test. Repeatability of test forms part of quality control

procedures to monitor the validity of tests.

2.5.8 Transparency of Process

Transparency of process means that the test procedures are opened to internal and

external scrutiny. Internal scrutiny includes the laboratory staff, internal audit and

management review. On the other hand, external scrutiny refers to customers and

the accreditation body as the latter cannot accredit a laboratory without a

complete assessment of competence by independent assessors. Customers in

some cases may ask the laboratory to provide data on the methods used.

23

2.6 Roadmap to Accreditation in Mauritius

2.6.1 MAURITAS

The Technical Assistance to Enhance Competitiveness (TAEC) project funded by

the World Bank, the Government of Mauritius and the private sector, in 1994,

recommended among others the establishment of an independent national

accreditation body to accredit testing and calibration laboratories, and

certification bodies, in order to enhance export quality (World Bank, 1994). In

1998, by an act of Parliament, the Mauritius Accreditation Service Act,

MAURITAS was created under the aegis of the Ministry of Industry, Commerce

and International Trade (Budoo, 2008). MAURITAS is the sole body providing

accreditation to conformity assessment bodies.

The main functions of MAURITAS are:

To provide a national unified service for the accreditation of conformity

assessment bodies.

To establish MRAs with other national, regional and international

accreditation bodies.

MAURITAS operates laboratory accreditation programmes in various fields of

testing and calibration, as listed in Appendix 3.

MAURITAS benchmarks its level of services with international guidelines and

standards and it is already an Associate Member of ILAC, and a member of the

International Accreditation Forum (IAF).

2.6.2 Accreditation by MAURITAS to ISO/IEC 17025

The procedures to seek accreditation with MAURITAS are:

1. Setting up of a Quality Management System in line with ISO/IEC 17025

for testing and calibration laboratories.

24

2. Filling of an application form (available from MAURITAS) and

submission of relevant documents, that is, the quality manual, quality

procedures and working instructions, to MAURITAS.

3. A pre-assessment visit will be conducted by MAURITAS. The pre-

assessment visit consists of a document review.

4. After the pre-assessment, MAURITAS will recommend whether the

laboratory is ready for accreditation.

5. If the laboratory can be accredited, within six months, an initial assessment

will be conducted by assessors against the requirements of ISO/IEC 17025

and any other relevant documents.

6. Any non conformances raised during the initial assessment have to be

cleared within 3 months. The laboratory should then submit proof of

corrective actions taken to MAURITAS.

7. If the corrective actions are accepted by MAURITAS, the Accreditation

Committee will recommend the accreditation of the laboratory for the

defined scope of accreditation. A certificate will be issued accordingly.

8. The accreditation granted to a laboratory by MAURITAS remains valid for

a period of four years subject to satisfactory annual surveillance.

2.6.3 Accreditation in Mauritius

Accreditation in Mauritius is voluntary, except if it is required by law, for

instance, the Environment Protection Act. There currently exist ten accredited

testing laboratories. Eight are accredited by MAURITAS, one by Singapore

Laboratory Accreditation Scheme (SAC-SINGLAS,), and one by Swedish Board

for Accreditation and Conformity Assessment (SWEDAC).

2.6.4 Implementation of ISO/IEC 17025 in Laboratories

Any laboratory willing to be accredited to ISO/IEC 17025 has to work according

to the requirements of the standard. For many laboratories the decision to attain

accreditation is taken by senior management of the organisation and passed down

for implementation by the laboratory personnel.

25

The laboratory may apply for as little as one to as many tests, which will be

defined under its scope of accreditation.

According to Wilson and Weir (1995), the steps involved in establishing a

management system for a laboratory are:

Choosing an accreditation body. The body will provide the laboratory with

relevant guidance documents to implement the system.

It is vitally important to involve all staff performing test right from the start.

They should be familiar with ISO/IEC 17025 and other relevant documents.

All documents in use should be an updated version approved by responsible

persons.

Establishing laboratory policy with respect to each area of the system. For

example, policy with respect to training of staff, dealing with complaints,

carrying out audit and handling of test items.

Appraise the current system and upgrade it to meet the requirements of the

standard.

Drafting the Quality Manual which contains policy statements of all clauses

of the standard and related procedures.

Audit the system

Review the system

However, there is no one way to implement a management system in a

laboratory.

Laboratories have the option of hiring the service of an expert in that field

(consultant) to implement ISO/IEC 17025, or this can be done in-house. An

additional cost will have to be borne by the organisation if a consultant is hired.

Top Management designate a person responsible to implement the management

system. A gap analysis is performed to know the current status of the laboratory.

A team is formed to establish relevant documents such as the quality manual,

quality procedures, working instructions, forms and other records. The team

should ensure that operating equipment manuals are available for ease of

reference.

26

The person in charge of the laboratory prepares a checklist to identify the current

calibration status of equipment. Equipment that needs to be calibrated is sent to a

metrology laboratory for calibration. The person in charge is required to set a

calibration schedule for all equipment used for testing.

A conducive environment should be provided to meet the requirements of the

tests. For instance, if a test needs to be performed at a temperature of 20oC,

appropriate measures should be taken to ensure that this condition is maintained

throughout the test.

Management has to provide training to staff to understand all relevant documents

in order to work accordingly. Further training on internal audit, uncertainty of

measurement and method validation will have to be conducted by external

trainers.

The person in charge of the laboratory and all the personnel who participate in

carrying out laboratory tests or any other tasks related to accreditation should be

qualified and properly trained.

The quality management system is run for a period of time as determined by the

organisation.

It is advisable that the laboratory performs an inter-laboratory comparison for

tests that are defined in the scope of accreditation for comparison of test results.

Internal audit is then carried out to assess the effectiveness of the system. For any

non-compliance with the standard, corrective actions are taken.

A management review meeting is conducted to ensure that the laboratory

management system is operating as per ISO/IEC 17025. Management decides to

submit the application to an accreditation body. In case, application is submitted

to MAURITAS, steps in 2.6.2 are followed.

27

2.6.5 Cost of Accreditation

There are several factors that affect the cost of accreditation which includes the

size of the laboratory, the location of the laboratory, the scope, type and fields of

testing, the gap between the status of the laboratory and the requirement for

accreditation and the fees required by the selected accreditation body (Wiegers,

2002).

Ratliff (2003) stated that there are four categories of quality cost related to

laboratory operations:

1. Prevention costs associated with keeping unacceptable data from being

generated in the first place such as:

Quality planning

Document control and revision

Quality training

Quality assurance plans for projects and programmes

Quality assurance manual

Preventive maintenance

2. Appraisal costs associated with efforts to maintain measurement system

performance such as:

System audits

Inter-laboratory/Proficiency testing

Data validation

Statistical analysis of data

Calibration

Procurement quality control

Quality assurance activities associated with pre-test preparation, sample

analysis and data reporting

3. Internal-failure costs caused by occurrence of determinations or test results

that do not meet acceptance standards such as:

28

Scrapping of defective materials

Cost of re-running tests

Cost of corrective actions efforts

Investigation or research efforts

4. External-failure costs caused by unacceptable test or analytical results that

have already left the laboratory such as:

Investigation of complaints from outside sources

Cost of corrective action efforts

Cost of re-running test and replacing samples

According to Ratliff (2003), the above costs are initially high, but decrease after

implementation of accreditation. Furthermore, it has been found that a relatively

small increase in prevention expenditures will yield large reductions in appraisal

and failure costs. Hence, laboratory management should consider adoption of

preventive measures to reduce the total quality control costs.

2.7 Conclusion

The various issues which have been discussed in this chapter, although not

exhaustive in themselves, have in a certain manner demonstrated the depth and

amount of research done on the impact and the associated benefits of

accreditation.

Relevant results from several studies on the subject carried out abroad were also

included.

It is good to point out that accreditation to ISO/IEC 17025 is gaining importance

not only in countries abroad but in Mauritius as well.

The next chapter will outline the research methods to carry out the survey.

CHAPTER 3

RESEARCH METHODOLOGY

30

3.1 Introduction

This chapter focuses on the steps used for the research methodology based on the

process developed by Churchill (1995). It includes the research design, research

method, target population, research instrument, questionnaire construction, pilot

study, research process, ethical considerations and limitations of the study.

3.2 Research Questions

The research questions have been outlined in the introductory chapter at section

1.5.

3.3 Research Design

3.3.1 Research Approach

The two main approaches to research are deductive and inductive (Saunders et al,

2003). Deductive approach is one where a researcher uses existing theory to

design the research strategy and to produce explanatory or descriptions of

findings, whereas in inductive approach, data are gathered, analysed and theory is

developed by the researcher. For this project, the research approach adopted was

deductive.

3.3.2 Testing Hypothesis

The following hypotheses were proposed:

Hypothesis 1

H01: There is no association between degree of impact of accreditation to

ISO/IEC 17025 and nature of organisation.

H11: There is an association between degree of impact of accreditation to

ISO/IEC 17025 and nature of organisation.

31

Hypothesis 2

H02: There is no association between level of employee satisfaction and the

impact of accreditation.

H12: There is an association between level of employee satisfaction and the

impact of accreditation.

3.3.3 Research Method

Research methods can be classified as:

1. Quantitative

2. Qualitative

Quantitative research is empirical research where the data are in the form of

numbers. Qualitative research is empirical research where the data are not in the

form of numbers (Blaxter et al, 2006). The research method followed in this

study was a combination of qualitative and quantitative approach.

3.3.4 Research Strategy

There are different strategies such as:

Grounded Theory

Ethnography

Action research

Case studies

Experiments

Surveys

For the purpose of this study, surveys, as a mean of collecting data from people,

were used to meet the research objectives. The surveys were relatively easy to

administer to the laboratories and their employees. It also provided a significant

amount of information quickly. Standardisation lies at the heart of survey

research, and the main objective is to obtain consistent answers to consistent

questions (Blaxter et al, 2006).

32

3.3.5 Target Population

The objective of most research projects is to obtain information about the

characteristics or parameters of a population. A population is the aggregate of all

the elements that share some common set of characteristics that comprises the

universe for the purpose of the research problem. A census involves a complete

enumeration of the elements of a population or study objects. A sample, on the

other hand, is a subgroup of the elements of the population selected for

participation in the study (Malhotra, 2004).

Thus, to conduct any research project, sample size chosen should be

representative of the target population. According to C. Dawson (2002),

researchers can overcome problems such as huge budget and time constraint by

choosing a smaller, more manageable number of people to take part in their

research. There are two types of sampling methods: probability and non-

probability sampling. Commonly used probability sampling techniques include

simple random, systematic, stratified, cluster sampling, while non-probability

sampling techniques include convenience, judgmental, quota and snow-ball

sampling (Malhotra, 2004). For this project, census technique has been adopted

to carry out the survey as the population size was small and it was possible to

establish a proper contact with the targeted audience. The audience, during the

period of this study, comprised of only five public and five private accredited

laboratories and sixty-nine employees involved in performing tests in these

laboratories.

3.3.6 Research Instruments

Data collection can be classified into two major categories namely: primary and

secondary data. Primary data are data collected by the researcher herself. On the

other hand, secondary data are obtained from existing empirical studies

(Malhotra, 2004).

Two survey questionnaires were used for this study to collect primary data from

the targeted audience over a limited period of time.

33

Secondary data was gathered through a literature review from various sources

which included books, journal abstracts, magazines, technical reports and the

internet.

3.3.7 Questionnaire Construction

The two questionnaires were designed according to the research objectives and

from data obtained in the literature review. Both questionnaires comprised of a

combination of open and closed-ended questions.

Use of multiple choice questions of dichotomous type, multiple response type

and five point likert-type formats have been employed while designing the

questionnaires.

The likert scale is the most widely used form of scaled items where respondents

can express their views. They are asked to indicate their degree of agreement or

disagreement with each of a series of statements related to the study (Malhotra,

2004). The scales used are as follows:

1-Strongly agree

2-Disagree

3-Neutral

4-Agree

5-Strongly Disagree

With a view to ensure bias free and reliable data, the following key issues were

taken into consideration while preparing the questionnaires:

The questions were numbered serially to avoid confusion during data

processing stage.

The questionnaires were divided into different sections to facilitate the

tasks of respondents in answering them.

The language used was tailored in such a way as to enable respondents to

provide their actual viewpoint without influencing the survey results since

the respondents were knowledgeable in the research topic.

34

Clear instructions were given to fill both questionnaires. Simple, polite and

concise language was employed to encourage respondents to fill them.

3.3.8 Questionnaire Items

A series of questions were asked with a number of statements grouped under

specific headings.

The first questionnaire, Survey1, (Appendix 4) was divided into four parts

namely: A, B, C and D. The questions were set up in a manner to achieve the

research objectives.

Part A seeks information on accreditation and is composed of 6 questions on the

following issues:

Year and scope of accreditation

Reasons behind accreditation (one of the objective of the study)

Choice of accreditation body

Willingness of staff towards ISO/IEC 17025.

Part B consists of 12 statements and 2 questions aimed at analysing the potential

obstacles during implementation of ISO/IEC 17025.

Part C consists of 33 statements and 8 questions to assess the impact of

accreditation to ISO/IEC 17025 on testing laboratories.

Part D provides general information of the laboratory.

The second questionnaire, Survey2, (Appendix 5) aimed at investigating whether

accreditation to ISO/IEC 17025 has improved employee satisfaction in accredited

testing laboratories and comprised of 13 statements and 3 questions.

35

3.3.9 Pilot Study

The survey instruments were pretested among ten persons who were familiar with

the topic to identify and eliminate potential problems. Seven of them were drawn

from the population to be surveyed and the remaining three were people involved

in laboratory accreditation. Their opinions and feedbacks were used to improve

the questionnaire. Some questions were deleted, modified and added, making

them more specific to answer the research questions. The revised questionnaires

were then administered to the ten laboratories including their technical staff

through the head of the department.

3.4 The Research Process

3.4.1 Administration of the Questionnaires

The fact that the researcher works under the same Ministry as the national

accreditation body, MAURITAS, facilitated direct contact with the ten accredited

laboratories. The heads of department of each laboratory was initially contacted

by phone to explain the purpose of the survey. They were asked whether they

would be agreeable to participate in the survey. In addition, they were queried on

the number of employees performing tests. Only one laboratory, Lab10, was

reluctant to participate (Table 3-1). The questionnaires were either emailed or

hand delivered to the ten laboratories and they were informed that the collection

time would be one week after. Each head of department was informed that the

first questionnaire had to be filled either by him or the quality manager, while the

second questionnaire to be filled by employees performing tests.

3.4.2 Data Collection

The Head of each laboratory’s department was contacted by phone after one

week to check whether questionnaires were filled. Appointment was also sought

to collect them. Among ten laboratories, only four (including their staff) had

completed their questionnaires and were collected.

By the end of the second week, the remaining six laboratories were again

contacted to confirm whether questionnaires were completed and could be

36

collected. It took four weeks to gather questionnaires from four laboratories. The

remaining two laboratories were contacted by phone and through emails. The

researcher waited for a further three weeks but they did not respond. The

response rate is shown in Table 3.1.

Table 3.1: Response Rate of Survey

The survey instruments were screened during collection to ensure that all sections

were properly filled. Respondents were asked of any difficulties encountered

during filling of questionnaire.

3.4.3 Data Analysis

The data gathered from the surveys has been analysed using the Statistical

Package for Social Sciences Version 17.0. The raw data was coded and entered in

the data matrix for ease of analysis.

A quantitative analysis was carried on data collected. For descriptive statistics,

charts, percentages, mean and mode score were computed.

Laboratories

Questionnaires

Distributed

Response

Frequency

Response Rate

(%)

Survey1 Survey2 Survey1 Survey2 Survey1 Survey2

Lab1 1 13 1 13 100 100

Lab2 1 6 1 6 100 100

Lab3 1 6 1 6 100 100

Lab4 1 6 1 6 100 100

Lab5 1 3 1 3 100 100

Lab6 1 2 1 2 100 100

Lab7 1 3 1 3 100 100

Lab8 1 5 1 5 100 100

Lab9 1 8 0 0 0 0

Lab10 1 17 0 0 0 0

Total 10 69 8 44 80 63.8

37

To determine whether there is an association between variables, cross-tabulations

and chi-square test were also performed. A chi-square probability (p-value) of

less than 5% implies that the null hypothesis will be rejected (Sukon, 2008). The

impact of accreditation (statements C1 to C32) of Survey1 and level of employee

satisfaction (statements 1 to 13) of Survey2 have been categorised and recoded

into the following to carry out the test of association between variables:

High: representing likert scales 1 and 2,

Average/moderate: representing likert scale 3, and

Low: representing likert scales 4 and 5.

If there is an association between variables, the strength of association is

determined by the Cramer’s V. The closer the value is to 1, the stronger the

association (Sukon, 2008).

3.4.4 Reliability and Validity of Findings

Cronbach’s alpha method was used to test the internal consistency of the

questions in both questionnaires.

Table 3.2: Reliability Statistics

Questionnaire Cronbach's Alpha No. of Items

Survey1 0.841 48

Survey2 0.922 13

The results obtained as illustrated in Table 3.2 are considered to be valid for

interpretation use.

3.5 Ethical Considerations

Respondents were informed in the introductory part of each questionnaire that all

information gathered during the survey will be treated in due confidentiality.

Anonymity of the respondents has been maintained throughout the study.

38

3.6 Limitations of the Study

Only ten laboratories were accredited in Mauritius during the period of the study.

It was not possible to survey the customers of the ten accredited laboratories, as

most of the laboratories declined to reveal the identity of their customers.

100% response rate could not be obtained as some respondents were not willing

to dedicate their time to fill in the questionnaires.

3.7 Conclusion

A particular research methodology has been devised. Details of the research

instrument and sampling approach have been outlined. Primary data gathered will

be analysed and discussed in the following chapter.

CHAPTER 4

ANALYSIS OF FINDINGS & PRESENTATION

OF RESULTS

40

4.1 Introduction

This chapter deals with the analysis and discussion of the findings of Survey1

(Appendix 4) and Survey2 (Appendix 5).

It is structured in three parts:

Section A: Analysis of background information of both surveys will be carried

out.

Section B: Descriptive statistics of the responses will be discussed.

Section C: Statistical hypotheses testing using Chi-square test will be presented.

4.2 Section A- Background Information

This section gives a description of respondents’ profile of both surveys carried

out. In addition, it will analyse the third objective of the study:

‘To identify reasons for seeking accreditation to ISO/IEC 17025’.

4.2.1 Laboratories’ Profile (Survey1)

Table 4.1: Profile of laboratories

Respondent Nature of

organisation Field of Testing

Years in operation

Year Accredited

Accreditation Body

Lab1 Public Chemical & Environment

16 2009 MAURITAS

Lab2 Private Textile & Garment

5 2008 MAURITAS

Lab3 Private Chemical, Biology & Environment

More than 40

2008 MAURITAS

Lab4 Public Biology 15 2009 MAURITAS Lab5 Private Mechanical 4 2005 SWEDAC Lab6 Public Food &

Agriculture 30 2008 MAURITAS

Lab7 Public Mechanical 30 2008 MAURITAS Lab8 Public Chemical 13 2008 MAURITAS

41

Figure 4.1: Nature of laboratories

Table 4.1 and Figure 4.1 show that out of the eight laboratories which responded

to the survey, five of them are from the public sector and three from private

organisations, representing 62.5%, and 37.5% respectively. They are accredited

in various field of testing as shown in the Table 4.1. Moreover, apart from Lab2

and Lab5, the other laboratories have been in operation for more than ten years. It

was not until the year 1994 following the TAEC report that the importance of

accreditation was felt as tool to enhance trade with Mauritius trading partners.

Government thereafter embarked on the project of accreditation with the setting

up of MAURITAS. In 2004, MAURITAS signed twinning agreements with two

accreditation bodies of international repute, SANAS and Norwegian

Accreditation (NA) for accreditation of laboratories and certification bodies

respectively and transfer of expertise (MAURITAS, n.d). Thus five respondents

received accreditation from MAURITAS in 2008 and two in 2009. As far as

Lab5 is concerned, it is a Swedish company implemented in Mauritius which is

accredited with SWEDAC since 2005.

42

Table 4.2: Reasons for seeking accreditation

Lab No. Reasons for seeking accreditation

Lab1 Requirement of the Environment Protection Act.

Lab2 To obtain a formal recognition of testing competence

Lab3 To obtain a formal recognition of testing competence

Lab4 To obtain a formal recognition of testing competence

Lab5 Mandatory requirement from customers

Lab6 To obtain a formal recognition of testing competence

Lab7 To obtain a formal recognition of testing competence

Lab8 To obtain a formal recognition of testing competence

Figure 4.2: Reasons for seeking accreditation

Table 4.2 summarises the reasons triggering laboratories to seek accreditation.

75% of respondents stated that they wanted to obtain a formal recognition of

testing competence, as pictured in Figure 4.2.

43

Lab1 pointed out that it was a requirement of the Environmental Protection Act

that the laboratory should be accredited for recognition of data before a Court of

law as stipulated under section 47 of the act.

As far as Lab5 is concerned, accreditation was a mandatory requirement from its

customers. It is interesting to point out that Lab5 deals with overseas customers

only and it was accredited on the very same year of its operation.

The reasons for seeking accreditation by the laboratories are supported in sections

2.2.5.1, 2.2.5.5 and 2.2.5.7.

4.2.2 Employees’ Profile (Survey2)

Table 4.3: Number of employee by nature of laboratory

Table 4.3 shows that out of 44 respondents, 29 employees representing 65.9%,

are from the public sector and 15, accounting for 34.1%, from private

organisations.

Table 4.4: Years of service by nature of laboratory

Out of 44 respondents surveyed, 31 have less than 10 years of service as shown

in Table 4.4. The majority of the respondents having between 5 to 10 years of

service are from public sector.

44

Table 4.5: Level of education by nature of laboratory

As shown in Table 4.5, 18 respondents from the public sector and 2 from private

organisations hold a degree. 10 respondents holding a masters degree or above

are from public laboratories while 3 are from private laboratories. It is the policy

of the government to recruit technical officers who possess as a minimum a

diploma qualification in scientific field. Holders of HSC qualification or below

were the ones from private laboratories. Those laboratories stated that the nature

of the tests do not require high skilled labour.

45

4.3 Section B- Descriptive Statistics

To summarise data gathered, the most commonly used statistics: mean, mode and

bar charts have been computed to analyse statements of both surveys.

4.3.1 Survey1- Part B: Potential Obstacles during Implementation of

ISO/IEC 17025

Table 4.6: Potential barriers during implementation of ISO/IEC 17025

Statements Mean Mode*

(B1) Choice of accreditation body 4.13 4

(B2) Unavailability of consultancy services 3.63 3

(B3) Lack of qualified staff 4.38 5

(B4) Unavailability of training facilities/needs 3.25 4

(B5) Unavailability of suppliers of calibrated instruments and equipment

2.50 2

(B6) Lack of accredited metrology laboratories for calibration of equipment

2.25 2

(B7) Unavailability of proficiency testing providers/Ease of finding another laboratory for inter-laboratory comparison

2.25 2

(B8) Bureaucratic procedures 2.25 2

(B9) Time consuming process 2.25 2

(B10) Cost associated with consultancy services 3.63 3

(B11) Cost associated with training 2.13 2

(B12) Cost associated with calibrated equipment 2.25 2 (*, 1=Strongly agree; 2=Agree; 3=Neutral; 4=Disagree; 5=Strongly disagree)

Note: (i) Mean score represents the average of respondents’ answer to each

statement on the likert scale. (ii) Mode is the likert scale that came out most often for each

statement.

46

12.525 25

12.5 12.5 12.525

37.5

12.5 12.5 12.5

25

37.550

62.5 62.5 62.5

12.5

62.525

37.5

12.5 12.5 12.5

37.5

25

50

25

25

50

37.525

12.5 12.5 12.5

25

37.525

62.5

12.525

12.5 12.5

0%

20%

40%

60%

80%

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Strongly Disagree

Disagree

Neutral

Agree

Strongly Agree

Figure 4.3: Potential barriers during implementation of ISO/IEC 17025

47

It is observed from Table 4.6 that statements B1, B2, B3, B4 and B10 are not

considered as obstacles for the accredited laboratories as their mean scores are

above 3.00. This indicates that respondents disagreed to the above mentioned

statements.

Figure 4.3 clearly indicates that 50% of the respondent disagreed and 37.5 %

strongly disagreed to B1. Table 4.1 shows that out of eight laboratories surveyed,

seven were accredited by MAURITAS as it is the sole accreditation body in

Mauritius. Only Lab5 was accredited by SWEDAC in year 2005. Lab5 stated

that SWEDAC is an internationally recognised accreditation body. A noteworthy

remark is that MAURITAS was not yet operational at that time.

37.5% was neutral, 25% disagreed and 25% strongly disagreed to B2 and B10 as

there are significant private companies providing services in the field of quality

management system. It is also worth pointing out that the eight laboratories are

sole providers of testing services in their field. Moreover, they have the required

expertise which is confirmed by 62.5% of respondents who strongly disagreed

and 25% disagreed to B3.

As required by ISO/IEC 17025, staff should be properly trained to work

according to this standard. All respondents provide in-house training to

laboratory personnel to conduct tests according to procedures. As stated by

respondents, on-going training is provided to their staff in the field of

accreditation. This is why 50% disagreed and 12.5% strongly disagreed to B4.

It is not surprising that B5 and B6 each yielded a mode value of ‘2’. In fact,

respondents expressed their concerns that it is difficult to obtain calibration

certificates from suppliers on purchase of equipment. There are only two

metrology laboratories providing calibration services in Mauritius, and they are

not yet accredited to ISO/IEC 17025. This can be considered as potential

hindrance to testing laboratories in their quest to accreditation.

B7, B8, and B9 have generated a mode value of ‘2’ implying that respondents are

agreeable to these statements. During implementation, 62.5% of respondents

48

confessed that proficiency/inter laboratory testing scheme is non-existent in their

field in Mauritius. They had to seek such services abroad, which bore hefty cost.

The implementation of IS0/IEC 17025 involves bureaucratic procedures and is

usually time consuming as supported in the literature review (section 2.2.5). This

fact was reflected by survey results whereby 62.5% respondents have agreed and

12.5% strongly agreed to statements B8 and B9.

As per the requirements of ISO/IEC 17025, staff training should not be focussed

on performing tests, but on other specific issues such as internal audit,

uncertainty of measurement and internal calibration controls. In addition,

equipment having validity on test results should be calibrated, hence leading to an

additional cost during implementation. This is confirmed by statements B11 and

B12 which have yielded a mode value of ‘2’. Only Lab5 (representing 12.5%)

has strongly disagreed to these statements as the Director stated that he has the

expertise to train his own staff and perform equipment calibration.

Additional difficulties faced during implementation of ISO/IEC 17025 mentioned

by respondents were:

Accreditation process from MAURITAS was lengthy.

Bureaucratic procedures in organisations restrained laboratories from

taking corrective action in a timely manner.

Laboratories claimed that they had to bear with these two above problems.

Traceability of reference materials was a major problem for Lab8 since

these reference materials were purchased when the laboratory started

operation. To overcome this particular problem, Lab8 had to send the

reference materials abroad for analysis to obtain certificates of

traceability as required by ISO/IEC 17025.

49

4.3.2 Survey1- Part C: Impact of Accreditation on Testing Laboratories

This section describes the findings of the impact of accreditation with respect to

performance, employees performing test, suppliers, cost and customer

satisfaction. It also highlights drawbacks of accreditation.

4.3.2.1 Performance

Table 4.7: Performance of laboratory

Statements Mean Mode*

(C1) Provides better control of laboratory operations 1.50 1

(C2) Improves service quality 1.75 2

(C3) Remains competitive 2.63 3

(C4) Increase in profitability 2.50 2

(C5) Enhances the organisation’s image 1.38 1

(C6) An effective marketing tool for your organisation 1.50 1

(C7) Provides a benchmark for performance against other laboratories/organisations

1.38 1

(C8) Guarantees that the laboratory performs the work correctly

1.50 1

(C9) Brings transfer of technology to your organisation 2.25 2

(C10) Increase in productivity 2.25 2

(C11) Increase in the ability to stay abreast of developments in requirements for competence and testing

1.38 1

(C12) Better utilisation of resources 2.50 2

(C13) Feedback from customer for improvement 1.75 2

(C14) Provides a recognition of testing competence to your customers

1.38 1

(*, 1=Strongly agree; 2=Agree; 3=Neutral; 4=Disagree; 5=Strongly disagree)

The results summarised in Table 4.7 show that all the mean scores are below

3.00. With exception of statement C3 which has a mode score of 3, all the other

statements yielded a mode value of ‘1’ and ‘2’. Hence, respondents were

agreeable that accreditation has a positive impact on the performance of their

laboratories. As pointed out in section 2.2.5 in the literature review, accreditation

enhances performance of an organisation.

50

75% of respondents (Appendix 6) were of no opinion to statement C3 as there are

no other similar testing service providers. Thus, the level of competition is

insignificant. It can be highlighted that from the above 75%, 50% represent

public laboratories whose main objective is to provide a better service quality to

society. It could be argued that the rationale of public laboratories implementing

ISO/IEC 17025 to improve on their service delivery predominated over their

quest of being competitive on the market. On the other hand, private laboratories

were accredited either to gain a form of testing competence or to satisfy their

customers.

Laboratory accreditation is highly regarded both nationally and internationally as

a reliable indicator of technical competence (Mukhopadhyay, 2004). This is

confirmed by 62.5% and 37.5% respondents who strongly agreed and agreed

respectively to statement C14 (Appendix 6).

4.3.2.2 Employees Performing Test

Figure 4.4: Impact of accreditation on employees performing tests

Looking at the mean and mode values in Figure 4.4, it is found that respondents

have agreed to statements C15, C16 and C17. This implies accreditation leads to

an increase in morale of staff as confirmed by section 2.2.5 in the literature

review.

51

Besides, all respondents confirmed that the staff involved in performing test was

willing to work according to ISO/IEC 17025 and the transition was successful.

4.3.2.3 Suppliers

Figure 4.5: Supplier and laboratory accreditation

As required by ISO/IEC 17025, testing laboratories shall evaluate suppliers of

critical consumables, supplies and services which affect the quality of testing and

calibration. This may lead to a closer supplier-laboratory working relationship.

To achieve deliveries only when needed, there should be mutual trust and

understanding between suppliers and purchasers. Figure 4.5 clearly shows that

the majority, that is, 62.5% respondents agreed to statement C18. However, 25%

was neutral and 12.5% disagreed to the said statement. This may be explained by

the fact that these respondents are not dependent on a particular supplier.

Moreover, it is interesting to note that 100% respondents agreed that

accreditation has helped them to better evaluate their suppliers-(C19). Evaluation

of suppliers eliminates poor suppliers. When an organisation reduces its number

of suppliers, it increases long term commitments.

52

4.3.2.4 Cost of Maintaining Accreditation

Figure 4.6: Additional costs related to accreditation

It is confirmed by all respondents that accreditation has an associated cost as

shown by statements in Figure 4.6.

Training of staff is considered by all the laboratories to be one of the major

aspects in accreditation in order to stay abreast in development in their respective

field of testing. 25% and 75% of respondents have strongly agreed and agreed

respectively to statement C20.

ISO/IEC 17025 requires that laboratories have a maintenance plan as part of the

equipment control system to ensure that calibration is done at recommended

intervals. Furthermore, when equipment has been damaged during a test, it

should be repaired. Usually, it takes time to repair the equipment and even in

some cases the equipment needs to be replaced. These lead to an additional cost

to the organisation. As shown in Figure 4.6, more than 50% of respondents or

more have agreed to statements C21, C22 and C23.

To maintain accreditation, laboratories undergo an annual evaluation by the

accreditation body. The cost of surveillance has to be borne by laboratories. This

53

is in line with the view that 62.5% of respondents agreed while 37.5 % strongly

agreed with statement C24.

Proficiency testing and inter laboratory comparison, as part of the requirement of

ISO/IEC 17025 to ensure the quality of test results, form part of the quality cost .

Accreditation bodies provide guidance on the frequency of proficiency

testing/inter laboratory comparison to laboratories. Results from proficiency

testing are an indication of a laboratory’s competence and are an integral part of

the assessment and accreditation process.

A very significant number of respondents, 62.5%, strongly agreed and 37.5%

have agreed to statement C25. This can be explained by the fact that there are no

proficiency testing providers in Mauritius and it is very difficult to find

accredited testing laboratories for inter-laboratory comparison. Typically, these

are done with accredited laboratories abroad.

In fact, as pointed out in the literature review in section 2.6.5, accreditation leads

to an increase in expenses.

4.3.2.5 Drawbacks

Figure 4.7: Drawbacks of accreditation

54

Figure 4.7 depicts that the mean score of both statements C26 and C27 is below

3.00. This implies that the majority of the respondents either strongly agreed or

agreed that accreditation leads to an increase in workload and paperwork. As per

ISO/IEC 17025, laboratories should have a proper way of maintaining records to

show evidence of traceability of work during internal audits, surveillances and

assessments. Records may be on paper and electronic media. All laboratories

surveyed kept paper records, hence an increase in paperwork and workload.

Only 25% of responses, representing two laboratories, have disagreed to

statements C26 and C27. This can be explained by the fact that they already have

proper records keeping and are working in accordance to in-house developed

procedures prior to accreditation.

4.3.2.6 Customer Focus

Figure 4.8: Impact of accreditation on customer satisfaction

12.5% of respondents strongly agreed and 37.5 % agreed to statement C29. It is

however worth pointing out that 37.5% respondents were uncertain and 12.5%

disagreed to this statement. The uncertainty and disagreement of respondents can

55

be explained by the fact that these laboratories cannot decrease the time taken to

perform tests as these tests are carried out within a minimum period of time.

It is surprising to note that 12.5% and 37.5% were neutral to C31and C32

respectively, as shown in Figure 4.8. It was expected that all respondents either

strongly agreed or agreed to both statements as the key benefits stemming from

accreditation is to facilitate trade through the acceptance of test data as pointed

out in section 2.2.5.6. This may be explained by the fact that these respondents

are unaware of their customers’ markets.

Figure 4.9: Percentage of customers requiring accredited test results

Based on question C33, with the exception of Lab8, respondents acknowledged

that their customers required accredited test data.

Figure 4.9 pictures the relative percentage of customers valuing accredited test

results for Lab1 to Lab7. A study, as pointed in the literature review, section

2.2.4.5, shows that customers favour accredited test results as they need objective

evidence that test data are delivered by an accredited laboratory.

Lab8 stated that it operates under a legal framework and is the only provider of

such services. Although there was not any demand from its customers to be

accredited, Lab8 viewed accreditation as a mean to enhance customer confidence

and satisfaction.

56

As per question C34, all respondents informed their customers that they have

been accredited to ISO/IEC 17025 by the following means:

Award ceremony

Email

Letter

Media

Website

Tender document

E-news

Table 4.8: Means of measuring customer satisfaction

How do you measure the present level of customer satisfaction?(C37) %

Online questionnaire 12.5

Survey form 62.5

Phone 50.0

Questionnaire sent to customer by post 25.0

Figure 4.8 shows that 50% of respondents strongly agreed and 37.5% agreed that

accreditation helps to measure customer satisfaction (statement C28). In fact, all

participants confirmed that they measure customer satisfaction once a year, based

on questions C35 and C36. It is worth noting that some laboratories have more

than one way of rating customer satisfaction as clearly indicated in Table 4.8. The

most popular way of measuring customer satisfaction is through ‘survey form’ as

acknowledged by 62.5% of respondents.

Accreditation helps laboratories deal with customer complaint efficiently

(statement C30) as confirmed by 87.5% of respondents and illustrated in Figure

4.9. Based on question C38, all respondents have a complaint procedure as a

requirement of ISO/IEC 17025. Furthermore, laboratories seek feedback and use

this information as an input to management review in order to improve the

management system.

With respect to question C39, the five public laboratories stated that they have

not received any complaint. Lab6 and Lab7 argued that the culture of complaint

in Mauritius is not yet well versed among customers.

57

As far as the private laboratories are concerned, Lab2 claimed that the level of

complaints has decreased since it has been accredited.

Figure 4.10: Additional services offered by respondents

ISO/IEC 17025 requires that laboratories cooperate with their customers in

clarifying the customer's request while performing tests. Ratliff (2003) stated that

laboratories should at all times deliver quality services by ensuring that staff are

aware of customers’ needs and expectations and make every effort to satisfy and

heighten customer satisfaction. Refering to question C40, all participants offer

additional services, apart from routine testing, to differentiate themselves and

better service and facilitate their customers as shown in Figure 4.10.

58

4.3.3 Part C: Section 3-Overall Satisfaction of Organisation

Figure 4.11: Opinion on overall satisfaction of respondents on accreditation

The results pictured in Figure 4.11 indicate that 62.5% respondents strongly

agreed to the statement “Accreditation has been worth the cost”. This implies that

laboratories valued accreditation despite the cost and trouble involved. A survey

conducted by ILAC in 2004 in 51 countries confirmed that out of 2130

respondents, 24.7% strongly agreed and 50.2% agreed that they valued laboratory

accreditation (McNair, n.d).

59

Figure 4.12: Employees’ opinion on accreditation

60

4.3.4 Survey 2: Employee Satisfaction

Figure 4.12 shows descriptive statistics generated from Survey2 and illustrates

the following:

18.2% strongly agreed and 59.1% agreed that accreditation enhance job

satisfaction;

65.9% agreed that accreditation provides a conducive working

environment;

47.7% agreed that they received sufficient training opportunities;

63.6% agreed that accreditation provides recognition of their work;

65.9% agreed that they contribute to achieve the quality objectives of the

organisations;

56.8% agreed that teamwork is enhanced;

54.5% agreed that they are encouraged to make suggestions to improve the

management system;

56.8% agreed that they performed laboratory work better due to availability

of information; and

the majority of respondents were proud to work in accredited laboratory

and they were more dedicated in their work.

This confirms the strong relationship between laboratory accreditation and

employee satisfaction as pointed out in section 2.2.5 in the literature review.

It is worth noting that 54.5% of respondents strongly agreed and 38.5% agreed

that accreditation involved more responsibilities as supported in section 2.2.5 in

the literature review. However, 68.1% of respondents claimed that they did not

gain more financial benefits- statement 11. It was expected that most respondents

would agree to this statement. According to Siloaho and Puhakainen (2000), the

first benefit of the quality system evaluated by the personnel was purely financial.

The PRB report (2008) stated that as from 2010, government departments which

are ISO certified would receive an additional bonus.

61

It is also worth pointing out that about 50% of respondents claimed that

accreditation has not improved the flow of communication from management-

statement 9. Furthermore, based on Question 14, the majority of respondents

commented that there is no effective communication between management and

technical cadre. ISO/IEC 17025 clearly states that top management must ensure

that appropriate communication processes should be established within the

laboratory.

62

4.4 Section C: Hypothesis Testing

Hypothesis 1

There is no association between degree of impact of accreditation to ISO/IEC

17025 and nature of laboratory.

Table 4.9: Cross tabulation-Nature of laboratory and impact of accreditation

Impact of

Accreditation Total

High

Impact

Average

Impact

Nature of

Laboratory

Public Count 3 2 5

% within Type of

Laboratory

60.0% 40.0% 100.0%

% within impact

category

50.0% 100.0% 62.5%

% of Total 37.5% 25.0% 62.5%

Private Count 3 0 3

% within Type of

Laboratory

100.0% 0.0% 100.0%

% within impact

category

50.0% 0.0% 37.5%

% of Total 37.5% 0.0% 37.5%

Total Count 6 2 8

% within Type of

Laboratory

75.0% 25.0% 100.0%

% within impact

category

100.0% 100.0% 100.0%

% of Total 75.0% 25.0% 100.0%

Table 4.9 indicates that accreditation to ISO/IEC 17025 has an impact on

laboratory operations. 60% of respondents from public laboratories and 100% of

the private laboratories agreed that accreditation has a high impact in their

organisation. This implies that accreditation has brought a significant positive

change in their processes despite an increase in workload.

63

On the other hand, 40% respondents from public laboratories claimed that there is

an average impact on implementing accreditation. These two laboratories

followed standardised procedures prior to accreditation and did not perceive a

radical change in their processes on implementation of ISO/IEC 17025.

Table 4.10:Chi-Square tests- Nature of laboratory and impact of accreditation

Value df

Asymp.

Sig. (2-

sided)

Exact Sig.

(2-sided)

Exact Sig. (1-

sided)

Pearson Chi-Square 1.600a 1 .206

Continuity Correctionb .178 1 .673

Likelihood Ratio 2.267 1 .132

Fisher's Exact Test .464 .357

Linear-by-Linear

Association

1.400 1 .237

N of Valid Cases 8

a. 4 cells (100.0%) have expected count less than 5. The minimum expected count is .75.

b. Computed only for a 2x2 table

Table 4.10 indicates that the p value under "Asymp. Sig" is 0.206 (> 5%). It can

be concluded that that there is no association between degree of impact of

accreditation to ISO/IEC 17025 and nature of laboratory. Thus, laboratories have

to follow same procedures as required by ISO/IEC 17025 irrespective of their

nature and gain similar benefits.

64

Hypothesis 2:

H02: There is no association between level of employee satisfaction and the

impact of accreditation.

Table 4.11: Cross tabulation- Impact of accreditation and level of employee satisfaction

Impact of Accreditation

Total High

Impact

Average

Impact

Level of Employee

Satisfaction

High satisfaction 24 2 26

Moderate

satisfaction

14 0 14

Low satisfaction 1 3 4

Total 39 5 44

Table 4.11 illustrates impact of accreditation and level of employee satisfaction.

The higher the impact, the more satisfied are the employees. The low employee

satisfaction may result from the lack of additional financial benefits as reported

by these respondents.

Table 4.12: Chi-Square Tests- Impact of accreditation and Level of employee satisfaction

Value df

Asymp. Sig.

(2-sided)

Pearson Chi-Square 19.179a 2 .000

Likelihood Ratio 14.601 2 .001

Linear-by-Linear

Association

3.241 1 .072

N of Valid Cases 44

a. 4 cells (66.7%) have expected count less than 5. The minimum

expected count is .45.

65

Table 4.13: Symmetric Measures- Impact of accreditation and Level of employee satisfaction

Value Approx.

Sig.

Nominal by Nominal Phi .660 .000

Cramer's V .660 .000

N of Valid Cases 44

Since p = 0.000 in Table 4.12 and less than 5% confirms the existence of an

association between employee satisfaction and impact of accreditation. Thus, the

null hypothesis is rejected.

In addition, the Cramer’s V = 0.660, as illustrated in Table 4.13, indicates that

there is a quite strong association between employee satisfaction and impact of

accreditation.

Therefore, it can be concluded that accreditation brings an improvement in

employee satisfaction.

4.5 Conclusion

This chapter described how research data were analysed and interpreted.

Statistical tools have been used to answer the research questions. The next

chapter will be focussed on the conclusion and recommendations of the study.

CHAPTER 5

CONCLUSION & RECOMMENDATIONS

67

5.1 Introduction

This chapter summarises the conclusion from the survey findings from the

various laboratories investigated and proposes recommendations. It also discusses

the extent to which this study has achieved its objectives and areas of further

research.

5.2 Conclusion

The first research objective of the study was to assess the impact of accreditation

to ISO/IEC 17025 in accredited testing laboratories in Mauritius. It is found that

the mean scores of all statements in section 4.3.2 confirms that accreditation to

ISO/IEC 17025 has a positive impact on laboratories. The performance of

laboratories has improved through better control of operations and staff working

diligently and efficiently, leading to enhanced customer satisfaction.

Furthermore, this study has shown that there was no association between degree

of impact and nature of laboratory (section 4.4). Both public and private

laboratories have reaped similar benefits from accreditation.

The second objective was to investigate whether accreditation has improved

employees’ satisfaction in testing laboratories. Results revealed that accreditation

provided better job satisfaction to employees despite no additional financial

benefit. Moreover, according to section 4.4, the higher the impact of

accreditation, the more satisfied are the employees. Thus, laboratories are

encouraged to implement ISO/IEC 17025 to improve employee satisfaction.

The third objective of this study was to identify reasons for seeking accreditation

to ISO/IEC 17025. An array of reasons have been identified (Section 4.2.1), with

the most pressing of them being the recognition of testing competence. The

benefits of accreditation extend not only to the accredited laboratories, but also to

users of these services, regulatory bodies and the general public.

The final objective of the study was to investigate potential barriers during

implementation of ISO/IEC 17025 in testing laboratories. Findings showed that

problems faced by laboratories were specific to Mauritius, such as unavailability

68

of proficiency testing scheme in their field of testing, lack of accredited

calibration services and lack of suppliers of calibrated equipment. However, it is

worth noting that staff was willing to work according to ISO/IEC 17025,

otherwise this would have been the major obstacle on implementing the

management system. Accreditation involves a cost of quality borne by the

laboratories. It can be concluded that there are no barriers as such to seek

accreditation, as the added value of accreditation far outweighs the necessary

investment in human resources, finances and time.

5.3 Recommendations

The majority of respondents complained that local providers of calibration

services are not accredited to ISO/IEC 17025. There are only two metrology

laboratories in Mauritius, namely the Mauritius Standards Bureau (MSB) and

Legal Metrology, both being government organisations. It will be in the interest

of the laboratory community for the calibration laboratories to be accredited at

the earliest. Subsequently, this will be beneficial to both accredited laboratories

and those seeking accreditation.

Respondents also pointed out that not all equipment could be calibrated locally.

The two metrology laboratories could invest in acquiring new technology and

capability for calibration of a wide range of instruments based on local laboratory

requirements. This will lead in reduction of cost calibration of equipment for

laboratories.

Another major difficulty faced by respondents was the non-existence of

proficiency testing providers. It would be advisable that MAURITAS acts as a

coordinating unit grouping the needs at the local level and acting as a focal point

for directing and assisting laboratories in their search of accredited proficiency

testing facilities at a lower cost abroad.

Most employees mentioned that there was no effective communication from

management. Communication is vital in any organisation. It helps to disseminate

information on the effectiveness of the system, on the importance of meeting

customer requirements and for continual improvement of the system.

69

Communication should be a two-way process. Constant feedback from

employees and continuous suggestions would be beneficial to the organisations.

A strong majority of employees (section 4.3.4) showed their disappointment with

regard to financial gain. Implementing ISO/IEC 17025 is not an easy task, and

laboratory personnel are actively involved. Recognition to employees’

contribution towards achieving accreditation and appropriate reward, for instance

a revision in the salary structure, would motivate further the staff. In the public

sector, head of departments could appeal to the Ministry of Civil Service and

Administrative Reforms for additional salary increment to technical staff on

successful implementation of ISO/IEC 17025 in laboratories. In private

companies, a remuneration package could be proposed on quality-based

performance.

Accreditation with MAURITAS is a lengthy process as acknowledged by

respondents. MAURITAS can urgently find ways to significantly reduce the lead

time for initial assessment of laboratories.

The current policy of MAURITAS requests accredited laboratories to perform

proficiency testing once every 4 years. In fact, most accreditation bodies abroad,

such as the American Association of Laboratory Accreditation (A2LA) and

NATA, request accredited laboratories to perform proficiency testing at least

once every two years. Reducing this time period to two years will be in the

advantage of local accredited laboratories to benchmark their technical

competence more frequently and to stay abreast in emerging technologies and

methods.

There is a lack of awareness on the benefits of using an accredited laboratory. To

promote laboratory accreditation on a national level, MAURITAS, in

collaboration with the Mauritius Quality Institute, could create awareness

campaigns to stress on the importance of the benefits of accreditation both to the

public and the industry. In addition, MAURITAS could publish an online

directory of accredited laboratories’ with their contact details. Moreover,

information on issues related to ISO/IEC 17025 could be made available on the

70

MAURITAS website- the use of internet has revealed to be the most widespread

and effective means of communication.

Before the termination of the twinning agreement with SANAS, MAURITAS

could seek full membership with ILAC hereby benefitting the local laboratory

community for easy acceptance of test data abroad. This will facilitate

international recognition of Mauritian products.

5.4 Future Work

Further research would be necessary to assess the views of laboratories’

customers on the value of accreditation. An analysis of customer satisfaction

could demonstrate the success of accredited laboratories.

This study focussed on the impact of accreditation to ISO/IEC 17025 on testing

laboratories in Mauritius. A larger sample population, including calibration

laboratories, could be surveyed in the future for an in-depth analysis of the

associated cost of accreditation.

BIBLIOGRAPHY

72

American Association of Laboratory Accreditation (A2LA), 2008. R 103- general requirements: proficiency testing for ISO/IEC 17025 laboratories [online]. April 2008. Available from: http://www.proficiency.org/Portals/0/A2LAAcred.pdf [Accessed on 10 January 2009]

Blaxter, L. Hughes, C. & Tight, M., 2006. How to research. 3rd ed. Berkshire, England: Open University Press.

Budoo, B. A., 2008. Standardization and conformity assessment-Mauritius case study [online]. Available from:

http://www.intracen.org/wedf/ef2001/fpsqammauritius.htm [Accessed on 28 February 2009]

Canadian Association for Environmental Analytical Laboratories, 2002. 2001 – Study performance and accreditation, laboratory accreditation: proof of performance [online]. Canada. Available from:

http://www.cala.ca/perfacred-2001.pdf [Accessed on 22 January 2009]

Churchill, G. A. Jr., 1995. Marketing research: methodological foundations. 6th ed. Chicago: The Dryden Press.

Dawson, C., 2002. Practical research methods: a user-friendly guide to mastering research techniques and projects. Oxford, England: How To Books.

European Commission (EC), 2008. Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing regulation (EEC) No 339/93 [online]. Official Journal of European Union, July 2008. Brussels. Available from:

http://www.european-accreditation.org/content/ea/docs/regulation.pdf [Accessed 29 December 2008]

Friesen, D. M. & Dodson, S., 2007. Implementing an ISO/IEC 17025 quality system in a commercial EMC test laboratory environment. Conformity [online]. 2007. Available from:

http://www.conformity.com/artman/publish/printer_195.shtml [Accessed on 22 January 2009]

Garside, J. H. & Gilmour, J. A., 1981. Developments in Australia and New Zealand laboratory evaluation criteria. In: H. Shocks, ed. 1983. Evaluation and accreditation of inspection and test activities, ASTM STP 814. American Society for Testing and Materials, pp. 170-179.

Gladhill, R. L., 1989. Advantages of laboratory accreditation. In: H. E. Schock, Jr., ed. 1989. Accreditation practices for inspections, tests and laboratories,

73

ASTM STP 1057. American Society for Testing Materials, Philadelphia, pp. 19-23.

Grachanen, C. L., 2008. So your laboratory is accredited - now what? Cal Lab, The International Journal of Metrology [online]. January, February and March 2008. 15 (1). pp 38-41. Available from:

http://www.callabmag.com/mdownloads/Jan08.pdf [Accessed on 28 February 2009]

Gravel, J. E. J., 2006. Understanding ISO/IEC 17025. Lab Manager [online]. April-May 2006, 1 (1), pp. 27-28. Available from:

http://www.labmanager.com/archives/labmanager20060405-dl.pdf [Accessed 18 February 2009]

Guasch, J. L., Racine, J-L., Sánchez, I. & Diop, M., 2007. Quality Systems and Standards for a Competitive Edge [online].Washington DC: The World Bank. Available from:

http://siteresources.worldbank.org/EXTEXPCOMNET/Resources/2463593-1213887855468/69_LAC_Quality_and_Standards_Pub_Nov_2007.pdf [Accessed on 01 April 2009]

Hacham, H. & Sheinman, R. 2003. The contribution of the accreditation process to public administration: promotion of vital organizational changes. Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement. [Online] 8 (6). Abstract Only. Available at SpringerLink

http://www.springerlink.com/content/lld8829urk982qq9/ [Accessed on 18 February 2009]

Halevy, A. 2004. The benefits calibration and testing laboratories may gain from ISO/IEC 17025 accreditation. Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement. [Online] 9 (1-2). Abstract Only. Available at SpringerLink

http://www.springerlink.com/content/n9b2qgdv7xe74ce3/ [Accessed 18 February 2009]

Heizer, J. & Render, B., 2007. Principles of Operations Management. 7th ed. Prentice Hall.

Holmgren, M. 2004. The view of laboratories’ clients on the value of accreditation. Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement. [Online] 9 (1-2). Abstract Only. Available at SpringerLink

http://www.springerlink.com/content/k0el6c1wjqak516f/?p=bb5de2f03fb44c80aae46dec9b82bdf0&pi=14 [Accessed 18 February 2009]

74

ILAC. n.d. The advantages of being an accredited laboratory [online]. Australia. Available from:

http://www.ilac.org/documents/Bro_english/the_advantages_of_being.pdf [Accessed on 25 October 2008]

ILAC. 2001. Why become an accredited laboratory? [online]. Australia. Available from:

http://www.ilac.org/documents/Bro_english/why_become_an_accred_lab.pdf [Accessed on 25 October 2008]

ILAC. 2001. Why use an accredited laboratory? [online]. Australia. Available from:

http://www.ilac.org/documents/Bro_english/why_use_an_accredited_lab.pdf [Accessed on 25 October 2008]

ILAC. 2008. How does using an accredited laboratory benefit government and regulators? [online]. Australia. Available from:

http://www.ilac.org/documents/Bro_english/How_does_using_benefit.pdf [Accessed on 25 October 2008]

ILAC, 2009. About ILAC [online]. Available from:

http://www.ilac.org/aboutilac.html [Accessed on 05 January 2009]

ILAC, 2009. Facts and figures [online]. Available from:

http://www.ilac.org/facts_fig.html [Accessed on 05 January 2009]

ILAC, 2009. ILAC’s role [online]. Available from:

http://www.ilac.org/role.html [accessed on 05 January 2009]

International Electrotechnical Commission, 2004. Inside the IEC information [online]. Geneva, Switzerland. Available from:

http://www.iec.ch/news_centre/onlinepubs/pdf/insideiec04_e.pdf [Accessed on 10 January 2009]

International Electrotechnical Commission, 2008. Conformity assessment for developing countries [online]. Geneva, Switzerland. Available from:

http://www.iec.ch/affiliates/pdf/ca_guide_ed3_en.pdf [Accessed 10 January 2009]

International Laboratory Accreditation Cooperation, 2004. ILAC Laboratory Survey on Conversion to ISO/IEC 17025 [online]. Available from:

75

http://www.cala.ca/ia_ILAC_survey_report.pdf [Accessed on 10 January 2009]

International Laboratory Accreditation Cooperation, 2005. ILAC-P9:2005, ILAC Policy for Participation in National and International Proficiency Testing Activities [online]. Rhodes, NSW, Australia. Available from:

http://www.ilac.org/documents/pub_Ilac-p9.pdf [Accessed on 10 January 2009]

International Laboratory Accreditation Cooperation (ILAC), 2007. The ILAC Mutual Recognition Arrangement [online]. Australia. Available from:

http://www.ilac.org/documents/Bro_english/ILAC_Mut_Rec_Arr_jun_2007.pdf [Accessed 25 October 2008]

International Organization for Standardization, 2004. ISO/IEC 17000, Conformity assessment-vocabulary and general principles. Geneva, ISO.

International Organization for Standardization, 2005. ISO/IEC 17025- General requirements for the competence of testing and calibration laboratories. Geneva, ISO.

International Organization for Standardization, 2008. Fast forward, national standard bodies in developing countries [online]. Geneva, Switzerland. Available from:

http://www.unido.org/fileadmin/ext_media/Publications/documents/fast_forward.pdf [Accessed 03 February 2009]

International Organization for Standardization (ISO), 2009. About ISO [online]. Available from:

http://www.iso.org/iso/about.htm [Accessed on 01 April 2009]

Malhotra, N. K., 2004. Marketing research- an applied orientation. 4th ed. India. Pearson Education.

MAURITAS, n.d. Mauritius Accreditation Service (MAURITAS) [online]. Available from:

http://www.gov.mu/portal/site/industry-site/menuitem.02db28c6296cfd4db3347524e2b521ca/ [Accessed on 28 October 2008]

McNair, B., n.d. ILAC laboratory survey on conversion to ISO/IEC 17025: a report on behalf of the ILAC Laboratory Committee [online]. Available from:

http://www.cala.ca/ia_ILAC_survey_report.pdf [Accessed on 22 January 2009]

76

Mukhopadhyay, R., 2004. An overview of laboratory accreditation. Rubber World [online]. October 2004. Available from:

http://www.thefreelibrary.com/_/print/PrintArticle.aspx?id=123572954 [Accessed on 10 January 2009]

National Accreditation Board for Testing and Calibration Services (NABL), n.d. About NABL laboratory accreditation [online]. Available from:

http://www.nabl-india.org/nabl/html/about-lab-acc.asp [Accessed on 28 February 2009]

NATA, 2008. Proficiency testing guide for the laboratories [online]. Available from: http://www.nata.asn.au/index.cfm?objectid=DBCABA6C-B07C-AD52-0EB6E2E877F61885&productId=B00F76B4-13D4-B1F1-48FFA4F0227EEF14 [Accessed on 10 January 2009]

Pay Research Bureau (PRB). 2003. Review of pay and grading structures and conditions of service in the public sector and private secondary schools. Volume 1. General background & related issues and conditions of service. Government Printing. May 2003. Mauritius

Pay Research Bureau (PRB). 2008. Review of pay and grading structures and conditions of service in the public sector and private secondary schools. Volume 1. General background & related issues and conditions of service. Government Printing. May 2008. Mauritius

Productivity Commission, 2006. Standard setting and laboratory accreditation [online]. Research Report, Canberra, November. Available from:

http://www.pc.gov.au/__data/assets/pdf_file/0012/11325/standards.pdf [Accessed 03 February 2009]

Ramani, C. P. & Nelson, D. S., 2008. The effect of accreditation on international trade. Building Safety Journal [online]. October-November 2008, pp 36-40. Available from:

http://www.iasonline.org/More/Oct-Nov08_BSJ-Accreditation.pdf [Accessed on 01 April 2009]

Ratliff, T. A., 2003. The laboratory quality assurance system: a manual of quality procedures and forms. 3rd ed. New York: John Wiley and Sons.

Robinson, M. R. & Valentine, C. D., 2001. Accreditation and Harmonization. In: D. C. Singer, ed. 2001. A Laboratory Quality Handbook of Best Practices and Relevant Regulations. American Society for Quality. Ch 13.

Saunders, M., Lewis, P. & Thornhill, A.,2003. Research methods for business students. 3rd ed. Harlow: Prentice Hall.

77

Siloaho, M. & Puhakainen, E., 2000. Implementation of a quality system in a clinical laboratory – evaluation of quality indicators. Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement. [Online] 5 (5). Abstract Only. Available at SpringerLink

http://www.springerlink.com/content/nyl7pqn0naaq58jw/?p=bfdc3834b45541108db5c5fc31577a8f&pi=3 [Accessed on 18 February 2009]

Squirrell, A., 2008. Conformity assessment: providing confidence in testing and calibration. Accreditation and Quality Assurance. June 2008, 13, pp 543-546.

Stanger, D. H., 1988. Evaluation of accreditation systems and their demands on the independent testing laboratories. In: H. E. Schock, Jr., ed. 1989. Accreditation practices for inspections, tests and laboratories, ASTM STP 1057. American Society for Testing Materials, Philadelphia, pp. 78-84.

Sukon, K., 2008. SPSS Lectures. Lecture notes in the unit MGT 6015Y, University of Mauritius, 09 March 2009.

Szewieczeka, D., Karkoszkaa, T., & Zającb, A., 2009. Analysis of the clients’ satisfaction in the accredited laboratory. Journal of Achievements in Materials and Manufacturing Engineering [online]. July 2009, 35(1), pp 95-102. Available from: http://www.journalamme.org/papers_vol35_1/35112 [Accessed on 15 July 2009]

The Mauritius Accreditation Service Act 1998. (c 8). Port Louis: Government Printing

Unger, P., 2006. One test, one accreditation- accepted everywhere. Lab Manager [online]. December 2006, 1(5), pp. 21-23. Available from:

http://www.labmanager.com/archives/labmanager200612-dl.pdf [Accessed 18 February 2009]

Unger, P., 2008. Conformity assessment and accreditation: their role in the global market. Conformity [online]. October 2008, pp. 34-37. Available from:

http://www.conformity.com/PDFs/0810/0810_F3.pdf [Accessed 22 February 2009]

Unger, P., 2009. The ILAC Arrangement: facilitating trade. Conformity [online]. February 2009, pp. 24-29. Available from:

http://conformity.com/PDFs/0902/0902_F2.pdf [Accessed 22 February 2009]

United Nations Industrial Development Organizations (UNIDO), 2003. Laboratory accreditation in developing economies, tested once- accepted everywhere, Working Paper No. 2. Vienna: UNIDO.

78

van de Leemput, P. J. H. A. M., 2000. ISO/IEC 17025 : 1999 – The new Standard for Laboratories. Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement. [Online] 9 (5). Abstract Only. Available at SpringerLink

http://www.springerlink.com/content/l27f1wuc5mxj8bkh/ [Accessed on 22 February 2009]

Verstraete, A., van Boeckel, E., Thys, M. & Engelen, F., 1998. Attitude of

laboratory personnel towards accreditation. International Journal of Health Care

Quality Assurance. [Online] 22 (5). Abstract Only. Available at Emerald

http://www.emeraldinsight.com/Insight/viewContentItem.do?contentType=Articl

e&contentId=840998 [Accessed on 22 February 2009]

Vlachos, N., Michail, C. & Sotiropoulou, D., 2002. Is ISO/IEC 17025 accreditation a benefit or hindrance to testing laboratories? The Greece experience. Journal of Food Composition and Analysis. [Online] 15 (6). Abstract Only Available at ScienceDirect

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WJH-47C3FXC-G&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=940320384&_rerunOrigin=scholar.google&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=471e6a19d4801cd67f574ab2cd3bf51f [Accessed on 22 February 2009]

Walsh, M. C., 1999. Revision of ISO Guide 25. Accreditation and Quality Assurance [online]. August 1999, 4(8), pp. 365-368. Available from:

http://www.springerlink.com/content/7464mlf3aykhtdp9/fulltext.pdf [Accessed 29 October 2008]

Wiegers, A. L., 2002. The age of competence: an update on the international laboratory accreditation scene for veterinary testing laboratories. Journal of Veterinary Diagnostic Investigation [online]. 14 (2). pp. 89-96. Available from:

http://jvdi.highwire.org/cgi/reprint/14/2/89 [Accessed on 28 February 2009]

Wilson, S. & Weir G. 1995. Food and drink laboratory accreditation: a practical approach. London: Springer.

World Bank, 1994. Technical assistance to enhance competitiveness project [online]. Africa Regional Office, World Bank. Available from:

http://www-wds.worldbank.org/external/default/WDSContentServer/WDSP/IB/1994/05/02/0

79

00009265_3961005222028/Rendered/PDF/multi0page.pdf [Accessed 28 February 2009]

World Health Organization, 2009. Toxicological and health aspects of melamine and cyanuric acid: report of a WHO expert meeting in collaboration with FAO, supported by Health Canada [online]. Ottawa, Canada, 1–4 December 2008. Available from:

http://whqlibdoc.who.int/publications/2009/9789241597951_eng.pdf [Accessed on 14 March 2009]

World Trade Organization, n.d. Agreement on technical barriers to trade [online]. Available from:

http://ec.europa.eu/enterprise/tbt/tbt_repository/Libdoc_1_EN.pdf [Accessed on 05 February 2009]

World Trade Organization, n.d. Technical Information on Technical barriers to trade [online]. Available from:

http://www.wto.org/english/tratop_e/tbt_e/tbt_info_e.htm [Accessed on 05 February 2009]

APPENDICES

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Appendix 1- Clauses of ISO/IEC 17025

Management Requirements

Organization

Management System

Document Control

Review of requests, tenders and

contracts

Subcontracting of tests and

calibrations

Purchasing services and supplies

Service to the customer

Complaints

Control of non-conforming

testing and/or calibration work

Improvement

Corrective action

Preventive action

Control of records

Internal audits

Management reviews

Technical Requirements

General

Personnel

Accommodation and

environmental conditions

Test and calibration methods

and method validation

Equipment

Measurement traceability

Sampling

Handling of test and calibration

items

Assuring the quality of test and

calibration results

Reporting the results

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Appendix 2- Clauses of ISO/IEC 17025 requiring procedures

Document Control

Review of requests, tenders and contracts

Purchasing services and supplies

Complaints

Control of nonconforming work

Corrective action

Preventive action

Control of records

Internal audits

Management reviews

Test and calibration methods and method validation

Maintenance of equipment

Measurement traceability

Sampling

Handling of tests and calibration items

Assuring the quality of test results

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Appendix 3- Accreditation services offered by MAURITAS

Field of Testing

Acoustics

Biology

Chemical

Construction and materials

Electrical

Environment

Food

Forensic

Mechanical

Medical

Non-Destructive Testing

Occupational

Textiles and garments

Veterinary

Field of Calibration

Acoustics

Dimensional calibration

Electrical calibration

Flow

Force/hardness

Humidity

Mass

Pressure

Thermal calibration

Time and frequency

Temperature

Viscosity

Volume

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Appendix 4- Survey1

Dear Sir/Madam,

As part of my MBA programme with the University of Mauritius, I am currently

conducting a research project on “The Impact of Accreditation to ISO/IEC

17025 in accredited testing laboratories in Mauritius”

I would be grateful if you kindly fill in the questionnaire below. Please rest

assured that all information gathered during the survey will be treated in

confidence.

Thanking you for your valuable participation.

Shehroze Ramjun (Ms)

--------------------------------------------------------------------------------------------------

PART A- ACCREDITATION

A1. In which year is your laboratory accredited to ISO/IEC 17025? ________

A2. In which field of testing are your laboratory accredited? (More than one

answer allowed)

Acoustics Biology

Chemical Construction and materials

Electrical Environment

Food Forensic

Mechanical Textile and garments

Any other, please specify ________________________________

A3. Why has your laboratory sought accreditation?

___________________________________________________________

___________________________________________________________

___________________________________________________________

A4. From which accreditation body is your laboratory accredited? ____________

A5. Why have you chosen this accreditation body? (More than one answer allowed)

Cost effective

Speed of delivery

Any other, please specify ________________________________

85

A6. Was the laboratory staff willing to work according to ISO/IEC 17025?

Yes No

If no, why?

___________________________________________________________

___________________________________________________________

PART B- POTENTIAL BARRIERS DURING IMPLEMENTATION OF

ISO/IEC 17025

To what extent do you agree to the following difficulties faced during the

implementation of ISO/IEC 17025 in your laboratory? (Tick as appropriate)

Str

ongl

y A

gree

1

Agr

ee2

Neu

tral

3

Dis

agre

e4

Str

ongl

y D

isag

ree5

Barriers

B1 Choice of accreditation body

B2 Unavailability of consultancy services

B3 Lack of qualified staff

B4 Unavailability of training facilities/needs

B5 Unavailability of suppliers of calibrated instruments and equipment

B6 Lack of accredited metrology laboratories for calibration of equipment

B7 Unavailability of proficiency testing providers/ Ease of finding another laboratory for inter- laboratory comparison

B8 Bureaucratic procedures

B9 Time consuming process

B10 Cost associated with consultancy services

B11 Cost associated with training

B12 Cost associated with calibrated equipment

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B13. Any other problem encountered during implementation of ISO/IEC 17025

which is not mentioned above?

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

B14. How did you deal with them?

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

PART C- IMPACT OF ACCREDITATION TO ISO/IEC 17025 ON YOUR

LABORATORY

Note: This part is divided into two sections 1 and 2. Section 1 is on the changes to your

organisation, and Section 2 on Customer Focus.

Section 1- Changes to your organisation

To what extent do you agree that being an accredited laboratory brings the

following changes to your organisation? (Tick as appropriate)

Str

ongl

y A

gree

1

Agr

ee2

Neu

tral

3

Dis

agre

e4

Str

ongl

y D

isag

ree5

Performance

C1 Provides better control of laboratory operations

C2 Improves service quality

C3 Remains competitive

C4 Increase in profitability

C5 Enhances the organisation’s image

C6 An effective marketing tool for your organisation

C7 Provides a benchmark for performance against other laboratories/organisations

C8 Guarantees that the laboratory performs the work correctly

C9 Brings transfer of technology to your organisation

87

Str

ongl

y A

gree

1

Agr

ee2

Neu

tral

3

Dis

agre

e4

Str

ongl

y D

isag

ree5

Performance

C10 Increase in productivity

C11 Increase in the ability to stay abreast of developments in requirements for competence and testing

C12 Better utilisation of resources

C13 Feedback from customer for improvement

C14 Provides a recognition of testing competence to your customers

Employees performing tests

C15 Imposes a discipline on laboratory staff to maintain the standard of accreditation

C16 Increase in personnel confidence performing tests

C17 Fewer errors from laboratory staff

Suppliers

C18 Brings a closer working relationship with your suppliers

C19 Better evaluation of suppliers

Additional Cost

C20 Training of staff

C21 Maintenance & calibration of equipment

C22 Purchase of new equipment

C23 Time to repair equipment

C24 Surveillance by accreditation body

C25 Inter-laboratory and proficiency testing scheme

Drawbacks

C26 Increase in paperwork

C27 Increase in workload

88

Section 2- Customer Focus

Str

ongl

y A

gree

1

Agr

ee2

Neu

tral

3

Dis

agre

e4

Str

ongl

y D

isag

ree5

Customer Satisfaction

C28 Helps to measure customer satisfaction

C29 Reduction in your service delivery time

C30 Deals with customer complaints efficiently

C31 Enable customer to reduce the cost as accreditation eliminates the need for retesting products

C32 Helps customers to enjoy greater access of their products in both domestic and international markets

C33. Do your customers require accredited tests results?

Yes No

If Yes, Percentage of customers requiring accredited test results _______

If No, why? __________________________________________________

C34. Have you informed the customer that your laboratory is accredited to

ISO/IEC 17025?

Yes No

If yes, how was it done? __________________________

C35. Does your laboratory have a mean to measure customer satisfaction?

Yes No

C36. What is the frequency of measuring customer satisfaction?

______________________________________________________________

C37. How do you measure the level of customer satisfaction? (More than on answer

allowed)

Online questionnaire

89

Customer survey form on laboratory’s premises

Phone

Questionnaire sent to customer by post

Or any other means _______________________________________

C38. Do you have a complaint procedure?

Yes No

C39. How do you rate the level of complaint in your organisation since you have

been accredited?

Decrease Increase Remain the same

C40. What additional services is your laboratory providing to your customers

apart from testing? (More than one answer allowed)

Witnessing of test

Advice and guide in technical matters and opinions and interpretations

based on results

Informing customers for any delays or major deviations in the

performance of test

Preparation, packaging, and dispatch of test and/or calibration items

needed by the customer for verification purposes

Please specify any other ____________________________________

_________________________________________________________________

Any Comments: ___________________________________________________

_________________________________________________________________

_________________________________________________________________

Section 3- Overall Satisfaction of your organisation

Str

ongl

y A

gree

1

Agr

ee2

Neu

tral

3

Dis

agre

e4

Str

ongl

y D

isag

ree5

(i) Accreditation has been worth the cost

90

PART D- GENERAL INFORMATION

D1. Name of Organisation ___________________________________________

D2. Nature of Laboratory: Public Private

D3. How many years is the laboratory in operation? _______________________

D4. How many persons are involved in performing tests? ___________________

End of Questionnaire

Thanking you for your precious time in completing the questionnaire

91

Appendix 5- Survey2

Dear Sir/Madam,

As part of my MBA programme with the University of Mauritius, I am currently

conducting a research project on “The Impact of Accreditation to ISO/IEC

17025 in accredited testing laboratories in Mauritius”.

I would be grateful if you kindly fill in the questionnaire below on satisfaction of

technical staff performing tests. Please rest assured that all information gathered

during the survey will be treated in confidence.

Thanking you for your valuable participation.

Shehroze Ramjun (Ms)

EMPLOYEE SATISFACTION

Accreditation has brought changes to your way of work. To what extent do you

agree to the following? (Tick as appropriate)

Str

ongl

y A

gree

1

Agr

ee 2

Neu

tral

3

Dis

agre

e 4

Str

ongl

y D

isag

ree

5

1. Better job satisfaction

2. Accreditation provides a conducive environment

3. Sufficient opportunities to receive training to improve skills

4. Recognition of your work

5. Contribution to achieve the quality objectives of your organisation

6. Accreditation enhances teamwork

7. You are encouraged to make suggestions

8. Availability of information to perform laboratory work, better working instructions and better knowledge of testing methods and equipment

9. Better flow of communication from management

10. Proud to work in an accredited laboratory using internationally recognised test method

11. Gain more financial benefits

92

Str

ongl

y A

gree

1

Agr

ee 2

Neu

tral

3

Dis

agre

e 4

Str

ongl

y D

isag

ree

5

12. More dedication in performing your work

13. More responsibilities

14. Any comments /suggestions/improvement regarding the management system in your laboratory?

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

15. Personal characteristics:

(a)How long have you been working for your organisation? __________

(b) Highest qualification held:

Below SC

SC/GCE ‘O’ Level

HSC/GCE ‘A’ Level

Diploma

Degree

Master’s Degree & above

End of Questionnaire

Thanking you for your precious time in completing the questionnaire

93

Appendix 6- Frequency Table of Impact of Accreditation on

Performance of the Laboratory

Str

ongl

y A

gree

1

Agr

ee2

Neu

tral

3

Dis

agre

e4

Str

ongl

y D

isag

ree5

Performance

C1 Provides better control of laboratory operations 50 50 - - -

C2 Improves service quality 25 75 - - -

C3 Remains competitive 12.5 12.5 75

C4 Increase in profitability 12.5 37.5 37.5 12.5 -

C5 Enhances the organisation’s image 62.5 37.5 - - -

C6 An effective marketing tool for your organisation 50 50 - - -

C7 Provides a benchmark for performance against other laboratories/organisations

62.5 37.5 - - -

C8 Guarantees that the laboratory performs the work correctly 50 50 - - -

C9 Brings transfer of technology to your organisation - 75 25 - -

C10 Increase in productivity - 75 25 - -

C11 Increase in the ability to stay abreast of developments in requirements for competence and testing

62.5 37.5 - - -

C12 Better utilisation of resources - 50 50 - -

C13 Feedback from customer for improvement 37.5 50 12.5 - -

C14 Provides a recognition of testing competence to your customers 62.5 37.5 - - -