Quality Standards Mö/3.6.2002 Folie 1 Quality Management Certification and Accreditation ICEL...

Quality StandardsMö/3.6.2002

Folie 1Quality Management Certification and Accreditation

ICEL

Quality Standards Application:

Quality Management Certification and Accreditation

Karl Heinrich MöllerGaertnerstr. 29

D-82194 GroebenzellTel: +49(8142)570144Fax: +49(8142)570145

Email: [email protected]



ICEL

Topics

• Definitions

• History of the ISO 9000 Family

• Compatibility of Management Standards (Quality, Environment, Safety, etc.)

• Process Orientation

• The 4 Main Standards of the Year 2000 Revision

• Documentation Requirements

• Accreditation



ICEL

DefinitionsPart 1

• Conformity (EN 45 020; 12.1):Fulfilment by a product, process or service of specified needs

• Conformity assessment (EN 45 020; 12.2):Any activity concerned with determining directly or indirectly that relevant requirements are fulfilled (see product and quality management certification, accreditation, etc.)

• Conformity evaluation (EN 45 020; 14.1):Systematic examination of the extent to which a product, process or service fulfils specified requirements (better, worse, see awards)



ICEL

DefinitionsPart 2

• Certificate of conformity (EN 45 020; 15.5):Document issued under the rules of a certification system, providing confidence that a duly identified product, process or service is in conformity with a specific standard or other normative document

• Suppliers declaration (EN 45 020; 15.1.1):Procedure by which a supplier gives written assurance (confidence) that a product, process or service conforms to specified requirements



ICEL

DefinitionsPart 3

• Certification (EN 45 020; 15.1.2):Procedure by which a third party gives written assurance (confidence) that a product, process or service conforms to specified requirements

• Accreditation (EN 45 020; 12.11):Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks



ICEL

Development of Quality Management Standards

• First Release 1987 (ISO 9001,2,3 und 9004)– In the language to construct big Power Plants, Traffic Projects etc.

– Guidance Documents for Software (1991), Processed Material (1993) und Services (1991)

– First Standards for Tools (ISO 10011: Audits, ISO 10012: Measurement equipment)

• First Revision 1994 (development, software, services)– Standards for industry sectors (medical equipment, Automotive, etc.)

– Additional standards for tools

• Second Revision 2000 (all Industry sectors)– Applicable for hardware, software, processed material und services; small companies

– Process oriented

– Several guidance document no longer needed.



ICEL

Standards for Management SystemsDifferent Groups of Standards

• Group 1: Standards Derived from ISO 9001– Medical equipment– ISO TR 16 949 (based on ISO 9001:1994)– ISO TR 16 949 (based on ISO 9001:2000, in preparation)– QS-9000 (Chrysler, Ford und GM)– VDA 6.1 (Verband der Automobilindustrie) different structure– TL 9000 (Quality Excellence for Suppliers of Telecommunication Equipment– AS 9000 (Aviation Industry)

• Group 2: Different Management System Standards– Quality Management Systems (ISO/TC 176; ISO 9001)– Environmental Management Systems (ISO/TC 207; ISO 14001)– Security Management Systems (BS 7799)

• Group 3: Guidance Documents– Road haulage, warehouse management– Environmental Management Systems – Maintenance Management



ICEL

Standards for Management SystemsTo Deal with Different Management Systems

•How to bring the different management systems together

– One management system standard (rejected)– Compatible standards for Quality, Environment, safety, etc.

•Goal: Compatible standards – Identical structure– Common nucleus– Partly identical text – Special addenda's for Quality, Environment, safety, etc.



ICELImprove Compatibility between Quality Management and Environmental Management

• Improve compatibility between ISO 9001 und ISO 14001, as well as ISO 9004 und ISO 14004

– Release of ISO 9001 und ISO 9004 in 2000

– Release ISO14001 und ISO 14004 not yet scheduled

• Combine the audit standards ISO 10011 und ISO 14 010 – 14 012 to a single Standard ISO 19 011



ICEL

Common Requirements for all Management Standards

• Management responsibility– Policy

– Management responsibility

• Objectives – Objectives and purpose of the

management system

– Planning

– Interfaces between quality, environment, etc.

• Management – Responsibilities

– Authorities

– Structure of the managementdocumentation

• Documentation and Communication – Description of the management system

– Documents

– Records

– Engagement of employees

• Control– Results (processes, products)

– Reviews/Audits

– Analysis

– Non conformities/corrections

• Process management– Process definitions

– Improvement processes



ICEL

Structure of ISO 9001 and ISO 9004Quality Elements versus Processes

•Structure follows quality elements – Quality management system documentation is only for quality

professionals

– Employees read procedure descriptions

•Structure follows Processes– Quality management system documentation is read by

employees

•New structure of the standard: Process oriented



ICEL

Structure of ISO 9001:2000Process definition

Controlling processes

supporting processes

cust

omerprocess

value addingactivities

Input

specifications, requirements,expectations

Output

product, fulfilment of needs

cust

omer

, m

arke

t, s

ocie

ty

Improvement processes



ICEL

Structure of ISO 9001:2000 Subdivision of processes

Input


Output


Process


Input


Output


Process


Input


Output


Process


Input


Output


Process


Input


Output


Process




ICEL

Structure of ISO 9001:2000 Examples for processes

• Controlling processes – Definition and improvement of policy

– Definition and improvement of objectives

– etc.

• Supporting processes – Performing internal audits

– Measuring and assessing of processes, inputs and outputs

– etc.

• Requirements of customers, markets and society– Definition and refinement of customer requirements

– Definition and refinement of market expectations

– etc.



ICEL

ISO 9001 Family Product Line for the Year 2000

• 9000:2000 (formerly ISO 8402)Concepts and Terminology

• 9001:2000 Quality Management Systems; Requirements In order to provide confidence as a result of demonstration...

• 9004:2000 Quality Management Systems; Guidance for performance

improvements Achieve benefits for all stakeholder groups

• 19011:2002Guidelines for quality and/or environmental management systems

auditing



ICEL

ISO 9001:2000Documentation Requirements 1

• ISO 9001:2000: The organization must have at least “documented procedures” for the following six activities:

– 4.2.3 Control of documents

– 4.2.4 Control of records

– 8.2.2 Internal audit

– 8.3 Control of nonconforming product

– 8.5.2 Corrective action

– 8.5.3 Preventive action



ICEL

ISO 9001:2000Documentation Requirements 2

• The only documents specifically mentioned in ISO 9001:2000 are:

– Quality policy (clause 4.2.1.a)

– Quality objectives (clause 4.2.1.a)

– Quality manual (clause 4.2.1.b)



ICEL

ISO 9001:2000Records required by ISO 9001:2000

5.6.1 Management reviews 6.2.2 (e) Education, training, skills and experience7.1 (d) Evidence that the realization processes and resulting product fulfil requirements7.2.2 Results of the review of requirements related to the product and actions

arising from the review7.3.2 Design and development inputs relating to product requirements7.3.4 Results of design and development reviews and any necessary actions7.3.5 Results of design and development verification and any necessary actions7.3.6 Results of design and development validation and any necessary actions7.3.7 Results of the review of design and development changes and any

necessary actions7.4.1 Results of supplier evaluations and any necessary actions arising from the

evaluations7.5.2 (d) As required by the organization to demonstrate the validation of processes

where the resulting output cannot be verified by subsequent monitoring or measurement



ICEL

ISO 9001:2000Records required by ISO 9001:2000

7.5.3 The unique identification of the product, where traceability is a requirement7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable

for use7.6 (a) Basis used for calibration or verification of measuring equipment where no

international or national measurement standards exist7.6 Validity of the previous measuring results when the measuring equipment is

found not to conform to requirements7.6 Results of calibration and verification of measuring equipment8.2.2 Internal audit results and follow-up actions8.2.4 Indication of the person(s) authorizing release of product. 8.3 Nature of the product nonconformities and any subsequent actions taken,

including concessions obtained8.5.2 Results of corrective action 8.5.3 Results of preventive action



ICEL

Conformity Assessmentand Accreditation

with accreditation

Level of assessment differs- Requirements for certification body- Requirements for supplier

Level of assessment always the same- Requirements for certification body- Requirements for supplier

certif. body certif. body certif. body

Accredit.

supplier same levelsame level

Accredit.

mutual recognition

Level of assessment

certification body

supplier supplier

certification body

without accreditation

certification body

supplier

supplier

supplier



ICELEuropean Co-operation for Accreditation (EA)Multilateral Agreement (Signatories until May 2001)

Calibration ; testing ; products quality systems and personnel certification

Calibration ; testing ; products andquality systems certification

Calibration ; testing

Calibration ; testing ; quality systems certification

Calibration ; testing ; products certification

Non signatories

Environnemental management systems certification



ICEL

Effort of Conformity AssessmentSeveral Suppliers with an Unique Quality System

employees Initial assessment

auditor days

Initial assessment

auditor days

annual surveillance

auditor days

annual surveillance

auditor days

re-assessment

auditor days

re-assessment

auditor days

total on-site total on-site total on-site

less than 5 2 1 1 0.5 1.5 1

5 - 9 2.5 1.5 1 0.5 1.5 1

10 -19 3 2 1 1 2 1

20 -29 4 2.5 1.5 1 3 2

30 - 59 6 4.5 2 1 4 2.5

60 - 100 7 5 2 1.5 4 3

100 - 250 8 6 2.5 2 5 3

250 - 500 10 7 3 2 6 4.5

500 - 1000 12 9 4 3 8 5.5

1000 - 2000 15 12 5 4 10 6.5



ICEL

Effort of Conformity AssessmentsSeveral Suppliers with an Unique Quality System

number of suppliers random sample random sampleFirst and Re Audit annual

1 - 3 1 14 - 8 2 2

9 - 15 3 316 - 25 5 426 - 50 7 5

51 - 100 10 6101 - 150 13 8151 - 200 16 10

>200 >20 >12



ICEL

ISO 9001:2000 ImplementationQuestions

• Management requirement

• Structure of the documentation

• Preparation of the documentation

• Implementation of the documentation

• Selection of the certification body

• Agreement with the certification body

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