Compliance to ISO 9001

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Taste is a Matter of Choice; butTaste is a Matter of Choice; butQuality is a Matter of FactQuality is a Matter of Fact

Complying to ISO 9001Complying to ISO 9001

Quality management systemsQuality management systems ± ± RequirementsRequirementsby Pradip V. Mehta, P.E.by Pradip V. Mehta, P.E.Fellow, American Society for QualityFellow, American Society for Quality





ISO 9001:2008ISO 9001:2008

Quality management systemsQuality management systems -- RequirementsRequirements




ISO 9000 StandardsISO 9000 Standards -- Based onBased on

Eight Management PrinciplesEight Management Principles Customer FocusCustomer Focus

LeadershipLeadership

Involvement of PeopleInvolvement of People Process ApproachProcess Approach

Systems Approach to ManagementSystems Approach to Management

Continual ImprovementContinual Improvement

Factual Approach to Decision MakingFactual Approach to Decision Making

Mutually Beneficial Supplier RelationshipsMutually Beneficial Supplier Relationships




Quality Management PrincipleQuality Management Principle

A quality management principle is a A quality management principle is a

fundamental rule or belief for leading andfundamental rule or belief for leading and

operating an organization.operating an organization. The eight quality management principlesThe eight quality management principles

addressed in the new standard are primarilyaddressed in the new standard are primarily

aimed at continually improving performanceaimed at continually improving performance

over the long term by focusing on internalover the long term by focusing on internal

and external customers.and external customers.




1 Customer 1 Customer--FocusedFocused

OrganizationOrganization

Strives to understand current and futureStrives to understand current and future

customer needs, meet customer customer needs, meet customer requirements, and exceed customer requirements, and exceed customer

expectations.expectations.



Taste is a Matter of Choice; butTaste is a Matter of Choice; but

Quality is a Matter of FactQuality is a Matter of Fact

³Exceed your customers¶ expectations.³Exceed your customers¶ expectations.If you do, they¶ll come back over and over.If you do, they¶ll come back over and over.

Let them know you appreciate them.´Let them know you appreciate them.´

Sam WaltonSam Walton

Wal Mart Founder Wal Mart Founder





2 Leadership2 Leadership

Leaders establish unity of purpose andLeaders establish unity of purpose and

direction within the organization to createdirection within the organization to createand maintain an internal environment inand maintain an internal environment in

which people can become fully involved inwhich people can become fully involved in

achieving the organization's objectives.achieving the organization's objectives.





3 Involvement of People3 Involvement of People

People are the most important asset of anPeople are the most important asset of an

organization. Their full involvement enablesorganization. Their full involvement enables

their abilities to be utilized for mutual benefit.their abilities to be utilized for mutual benefit.





4 Process Approach4 Process Approach

A desired result is achieved more effectively A desired result is achieved more effectively

when activities and related resources arewhen activities and related resources aremanaged as a process.managed as a process.





Process ApproachProcess Approach





4 Process Approach4 Process Approach

You have achieved process approach whenYou have achieved process approach when

Processes are basis for management review, internalProcesses are basis for management review, internal

audits, general meetings, results monitoring, andaudits, general meetings, results monitoring, andforecastingforecasting

Internal customer concept is establishedInternal customer concept is established

There is teamwork and open communicationThere is teamwork and open communication

There is self There is self--sustaining continual improvementsustaining continual improvement

Operating efficiency goes up and costs go downOperating efficiency goes up and costs go down





5 System Approach to5 System Approach to

ManagementManagement

Identifying, understanding and managingIdentifying, understanding and managing

interrelated processes as a system tointerrelated processes as a system toachieve given objectives.achieve given objectives.





6 Continual Improvement6 Continual Improvement

Continual improvement of the organization¶sContinual improvement of the organization¶s

performance should be a permanentperformance should be a permanentobjective of the organization.objective of the organization.





7 Factual Approach to Decision7 Factual Approach to Decision

MakingMaking

Management by fact. Effective decisionsManagement by fact. Effective decisions

are based on an analysis of data andare based on an analysis of data andinformation.information.





8 Mutually Beneficial Supplier 8 Mutually Beneficial Supplier

RelationshipsRelationships

An organization and its suppliers are An organization and its suppliers are

interdependent, and a mutually beneficialinterdependent, and a mutually beneficialrelationship enhances the ability of both torelationship enhances the ability of both to

create value.create value.





Model for a Process BasedModel for a Process Based

Quality Management SystemQuality Management System

Customer

RequirementsCustomer

Satisfaction

ProductProduct

Realization

Measurement,

Analysis, and

Improvement

Management

Responsibility

Resource

Management

Continual Improvement of the

quality management system





RequirementsRequirements

Quality management systemQuality management system

Management responsibilityManagement responsibility

Resource managementResource management

Product realizationProduct realization

Measurement, analysis and improvementMeasurement, analysis and improvement





4 Quality Management System4 Quality Management System

4.1 General4.1 General

4.2 Documentation4.2 Documentation





Sample Process ChartSample Process Chart

Determinecustomer re uirements

Quote job &take order

Schedule work

Purchase

supplies &materials

Receive &verifymaterials

Manufactureproduct

Inspect&test

Package,label, andstore

Shipproduct

Customer satisfaction





Sample ProcessesSample Processes






4.1 General4.1 General

4.2 Documentation4.2 Documentation






Quality policy (clause 5.3)Quality policy (clause 5.3)

Quality objectives (sub clause 5.4.1)Quality objectives (sub clause 5.4.1)

Quality manual (sub clause 4.2.2)Quality manual (sub clause 4.2.2)





Advantages of Quality Manual Advantages of Quality Manual Educate employees about the structure of the quality managementEducate employees about the structure of the quality management

system, its processes, and its broad intentionssystem, its processes, and its broad intentions

Define the system for third party registrarsDefine the system for third party registrars

Provide an initial basis for internal and external auditingProvide an initial basis for internal and external auditing

Instill confidence in existing customers by indicating the organization¶sInstill confidence in existing customers by indicating the organization¶scommitment to continual improvement and customer satisfactioncommitment to continual improvement and customer satisfaction

Provide top management with a starting point for strategic planning andProvide top management with a starting point for strategic planning and

the development of key measuresthe development of key measures

Guide middle managers in the development of functional/departmentalGuide middle managers in the development of functional/departmental

systems and proceduressystems and procedures

Provide a road map to lower Provide a road map to lower--level documents within the systemlevel documents within the system

Sell the organization to potential customers by revealing theSell the organization to potential customers by revealing the

organization¶s advantages over competitorsorganization¶s advantages over competitors






Document control (sub clause 4.2.3)

Record control (sub clause 4.2.4)

Internal audit (sub clause 8.2.2) Control of non-conforming product (clause 8.3)

Corrective action (sub clause 8.5.2)

Preventive action (sub clause 8.5.3)





Simple Rules for DocumentationSimple Rules for Documentation

A written procedure is not necessary for every process.

Don¶t write a procedure for the sake of writing one. Learn and

understand when a procedure is required.

Don¶t write a procedure around how you want to do a process or thinka process should be done. The procedure should reflect what you

actually do.

Create the documentation in a format that makes most sense to the

people using the document. Don¶t be afraid to use pictures and videos,

and don¶t be afraid to call them ³training materials.´ Appearance and formatting are not important. It¶s content that matters.

(Kelly, 2009)





Examples of Scope & ExclusionExamples of Scope & Exclusion

The scope of the XYZ, Inc.¶s quality management systemThe scope of the XYZ, Inc.¶s quality management systemincludes sales, manufacture, testing & inspection,includes sales, manufacture, testing & inspection,warehousing, and servicing of all clothing produced at thewarehousing, and servicing of all clothing produced at the

______ plant in ______. ______ plant in ______.

Design & development has been excluded from the qualityDesign & development has been excluded from the qualitymanagement system because those activities do not takemanagement system because those activities do not takeplace at XYZ, Inc. All product designs are received directlyplace at XYZ, Inc. All product designs are received directly

from customers in the form of sketches, markers andfrom customers in the form of sketches, markers andspecifications.specifications.





5 Management Responsibility5 Management Responsibility

5.1 Management Commitment5.1 Management Commitment

5.2 Customer Focus5.2 Customer Focus

5.3 Quality Policy5.3 Quality Policy

5.4 Planning5.4 Planning

5.5 Responsibility, authority and5.5 Responsibility, authority and

communicationcommunication






5.1 Management Commitment5.1 Management Commitment EmpowermentEmpowerment

Contingent RewardContingent Reward

CharismaCharisma Intellectual StimulationIntellectual Stimulation

ManagementManagement--ByBy--ExceptionException







EmpowermentEmpowerment

+ Providing subordinates with sufficient training to achieve goals+ Providing subordinates with sufficient training to achieve goals

+ Providing subordinates with sufficient resources to achieve goals+ Providing subordinates with sufficient resources to achieve goals

+ Supporting the professional growth of employees+ Supporting the professional growth of employees

+ Sharing information with employees+ Sharing information with employees

+ Enabling employees+ Enabling employees

+ Ensuring good working environment+ Ensuring good working environment

+ Clearly explaining what is expected from employees+ Clearly explaining what is expected from employees







Contingent RewardContingent Reward

Clarifying what is expected from followers andClarifying what is expected from followers and

what they will receive if meet expectations.what they will receive if meet expectations.







CharismaCharisma

Inspiring followers and providing them with a clear Inspiring followers and providing them with a clear

sense of purpose, being a role model for ethicalsense of purpose, being a role model for ethicalconduct, building identification with the leader andconduct, building identification with the leader and

his vision.his vision.







Intellectual StimulationIntellectual Stimulation

Getting employees to question the tried ways of Getting employees to question the tried ways of

solving problems and encouraging them tosolving problems and encouraging them toquestion the methods they use.question the methods they use.







ManagementManagement--ByBy--ExceptionException

Monitoring task execution and any problems thatMonitoring task execution and any problems thatmight arise and correcting those problems tomight arise and correcting those problems to

maintain current performance.maintain current performance.






5.2 Customer Focus5.2 Customer Focus





5 Management Responsibility5 Management Responsibility5.3 Quality Policy5.3 Quality Policy

PolicyPolicy ± ± A guide to managerial action. A guide to managerial action.

Quality PolicyQuality Policy ± ± Overall intentions andOverall intentions anddirections of an organization related todirections of an organization related to

quality as formally expressed by topquality as formally expressed by top

management.management.---- ISO 9000ISO 9000





Ann Taylor Ann Taylor Quality PolicyQuality Policy

We are committed to meeting evolving needs of We are committed to meeting evolving needs of

women who want feminine, stylish and versatilewomen who want feminine, stylish and versatile

fashions that are of great quality and value and thatfashions that are of great quality and value and that

inspire women to look as beautiful as they feel.inspire women to look as beautiful as they feel.





Prakash Steelage Ltd.Prakash Steelage Ltd.Quality PolicyQuality Policy

Endeavour to enhance customer Endeavour to enhance customer

satisfaction through supply of technologicallysatisfaction through supply of technologically

advanced and cost effectiveadvanced and cost effective

quality productsquality products





Texas Instruments (TI)Texas Instruments (TI)

Quality PolicyQuality Policy

We will achieve business excellence byWe will achieve business excellence by

Encouraging and expecting the creative involvement of Encouraging and expecting the creative involvement of every Tier every Tier

Listening to our customers and meeting their needsListening to our customers and meeting their needs

Continuously improving our processes, products, andContinuously improving our processes, products, and

servicesservices





5 Management Responsibility5 Management Responsibility5.4 Planning5.4 Planning

Quality PlanQuality Plan -- A document or a set of A document or a set of

documents that describe the standards,documents that describe the standards,

quality practices, resources and processesquality practices, resources and processespertinent to a specific product, service or pertinent to a specific product, service or

project.project.





5 Management Responsibility5 Management Responsibility5.45.4 PlanningPlanning

Identify the customers, both external and internal.Identify the customers, both external and internal.

Determine customer needs.Determine customer needs.

Develop specifications that meet customer needs.Develop specifications that meet customer needs.

Establish quality goals that meet customer needs and doEstablish quality goals that meet customer needs and doso at a minimum cost.so at a minimum cost.

Develop a process that can meet the needs of theDevelop a process that can meet the needs of the

customers.customers.

Prove process capabilityProve process capability ± ± prove that the process can meetprove that the process can meetquality goals under operating conditions.quality goals under operating conditions.





5 Management Responsibility5 Management Responsibility5.4 Planning5.4 Planning -- Quality GoalsQuality Goals

Reduce customer returns by 5 % per year Reduce customer returns by 5 % per year

(25 % over five years). Annual targets are(25 % over five years). Annual targets are

established for each product line.established for each product line.

Reduce internal scrap (as measured inReduce internal scrap (as measured in

cost/unit) by 10 % from the previous year.cost/unit) by 10 % from the previous year.

Ensure 100 % adherence to the ISO qualityEnsure 100 % adherence to the ISO quality

system audit program.system audit program.






5.5 Responsibility, authority and5.5 Responsibility, authority and

communicationcommunication





6 Resource Management6 Resource Management

6.1 Provision of Resources6.1 Provision of Resources

6.2 Human Resources6.2 Human Resources

6.3 Infrastructure6.3 Infrastructure

6.4 Work Environment6.4 Work Environment





7 Product Realization7 Product Realization

7.1 Planning of Product Realization7.1 Planning of Product Realization

7.2 Customer 7.2 Customer--related Processesrelated Processes

7.3 Design and Development7.3 Design and Development 7.4 Purchasing7.4 Purchasing

7.5 Production and Service Provision7.5 Production and Service Provision

7.6 Control of Measuring and Monitoring Devices7.6 Control of Measuring and Monitoring Devices





8 Measurement, Analysis &8 Measurement, Analysis &

ImprovementImprovement

8.1 General Requirements8.1 General Requirements

8.2 Monitoring & Measurement8.2 Monitoring & Measurement

8.3 Control of Non8.3 Control of Non--Conforming ProductConforming Product

8.4 Analysis of Data8.4 Analysis of Data

8.5 Improvement8.5 Improvement





Compliance to ISO 9001Compliance to ISO 9001

Transition from ISO 9001:2000 to ISO 9001:2008 isTransition from ISO 9001:2000 to ISO 9001:2008 is

An opportunity to improve Quality Management System An opportunity to improve Quality Management Systemthrough a better understanding of the requirements.through a better understanding of the requirements.





Complying to ISO 9001Complying to ISO 90012000 Version2000 Version6.2 Human Resources6.2 Human Resources

6.2.1 Personnel performing work affecting product6.2.1 Personnel performing work affecting product qualityquality shall be competent onshall be competent onthe basis of appropriate education, training, skills and experience.the basis of appropriate education, training, skills and experience.

2008 Version2008 Version

6.2 Human Resources6.2 Human Resources

6.2.1 Personnel performing work affecting6.2.1 Personnel performing work affecting conformityconformity to productto product requirementrequirementshall be competent on the basis of appropriate education, training, skillsshall be competent on the basis of appropriate education, training, skillsand experience.and experience.

Note: Conformity to product requirements can be affected directly or indirectly byNote: Conformity to product requirements can be affected directly or indirectly bypersonnel performing any task within the quality management system.personnel performing any task within the quality management system.






ISO 9001:2000 sometimes used the term ³regulatory´ISO 9001:2000 sometimes used the term ³regulatory´

requirements. This has been consistently changed torequirements. This has been consistently changed to³statutory and regulatory´ requirements.³statutory and regulatory´ requirements.





Transition GuidelineTransition Guideline

One year after publication of ISO 9001:2008One year after publication of ISO 9001:2008

all accredited certifications issued (newall accredited certifications issued (new

certifications or recertifications or re--certifications) must be tocertifications) must be toISO 9001:2008.ISO 9001:2008.

Two years after publication by ISO, any existingTwo years after publication by ISO, any existing

certifications issued to ISO 9001:2000 will notcertifications issued to ISO 9001:2000 will notbe valid.be valid.





Transition from ISO 9001:2000 toTransition from ISO 9001:2000 to

ISO 9001:2008ISO 9001:2008

Get acquainted with the new edition of the standard. Use Annex BGet acquainted with the new edition of the standard. Use Annex Bin ISO 9001:2008 to facilitate identification of the clarifications.in ISO 9001:2008 to facilitate identification of the clarifications.

Was your former interpretation of ISO 9001:2000 different from theWas your former interpretation of ISO 9001:2000 different from the

clarifications provided by ISO 9001:2008?clarifications provided by ISO 9001:2008? If not, communicate to both internal and external parties theIf not, communicate to both internal and external parties the

conclusion and results of your implementation of ISO 9001:2008conclusion and results of your implementation of ISO 9001:2008

If yes, determine the impact of the clarifications of the new versionIf yes, determine the impact of the clarifications of the new versionon your current use of ISO 9001 and plan any necessary remedialon your current use of ISO 9001 and plan any necessary remedialactions.actions.

Verify your remedial actionsVerify your remedial actions





Typical Reasons for NonTypical Reasons for Non--compliancecompliance

Can not explain system and/or documentationCan not explain system and/or documentation

Lack of management involvementLack of management involvement

Poor communication and/or trainingPoor communication and/or training

Personnel not following documentationPersonnel not following documentation

Lack of documentationLack of documentation

No or inadequate document controlNo or inadequate document control

Poor record keepingPoor record keeping





Questions to Ask RegistrarsQuestions to Ask Registrars Who is the accrediting authority?Who is the accrediting authority?

How long has the registrar been in business?How long has the registrar been in business?

How many audits/certifications have they done in your How many audits/certifications have they done in your

industry?industry?

What are registrar¶s requirements for auditor What are registrar¶s requirements for auditor

qualifications?qualifications?

How many organization has the typical auditor How many organization has the typical auditor

certified?certified?

How many auditors does the registrar have?How many auditors does the registrar have?

What is the turn over rate for auditors in the registrar¶sWhat is the turn over rate for auditors in the registrar¶s

company?company?





Questions to Ask RegistrarsQuestions to Ask Registrars

How are auditor substitution handled?How are auditor substitution handled?

Does the registrar provide training for auditors?Does the registrar provide training for auditors?

Will the registrar make the lead auditor available for anWill the registrar make the lead auditor available for aninterview for you to assess his/her suitability?interview for you to assess his/her suitability?

Are the auditors full time employees of the registrar or Are the auditors full time employees of the registrar or

on contract?on contract?

Will your company have the same lead auditor for everyWill your company have the same lead auditor for everyaudit?audit?






How far in advance will they notify you of an impendingHow far in advance will they notify you of an impending

audit?audit?

What quality system does the registrar have in place?What quality system does the registrar have in place? Will they provide you with their internal audit scheduleWill they provide you with their internal audit schedule

and results of audit and corrective and preventiveand results of audit and corrective and preventive

actions?actions?

How long will it take them to issue a certificate onceHow long will it take them to issue a certificate once

they have recommended you for certification?they have recommended you for certification?






How long does it take their office to respond toHow long does it take their office to respond to

questions? If it becomes necessary to speak with thequestions? If it becomes necessary to speak with the

lead auditor, how is that done and how soon after thelead auditor, how is that done and how soon after the

request will the lead auditor contact you?request will the lead auditor contact you?

Is there a complete reIs there a complete re--audit every three years or doaudit every three years or do

they audit on a continuous basis?they audit on a continuous basis?

How frequently are surveillance audits conducted andHow frequently are surveillance audits conducted and

how much is covered in each audit?how much is covered in each audit?






How shall we be notified of nonHow shall we be notified of non--conformances or conformances or

deficiencies?deficiencies?

What is the typical response time allowed for initialWhat is the typical response time allowed for initialresponse to a nonresponse to a non--conformance identified during anconformance identified during an

audit ?audit ?

Will a nonWill a non--conformance during the initial assessmentconformance during the initial assessment

require a partial or follow up assessment to verifyrequire a partial or follow up assessment to verify

corrective action? If yes, what shall be the cost of followcorrective action? If yes, what shall be the cost of followup audits be?up audits be?






How are disputes with an audit finding handled? Ask

them to explain their system. Request a copy of their

procedure.

How does the registrar ensure consistency of

interpretations within their company?

If you will one day be going for ISO 14000 or SA 8000,

does the registrar support these standards as well? Will

the registrar able to combine all these audits?






Ask the registrar to explain the details of their billing. Ask the registrar to explain the details of their billing.

When you get a copy of the registrar¶s contract, read itWhen you get a copy of the registrar¶s contract, read it

very carefully and try to imagine worst possiblevery carefully and try to imagine worst possiblescenario.scenario.

³XXXX reserves the right to increase charges during the certification³XXXX reserves the right to increase charges during the certification

period´period´

³approximately 45 days prior to the anniversary date of certificate³approximately 45 days prior to the anniversary date of certificate

issuance, XXXX shall notify the client in writing of the annual cost toissuance, XXXX shall notify the client in writing of the annual cost to

maintain the certificate´maintain the certificate´





Compliance EssentialsCompliance Essentials

You can not give someone responsibility without

publicly conferring authority to act.

If top management does not care, no one else will.

If planned meetings are not attended, someone is not

serious about their part in compliance.

Track the compliance publicly. Publicize status

regularly.





Compliance EssentialsCompliance Essentials

Communicate, communicate, communicate

If people do not have time to begin with, they will not have time for compliance.

Must complete at least one full internal audit prior to registrationaudit. Show at least one example of where a nonconformance wasidentified and corrected. Verify the effectiveness of the correctiveaction.

Use internal audit as a method of training departmental managersand others. As you go through the audit, you explain the basics of

that person¶s responsibility with respect to ISO 9001.





Accreditation in India Accreditation in India

NABCB

Registrars

Assessors





Publicizing ISO 9001:2000Publicizing ISO 9001:2000

RegistrationRegistration ISO 9001:2008 and certification marks of ISO 9001:2008 and certification marks of

conformity should not appear on products,conformity should not appear on products,

product labels or product packaging, or inproduct labels or product packaging, or in

any way that might be interpreted asany way that might be interpreted as

denoting product conformity.denoting product conformity.





Publicizing ISO 9001:2000Publicizing ISO 9001:2000

RegistrationRegistration ³The management system governing the³The management system governing the

manufacture of this product is ISO 9001:2008manufacture of this product is ISO 9001:2008

certified.´certified.´

³The management system governing the provision³The management system governing the provisionof this service is ISO 9001:2008 certified.´of this service is ISO 9001:2008 certified.´

³ISO 9001:2008 certified quality management³ISO 9001:2008 certified quality management

system.´system.´

³ISO 9001:2008 Quality Management System.´³ISO 9001:2008 Quality Management System.´

³ISO 9001:2008 certified processes.´³ISO 9001:2008 certified processes.´





Benefits of ISO 9001 RegistrationBenefits of ISO 9001 Registration

A Spanish fashion house called Roberto Verino A Spanish fashion house called Roberto Verino

received such positive results from its ISO 9000received such positive results from its ISO 9000

implementation that the company has published aimplementation that the company has published a

book in Spanish entitled ³Quality as a Strategy:book in Spanish entitled ³Quality as a Strategy:

Experience of Roberto Verino.´Experience of Roberto Verino.´

(IMS 2002)(IMS 2002)





Questions?Questions?

??




ReferencesReferences

Cochran, Craig. 2008.Cochran, Craig. 2008. ISO 9001 in Plain EnglishISO 9001 in Plain English..

Paton Professional;Paton Professional; www.patonprofessional.comwww.patonprofessional.com

Cianfrani, Charles A., Tsiakals, Joseph T. and West, John E.Cianfrani, Charles A., Tsiakals, Joseph T. and West, John E.

³Jack.´ 2009.³Jack.´ 2009. ISO 9001:2008 Explained.ISO 9001:2008 Explained. Quality Press, AmericanQuality Press, AmericanSociety for Quality.Society for Quality.

Kelly, Bretta. 2009. ISO 9001 Documentation Is Like a Box of Kelly, Bretta. 2009. ISO 9001 Documentation Is Like a Box of Chocolates. Quality Digest. February.Chocolates. Quality Digest. February.www.qualitydigest.com/print/7434www.qualitydigest.com/print/7434 (Accessed on 2 Sept. 2009)(Accessed on 2 Sept. 2009)

Hunt, Lorri., Robitaille, Denise., Williams, Craig. 2008. TheHunt, Lorri., Robitaille, Denise., Williams, Craig. 2008. The

Insider¶s Guide to ISO 9001:2008. Quality Digest. October.Insider¶s Guide to ISO 9001:2008. Quality Digest. October.www.qualitydigest.com/print/4488www.qualitydigest.com/print/4488 (Accessed on 2 Sept. 2009)(Accessed on 2 Sept. 2009)

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