Oct 2008 -IsO 9001-2008-9 Standard by Asim Baig

8/8/2019 Oct 2008 -IsO 9001-2008-9 Standard by Asim Baig

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1010thth October 2008October 2008 ISO 9001:2008ISO 9001:2008 11

ISO 9001: 2008

Clock Ticking on ISO 9001 Users

Be Ready For The New Version

DISCLAIMERWhile minimal change is expected to the standard during the next commentperiod, the contents of the DIS are subject to change and should not be used in any contractual

or legally binding agreements.

Welcome To The Program


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About MEQMPAbout MEQMP(Share, Exchange & Learn)(Share, Exchange & Learn)Formed in April 2005Formed in April 2005

To gather Quality Management ProfessionalsTo gather Quality Management Professionals

More than 1250 members from Middle East includingMore than 1250 members from Middle East includingUAE, Kuwait, Qatar, Saudi Arabia, Bahrain, Oman, Iran,UAE, Kuwait, Qatar, Saudi Arabia, Bahrain, Oman, Iran,

Iraq, Jordan, Pakistan and IndiaIraq, Jordan, Pakistan and India

Network of Consultants, Trainers, Auditors, Managers orNetwork of Consultants, Trainers, Auditors, Managers orCoordinatorsCoordinators

Programs for different management issues like Quality,Programs for different management issues like Quality,Environment, H & S and Knowledge managementEnvironment, H & S and Knowledge management


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AchievementsAchievementsConducted courses for IRCA accredited LeadConducted courses for IRCA accredited Lead

Auditor Course for different ManagementAuditor Course for different Management

SystemsSystems

Six Sigma AwarenessSix Sigma Awareness

UK accredited Six Sigma Green BeltUK accredited Six Sigma Green Belt

UK accredited Online Six Sigma Green BeltUK accredited Online Six Sigma Green Belt

Contact:Contact: www.meqmp.comwww.meqmp.com

http://groups.yahoo.com/group/meqmphttp://groups.yahoo.com/group/meqmpEmail:Email: [email protected]@meqmp.com


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About the presentationAbout the presentation

ISO standards an introductionISO standards an introduction

Change processChange process

Reasons for the amendmentReasons for the amendment

Scope of the amendmentScope of the amendmentClauseClause--byby--clause review of changesclause review of changes

Timetable of next stepsTimetable of next stepsMigration processMigration process


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ISO standards an introductionISO standards an introductionWhat is ISO?What is ISO?

170 countries170 countries

More than 17000 standardsMore than 17000 standards

Central office in Geneva, SwitzerlandCentral office in Geneva, Switzerland

More than 1 Million certification for ISO 9001: 2000More than 1 Million certification for ISO 9001: 2000

Who pays for ISO?Who pays for ISO?

ISO's national membersISO's national members according to country's GNP and trade figuresaccording to country's GNP and trade figures

Sale of standardsSale of standards

Can anyone join ISO?Can anyone join ISO?

Not as individuals or as enterprises National standards institutNot as individuals or as enterprises National standards institutes Fulles Fullmembers each have one votemembers each have one vote


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Who runs ISO?Who runs ISO?

President (For two years)

ISO Council (BOD)Meet twice a year

General secretary (Permanent position)

ISO Members Total 170(Participating 80 and observing 21 )


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Participating & ObservingParticipating & Observing

CountriesCountries

Participating CountriesParticipating Countries

Algeria ( IANOR )Algeria ( IANOR )

Iran ( ISIRI )Iran ( ISIRI )

Iraq ( COSQC )Iraq ( COSQC )

Jordan ( JISM )Jordan ( JISM )Kuwait ( KOWSMD )Kuwait ( KOWSMD )

Lebanon ( LIBNOR )Lebanon ( LIBNOR )

Libya ( LNCSM )Libya ( LNCSM )Oman ( DGSM )Oman ( DGSM )

Qatar ( QS )Qatar ( QS )

Turkey ( TSE )Turkey ( TSE )

Observing CountriesObserving Countries

Palestine ( PSI )Palestine ( PSI )

Syria ( SASMO )Syria ( SASMO )

Yemen ( YSMO )Yemen ( YSMO )


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ISO StandardsISO Standards

Over 17000 International StandardsOver 17000 International Standards

1100 new ISO standards are published every year1100 new ISO standards are published every year

AutomotiveAutomotive ISO/TS 16949:2002ISO/TS 16949:2002EducationEducation IWA 2:2007IWA 2:2007

EnergyEnergy PC 242, ISO 50001PC 242, ISO 50001

Food safetyFood safety ISO 22000:2005ISO 22000:2005

Information securityInformation security ISO/IEC 27001:2005ISO/IEC 27001:2005

Medical devicesMedical devices ISO 13485:2003ISO 13485:2003

Petroleum and gasPetroleum and gas ISO 29001:2003ISO 29001:2003

Supply chain securitySupply chain security ISO 28000:2007ISO 28000:2007


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Technical CommitteesTechnical CommitteesTotal 245Total 245

JTC 1JTC 1InformationInformationtechnologytechnology

TC 11TC 11Boilers andBoilers and

pressure vesselspressure vesselsTC 17TC 17SteelSteel

TC 44TC 44Welding and alliedWelding and alliedprocessesprocesses

TC 85TC 85Nuclear energyNuclear energy

TC 86TC 86Refrigeration andRefrigeration andairair--conditioningconditioning

TC 127TC 127EarthEarth--movingmovingmachinerymachinery

TC 162TC 162Doors andDoors and

windowswindowsTC 176TC 176QualityQualitymanagement and qualitymanagement and qualityassuranceassurance

TC 207TC 207EnvironmentalEnvironmentalmanagementmanagement


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TC 176TC 176

TC 176TC 176 -- Quality management and qualityQuality management and quality

assuranceassurance

SubcommitteesSubcommittees

TC 176/SC 1TC 176/SC 1 Concepts and terminologyConcepts and terminologyTC 176/SC 2TC 176/SC 2 Quality systemsQuality systems

TC 176/SC 3TC 176/SC 3 Supporting technologiesSupporting technologies


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TC 176 (Total 18)TC 176 (Total 18)ISO 9000:2005ISO 9000:2005Quality management systemsQuality management systems ----

Fundamentals and vocabularyFundamentals and vocabularyISO 9001:2000ISO 9001:2000Quality management systemsQuality management systemsRequirementsRequirements

ISO 9004:2000ISO 9004:2000Quality management systemsQuality management systems ----

Guidelines for performanceGuidelines for performanceimprovementsimprovements

ISO 10002:2004ISO 10002:2004Quality managementQuality management ---- CustomerCustomersatisfactionsatisfaction ---- Guidelines forGuidelines forcomplaints handling incomplaints handling in

organizationsorganizationsISO 10006:2003ISO 10006:2003Quality management systemsQuality management systems ----Guidelines for qualityGuidelines for qualitymanagement in projectsmanagement in projects

ISO 10012:2003ISO 10012:2003Measurement managementMeasurement management

systemssystems ---- Requirements forRequirements formeasurement processes andmeasurement processes andmeasuring equipmentmeasuring equipment

ISO/TR 10013:2001ISO/TR 10013:2001Guidelines for qualityGuidelines for qualitymanagement systemmanagement system

documentationdocumentationISO/TS 16949:2002ISO/TS 16949:2002Quality management systemsQuality management systems ----Particular requirements for theParticular requirements for theapplication of ISO 9001:2000 forapplication of ISO 9001:2000 forautomotive production andautomotive production and

relevant service part organizationsrelevant service part organizationsISO 19011:2002ISO 19011:2002Guidelines for quality and/orGuidelines for quality and/orenvironmental managementenvironmental managementsystems auditingsystems auditing


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ExampleExampleA large chemical processing companyA large chemical processing company was required by its majorwas required by its majorcustomers to gain certification tocustomers to gain certification to ISO 9001ISO 9001 and to beand to be

environmentally friendly. To address these issues, the companyenvironmentally friendly. To address these issues, the companyleadership planned a comprehensive management strategy linkingleadership planned a comprehensive management strategy linkingtheir QMS and an environmental management system (EMS). Atheir QMS and an environmental management system (EMS). Athorough review of their business processes indicated that allthorough review of their business processes indicated that allelements of ISO 9001 were applicable to their quality managementelements of ISO 9001 were applicable to their quality managementsystem and the Annex in ISO 9001 provided the information neededsystem and the Annex in ISO 9001 provided the information neededto effectively link it to theto effectively link it to the ISO 14001ISO 14001 EMS standard. The companyEMS standard. The companyusedused ISO/TR 10013ISO/TR 10013 to guide the development of the requiredto guide the development of the requireddocumentation in its various production divisions,documentation in its various production divisions, ISO 10015ISO 10015 forforguidance in the preparation of training plans for their employeeguidance in the preparation of training plans for their employees ands andISO 19011ISO 19011 for auditing both the QMS and EMS. Managementfor auditing both the QMS and EMS. Management

achieved additional benefits and continual improvements using ISachieved additional benefits and continual improvements using ISOO9000 and ISO 9004.9000 and ISO 9004.


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Process ModelProcess Model


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History of ChangeHistory of ChangeNot very old. The first standard was published in the yearNot very old. The first standard was published in the year

1987.1987.

It was revised in years 1994It was revised in years 1994

The last revision was in 2000 which is the currentThe last revision was in 2000 which is the currentversion known as ISO 9001:2000.version known as ISO 9001:2000.

It will be revised again in the end of 2008 or early 2009,It will be revised again in the end of 2008 or early 2009,and the new version will be called ISO 9001:200X.and the new version will be called ISO 9001:200X.

A design specification was balloted during the year 2005.A design specification was balloted during the year 2005.

Expected to contain little changes or additions toExpected to contain little changes or additions torequirements.requirements.

However, even small changes to the standard canHowever, even small changes to the standard candramatically impact a userdramatically impact a users QMS.s QMS.


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Reason for ChangeReason for ChangeISO 9001, like all standards is subject to periodicISO 9001, like all standards is subject to periodic

reviewreviewNormally the review period is around 5Normally the review period is around 56 years6 years

One Major One MinorOne Major One Minor

Proposed changes are more based on theProposed changes are more based on the

clarification of points already in the standardclarification of points already in the standard

rather than the inclusion of new requirements.rather than the inclusion of new requirements.

However, the proposed changes to ISO 9001However, the proposed changes to ISO 9001ss

sistersister standard, ISO 9004standard, ISO 9004


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Current ChangeCurrent ChangeCurrently ISO TC 176 SC2 is working onCurrently ISO TC 176 SC2 is working on

an amendment of ISO 9001:2000.an amendment of ISO 9001:2000.The main purpose of the amendment is toThe main purpose of the amendment is to

enhance the clarity of the current versionenhance the clarity of the current version

of the ISO 9001:2000 standardof the ISO 9001:2000 standardTo enhance its compatibility with the latestTo enhance its compatibility with the latestrevision of the Environmentalrevision of the Environmental

Management Specification standard,Management Specification standard,14001:2004.14001:2004.


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Current ChangeCurrent ChangeA number of users reported difficultyA number of users reported difficulty

transitioning to the 2000 edition of ISO 9001,transitioning to the 2000 edition of ISO 9001,which incorporated major changes from earlierwhich incorporated major changes from earliereditions, including a new clause structure.editions, including a new clause structure.

No new requirement same clause numbersNo new requirement same clause numbers

No significant changeNo significant change

Clarification to existing requirements for moreClarification to existing requirements for moreconsistency with ISO 14001consistency with ISO 14001

Mainly in Clause 7Mainly in Clause 7

Significant change in ISO 9004Significant change in ISO 9004


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Change ProcessChange ProcessStandard process which is usually followedStandard process which is usually followed

The standard is reviewed by various workingThe standard is reviewed by various working

groups and committees and suggestions are putgroups and committees and suggestions are put

forward for amendments.forward for amendments.

Amendments are incorporated into a draftAmendments are incorporated into a draft

version of the standard which is known as aversion of the standard which is known as a

Committee Draft (CD)Committee Draft (CD)

There may be more than 1 CD in which caseThere may be more than 1 CD in which case

they are sequentially numbered e.g. CD1, CD2,they are sequentially numbered e.g. CD1, CD2,

etc.etc.


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Change ProcessChange Process

Formal feedback to the CDFormal feedback to the CDs can bes can be

submitted by anyone.submitted by anyone.

Following feedback to the CDFollowing feedback to the CDs, a Drafts, a Draft

International standard (DIS) is publishedInternational standard (DIS) is published

and this is followed by the Final Draftand this is followed by the Final Draft

International Standard (FDIS) normallyInternational Standard (FDIS) normally

represents what the finished standard willrepresents what the finished standard willlook like barring punctuation errors etc.look like barring punctuation errors etc.


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Proposed changesProposed changesFDIS ISO 9001:2008 proposed changes:FDIS ISO 9001:2008 proposed changes:--

Clause 0.2 (Process approach)Clause 0.2 (Process approach)

Text added to emphasize the importance ofText added to emphasize the importance ofprocesses being capable of achieving desiredprocesses being capable of achieving desiredoutputsoutputsClause 1.1 (Scope)Clause 1.1 (Scope)

Clarification thatClarification that productproduct also includesalso includes

intermediate productintermediate productExplanation regarding statutory, regulatory andExplanation regarding statutory, regulatory andlegal requirementslegal requirements


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Proposed changesProposed changesClause 4.1 (General requirements)Clause 4.1 (General requirements)

Notes added to explain more about outsourcingNotes added to explain more about outsourcing

Types of control that may be applied toTypes of control that may be applied to

outsourced processesoutsourced processes

Relationship to clause 7.4 (Purchasing)Relationship to clause 7.4 (Purchasing)

Clarification that outsourced processes are stillClarification that outsourced processes are still

responsibility of the organization and must beresponsibility of the organization and must be

included in the quality management systemincluded in the quality management system


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Proposed changesProposed changes

Outsourced processes comply with all customer andOutsourced processes comply with all customer andlegal requirements.legal requirements.New standard goes further by expecting you also toNew standard goes further by expecting you also tospecify the type, nature, and extent of control.specify the type, nature, and extent of control.

How youHow youre going to control outsourced processes?re going to control outsourced processes?

How you choose to control an outsourced processHow you choose to control an outsourced processshould be influenced by the potential impact it couldshould be influenced by the potential impact it couldhave on your products, whether or not processhave on your products, whether or not processcontrol will be shared with the process supplier, andcontrol will be shared with the process supplier, and

whether or not adequate controls can bewhether or not adequate controls can becontractually established using your purchasingcontractually established using your purchasingprocess.process.


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Proposed changesProposed changesClause 4.2.1 (Documentation)Clause 4.2.1 (Documentation)

Clarification that QMS documentation alsoClarification that QMS documentation alsoincludes records which have an impact on yourincludes records which have an impact on yourQMSQMS

Documents required by the standard may beDocuments required by the standard may be

combinedcombinedISO 9001 requirements may be covered by moreISO 9001 requirements may be covered by morethan one documented procedurethan one documented procedure

Clause 4.2.3 (Document control)Clause 4.2.3 (Document control)

Clarification that only external documentsClarification that only external documentsrelevant to the QMS need to be controlledrelevant to the QMS need to be controlled


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Proposed changesProposed changesClause 4.2.4 (Records control)Clause 4.2.4 (Records control)

Editorial changes only (better alignment with ISO 14001)Editorial changes only (better alignment with ISO 14001)Clause 5.5.2 (Management rep)Clause 5.5.2 (Management rep)

Clarifies that this must be a member of the organizationClarifies that this must be a member of the organizationssown managementown management

Clause 6.2.1 (Human resources)Clause 6.2.1 (Human resources)Clarification that competence requirements are relevantClarification that competence requirements are relevantfor any personnel who are involved in the operation offor any personnel who are involved in the operation ofthe quality management systemthe quality management system

Clause 6.3 (Infrastructure)Clause 6.3 (Infrastructure)

More clear includes information systems as exampleMore clear includes information systems as example


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Proposed changesProposed changes

Clause 6.4 (Work environment)Clause 6.4 (Work environment)

Clarifies that this includes conditions under which work isClarifies that this includes conditions under which work isperformed and includes, for example physical,performed and includes, for example physical,

environmental and other factors such as noise,environmental and other factors such as noise,temperature, humidity, lighting, or weathertemperature, humidity, lighting, or weather

Clause 7.2.1 (Customer related processes)Clause 7.2.1 (Customer related processes)

Clarifies that postClarifies that post--delivery activities may include:delivery activities may include:

Actions under warranty provisionsActions under warranty provisions

Contractual obligations such as maintenance servicesContractual obligations such as maintenance services

Supplementary services such as recycling or finalSupplementary services such as recycling or finaldisposaldisposal


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Proposed changesProposed changesClause 7.3.1 (Design & development planning)Clause 7.3.1 (Design & development planning)

Clarifies that design and development review, verificationClarifies that design and development review, verificationand validation have distinct purposesand validation have distinct purposes

These may be conducted and recorded separately or inThese may be conducted and recorded separately or inany combination as suitable for the product and theany combination as suitable for the product and the

organizationorganizationClause 7.3.3(Design & development outputs)Clause 7.3.3(Design & development outputs)

Clarifies that information needed for production andClarifies that information needed for production andservice provision includes preservation of the productservice provision includes preservation of the product

Clause 7.5.4 (Customer property)Clause 7.5.4 (Customer property)Explains that both intellectual property and personal dataExplains that both intellectual property and personal datashould be considered as customer propertyshould be considered as customer property


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Proposed changesProposed changesClause 7.6 (NowClause 7.6 (Now retitledretitled Control of Monitoring andControl of Monitoring andMeasuring equipment)Measuring equipment)

Explanatory notes added regarding the use of computerExplanatory notes added regarding the use of computersoftware:software: Confirmation of the ability of computerConfirmation of the ability of computersoftware to satisfy the intended application wouldsoftware to satisfy the intended application wouldtypically include its verification and configurationtypically include its verification and configuration

management to maintain its suitability for use.management to maintain its suitability for use.Clause 8.2.1 (Customer satisfaction)Clause 8.2.1 (Customer satisfaction)

Note added to explain that monitoring of customerNote added to explain that monitoring of customerperception may include input from sources such asperception may include input from sources such as

customer satisfaction surveys, customer data oncustomer satisfaction surveys, customer data ondelivered product quality, user opinion surveys, lostdelivered product quality, user opinion surveys, lostbusiness analysis, compliments, and dealer reportsbusiness analysis, compliments, and dealer reports


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Proposed changesProposed changesClause 8.2.3 (Monitoring / Measurement ofClause 8.2.3 (Monitoring / Measurement of

process)process)Note added to clarify that when decidingNote added to clarify that when deciding

on appropriate methods, the organizationon appropriate methods, the organization

should consider impact on the conformityshould consider impact on the conformity

to product requirements and on theto product requirements and on the

effectiveness of the quality managementeffectiveness of the quality managementsystem.system.


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Validity of certifications to ISOValidity of certifications to ISO

9001:20009001:2000

One year after publication of ISOOne year after publication of ISO

9001:2008 all accredited certifications9001:2008 all accredited certificationsissued (new certifications orissued (new certifications orrecertification's) shall be to ISOrecertification's) shall be to ISO

9001:2008.9001:2008.Twenty four months after publication byTwenty four months after publication byISO of ISO 9001:2008, any existingISO of ISO 9001:2008, any existing

certification issued to ISO 9001:2000 shallcertification issued to ISO 9001:2000 shallnot be valid.not be valid.


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What to do?What to do?Wait for the new standardWait for the new standard

Clarify the doubtsClarify the doubts

Make changes accordinglyMake changes accordingly

Conduct Internal audit and ManagementConduct Internal audit and ManagementReviewReview

Ask the certification body for auditAsk the certification body for audit


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Presented byPresented byMuhammad Asim BaigMuhammad Asim Baig

Group Business Improvement ConsultantGroup Business Improvement Consultant

Abdulla Fouad HoldingAbdulla Fouad HoldingPresidentPresident

Middle East Quality Management ProfessionalsMiddle East Quality Management Professionals

Cell: +966 507879405Cell: +966 507879405

Email:Email:

[email protected]@abdulla

--fouad.comfouad.com

[email protected]@meqmp.com

web:web: www.abdullawww.abdulla--fouad.comfouad.com

www.meqmp.comwww.meqmp.com

"Biggest room in the world is the room for improvement""Biggest room in the world is the room for improvement"