Quality Management Quality Management SystemsSystems

Anurag SharmaAnurag Sharma

Alfred Borget AnoyeAlfred Borget Anoye

IntroductionIntroduction

Why develop quality Why develop quality standard?standard?

To increase quality oriented To increase quality oriented customerscustomers

To generalize norms of qualityTo generalize norms of quality To prepare credible benchmarkingTo prepare credible benchmarking

Most prevalent standardsMost prevalent standards ISO 9000: specifies necessary ISO 9000: specifies necessary

components of a quality management components of a quality management system system

ISO 14001: manages environment ISO 14001: manages environment processes and impacts processes and impacts

QS 9000: supplement of IS0 9000:1994 QS 9000: supplement of IS0 9000:1994 for continuous improvement, for continuous improvement, prevention of nonconformance, and prevention of nonconformance, and scrap and rework reductionscrap and rework reduction

ISO/TS 16949: specific to the ISO/TS 16949: specific to the Automotive industry Automotive industry

Most prevalent standards Most prevalent standards (cont’d)(cont’d)

AS 9100: specific to aerospace AS 9100: specific to aerospace industry industry

TL 9000: specific to TL 9000: specific to telecommunications industry telecommunications industry

ISO 13485 & 88: specific to medical ISO 13485 & 88: specific to medical devices devices

TE Supplement: specific to US TE Supplement: specific to US automotive suppliersautomotive suppliers

History of ISOHistory of ISO

Found in 1946Found in 1946 International standards for quality International standards for quality

systems published in 1987systems published in 1987 Republished and updated version in Republished and updated version in

19941994

Benefits of ISO regulationBenefits of ISO regulation

Significant improvement on:Significant improvement on: Internal qualityInternal quality Production reliabilityProduction reliability External qualityExternal quality Time performanceTime performance Cost of poor qualityCost of poor quality

ISO 9000 series of ISO 9000 series of StandardsStandards

ISO 9000: 2000 –focus on ISO 9000: 2000 –focus on fundamentals and vocabularyfundamentals and vocabulary

ISO 9001: 2000—focus on ISO 9001: 2000—focus on requirementsrequirements

ISO 9004: 2000—focus on guidelines ISO 9004: 2000—focus on guidelines for performance improvementfor performance improvement

ISO 2001 RequirementsISO 2001 Requirements

It is the standard used for It is the standard used for registration by acquiring conformity registration by acquiring conformity of the quality management systemof the quality management system

More details of IS0 9001 found in More details of IS0 9001 found in www.praxiom.comwww.praxiom.com

Implementing ISOImplementing ISO

Management InterestManagement Interest Management representationManagement representation Awareness and communicationAwareness and communication Assigning a teamAssigning a team Training and practicesTraining and practices Time FrameTime Frame Element ownershipElement ownership

Implementing ISO (cont’d)Implementing ISO (cont’d)

Revision of the current systemRevision of the current system DocumentationDocumentation Identifying flawsIdentifying flaws Installing new systemInstalling new system AuditingAuditing Management assessmentManagement assessment RegistrationRegistration

Documentation Documentation (why is it needed?)(why is it needed?)

Records or proofsRecords or proofs Future referencesFuture references Planning and updatingPlanning and updating TraceabilityTraceability

Cascading documentationCascading documentation

PolicyPolicy

ProcedureProcedure

Work InstructionsWork Instructions

Document Document DevelopmentDevelopment

Document developmentDocument development

Policies, procedures and work Policies, procedures and work instruction brought togetherinstruction brought together

RevisionRevision Discarding irrelevant documentsDiscarding irrelevant documents Changes and amendmentsChanges and amendments UpdatingUpdating Reader friendly formatReader friendly format

DocumentationDocumentation

SimplicitySimplicity Brevity and ConcisenessBrevity and Conciseness Attractive formatAttractive format Good fonts and designsGood fonts and designs Relevant informationRelevant information TraceabilityTraceability Underscoring important issuesUnderscoring important issues

Creating ManualsCreating Manuals

Statement of purposeStatement of purpose Company’s policyCompany’s policy Making controlled copiesMaking controlled copies Inclusion of ISO 9001Inclusion of ISO 9001 Flow diagrams and figures instead of Flow diagrams and figures instead of

verbiageverbiage Procedure manuals (refer to flow Procedure manuals (refer to flow

diagram in text)diagram in text)

AuditingAuditing

One of the key elements of ISO One of the key elements of ISO standard, audit is performed in order standard, audit is performed in order to make sure if the system is being to make sure if the system is being followed and the expected results followed and the expected results are obtained. are obtained.

It is done by the qualified individuals It is done by the qualified individuals who are trained in auditing principles who are trained in auditing principles and procedures.and procedures.

Objectives of AuditingObjectives of Auditing

Conformance of actual performanceConformance of actual performance Identifying deficiencies and Identifying deficiencies and

implementing corrective actionsimplementing corrective actions Improvising the systemImprovising the system Inculcating flawless process to Inculcating flawless process to

employeesemployees

Auditing techniquesAuditing techniques

Examining documentationExamining documentation Observing activitiesObserving activities Listening to employeesListening to employees Identifying significant issues from Identifying significant issues from

trivialtrivial Generating appropriate Generating appropriate

questionnairequestionnaire

Auditing procedureAuditing procedure

Auditing procedure comprises of Auditing procedure comprises of making audit plan and checklist first. making audit plan and checklist first. The plan should contain department, its The plan should contain department, its activity, list of procedures and activity, list of procedures and regulatory requirement. The checklist regulatory requirement. The checklist on the other hand is a form of on the other hand is a form of questions based on procedures, records questions based on procedures, records and work instruction to ensure the well and work instruction to ensure the well running of system.running of system.

RegistrationRegistration

Quality systems registration is an Quality systems registration is an assessment and audit of a quality assessment and audit of a quality system by a third party; a registrar. system by a third party; a registrar. Selecting a registrar is based upon Selecting a registrar is based upon the qualifications, recognition, the qualifications, recognition, process of registration and time process of registration and time limits.limits.

Registration processRegistration process

ApplicationApplication ReviewReview PreassessmentPreassessment AssessmentAssessment RegistrationRegistration Follow-up surveillanceFollow-up surveillance

QuestionsQuestions What is more important, What is more important,

implementation of an ISO or its implementation of an ISO or its registration?registration?

Case studyCase study

Company A has an ISO 9001 registration, Company A has an ISO 9001 registration, all its processes are well governed and all its processes are well governed and follow ISO regulations. It delivers excellent follow ISO regulations. It delivers excellent products to customers.products to customers.

Company B does not have ISO registration, Company B does not have ISO registration, but it still manufactures products as good but it still manufactures products as good as Company A.as Company A.

How can we prove company A superior to How can we prove company A superior to company B?company B?