Iso16949 new

1©Robere & Associates (Thailand) Ltd. 2002

To an Introduction to To an Introduction to

ISO/TS/16949ISO/TS/16949


AgendaAgenda

• Company approachCompany approach

• The SpecificationThe Specification

• Administrative issuesAdministrative issues


How to Create, Implement and How to Create, Implement and Maintain an ISO/TS16949 System that Maintain an ISO/TS16949 System that adds “value” to your company..adds “value” to your company..


Management vs AssuranceManagement vs Assurance

• QS9000 with it’s foundation in ISO9001:1994 is QS9000 with it’s foundation in ISO9001:1994 is a Quality a Quality AssuranceAssurance Customer requirement. Customer requirement.

• ISO/TS 16949 with it’s foundation in ISO/TS 16949 with it’s foundation in ISO9001:2000 is a Quality ISO9001:2000 is a Quality ManagementManagement SystemSystem

• This difference identifies the focus of our This difference identifies the focus of our activities. activities.


Steps to transition..QS – TSSteps to transition..QS – TS- - The Seven “R’s” - The Seven “R’s” -

1.1. ReviewReview your existing system against the new your existing system against the new requirementsrequirements

2.2. ReformatReformat the structure and the approach the structure and the approach

3.3. RegulateRegulate the implementation activities the implementation activities

4.4. RenewRenew your skills for the new system your skills for the new system

5.5. RejoiceRejoice in the improvements in the improvements

6.6. ReportReport on the Audit activities and on the Audit activities and

7.7. RedoRedo the process the process


ReviewReview your existing system your existing system against the new requirementsagainst the new requirements

• The second edition of the standard is being The second edition of the standard is being finalizedfinalized

• Look at the QS9000 requirements against Look at the QS9000 requirements against ISO/TS16949 as well as ISO9001:2000.ISO/TS16949 as well as ISO9001:2000.

• Determine the “gap”. Determine the “gap”. • There have been some “relaxations in the revised There have been some “relaxations in the revised

requirementrequirement


ReformatReformat the structure and the the structure and the approachapproach

• Existing document Existing document structure will workstructure will work

• Identify new Identify new referencesreferences

• ISO/TS 16949 more ISO/TS 16949 more prescriptive than prescriptive than ISO9001:2000ISO9001:2000

QUALITY SYSTEM DOCUMENTATIONQUALITY SYSTEM DOCUMENTATIONPROGRESSIONPROGRESSION

International Standards ISO 9001/ISO9002

Sector Requirements

ISO/TS 16949Part and Process Approval

Procedures

Defines international quality system requirements

QualityManual

Procedures

Job Instructions

Other Documentation

INDIV

IDUAL SUPPLIE

RS

Customer-supporting reference manuals on:

(see bibliography)

AdvancedQuality Planning

Control Plan

Tools and techniques

Level 1DefinesApproach &Responsibility

Level 2Defines WhoWhat, When

Level 3AnswersHow

Level 4Prompts recording of information such as forms, tags, labels

International automotive quality

system requirements


QUALITY SYSTEM DOCUMENTATIONQUALITY SYSTEM DOCUMENTATIONPROGRESSIONPROGRESSION

International Standards ISO 9001/ISO9002

Sector Requirements

ISO/TS 16949Part and Process Approval

Procedures

Defines international quality system requirements

QualityManual

Procedures

Job Instructions

Other Documentation

INDIV

IDUAL SUPPLIE

RS

Customer-supporting reference manuals on:

(see bibliography)

AdvancedQuality Planning

Control Plan

Tools and techniques

Level 1 Defines Approach & Responsibility

Level 2 Defines Who What, When

Level 3 Answers How

Level 4 Prompts recording of information such as forms, tags, labels

International automotive quality

system requirements


Product/Product/ServiceService

QUALITY MANAGEMENT SYSTEMQUALITY MANAGEMENT SYSTEMCONTINUAL IMPROVEMENTCONTINUAL IMPROVEMENT

ManagementManagementresponsibilityresponsibility

Measurement,Measurement, analysisanalysis

improvementimprovement

ResourceResourcemanagementmanagement

SSaattiissffaaccttoonn

CCuussttoommeerr

CCuussttoommeerr

RReeqquuiirreemmeennttss

OutputOutputInputInput

Quality Management Process ModelQuality Management Process Model

ProductProduct(and/or service(and/or service))RRealizationealization

55

88

77

66


RegulateRegulate the implementation the implementation activities activities

• Establish the QMR Establish the QMR and the teamand the team

• Establish the planEstablish the plan• Follow the planFollow the plan• Management must Management must

“lead” the activities “lead” the activities through examplethrough example


RenewRenew your skills for the new your skills for the new systemsystem

• Ensure that all staff responsible Ensure that all staff responsible for the system are trained in:for the system are trained in:– Customer focused activitiesCustomer focused activities– LeadershipLeadership– How to involve their staff in the day How to involve their staff in the day

to day activitiesto day activities– The philosophy of a process and The philosophy of a process and

system approach to managementsystem approach to management– Continuous improvement toolsContinuous improvement tools– The methods of a factual approach to The methods of a factual approach to

decision makingdecision making– The steps to develop supplier The steps to develop supplier

relationshipsrelationships

1.1. CustomerCustomer--Focused Organization.Focused Organization.

2.2. Leadership.Leadership.

3.3. Involvement of People.Involvement of People.

4.4. Process Approach.Process Approach.

5.5. System Approach to Management.System Approach to Management.

6.6. Continual Improvement.Continual Improvement.

7.7. Factual approach to decision making.Factual approach to decision making.

8.8. Mutually beneficial supplier relationships.Mutually beneficial supplier relationships.

Eight Quality Management PrinciplesEight Eight Quality Management PrinciplesQuality Management Principles1.1. CustomerCustomer--Focused Organization.Focused Organization.








Eight Quality Management PrinciplesEight Eight Quality Management PrinciplesQuality Management Principles


1.1. Customer-Focused Organization.Customer-Focused Organization.








Eight Eight Quality Management PrinciplesQuality Management PrinciplesEight Eight Quality Management PrinciplesQuality Management Principles


RenewRenew your skills for the your skills for the additional requirementsadditional requirements

• All clauses of ISO9001:2000All clauses of ISO9001:2000• Many requirements were Many requirements were

carried over from the 1carried over from the 1stst editionedition

• Helps to strengthen the Helps to strengthen the automotive QMS automotive QMS RequirementsRequirements


RejoiceRejoice in the improvements in the improvements

• Recognize those who have Recognize those who have contributed to the system contributed to the system improvementsimprovements

• Plan other activities that Plan other activities that would involve more staffwould involve more staff

• ““Post” all the improvement Post” all the improvement activities for everyone to see.activities for everyone to see.


ReportReport on the Audit activities on the Audit activities

• Audits are for Audits are for improvement and for improvement and for the prevention of the prevention of non-conformances.non-conformances.

• Use the internal Use the internal audits for continuous audits for continuous improvementsimprovements


RedoRedo the process the process

• Even though you’ve been Even though you’ve been certified, constantly certified, constantly review existing process review existing process for improvement.for improvement.

• Document your Document your activities..they become activities..they become part of your overall part of your overall quality improvement quality improvement programprogram


Part 1: Conclusion..Part 1: Conclusion..

• The new requirement The new requirement brings greater brings greater benefitsbenefits

• Upgrade your system Upgrade your system for improvement, for improvement, using the using the “Quality “Quality Management ToolsManagement Tools

• Focus on the long-Focus on the long-term improvementterm improvement


THE GLOBAL QUALITY SYSTEM SPECIFICATION FOR THE AUTOMOTIVE INDUSTRY

THE GLOBAL QUALITY SYSTEM SPECIFICATION FOR THE AUTOMOTIVE INDUSTRY


Evolution of ISO/TS16949Evolution of ISO/TS16949

International Automotive Task Force (IATF)

•France (EAQF-94)

•Germany (VDA 6.1)

•Italy (AVSQ)

•USA (QS-9000)

Peugeot / Citroen, Renault Automobiles

BMW, AUDI, Bosch, GME/Opel, Mercedes Benz, Volkswagen

Fiat, Magneti Marelli

Daimler Chrysler, Ford, General Motors, VW of America


Evolution of ISO/TS16949Evolution of ISO/TS16949

Trade Associations supporting the IATFTrade Associations supporting the IATF

•AIAG, USAAIAG, USA

•ANFIA, ItalyANFIA, Italy

•CCFA, FranceCCFA, France

•FIEV, FranceFIEV, France

•SMMT Ltd., UKSMMT Ltd., UK

•VDA, GermanyVDA, Germany


Goal of ISO/TS 16949Goal of ISO/TS 16949

““The goal of this Technical Specification is the The goal of this Technical Specification is the

development of a quality management system that provide development of a quality management system that provide

for continuous improvement, emphasizing defect for continuous improvement, emphasizing defect

prevention and the reduction of variation and waste in the prevention and the reduction of variation and waste in the

supply chain”.supply chain”.


Scope of ISO/TS16949Scope of ISO/TS16949The Technical Specification is applicable to production and The Technical Specification is applicable to production and

service part supplier and subcontractor “sites” providing:service part supplier and subcontractor “sites” providing:

•Parts or Materials, orParts or Materials, or

•Heat Treating, painting, plating, or other finishing services, or other Heat Treating, painting, plating, or other finishing services, or other

customer-specified products.customer-specified products.

•““Remote Locations” need to be covered too.Remote Locations” need to be covered too.

•““Remote Locations” cannot obtain standalone certificationRemote Locations” cannot obtain standalone certification

•The Technical Specification can be applied throughout the automotive The Technical Specification can be applied throughout the automotive supply chain.supply chain.


How does ISO/TS16949 align with the How does ISO/TS16949 align with the existing Sector Specific Standards?existing Sector Specific Standards?

• The elements of the ISO/TS/are closely aligned with The elements of the ISO/TS/are closely aligned with

the elements of the four automotive standards the elements of the four automotive standards

•Most of the elements of ISO/TS/can be traced to a Most of the elements of ISO/TS/can be traced to a

minimum of one of the four automotive standards.minimum of one of the four automotive standards.

•Many of the elements can be traced to all four Many of the elements can be traced to all four

standardsstandards


Quality Related RequirementsQuality Related Requirements

PartPart

CommodityCommodity

DivisionDivision

CompanyCompany

SectorSector

FundamentalFundamental

MoreMoreSpecificSpecific

MoreMoreGenericGeneric

ISO/TS /TS16949ISO/TS /TS16949

ISO/TS 9001:2000ISO/TS 9001:2000


Expected Benefits of Expected Benefits of ISO/TS/16949ISO/TS/16949

• Improved product and process qualityImproved product and process quality

•Provide additional confidence for global sourcingProvide additional confidence for global sourcing

•Freeing up supplier resources for other quality activitiesFreeing up supplier resources for other quality activities

•Common quality system approach in the supply chain for Common quality system approach in the supply chain for

supplier/subcontractor development and consistency.supplier/subcontractor development and consistency.

•Reduction of variation and increased efficiencyReduction of variation and increased efficiency


Benefits of ISO/TS/16949Benefits of ISO/TS/16949

• Reduction in 2nd party system auditsReduction in 2nd party system audits

•Reduction in multiple 3rd party registrationsReduction in multiple 3rd party registrations

•Common language to improve understanding of quality Common language to improve understanding of quality requirementsrequirements


Foreword to the ISO/TS/16949Foreword to the ISO/TS/16949

•Based on ISO9000 - ISO 9001:2000 Text is BoxedBased on ISO9000 - ISO 9001:2000 Text is Boxed

•““Shall” is a mandatory requirementShall” is a mandatory requirement

•““Notes” are for guidance in understandingNotes” are for guidance in understanding

•““Should” in a note is for guidance purposes onlyShould” in a note is for guidance purposes only

•Sector specific requirements are outside the boxesSector specific requirements are outside the boxes

•The term “such as” is used only for guidanceThe term “such as” is used only for guidance


More Requirements for More Requirements for management!!management!!

To list the goals, objectives, and measurements used to To list the goals, objectives, and measurements used to support the quality policysupport the quality policy

To put in place a method of determining customer To put in place a method of determining customer satisfaction satisfaction

To develop a method of continuous improvement To develop a method of continuous improvement To assign a customer representative (different from To assign a customer representative (different from

management representative) management representative) To inform management of noncompliant goods and To inform management of noncompliant goods and

take corrective action take corrective action To assign quality responsible people on all shifts To assign quality responsible people on all shifts


More Requirements for More Requirements for management!!management!!

To use of project management To use of project management To use of advanced product quality planning (APQP) To use of advanced product quality planning (APQP) To establish cost of quality as part of management To establish cost of quality as part of management To review a detailed business plan for the company To review a detailed business plan for the company To analyze the company data on effectiveness, To analyze the company data on effectiveness,

efficiency, quality, etc. efficiency, quality, etc. To use of benchmarking system of motivating To use of benchmarking system of motivating

employees towards continuous improvement employees towards continuous improvement To analyze product safetyTo analyze product safety To account for applicable regulations, including health, To account for applicable regulations, including health,

safety, and the environment. safety, and the environment.


ISO/TS 16949 ISO/TS 16949 Conformance andConformance and

Guidance StandardsGuidance Standards

Foundation & FamiliarizationFoundation & Familiarization


The ISO/TS 16949 Conformance The ISO/TS 16949 Conformance

standard:standard:– Contains five primary clauses (4-8) and Contains five primary clauses (4-8) and

23 sub-clauses23 sub-clauses– 116 sub-sub clauses, 91 of which are 116 sub-sub clauses, 91 of which are

directly related to automotive directly related to automotive requirements.requirements.

Foundation & FamiliarizationFoundation & Familiarization


ISO/TS16949:2000 Clause - 0 ISO/TS16949:2000 Clause - 0 IntroductionIntroduction

• Describes the standard to address Describes the standard to address customer satisfaction and regulatory customer satisfaction and regulatory requirements to compliment product requirements to compliment product technical requirementstechnical requirements

• Defines the “process approach” as the Defines the “process approach” as the systematic identification and systematic identification and management of processes and their management of processes and their interactioninteraction

• The clause structure of The clause structure of ISO/TS16949:2000 follows this “process ISO/TS16949:2000 follows this “process approach”approach”


ISO/TS16949:2000 – Clause 1 ISO/TS16949:2000 – Clause 1 Scope (1.1)Scope (1.1)

• Establishes the “intent” of the standardEstablishes the “intent” of the standard– To provide a product that meets specificationTo provide a product that meets specification– To address customer satisfactionTo address customer satisfaction– To ensure continual improvementTo ensure continual improvement– To prevent nonconformityTo prevent nonconformity– Additional focus on Automotive requirementsAdditional focus on Automotive requirements– Applicable to production and service part organization sites where Applicable to production and service part organization sites where

customer specified products are manufactured.customer specified products are manufactured.– Remote locations such as design centers, corp headquarters, but Remote locations such as design centers, corp headquarters, but

cannot obtain a “stand-alone” certificationcannot obtain a “stand-alone” certification– Can be applied throughout the automotive supply chain.Can be applied throughout the automotive supply chain.


ISO/TS16949:2000 – Clause ISO/TS16949:2000 – Clause 1.2 Application (Exclusions)1.2 Application (Exclusions)• States the rules for permitting States the rules for permitting

exclusion of requirements of clause exclusion of requirements of clause 7, where they do not apply because 7, where they do not apply because of the nature of the organization:of the nature of the organization:– For ISO/TS16949 only 7.3 (Design) can be For ISO/TS16949 only 7.3 (Design) can be

excludedexcluded– Cannot exclude “manufacturing process” Cannot exclude “manufacturing process”

designdesign


ISO/TS16949:2000 – Clause ISO/TS16949:2000 – Clause 2 Normative reference2 Normative reference

• Identifies Identifies ISO 9000:2000 Quality ISO 9000:2000 Quality Management Systems – Management Systems – Fundamentals and Vocabulary Fundamentals and Vocabulary as a as a standard whose content also applies standard whose content also applies in meeting ISO/TS16949 in meeting ISO/TS16949 requirements.requirements.


ISO/TS16949:2000 ISO/TS16949:2000 Clause 3:Terms and definitionsClause 3:Terms and definitions Describes the change in terms:Describes the change in terms:

Supplier (old) = organization (new)Supplier (old) = organization (new) Sub-contractor (old) = supplier (new)Sub-contractor (old) = supplier (new)

Notes that “product” can apply to hardware, Notes that “product” can apply to hardware, software, services and processed materials.software, services and processed materials.

Product can therefore be a “product” or Product can therefore be a “product” or “service”.“service”.


Additional ISO/TS 16949 Additional ISO/TS 16949 3.1 Terms and Definitions for the 3.1 Terms and Definitions for the

automotive Industryautomotive Industry• Continual ImprovementContinual Improvement

• Control PlanControl Plan

• Design Responsible OrganizationDesign Responsible Organization

• Error ProofingError Proofing

• Laboratory ScopeLaboratory Scope

• ManufacturingManufacturing

• OutsourcingOutsourcing

• Predictive MaintenancePredictive Maintenance

• Premium freightPremium freight


4.1 General Requirements4.1 General Requirements

• ShallShall– EstablishEstablish– DocumentDocument– ImplementImplement– MaintainMaintain– Continually improve the Quality Continually improve the Quality

Management System (QMS)Management System (QMS)


4.1 General Requirements4.1 General Requirements• ShallShall implement by; implement by;

a.a. Identify processes required for the QMSIdentify processes required for the QMS

b.b. Determine sequence & interaction of processDetermine sequence & interaction of process

c.c. Determine criteria and methods required for effective Determine criteria and methods required for effective operation and controloperation and control

d.d. Ensure availability of resources/information to support Ensure availability of resources/information to support operations and monitoringoperations and monitoring

e.e. Measure, monitor & analyseMeasure, monitor & analyse

f.f. Implement actions necessary to achieve planned Implement actions necessary to achieve planned results & continual improvementresults & continual improvement

Note: Note: When an organization outsources, they cannot delegate When an organization outsources, they cannot delegate the technical responsibilitythe technical responsibility


4.2 General - Documentation 4.2 General - Documentation requirementsrequirements

• The QMS documentation The QMS documentation shallshall include; include;a.a. Documented statements of a quality policy and quality Documented statements of a quality policy and quality

objectivesobjectives

b.b. A Quality ManualA Quality Manual

c.c. Documented procedures as required by ISO/TS Documented procedures as required by ISO/TS 9001:20009001:2000

d.d. Documents required by an organisation to ensure;Documents required by an organisation to ensure;• Effective planning/operationEffective planning/operation

• Control of its processesControl of its processes

e.e. Quality records required by ISO/TS 9001:2000Quality records required by ISO/TS 9001:2000


4.2 General Documentation 4.2 General Documentation requirementsrequirements

• Note:Note:• The scope of the QMS The scope of the QMS shallshall be dependant upon be dependant upon

a.a. Size and type of the organisationSize and type of the organisation

b.b. Complexity and interaction of the processesComplexity and interaction of the processes

c.c. Competence of personnelCompetence of personnel


4.2.2 Quality Manual4.2.2 Quality Manual

• A quality manual A quality manual shallshall be be established and maintained which established and maintained which includes;includes;a.a. The scope of the QMSThe scope of the QMS

• Including details and justification of any exclusionsIncluding details and justification of any exclusions

b.b. Documented procedures or reference to Documented procedures or reference to thesethese

c.c. Description of sequence & interaction of Description of sequence & interaction of processes included in the QMS.processes included in the QMS.


4.2.3 Control of documents4.2.3 Control of documents• Documents required for the QMS Documents required for the QMS shallshall be controlled. be controlled.

Documents defined as quality records Documents defined as quality records shallshall be controlled be controlled as per 4.2.4as per 4.2.4

• A documented procedure A documented procedure shallshall be established to; be established to;a.a. approve documents for adequacy prior to useapprove documents for adequacy prior to useb.b. review, update as necessary and re-approve documentsreview, update as necessary and re-approve documentsc.c. To assure that changes and the current revision status of documents To assure that changes and the current revision status of documents

are identifiedare identifiedd.d. Ensure that relevant versions of applicable documents are available Ensure that relevant versions of applicable documents are available

at points of useat points of usee.e. Ensure that documents remain legible and readily identifiableEnsure that documents remain legible and readily identifiablef.f. Ensure documents of external origin are identified and their Ensure documents of external origin are identified and their

distribution controlleddistribution controlledg.g. Prevent unintended use of obsolete documents, and to apply Prevent unintended use of obsolete documents, and to apply

suitable identification to them if they are retained for any other suitable identification to them if they are retained for any other purposepurpose


4.2.3 Control of documents4.2.3 Control of documents

4.2.3.1 – Engineering Specifications4.2.3.1 – Engineering Specifications

•Shall have a process to assure a timely (not Shall have a process to assure a timely (not more than two weeks) review, distribution and more than two weeks) review, distribution and implementation of all customer engineering implementation of all customer engineering standards/specifications and changes.standards/specifications and changes.

•Must keep records of the changeMust keep records of the change


4.2.4 Control of Quality Records4.2.4 Control of Quality Records• Quality records Quality records shallshall be established and maintained as objective be established and maintained as objective

evidenceevidence• Quality records Quality records shallshall be be

– LegibleLegible– Readily identifiableReadily identifiable– RetrievableRetrievable

• A documented procedure A documented procedure shallshall define; define;– IdentificationIdentification– LegibilityLegibility– StorageStorage– ProtectionProtection– RetrievalRetrieval– Retention periodRetention period– Disposition of quality recordsDisposition of quality records

• 4.2.4.1: 4.2.4.1: The organization shall define retention periods for QMS related The organization shall define retention periods for QMS related documents and records to satisfy retulatory and customer requirementsdocuments and records to satisfy retulatory and customer requirements

ISO/TS16949

ISO/TS16949ISO/TS9001

ISO/TS9001

ISO/TS9004

ISO/TS9004ISO/TS10011

ISO/TS10011


TEAM EXERCISE: 15 TEAM EXERCISE: 15 MinutesMinutes

Summarize in your team Summarize in your team the preceding element of the preceding element of ISO/TS16949:2001. Explain ISO/TS16949:2001. Explain in a short statement what in a short statement what the intent of the element is the intent of the element is and it’s affect on your and it’s affect on your management approach.management approach.


5.1 Management Commitment5.1 Management Commitment• Top management Top management shallshall provide provide

evidence of commitment to the evidence of commitment to the development and improvement development and improvement of the QMS by;of the QMS by;

a.a. Communicating the importance of meeting Communicating the importance of meeting – CustomerCustomer– StatutoryStatutory– RegulatoryRegulatory

b.b. Establishing the quality policy Establishing the quality policy c.c. Ensuring quality objectives are establishedEnsuring quality objectives are establishedd.d. Conducting management reviewsConducting management reviewse.e. Ensuring the availability of resourcesEnsuring the availability of resources


5.1.1 Process efficiency5.1.1 Process efficiency

• Top management Top management shallshall monitor the monitor the product realization processes and the product realization processes and the support processes to assure their support processes to assure their effectiveness and efficiencyeffectiveness and efficiency


5.2 Customer Focus5.2 Customer Focus

• Top management Top management shallshall ensure ensure– Customer requirements are determined, Customer requirements are determined,

thenthen– Fulfilled, thereby,Fulfilled, thereby,– enhancing customer satisfactionenhancing customer satisfaction


5.3 Quality Policy5.3 Quality Policy• Top management Top management shallshall ensure that the ensure that the

quality policy;quality policy;a.a. is appropriate to the purpose of the organisationis appropriate to the purpose of the organisation

b.b. Includes a commitment to comply with requirements Includes a commitment to comply with requirements and continual improve the effectiveness of the QMSand continual improve the effectiveness of the QMS

c.c. Provides a framework for establishing and reviewing Provides a framework for establishing and reviewing quality objectivesquality objectives

d.d. Is communicated and understood within the Is communicated and understood within the organisationorganisation

e.e. Is reviewed for continuing suitabilityIs reviewed for continuing suitability


Planning: Planning: 5.4.1 Quality Objectives5.4.1 Quality Objectives

• Top Management Top Management shallshall ensure objectives, ensure objectives, including product related objectives, are including product related objectives, are established at relevant functions and levels of the established at relevant functions and levels of the organisation.organisation.

• These objectives These objectives shallshall be; be;– MeasurableMeasurable– Consistent with the Quality PolicyConsistent with the Quality Policy

• 5.4.1.1: The objectives shall be included in the 5.4.1.1: The objectives shall be included in the business plan and used to deploy the quality business plan and used to deploy the quality policypolicy


5.4.2 Quality Management 5.4.2 Quality Management System PlanningSystem Planning

• Top management Top management shallshall ensure that ensure thata.a. The planning of the QMS is carried out The planning of the QMS is carried out

such that in meets the requirements of such that in meets the requirements of

• ““General Requirements” (4.1)General Requirements” (4.1)• The stated Quality ObjectivesThe stated Quality Objectives

b.b. The integrity of the QMS is maintained The integrity of the QMS is maintained when changes to the QMS are planned when changes to the QMS are planned and implementedand implemented


5.5.1 Responsibility, 5.5.1 Responsibility, Authority and CommunicationAuthority and Communication

• Top management Top management shallshall ensure that the ensure that the– Responsibilities and theResponsibilities and the– Authorities are defined and communicated within the Authorities are defined and communicated within the

organizationorganization

• 5.5.1.1: 5.5.1.1: – Management responsible for corrective action shall be Management responsible for corrective action shall be

promptly informed of non-conforming products or promptly informed of non-conforming products or processesprocesses

– Personnel responsible for quality shall have the Personnel responsible for quality shall have the authority to stop production to correct problems.authority to stop production to correct problems.

– All shifts shall have someone responsible for qualityAll shifts shall have someone responsible for quality


5.5.2 Management 5.5.2 Management RepresentativeRepresentative

Top Management Top Management shallshall appoint a member(s) appoint a member(s) from within its management team who is from within its management team who is responsible for;responsible for; Ensuring the processes of the QMS are established,

implemented and maintained Reporting to top management on the performance of the

QMS, including needs for improvement Promoting awareness of customer requirements

throughout the organization

5.5.2.1: Customer representative: 5.5.2.1: Customer representative: Top management Top management shallshall designate someone to represent the needs of designate someone to represent the needs of the customer in all areas.the customer in all areas.


5.5.3 Internal 5.5.3 Internal CommunicationCommunication

• Top management Top management shallshall;;– Ensure appropriate communication Ensure appropriate communication

processes are establishedprocesses are established– Ensure communication takes place Ensure communication takes place

regarding the effectiveness of the QMSregarding the effectiveness of the QMS


5.6.1 Management Review:5.6.1 Management Review:GeneralGeneral

• Top Management Top Management shallshall review the organisations QMS at planned review the organisations QMS at planned intervals to ensure continuing;intervals to ensure continuing;– SuitabilitySuitability– AdequacyAdequacy– EffectivenessEffectiveness

• The review The review shallshall include include– Assessing opportunities for improvementAssessing opportunities for improvement– Need for changes to the QMSNeed for changes to the QMS– Review of quality policyReview of quality policy– Review of quality objectivesReview of quality objectives

• Records of management reviews Records of management reviews shallshall be maintained be maintained• 5.6.1.1: The review 5.6.1.1: The review shall shall cover cover

– all elements of the QMS and performance trends.all elements of the QMS and performance trends.– Cost of poor qualityCost of poor quality– The achievement of objectives in the Quality Policy, the business plan The achievement of objectives in the Quality Policy, the business plan

and the level of customer satisfaction with supplied productand the level of customer satisfaction with supplied product


5.6.2 Review Input5.6.2 Review Input The input to management review The input to management review shallshall

include information on;include information on;• Results of auditsResults of audits• Customer feedbackCustomer feedback• Process performance and product conformityProcess performance and product conformity• Status of preventive and corrective actionStatus of preventive and corrective action• Follow up actions from previous management reviewsFollow up actions from previous management reviews• Planned changes that could effect the QMSPlanned changes that could effect the QMS• Recommendations for improvementRecommendations for improvement

• 5.6.2.1: Input 5.6.2.1: Input shall shall include an analysis of actual include an analysis of actual and potential field-failures and their impact on and potential field-failures and their impact on quality, safety, or the environmentquality, safety, or the environment


5.6.3 Review Output5.6.3 Review Output

• The output from the management The output from the management review review shallshall include any decisions include any decisions and actions related to;and actions related to;– Improvement of the effectiveness of the Improvement of the effectiveness of the

QMS and its processesQMS and its processes– Improvement of product, related to Improvement of product, related to

customer requirementscustomer requirements– Resource needsResource needs





Resource Management: Resource Management: 6.1 Provision of resources6.1 Provision of resources

• The organisation The organisation shallshall determine determine and provide the resources and provide the resources needed to;needed to;

a.a. To implement and maintain the QMS To implement and maintain the QMS and continually improve its and continually improve its effectivenesseffectiveness

b.b. To enhance customer satisfactionTo enhance customer satisfaction


Human Resources:Human Resources:6.2.1 General6.2.1 General

• Personnel performing work affecting Personnel performing work affecting quality quality shallshall be competent on the be competent on the basis of;basis of;– Appropriate educationAppropriate education– TrainingTraining– Skills Skills – ExperienceExperience


6.2.2 Competence, 6.2.2 Competence, awareness and trainingawareness and training

• The organisation The organisation shallshall;;a.a. Determine the necessary competence for personnel Determine the necessary competence for personnel

performing work affecting qualityperforming work affecting quality

b.b. Provide training or take other actions to satisfy these Provide training or take other actions to satisfy these needsneeds

c.c. Evaluate the effectiveness of the actions takenEvaluate the effectiveness of the actions taken

d.d. Ensure that its personnel are aware of their own Ensure that its personnel are aware of their own impact on qualityimpact on quality

e.e. Maintain appropriate records of education/training, Maintain appropriate records of education/training, skills and experienceskills and experience


Additional Automotive Additional Automotive Requirements for trainingRequirements for training

• 6.2.2.1: 6.2.2.1: Product design skills: Product design skills: Individuals Individuals responsible for product design must be responsible for product design must be trained in tools and techniquestrained in tools and techniques

• 6.2.2.2: 6.2.2.2: TrainingTraining: Must have a : Must have a documented proceduredocumented procedure to identify needs to identify needs and achieving competence. Applies to and achieving competence. Applies to everyone in the organization.everyone in the organization.


Additional Automotive Additional Automotive Requirements for trainingRequirements for training

• 6.2.2.3: 6.2.2.3: Training on the job:Training on the job:Must have training Must have training in any new or modified job affecting product in any new or modified job affecting product quality (includes contract or agency personnel)quality (includes contract or agency personnel)

• 6.2.2.4: 6.2.2.4: Employee Motivation and Employee Motivation and Empowerment: Empowerment: shall have a process to motivate shall have a process to motivate and measure the extent the employees :and measure the extent the employees :– achieve quality objectives, achieve quality objectives, – make continual improvements andmake continual improvements and– Create an environment to promote innovationCreate an environment to promote innovation– Shall include the promotion of quality and technological Shall include the promotion of quality and technological

awareness throughout the whole organization.awareness throughout the whole organization.


6.3 Infrastructure6.3 Infrastructure• The organisation The organisation shall:shall:

– DetermineDetermine– ProvideProvide– MaintainMaintain

The infrastructure needed to achieve conformity The infrastructure needed to achieve conformity to product requirements. As an example, to product requirements. As an example, infrastructure might be;infrastructure might be;

a.a. Buildings, workspace and associated utilitiesBuildings, workspace and associated utilities

b.b. Process equipment, both hardware & softwareProcess equipment, both hardware & software

c.c. Supporting services such as transport or Supporting services such as transport or communicationcommunication


Additional Automotive Additional Automotive RequirementsRequirements

• 6.3.16.3.1 Plant, Facility and equipment planning:Plant, Facility and equipment planning:– Use a multidisciplinary approachUse a multidisciplinary approach– Shall optimize material travel, handling and value-Shall optimize material travel, handling and value-

added use of floor spaceadded use of floor space– Shall facilitate synchronous material flowShall facilitate synchronous material flow– Methods shall be developed and implemented to Methods shall be developed and implemented to

evaluate and monitor the effectiveness of existing evaluate and monitor the effectiveness of existing operations.operations.

• 6.3.2 Contingency Plans: 6.3.2 Contingency Plans: – Shall prepare contingency plans to satisfy customer Shall prepare contingency plans to satisfy customer

requirements in case of emergencyrequirements in case of emergency


6.4 Work Environment6.4 Work Environment

• The organisation The organisation shallshall– Determine and manage the conditions of the Determine and manage the conditions of the

work environment needed to achieve work environment needed to achieve conformity to product requirementsconformity to product requirements

• 6.4.1 Personnel safety:6.4.1 Personnel safety:– The quality policy and practices shall address The quality policy and practices shall address

activities to minimize potential risksactivities to minimize potential risks

• 6.4.2 Cleanliness of premises6.4.2 Cleanliness of premises– Shall maintain the premises in a state of order, Shall maintain the premises in a state of order,

cleanliness and repair.cleanliness and repair.





Product realization: Product realization: 7.1 Planning and product realization7.1 Planning and product realization

The organisation The organisation shallshall plan and develop the plan and develop the processes needed for product realization.processes needed for product realization.

Planning of product realization Planning of product realization shallshall be be consistent with the QMSconsistent with the QMS

In planning product realization, the organisation In planning product realization, the organisation shallshall determine the following as appropriate determine the following as appropriate Quality objectives & requirements for the productQuality objectives & requirements for the product The need to establish processes, documents, and The need to establish processes, documents, and

provide product specific resourcesprovide product specific resources

Continued next slideContinued next slide


7.1 Planning and product 7.1 Planning and product realization realization ….cont…….cont…

• In planning product realization, the organisation In planning product realization, the organisation shallshall determine the following as appropriate…..determine the following as appropriate…..c.c. RequiredRequired

• Verification,Verification,• Validation,Validation,• Monitoring,Monitoring,• Inspection and test activities specific to the product and the Inspection and test activities specific to the product and the

criteria for product acceptancecriteria for product acceptance

d.d. Records needed to provide evidence that the realization Records needed to provide evidence that the realization processes and resulting product fulfill requirementsprocesses and resulting product fulfill requirements

• The output of this planning The output of this planning shallshall be in a form suitable for be in a form suitable for the organisations method of operationsthe organisations method of operations



• 7.1.1 Planning of product realization:7.1.1 Planning of product realization: Customer requirements and tech specs shall Customer requirements and tech specs shall be included in the planningbe included in the planning

• 7.1.2 Acceptance criteria:7.1.2 Acceptance criteria: shall be defined shall be defined by the organization and, where required, by by the organization and, where required, by the customer. For attribute data sampling, the customer. For attribute data sampling, zero defects is requiredzero defects is required



• 7.1.3 Confidentiality: 7.1.3 Confidentiality: Organization Organization shallshall ensure ensure the confidentiality of customer-contracted the confidentiality of customer-contracted products and projectsproducts and projects

• 7.1.4 Change Control: 7.1.4 Change Control: – Organization must have a process to control and react Organization must have a process to control and react

to changes that impact product realization (including to changes that impact product realization (including the supplier). the supplier).

– All proprietary designs, impact on form, fit and All proprietary designs, impact on form, fit and function function shall be reviewed with the customershall be reviewed with the customer

– If customer has additional verification/identification If customer has additional verification/identification requirements, they shall be met requirements, they shall be met


Customer Related Processes:Customer Related Processes:7.2.1 Determination of requirements 7.2.1 Determination of requirements

related to the productrelated to the product• The organisation The organisation shallshall determine; determine;

a.a. Requirements specified by customer includingRequirements specified by customer including

• Requirements for delivery and post-delivery activitiesRequirements for delivery and post-delivery activities**b.b. Requirements not stated by the customer but Requirements not stated by the customer but

necessary for specified use or known intended usenecessary for specified use or known intended usec.c. Statutory and regulatory requirements related to the Statutory and regulatory requirements related to the

productproductd.d. Any additional requirements determined by the Any additional requirements determined by the

organisationorganisation

* Post-delivery includes any after sales servicing* Post-delivery includes any after sales servicing



• 7.2.1.1 Customer-designated special 7.2.1.1 Customer-designated special characteristics: characteristics: The organization The organization shallshall demonstrate conformity to customer demonstrate conformity to customer requirements for designation, requirements for designation, documentation and control of special documentation and control of special characteristics.characteristics.


7.2.2 Review of requirements 7.2.2 Review of requirements related to the productrelated to the product

• The organisation The organisation shallshall – Review the requirements related to the productReview the requirements related to the product– Conduct this review prior a commitment to supplyConduct this review prior a commitment to supply

• The review The review shallshall ensure ensure– Product requirements are definedProduct requirements are defined– Contract or order requirements differing from those Contract or order requirements differing from those

previously expressed are resolvedpreviously expressed are resolved– The organisation has the ability to meet the defined The organisation has the ability to meet the defined

requirementsrequirements

• Records of the results of the review and actions Records of the results of the review and actions arising from the review arising from the review shallshall be maintained. be maintained.

Continued next slide…..Continued next slide…..


7.2.2 Review of requirements 7.2.2 Review of requirements related to the product…(cont)related to the product…(cont)• Where the customer provides no Where the customer provides no

documented statement of requirement, the documented statement of requirement, the customer requirements customer requirements shallshall be confirmed be confirmed by the organisation before acceptanceby the organisation before acceptance

• Where product requirements are changed, Where product requirements are changed, the organisation shall ensure the organisation shall ensure – that relevant documents are amendedthat relevant documents are amended– Relevant personnel are made aware of the Relevant personnel are made aware of the

changeschanges



• 7.2.2.1 Organization manufacturing 7.2.2.1 Organization manufacturing feasibility:feasibility:– The organization shall investigate, confirm and The organization shall investigate, confirm and

document the manufacturing feasibility of the document the manufacturing feasibility of the proposed products in the contract review proposed products in the contract review process including risk analysis.process including risk analysis.


7.2.3 Customer 7.2.3 Customer CommunicationCommunication

The organisation The organisation shallshall determine determine and implement effective and implement effective arrangements for customer arrangements for customer communication in relation to;communication in relation to;

Product informationProduct information Enquiries, contracts or order handling, Enquiries, contracts or order handling,

including amendmentsincluding amendments Customer feedback, including Customer feedback, including

customer complaintscustomer complaints



• 7.2.3.1 Customer communication – 7.2.3.1 Customer communication – SupplementalSupplemental– The organization shall have the ability to The organization shall have the ability to

communicate necessary information, including communicate necessary information, including data, in a customer-specified language and data, in a customer-specified language and format (e.g. computer-aided design data, format (e.g. computer-aided design data, electronic data exchange).electronic data exchange).


Design and Development:Design and Development:7.3.1 Design & Development 7.3.1 Design & Development planningplanning• The organisation The organisation shallshall plan and control the design and plan and control the design and

development of the product.development of the product.

• During this stage the organisation During this stage the organisation shallshall determine; determine; The design and development stagedThe design and development staged The review, verification and validation that are appropriate The review, verification and validation that are appropriate

to each design and development stageto each design and development stage The responsibilities and authorities for design and The responsibilities and authorities for design and

developmentdevelopment

• The organisation The organisation shallshall manage all interfaces involved in manage all interfaces involved in design and development to ensure effective design and development to ensure effective communication and clear assignment of responsibilitycommunication and clear assignment of responsibility

• Planning output Planning output shallshall be updated, as appropriate, as the be updated, as appropriate, as the design and development progresses.design and development progresses.



• 7.3.1.1 Multidisciplinary approach:7.3.1.1 Multidisciplinary approach:– The organization shall use a multidisciplinary The organization shall use a multidisciplinary

approach to prepare for product realization, approach to prepare for product realization, including:including:

• Development/finalization and monitoring of special Development/finalization and monitoring of special characteristics,characteristics,

• Development and review of FMEAs including Development and review of FMEAs including actions to reduce potential risks, andactions to reduce potential risks, and

• Development and review of control plansDevelopment and review of control plans


7.3.2 Design & Development 7.3.2 Design & Development Inputs Inputs• Inputs relating to product requirements Inputs relating to product requirements shallshall be be

determined and records maintained. The determined and records maintained. The shallshall include;include;– Functional and performance requirementsFunctional and performance requirements– Applicable statutory and regulatory requirementsApplicable statutory and regulatory requirements– Where applicable, information derived from previous Where applicable, information derived from previous

similar designssimilar designs– Other requirements essential for design and Other requirements essential for design and

developmentdevelopment

• These inputs These inputs shallshall be reviewed for adequacy. be reviewed for adequacy. Requirements Requirements shallshall be complete, unambiguous be complete, unambiguous and not in conflict with each other.and not in conflict with each other.



• 7.3.2.1 Product design input:7.3.2.1 Product design input:– Shall identify, document and review the product design Shall identify, document and review the product design

inputs including:inputs including:• Customer requirementsCustomer requirements• Use of informationUse of information

• 7.3.2.2 Manufacturing process design input:7.3.2.2 Manufacturing process design input:– Shall identify, document and review the manufacturing Shall identify, document and review the manufacturing

design inputs including:design inputs including:• Product design output dataProduct design output data• Targets for productivityTargets for productivity• Customer requirementsCustomer requirements• Experience from previous developmentsExperience from previous developments



• 7.3.2.3 Special Characteristics:7.3.2.3 Special Characteristics:– The organization shall identify special The organization shall identify special

characteristics andcharacteristics and• Include all special characteristics in the control planInclude all special characteristics in the control plan

• Comply with customer specified definitions and Comply with customer specified definitions and symbols andsymbols and

• Identify process control documents including:Identify process control documents including:– Drawings, FMEAs, control plans, and operator Drawings, FMEAs, control plans, and operator

instructions with customer’s special characteristic symbol.instructions with customer’s special characteristic symbol.


7.3.3 Design & Development 7.3.3 Design & Development OutputsOutputs

• The outputs of design and development The outputs of design and development shallshall be be provided in a form that enable verification provided in a form that enable verification against the design and development input and against the design and development input and shallshall be approved prior to release. Design and be approved prior to release. Design and development outputs development outputs shallshall;;

a.a. Meet the input requirements for design and Meet the input requirements for design and developmentdevelopment

b.b. Provide appropriate information for purchasing, Provide appropriate information for purchasing, production and for service provisionproduction and for service provision

c.c. Contain or reference product acceptance criteriaContain or reference product acceptance criteriad.d. Specify the characteristics of the product that are Specify the characteristics of the product that are

essential for its safe and proper useessential for its safe and proper use



• 7.3.3.1 Product design outputs – Supplemental:7.3.3.1 Product design outputs – Supplemental:– Product design output Product design output shallshall be expressed in terms that be expressed in terms that

can be verified and validated against product design can be verified and validated against product design input requirementsinput requirements

– Shall include:Shall include:• Design FMEA, reliability results,Design FMEA, reliability results,• Product special characteristics, specifications,Product special characteristics, specifications,• Product error-proofing, as appropriate,Product error-proofing, as appropriate,• Product definition including drawings or mathematically based Product definition including drawings or mathematically based

data,data,• Product design reviews results, andProduct design reviews results, and• Diagnostic guidelines where applicable.Diagnostic guidelines where applicable.



• 7.3.3.2 Manufacturing process design output:7.3.3.2 Manufacturing process design output:– The output shall be expressed in terms that can be verified. They The output shall be expressed in terms that can be verified. They

shall include:shall include:• Specifications and drawings,Specifications and drawings,• Manufacturing process flow chart/layout,Manufacturing process flow chart/layout,• Manufacturing process FMEAsManufacturing process FMEAs• Control planControl plan• Work instructions,Work instructions,• Process approval acceptance criteria,Process approval acceptance criteria,• Data for quality, reliability, maintainability and measurability,Data for quality, reliability, maintainability and measurability,• Results of error-proofing activities as appropriateResults of error-proofing activities as appropriate• Methods of rapid detection and feedback of product/manufacturing Methods of rapid detection and feedback of product/manufacturing

nonconformitiesnonconformities


7.3.4 Design & Development 7.3.4 Design & Development review review

• At suitable stages, systematic reviews of design At suitable stages, systematic reviews of design and development and development shallshall be conducted; be conducted;

a.a. To evaluate the ability of the results of design and To evaluate the ability of the results of design and development to fulfill requirementsdevelopment to fulfill requirements

b.b. To identify any problems and propose necessary To identify any problems and propose necessary actionsactions

• Participants in such reviews shall include Participants in such reviews shall include representatives of functions concerned I the representatives of functions concerned I the design and development area. Records of both design and development area. Records of both the results of the reviews and actions shall be the results of the reviews and actions shall be maintainedmaintained



• 7.3.4.1 Monitoring7.3.4.1 Monitoring– Measurements at specified stages of design and Measurements at specified stages of design and

development shall be defined, analyzed and development shall be defined, analyzed and reported with summary results as an input to reported with summary results as an input to management review.management review.


• Verification Verification shallshall be performed to be performed to ensure;ensure;– Design & development outputs have Design & development outputs have

satisfied the design and development satisfied the design and development inputs.inputs.

• Records of the results of the Records of the results of the verification and any action verification and any action shallshall be be maintainedmaintained

7.3.5 Design & Development 7.3.5 Design & Development Verification Verification


7.3.6 Design & Development 7.3.6 Design & Development validation validation

• Design and Development validation Design and Development validation shallshall be be performed in accordance with planned performed in accordance with planned arrangements to ensurearrangements to ensure– The product is capable of fulfilling the requirements for The product is capable of fulfilling the requirements for

the specified or known intended use or application.the specified or known intended use or application.

• Wherever, practical, validation Wherever, practical, validation shallshall be completed be completed prior to delivery or implementation of the prior to delivery or implementation of the product.product.

• Records of the results of validation and any Records of the results of validation and any necessary actions necessary actions shallshall be maintained. be maintained.



• 7.3.6.1 Design and development validation – 7.3.6.1 Design and development validation – Supplemental:Supplemental:– Design and development shall be performed in Design and development shall be performed in

accordance with customer requirements including accordance with customer requirements including timingtiming

• 7.3.6.2 Prototype program:7.3.6.2 Prototype program:– When required, the organization When required, the organization shallshall have a prototype have a prototype

program and control plan.program and control plan.– All testing activities All testing activities shallshall be monitored be monitored– Must be responsible for all outsourced servicesMust be responsible for all outsourced services



• 7.3.6.3 Product approval process:7.3.6.3 Product approval process:– The organization shall conform to a product The organization shall conform to a product

and process approval procedure recognized by and process approval procedure recognized by the customer.the customer.


7.3.7 Control of design and 7.3.7 Control of design and development stagesdevelopment stages• Design and development changes Design and development changes shallshall be be

implemented and records maintained.implemented and records maintained.• The changes The changes shallshall be reviewed, verified and be reviewed, verified and

validated, as appropriate, and approved prior to validated, as appropriate, and approved prior to implementation.implementation.

• The review of design and development changes The review of design and development changes shallshall include evaluation of the effect of the include evaluation of the effect of the changes on constituent parts and delivered changes on constituent parts and delivered product.product.

• Records of the result of the review of changes Records of the result of the review of changes and any necessary actions and any necessary actions shallshall be maintained be maintained


Purchasing: Purchasing: 7.4.1 Purchasing process7.4.1 Purchasing process

• The organisation The organisation shallshall ensure that purchased product ensure that purchased product conforms to specified purchase requirements.conforms to specified purchase requirements.

• The type and extent of control applied to the supplier and The type and extent of control applied to the supplier and the purchased product is dependant upon the effect of the the purchased product is dependant upon the effect of the purchased product on subsequent product realization or purchased product on subsequent product realization or the final product.the final product.

• The organisation The organisation shallshall evaluate and select suppliers based evaluate and select suppliers based on their ability to supply product in accordance with the on their ability to supply product in accordance with the organisation's requirements.organisation's requirements.

• Criteria for selection, evaluation and re-evaluation Criteria for selection, evaluation and re-evaluation shallshall be be established.established.

• Records of the results of evaluations and any necessary Records of the results of evaluations and any necessary actions arising from the evaluation actions arising from the evaluation shallshall be maintained. be maintained.



• 7.4.1.1 Regulatory compliance: 7.4.1.1 Regulatory compliance: all products or materials all products or materials shall satisfy applicable regulatory requirements.shall satisfy applicable regulatory requirements.

• 7.4.1.2 Supplier quality management system 7.4.1.2 Supplier quality management system development: development: suppliers to the organization suppliers to the organization shall beshall be third- third-party registered to ISO9001:2000 by an accredited third party registered to ISO9001:2000 by an accredited third party certification bodyparty certification body

• 7.4.1.3 customer-approved sources: 7.4.1.3 customer-approved sources: where specified by where specified by the contract (e.g. customer engineering drawing the contract (e.g. customer engineering drawing specification) the organization specification) the organization shallshall purchase products, purchase products, materials or services from approved sourcesmaterials or services from approved sources


7.4.2 Purchasing 7.4.2 Purchasing InformationInformation

• Purchasing information Purchasing information shallshall describe the describe the product to be purchased, including where product to be purchased, including where appropriate;appropriate;

a.a. Requirements for approval of product, procedures, Requirements for approval of product, procedures, processes and equipmentprocesses and equipment

b.b. Requirements for qualification of personnelRequirements for qualification of personnel

c.c. QMS requirementsQMS requirements

• The organisation The organisation shallshall ensure the adequacy of ensure the adequacy of specified purchase requirements prior to their specified purchase requirements prior to their communication to the suppliercommunication to the supplier


7.4.3 Verification of 7.4.3 Verification of purchased productpurchased product

• The organisation The organisation shallshall establish and implement establish and implement the inspection or other activities necessary for the inspection or other activities necessary for ensuring that purchased product conforms to ensuring that purchased product conforms to specified requirements.specified requirements.

• Where the organisation or the customer intends Where the organisation or the customer intends to perform verification at the suppliers premises, to perform verification at the suppliers premises, the organisation the organisation shallshall state the intended state the intended verification arrangements and method of product verification arrangements and method of product release in the purchasing information.release in the purchasing information.



• 7.4.3.1 Incoming product quality:7.4.3.1 Incoming product quality:– The organization The organization shall haveshall have a proces to assure a proces to assure

the quality of purchased products:the quality of purchased products:• Receipt of and evaluation of statistical data by the Receipt of and evaluation of statistical data by the

organizationorganization

• Receiving inspection and/or testingReceiving inspection and/or testing

• Second or third party assessments or auditsSecond or third party assessments or audits

• Part evaluation by a designated laboratoryPart evaluation by a designated laboratory

• Another method agreed with the customerAnother method agreed with the customer



• 7.4.3.2 Supplier monitoring:7.4.3.2 Supplier monitoring:– Supplier monitoring Supplier monitoring shall beshall be monitored monitored

through:through:• Delivered part quality performanceDelivered part quality performance

• Customer disruptions including field returnsCustomer disruptions including field returns

• Delivery schedule performanceDelivery schedule performance

• Special status customer notifications related to Special status customer notifications related to quality or delivery issuesquality or delivery issues


Production and service Provision:Production and service Provision:7.5.1 Control of production & service 7.5.1 Control of production & service

provisionprovision

• The organisation The organisation shallshall plan and carry out plan and carry out production and service provision under production and service provision under controlled conditions that controlled conditions that shallshall include, as include, as applicable;applicable;

a.a. The availability of information that describes the The availability of information that describes the characteristics of the productcharacteristics of the product

b.b. The availability of work instructionsThe availability of work instructionsc.c. The use of suitable equipmentThe use of suitable equipmentd.d. The availability and use of monitoring and measuring The availability and use of monitoring and measuring

devicesdevicese.e. The implementation of monitoring and measurementThe implementation of monitoring and measurementf.f. The implementation of release, delivery and post delivery The implementation of release, delivery and post delivery

activitiesactivities



• 7.5.1.1 Control Plan7.5.1.1 Control Plan– Organization Organization shallshall::

• Develop control plansDevelop control plans

• Have a control plan for pre-launch and productionHave a control plan for pre-launch and production

– The control plan The control plan shallshall::• List the controls used for the manufacturing processList the controls used for the manufacturing process

• Include methods for monitoring special characteristicsInclude methods for monitoring special characteristics

• Include customer required informationInclude customer required information

• Initiate the specified reaction plan when the process is Initiate the specified reaction plan when the process is unstable.unstable.



• 7.5.1.2 Work Instructions:7.5.1.2 Work Instructions: The organization The organization shallshall prepare documented work instructions for all prepare documented work instructions for all employees having responsibilities for the employees having responsibilities for the operation of the processes.operation of the processes.

• 7.5.1.2 Verification of Job set-ups7.5.1.2 Verification of Job set-ups– ShallShall be verified whenever performed be verified whenever performed

– Work instructions Work instructions shall beshall be available for set-up available for set-up personnelpersonnel



• 7.5.1.4 Prevention and predictive maintenance:7.5.1.4 Prevention and predictive maintenance:– The organization The organization shallshall identify key process equipment identify key process equipment

and provide a planned preventive maintenance system:and provide a planned preventive maintenance system:• Planned maintenance activitiesPlanned maintenance activities

• Packaging and preservation of equipment, toolingPackaging and preservation of equipment, tooling

• Availability of replacement parts for key manufacturing Availability of replacement parts for key manufacturing equipmentequipment

• Documenting, evaluating and improving maintenance Documenting, evaluating and improving maintenance objectives.objectives.



• 7.5.1.5 Management of production tooling:7.5.1.5 Management of production tooling:– Shall Shall provide resources for tool and guage design, fabrication and provide resources for tool and guage design, fabrication and

verificationverification– Shall Shall establish a system for production tooling management:establish a system for production tooling management:

• Maintenance and repair facilities and personnel Maintenance and repair facilities and personnel • Storage and recoveryStorage and recovery• Set-upSet-up• Tool-change programs for perishable toolsTool-change programs for perishable tools• Tool design modification documentationTool design modification documentation• Tool modification and revision to documentationTool modification and revision to documentation• Tool identification, defining the status, production repair or Tool identification, defining the status, production repair or

disposaldisposal

– ShallShall implement a system to monitor these activities if any work is implement a system to monitor these activities if any work is outsourcedoutsourced



• 7.5.1.6 Production scheduling: 7.5.1.6 Production scheduling: shall shall be scheduled to be scheduled to meet customer requirementsmeet customer requirements

• 7.5.1.7 Feedback of Information from service:7.5.1.7 Feedback of Information from service: a a process for communication of information process for communication of information shall shall be be established and maintainedestablished and maintained

• 7.5.1.8 Servicing agreement with customer: 7.5.1.8 Servicing agreement with customer: if there if there is a servicing agreement with the customer the is a servicing agreement with the customer the organization organization shallshall verify the effectiveness of: verify the effectiveness of:– Organization service centers,Organization service centers,– Any special purpose tools or measurement equipmentAny special purpose tools or measurement equipment– The training of servicing personnelThe training of servicing personnel


7.5.2 Validation of processes 7.5.2 Validation of processes for product and service for product and service

provisionprovision• The organisation The organisation shallshall validate any processes for validate any processes for

production and service provision where the production and service provision where the resulting output cannot be verified by resulting output cannot be verified by subsequent monitoring or measurement.subsequent monitoring or measurement.

• This includes any processes where deficiencies This includes any processes where deficiencies become apparent only after the product is in use become apparent only after the product is in use or the service has been delivered.or the service has been delivered.

• Validation Validation shallshall demonstrate the ability of these demonstrate the ability of these processes to achieve planned resultsprocesses to achieve planned results



7.5.2 Validation of processes for 7.5.2 Validation of processes for product and service provisionproduct and service provision..cont..cont

• The organisation The organisation shallshall establish establish arrangements for these processes arrangements for these processes including, as applicable;including, as applicable;

Defined criteria for review and approval of Defined criteria for review and approval of processesprocesses

Approval of equipment and qualification of Approval of equipment and qualification of personnelpersonnel

Use of specific methods and proceduresUse of specific methods and procedures Requirements for recordsRequirements for records Re-validation Re-validation


7.5.3 Identification & 7.5.3 Identification & TraceabilityTraceability

• The organisation The organisation shallshall identify, identify, where where appropriateappropriate**, the product by suitable means , the product by suitable means through product realizationthrough product realization

• The organisation The organisation shallshall identify the product status identify the product status with respect to monitoring and measuring with respect to monitoring and measuring requirementsrequirements

• Where traceability is a specified requirement, the Where traceability is a specified requirement, the organisation organisation shallshall control and record the unique control and record the unique identification of the product.identification of the product.

7.5.3.1: the words “where appropriate” do not apply


7.5.4 Customer property7.5.4 Customer property• The organisation The organisation shallshall exercise care with exercise care with

customer property while it is under the customer property while it is under the organisations control.organisations control.

• The organisation The organisation shallshall;;– IdentifyIdentify– VerifyVerify– ProtectProtect– Safeguard customer propertySafeguard customer property

• If any customer property is lost, damaged or If any customer property is lost, damaged or otherwise found to be unsuitable for use, this otherwise found to be unsuitable for use, this shallshall be reported to the customer and records be reported to the customer and records maintainedmaintained

7.5.4.1 Customer-owned production tooling: shall be permanently marked so that the ownership is visible and can be determined.


7.5.5 Preservation of product7.5.5 Preservation of product• The organisation The organisation shallshall preserve the conformity of preserve the conformity of

product during internal processing and delivery product during internal processing and delivery to the intended destination. to the intended destination.

• This preservation This preservation shallshall include; include;– IdentificationIdentification– HandlingHandling– PackagingPackaging– StorageStorage– ProtectionProtection

• Preservation Preservation shallshall also apply to the constituent also apply to the constituent parts of a productparts of a product

7.5.5.1 Storage and Inventory: stock shall be assessed at appropriate intervals. Organization shall use a stock rotation system like “FIFO”. Obsolete material shall be controlled.


7.6 Control of Monitoring and 7.6 Control of Monitoring and measuring devicesmeasuring devices

• The organisation The organisation shallshall determine the monitoring determine the monitoring and measurement to be taken and the monitoring and measurement to be taken and the monitoring and measuring devices needed to provide and measuring devices needed to provide evidence of conformity of product to determined evidence of conformity of product to determined requirementsrequirements

• The organisation The organisation shallshall establish processes to establish processes to ensure that monitoring and measurement can be ensure that monitoring and measurement can be carried out and are carried out in a manner that is carried out and are carried out in a manner that is consistent with the monitoring and measurement consistent with the monitoring and measurement requirementsrequirements



7.6 Control of Monitoring and 7.6 Control of Monitoring and measuring devices….measuring devices….contcont……• Where necessary to ensure valid results, Where necessary to ensure valid results,

measuring equipment measuring equipment shallshall;;a.a. Be calibrated or verified at specified intervals or prior to use, Be calibrated or verified at specified intervals or prior to use,

against national or international standardsagainst national or international standards• Where no such standards exist, the basis used for calibration or Where no such standards exist, the basis used for calibration or

verification shall be recordedverification shall be recorded

b.b. Be adjusted or re-adjusted as necessaryBe adjusted or re-adjusted as necessaryc.c. Be identified to enable calibration status to be determinedBe identified to enable calibration status to be determinedd.d. Be safeguarded from adjustments that would invalidate the Be safeguarded from adjustments that would invalidate the

measurement resultmeasurement resulte.e. Be protected from damage and deterioration during handling, Be protected from damage and deterioration during handling,

maintenance and storagemaintenance and storage

Continued next slide…Continued next slide…


7.6 Control of Monitoring and 7.6 Control of Monitoring and measuring devices….measuring devices….contcont…… Additionally, that organisation Additionally, that organisation shallshall assess and record assess and record

the validity of previous measuring results when the validity of previous measuring results when equipment is found not to conform to specified equipment is found not to conform to specified requirements.requirements.

The organisation The organisation shallshall take appropriate action on the take appropriate action on the equipment and any product affected.equipment and any product affected.

Records of the results of calibration and verification Records of the results of calibration and verification shallshall be maintained.be maintained.

When used in the monitoring and measurement of When used in the monitoring and measurement of specified requirements, the ability of computer software specified requirements, the ability of computer software to satisfy the intended application to satisfy the intended application shallshall be confirmed. be confirmed. This This shallshall be undertaken prior to initial use and be undertaken prior to initial use and reconfirmed as necessaryreconfirmed as necessary



• 7.6.1 Measurement system analysis: 7.6.1 Measurement system analysis: – statistical studies statistical studies shallshall be conducted to analyze be conducted to analyze

the variation in each type of measuring and test the variation in each type of measuring and test equipmentequipment

– ShallShall apply to measurement systems referenced apply to measurement systems referenced in the control planin the control plan

– Shall Shall conform to those in customer reference conform to those in customer reference manualsmanuals



• 7.6.2 Calibration records: 7.6.2 Calibration records: – Records of the calibration Records of the calibration shall shall include:include:

• Equipment identificationEquipment identification• Revisions from engineering changesRevisions from engineering changes• Any out-of-specification readingsAny out-of-specification readings• An assessment of the impact of the out-of-An assessment of the impact of the out-of-

specificationspecification• Statements of conformance to specStatements of conformance to spec• Notification to the customer is suspect product has Notification to the customer is suspect product has

been shipped.been shipped.


Additional Automotive Requirements Additional Automotive Requirements – 7.6.3 Laboratory Requirements– 7.6.3 Laboratory Requirements• 7.6.3.1 Internal Laboratory:7.6.3.1 Internal Laboratory:

– Shall Shall have a defined scope that includes its capability to have a defined scope that includes its capability to perform the required inspection, test or calibration perform the required inspection, test or calibration services. services.

– Scope Scope shall shall be included in the QMS documentationbe included in the QMS documentation– ShallShall comply with: comply with:

• Adequacy of laboratory proceduresAdequacy of laboratory procedures• Qualifications of the laboratory personnel conducting testsQualifications of the laboratory personnel conducting tests• Testing of the commoditiesTesting of the commodities• Capability to performs tests correctly traceable to standardCapability to performs tests correctly traceable to standard• Review of related quality recordsReview of related quality records


Additional Automotive Requirements Additional Automotive Requirements – 7.6.3 Laboratory Requirements– 7.6.3 Laboratory Requirements• 7.6.3.2 External Laboratory:7.6.3.2 External Laboratory:

– Shall Shall have a defined scope that includes its have a defined scope that includes its capability to perform the required inspection, capability to perform the required inspection, test or calibration services. test or calibration services.

• Shall Shall be accredited to ISO/IEC 17025 or equivalent be accredited to ISO/IEC 17025 or equivalent oror

• Shall Shall be evidence that the lab is acceptable to the be evidence that the lab is acceptable to the customercustomer





Measurement, Analysis and Measurement, Analysis and Improvement:Improvement:8.1 General8.1 General

1.1. The organisation The organisation shallshall plan and implement plan and implement the monitoring, measurement, analysis and the monitoring, measurement, analysis and improvement processes needed;improvement processes needed;

a.a. To demonstrate conformity of the productTo demonstrate conformity of the product

b.b. To ensure conformity of the QMSTo ensure conformity of the QMS

c.c. To continually improve the effectiveness of the To continually improve the effectiveness of the QMSQMS

2.2. This This shallshall include determination of include determination of applicable methods, including statistical applicable methods, including statistical techniques and the extent of their use.techniques and the extent of their use.



• 8.1.1 Identification of statistical tools: 8.1.1 Identification of statistical tools: appropriate tools for each process appropriate tools for each process shallshall be be determined during advanced quality determined during advanced quality planning and included in the control planplanning and included in the control plan

• 8.1.2 Knowledge of basic statistical 8.1.2 Knowledge of basic statistical concepts:concepts: shallshall be understood and utilized be understood and utilized throughout the organizationthroughout the organization


Monitoring and measurement:Monitoring and measurement:8.2.1 Customer satisfaction8.2.1 Customer satisfaction

• The organisation The organisation shallshall monitor monitor information relating to customer information relating to customer perception as to whether the perception as to whether the organisation has fulfilled customer organisation has fulfilled customer requirements.requirements.

• The methods for obtaining and using The methods for obtaining and using this information this information shallshall be determined be determined



• Customer satisfaction – Supplemental:Customer satisfaction – Supplemental: shall shall be continually evaluated. be continually evaluated. Performance indicators includePerformance indicators include– Delivered part quality performanceDelivered part quality performance– Customer disruptions including field returnsCustomer disruptions including field returns– Delivery schedule performanceDelivery schedule performance– Customer notification related to quality or Customer notification related to quality or

delivery issuesdelivery issues


8.2.2 Internal Audit8.2.2 Internal Audit

• The organisation The organisation shallshall conduct internal conduct internal audits at planned intervals to determine audits at planned intervals to determine whether the QMS;whether the QMS;

a.a. Conforms to planned arrangements, to the Conforms to planned arrangements, to the requirements of this international standard requirements of this international standard and to the QMS requirements established by and to the QMS requirements established by the organisationthe organisation

b.b. Is effectively implemented and maintainedIs effectively implemented and maintained

Continued next slide…Continued next slide…


8.2.2 Internal Audit 8.2.2 Internal Audit …cont..…cont..

• An audit program An audit program shallshall be planned, taking into be planned, taking into consideration;consideration;

The status of the importance of the activity being auditedThe status of the importance of the activity being audited Results of previous auditsResults of previous audits

• The audit criteria, scope, frequency and methods The audit criteria, scope, frequency and methods shallshall be be defineddefined

• The process of selection of auditors and auditors The process of selection of auditors and auditors themselves shall ensure objectivity and impartiality of the themselves shall ensure objectivity and impartiality of the audit process.audit process.

• Auditors Auditors shallshall not audit their own work. not audit their own work.

• Continued next slide…Continued next slide…


8.2.2 Internal Audit 8.2.2 Internal Audit …cont..…cont..

• The responsibilities and requirements for The responsibilities and requirements for planning and conducting audits, and for planning and conducting audits, and for reporting results and maintaining records reporting results and maintaining records shallshall be defined in a documented procedure.be defined in a documented procedure.

• The management responsible for the area being The management responsible for the area being audited audited shallshall ensure that actions are taken ensure that actions are taken without undue delay to eliminate detected without undue delay to eliminate detected nonconformities and their causes.nonconformities and their causes.

• Follow up activities Follow up activities shallshall include the include the verification of the actions taken and the verification of the actions taken and the reporting of verification results.reporting of verification results.



• 8.2.2.1 Quality management system audit:8.2.2.1 Quality management system audit: shallshall audit the QMS to verify compliance with this TS and audit the QMS to verify compliance with this TS and additional QMS requirementsadditional QMS requirements

• 8.2.2.2 Manufacturing process audit:8.2.2.2 Manufacturing process audit: shallshall audit audit each manufacturing process to determine each manufacturing process to determine effectivenesseffectiveness

• 8.2.2.3 Product audit:8.2.2.3 Product audit: shall shall audit products at audit products at appropriate stages of production and delivery to very appropriate stages of production and delivery to very conformance to all specified requirements conformance to all specified requirements (e.g.dimensions, functionality, packaging and (e.g.dimensions, functionality, packaging and labeling)labeling)



• 8.2.2.4 Internal Audit plans:8.2.2.4 Internal Audit plans: audits audits shallshall cover quality management related cover quality management related processes, activities and shifts, and processes, activities and shifts, and shallshall be be scheduled according to an scheduled according to an annualannual plan plan

• 8.2.2.5 Internal auditor qualification: 8.2.2.5 Internal auditor qualification: auditors auditors shallshall be be qualifiedqualified to audit the to audit the requirements of this technical specificationrequirements of this technical specification


8.2.3 Monitoring & 8.2.3 Monitoring & Measurement of processesMeasurement of processes

• The organisation The organisation shallshall apply suitable methods for apply suitable methods for monitoring and, where applicable, measurement monitoring and, where applicable, measurement of the QMS processes.of the QMS processes.

• These methods These methods shallshall demonstrate the ability of demonstrate the ability of the processes to achieve planned resultsthe processes to achieve planned results

• When planned results are not achieved, When planned results are not achieved, correction and preventive action correction and preventive action shallshall be taken, be taken, as appropriate, to ensure conformity of productas appropriate, to ensure conformity of product


Additional Automotive RequirementsAdditional Automotive Requirements• 8.2.3.1 Monitoring and measurement of 8.2.3.1 Monitoring and measurement of

manufacturing processes:manufacturing processes:– ShallShall perform process studies on all new manufacturing perform process studies on all new manufacturing– ShallShall maintain manufacturing process capability or maintain manufacturing process capability or

performance as specified by the customerperformance as specified by the customer• Measurement techniquesMeasurement techniques• Sampling plansSampling plans• Acceptance criteria, andAcceptance criteria, and• Reaction plans when acceptance criteria are not metReaction plans when acceptance criteria are not met

– Significant process events Significant process events shallshall be noted on control charts be noted on control charts– Shall Shall initiate a reaction plan for unstable or non-capable initiate a reaction plan for unstable or non-capable

characteristicscharacteristics


8.2.4 Monitoring & 8.2.4 Monitoring & measurement of productmeasurement of product• The organisation The organisation shallshall monitor and measure the monitor and measure the

characteristics of the product to verify that product characteristics of the product to verify that product requirements are fulfilled.requirements are fulfilled.

• This This shallshall be carried out at appropriate stages of product be carried out at appropriate stages of product realization in accordance with planned arrangementsrealization in accordance with planned arrangements

• Evidence of conformance with the acceptance criteria Evidence of conformance with the acceptance criteria shallshall be be maintained. Records maintained. Records shallshall indicate person(s) authorising indicate person(s) authorising release of productrelease of product

• Product release and service delivery Product release and service delivery shallshall not proceed until all not proceed until all the planned arrangements have been satisfactorily completed, the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where unless otherwise approved by a relevant authority, and where applicable by the customer.applicable by the customer.



• 8.2.4.1 Layout inspection and functional 8.2.4.1 Layout inspection and functional testing:testing: a layout inspection and a functional a layout inspection and a functional verification verification shallshall be perform for all products be perform for all products

• 8.2.4.2 Appearance items:8.2.4.2 Appearance items: for products that are for products that are “appearance items” the organization “appearance items” the organization shallshall provide: provide:– Appropriate resources including lightingAppropriate resources including lighting– Masters for color, grain, gloss, metallic brilliance, Masters for color, grain, gloss, metallic brilliance,

texture, distinctness of image (as appropriatetexture, distinctness of image (as appropriate– Maintenance of appearance masters Maintenance of appearance masters – Verification that “qualified” personal are usedVerification that “qualified” personal are used


8.3 Control of Nonconforming 8.3 Control of Nonconforming productproduct

• The organisation The organisation shallshall ensure that product that does not ensure that product that does not conform to product requirements is identified and conform to product requirements is identified and controlled to prevent unintended use or delivery.controlled to prevent unintended use or delivery.

• The controls are related to responsibilities and authorities The controls are related to responsibilities and authorities for dealing with nonconforming product for dealing with nonconforming product shallshall be defined in be defined in a documented procedurea documented procedure



8.3 Control of Nonconforming 8.3 Control of Nonconforming product….contproduct….cont

• The organisation The organisation shallshall deal with nonconforming deal with nonconforming product by one or more of the following methods;product by one or more of the following methods;– By taking action to eliminate the detected By taking action to eliminate the detected

nonconformitynonconformity– By authorising its use, release or acceptance under By authorising its use, release or acceptance under

concession by a relevant authority and where applicable concession by a relevant authority and where applicable by the customerby the customer

– By taking action to preclude its original intended use or By taking action to preclude its original intended use or applicationapplication



8.3 Control of Nonconforming 8.3 Control of Nonconforming product….contproduct….cont

• Records of the nature of nonconformities and any Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, subsequent actions taken, including concessions obtained, shallshall be maintained. be maintained.

• When nonconforming product is corrected, it When nonconforming product is corrected, it shallshall be be subject to re-verification to demonstrate conformity to the subject to re-verification to demonstrate conformity to the requirementsrequirements

• When nonconforming product is detected after delivery or When nonconforming product is detected after delivery or use has started, the organisation use has started, the organisation shallshall take action take action appropriate to the effects, or potential effects, of the appropriate to the effects, or potential effects, of the nonconformitynonconformity



• 8.3.1 Control of nonconforming product: 8.3.1 Control of nonconforming product: product with unidentified or suspect status product with unidentified or suspect status shall shall be classified as nonconforming be classified as nonconforming

• 8.3.2 Control of reworked product: 8.3.2 Control of reworked product: Instruction for rework, including re-Instruction for rework, including re-inspection requirements, inspection requirements, shallshall be accessible be accessible to and utilized by the appropriate personnelto and utilized by the appropriate personnel



• 8.3.3 Customer information: 8.3.3 Customer information: customers customers shallshall be be informed promptly in the event that nonconforming informed promptly in the event that nonconforming product has been shipped.product has been shipped.

• 8.3.4 Customer waiver:8.3.4 Customer waiver:– ShallShall obtain customer concession or deviation prior to obtain customer concession or deviation prior to

processing the orderprocessing the order– Shall Shall maintain a record of the expiration date.maintain a record of the expiration date.– shallshall adhere to the original spec at expiration adhere to the original spec at expiration– Also applies to purchased product; the organization Also applies to purchased product; the organization shallshall

agree with any requests from suppliers before submission agree with any requests from suppliers before submission to customerto customer


8.4 Analysis of data8.4 Analysis of data• The organisation The organisation shallshall determine, collect and analyse determine, collect and analyse

appropriate data to demonstrate the suitability and appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual effectiveness of the QMS and to evaluate where continual improvement of the QMS can be made.improvement of the QMS can be made.

• This This shallshall include data generated as a result of monitoring include data generated as a result of monitoring and measurement and from other relevant sources.and measurement and from other relevant sources.

• The analysis of data The analysis of data shallshall provide information relating to; provide information relating to;

a.a. Customer satisfactionCustomer satisfactionb.b. Conformance to product requirementsConformance to product requirementsc.c. Characteristics and trends of processes and products Characteristics and trends of processes and products

including opportunities for preventive actionincluding opportunities for preventive actiond.d. supplierssuppliers



• 8.4.1 analysis and use of data:8.4.1 analysis and use of data:– Trends in quality and operational performance Trends in quality and operational performance shallshall be be

compared with progress toward objectivescompared with progress toward objectives• Development of priorities for prompt solutions to customer-Development of priorities for prompt solutions to customer-

related problemsrelated problems

• Determination of key customer-related trends and correlation Determination of key customer-related trends and correlation to support status review, decision making and longer term to support status review, decision making and longer term planningplanning

• An information system for the timely reporting of product An information system for the timely reporting of product information arising from usage.information arising from usage.


Improvement:Improvement:8.5.1 Continual Improvement8.5.1 Continual Improvement

• The organisation The organisation shallshall continually continually improve the effectiveness of the QMS improve the effectiveness of the QMS through the use of the;through the use of the;

– Quality Policy Quality Policy – Quality objectivesQuality objectives– Audit resultsAudit results– Analysis of dataAnalysis of data– Corrective and preventive actionCorrective and preventive action– Management reviewManagement review



• 8.5.1.1 Continual improvement of the 8.5.1.1 Continual improvement of the organization: organization: the organization the organization shallshall define define a process for continual improvementa process for continual improvement

• 8.5.1.2 Manufacturing process 8.5.1.2 Manufacturing process improvement: improvement: Continual improvement Continual improvement shallshall focus on control and reduction of focus on control and reduction of variation in product characteristics and variation in product characteristics and manufacturing process parameters.manufacturing process parameters.


8.5.2 Corrective Action8.5.2 Corrective Action• The organisation The organisation shallshall take action to eliminate the cause take action to eliminate the cause

of nonconformities in order to prevent recurrence.of nonconformities in order to prevent recurrence.

• Corrective actions Corrective actions shallshall be appropriate to the effects of be appropriate to the effects of the nonconformities encounteredthe nonconformities encountered

• A documented procedure A documented procedure shallshall be established to define be established to define requirements for;requirements for;

a.a. Reviewing nonconformities (including customer complaints)Reviewing nonconformities (including customer complaints)b.b. Determining the causes of nonconformitiesDetermining the causes of nonconformitiesc.c. Evaluating the need for action to ensure that Evaluating the need for action to ensure that

nonconformities do not recurnonconformities do not recurd.d. Determining and implementing the actions neededDetermining and implementing the actions needede.e. Records of results of action takenRecords of results of action takenf.f. Reviewing corrective action takenReviewing corrective action taken



• 8.5.2.1 Problem solving:8.5.2.1 Problem solving: the organization the organization shallshall have a defined process for problem have a defined process for problem solving leading to root cause identification solving leading to root cause identification and eliminationand elimination

• 8.5.2.2 Error-proofing: 8.5.2.2 Error-proofing: the organization the organization shallshall use error-proofing methods in their use error-proofing methods in their corrective action process.corrective action process.


Additional Automotive RequirementsAdditional Automotive Requirements

• 8.5.2.3 Corrective action impact: 8.5.2.3 Corrective action impact: the organization the organization shallshall apply to other similar processes and products apply to other similar processes and products the corrective action, and controls implemented, to the corrective action, and controls implemented, to eliminate the cause of a nonconformity.eliminate the cause of a nonconformity.

• 8.5.2.4 Rejected product test/analysis:8.5.2.4 Rejected product test/analysis: – the organization the organization shallshall analyze parts rejected by the analyze parts rejected by the

customer’s manufacturing plantscustomer’s manufacturing plants– The organization The organization shallshall minimize the cycle time for this minimize the cycle time for this

activityactivity– The organization The organization shallshall perform analysis and initiate perform analysis and initiate

corrective action to prevent recurrence.corrective action to prevent recurrence.


8.5.3 Preventive action8.5.3 Preventive action• The organisation The organisation shallshall take action to eliminate the cause take action to eliminate the cause

of potential nonconformities in order to prevent of potential nonconformities in order to prevent occurrence.occurrence.

• Preventive actions Preventive actions shallshall be appropriate to the effects of be appropriate to the effects of the potential problemsthe potential problems

• A documented procedure A documented procedure shallshall be established to define be established to define requirements for;requirements for;

• Determining potential nonconformities and their Determining potential nonconformities and their nonconformitiesnonconformities

• Evaluating the need for action to prevent occurrence of Evaluating the need for action to prevent occurrence of nonconformities nonconformities

• Determining and implementing action neededDetermining and implementing action needed

• Records of results of action takenRecords of results of action taken

• Reviewing preventive action takenReviewing preventive action taken



Activities before the auditActivities before the auditSupplier Responsibilities - at starting pointSupplier Responsibilities - at starting point

• Provide Registrar basic information regarding products

and/or employees• Provide Registrar “Operational Performance Trends” for the last

twelve months minimum• Scope of Certification

• Product Design Responsibility

• Sites to be registered

• Remote Locations

• Quality Systems Certifications obtained

• Quality Manual - for each site


Activities before the auditActivities before the auditSupplier Responsibilities - at starting Supplier Responsibilities - at starting pointpoint

• Internal Audit and Management Review planning and results fromInternal Audit and Management Review planning and results from

previous twelve monthsprevious twelve months• List of Qualified Internal AuditorsList of Qualified Internal Auditors

• List of Customers and Customer Specific RequirementsList of Customers and Customer Specific Requirements

• Customer Complaints ManagementCustomer Complaints Management


Design ResponsibilityDesign ResponsibilityThere are only two options:There are only two options:

1.1. Supplier Responsibility (could be sub-contracted)Supplier Responsibility (could be sub-contracted)

2.2. Customer ResponsibilityCustomer Responsibility

For sub contracted design, the auditor must verify that both For sub contracted design, the auditor must verify that both

supplier and design subcontractors have appropriate capabilitysupplier and design subcontractors have appropriate capability

to meet element 4.4 requirements in its totality, including to meet element 4.4 requirements in its totality, including

interfaces between suppliers and sub contractorsinterfaces between suppliers and sub contractors


Other activities Other activities Registrar Responsibilities - at starting Registrar Responsibilities - at starting pointpoint

• Analysis of information provide by supplier to determine Analysis of information provide by supplier to determine

a. The appropriate scope of Registrationa. The appropriate scope of Registration

b. Readiness for on-site auditb. Readiness for on-site audit

• Preliminary audit is an optional activity- only one allowed!Preliminary audit is an optional activity- only one allowed!

• Preliminary audit is not to be considered part of registration auditPreliminary audit is not to be considered part of registration audit

• Time spent for Preliminary audit will not reduce audit days Time spent for Preliminary audit will not reduce audit days

requirementrequirement• In case of insufficient readiness to conduct initial audit, the process can In case of insufficient readiness to conduct initial audit, the process can

be stopped by supplier in consultation with registrarbe stopped by supplier in consultation with registrar• This aspect is to be recorded by registrar in its databaseThis aspect is to be recorded by registrar in its database


Other activities Other activities Registrar Responsibilities - Audit Registrar Responsibilities - Audit Planning & ExecutionPlanning & Execution• Compliance to specified on-site audit days requirementCompliance to specified on-site audit days requirement

• Initial Audit to be completed within 3 months of document reviewInitial Audit to be completed within 3 months of document review

• Multiple visits for initial audit not acceptableMultiple visits for initial audit not acceptable

• At least two auditors on team if the audit exceeds 4 Mandays - atAt least two auditors on team if the audit exceeds 4 Mandays - at

least one of initial audit team to participate in all visits in the cycleleast one of initial audit team to participate in all visits in the cycle• Communication of Monthly Audit Plan to IATFCommunication of Monthly Audit Plan to IATF• ISO/TS/16949 checklist to be used for each siteISO/TS/16949 checklist to be used for each site

• Scope in Audit Report to list products and customer specificScope in Audit Report to list products and customer specific

requirements with revision numberrequirements with revision number• Report to be handed over within 15 days of the audit completion-Report to be handed over within 15 days of the audit completion-

Report may also be sought by IATF - contract to provide for thisReport may also be sought by IATF - contract to provide for this


Audit Mandays for certification to Audit Mandays for certification to ISO/TS/16949ISO/TS/16949

Audited Entity Initial Audit Surveillance Audits Re-certification AuditNumber of Employees (On Site mandays) (Years 1 & 2) (Year 3)

(On-site mandays (On Site mandays)within each 12Month Period)

1-15 2 2 216-30 4 2 231-60 5 3 361-100 6 3 4101-250 8 4 5251-500 10 5 7501-1000 12 6 81001-2000 15 7 102001-4000 18 9 12

>4001 21 11 14


Comments on the Audit Mandays ChartComments on the Audit Mandays Chart

• A manday is considered to be eight working hours exclusive ofA manday is considered to be eight working hours exclusive of

travel, breaks etc.travel, breaks etc.• On-site review of corrective actions arising from initial audit areOn-site review of corrective actions arising from initial audit are

not included included in the chartnot included included in the chart• 50% reduction in initial audit days admissible for upgrade audits50% reduction in initial audit days admissible for upgrade audits

from current automotive certificates from IATF recognized from current automotive certificates from IATF recognized

certification bodies, provided the scope is unchanged.certification bodies, provided the scope is unchanged.• 100% of audit days to be done in case of a change in scope100% of audit days to be done in case of a change in scope

• Upgrades are applicable only if the registrar is the sameUpgrades are applicable only if the registrar is the same

• On-site mandays may be reduced by 15% for non design capableOn-site mandays may be reduced by 15% for non design capable

supplierssuppliers• Reductions in mandays are possible for Corporate / Multi-siteReductions in mandays are possible for Corporate / Multi-site

activitiesactivities


Non Conformity ManagementNon Conformity ManagementSupplier ResponsibilitySupplier Responsibility

• Perform Root Cause Analysis and take corrective actions withinPerform Root Cause Analysis and take corrective actions within

three months from the end of the site visitthree months from the end of the site visit

• Verify corrective actions and provide a supplementary reportVerify corrective actions and provide a supplementary report

• Follow up visit to verify implementation of Corrective Action\Follow up visit to verify implementation of Corrective Action\

within 90 days of handing over of audit report (if reqd.)within 90 days of handing over of audit report (if reqd.)• Certification decision taken if all issues are resolved 100%Certification decision taken if all issues are resolved 100%

Registrar ResponsibilityRegistrar Responsibility


ISO/TS/16949 Certificate – ISO/TS/16949 Certificate – Some Content RequirementsSome Content Requirements

• Scope statement to include all products and services being supplied Scope statement to include all products and services being supplied

to all customers subscribing to this documentto all customers subscribing to this document• Standard Reference, certificate validity and exclusionsStandard Reference, certificate validity and exclusions

• Reference to assessment in accordance to “Rules for the registration Reference to assessment in accordance to “Rules for the registration

scheme for ISO/TS/16949 certification bodies - Second Edition”scheme for ISO/TS/16949 certification bodies - Second Edition”• List and scope of every registered site (for multi sites) as well asList and scope of every registered site (for multi sites) as well as

remote locationsremote locations• IATF logoIATF logo


Status of Acceptance of Status of Acceptance of ISO/TS/16949 by ISO/TS/16949 by

Automotive OEM’sAutomotive OEM’s


Acceptance of ISO/TS/16949Acceptance of ISO/TS/16949

Daimler Chrysler, Ford & GMDaimler Chrysler, Ford & GM

• Letters sent out to suppliers recognize ISO/TS/16949 as a Letters sent out to suppliers recognize ISO/TS/16949 as a

sanctioned alternative to QS-9000.sanctioned alternative to QS-9000.BMW GroupBMW Group

• In future, a quality standard in accordance with ISO/TS/16949 will be In future, a quality standard in accordance with ISO/TS/16949 will be

required in the international purhasing conditions. However, the supplier is required in the international purhasing conditions. However, the supplier is

generally free to chose an automotive quality standardgenerally free to chose an automotive quality standard


Acceptance of ISO/TS/16949Acceptance of ISO/TS/16949FiatFiat

• In a letter to all suppliers, ISO/TS/16949 was introduced as a new In a letter to all suppliers, ISO/TS/16949 was introduced as a new

quality standard. The ISO/TS/16949 is recognized immediately as an quality standard. The ISO/TS/16949 is recognized immediately as an

equal quality standard and with effect from the 1st July 2000 a equal quality standard and with effect from the 1st July 2000 a

certification in accordance with ISO/TS/16949 will be compulsory for all certification in accordance with ISO/TS/16949 will be compulsory for all

new and expired 3rd party certificatesnew and expired 3rd party certificatesBoschBosch

• As soon as the ISO/TS/16949 is uniformly required/ recognized by all As soon as the ISO/TS/16949 is uniformly required/ recognized by all

car manufacturers, Bosch will press forward with the realization in its car manufacturers, Bosch will press forward with the realization in its

own production plants and require the application of the ISO/TS16949 own production plants and require the application of the ISO/TS16949

from all its suppliersfrom all its suppliers


Acceptance of ISO/TS/16949Acceptance of ISO/TS/16949

VolkswagenVolkswagen

• ISO/TS/16949 is now acceptable for US and Canada based suppliers ISO/TS/16949 is now acceptable for US and Canada based suppliers

as an alternative to VDA 6.1 third-party registrationas an alternative to VDA 6.1 third-party registration

What about the future?What about the future?


Questions….?Questions….?

Iso16949 new

Automotive

documents

documents

advancedquality

2002additional

2002additional

supporting

emphasizing

2002additional