lo nuevo y diferente de iso ts 4

8/12/2019 Lo Nuevo y Diferente de ISO TS 4

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By Tripp Martin

30 Exploring ISO/TS 16949:2002

Editors note: The following article is an excerpt from a new AIAG document under develop-ment. The new document (working title,ISO/TS 16949:2002 ImplementationGuideline) should be available through AIAG

rst quarter 2003.

The long awaited release of ISO/TS16949:2002, coupled with the Daimler-Chrysler requirement for its supplybase to be third-party certied by July 1,2004, has sparked interest in understand-ing the revised Technical Specication.Automotive suppliers are asking:

What is new in ISO/TS 16949:2002?

What is different from both QS-9000Third Edition and ISO/TS 16949:1999?How should I modify my systems to

meet the new requirements?What opportunity does ISO/TS

16949:2002 present for my quality man-agement system?

One of the strengths of the new tech-nical specification is that it is alignedwith the process-based approach of ISO9001:2000, said Joe Bransky, IATF mem-ber. The process approach is enhancedin an automotive context. This enhance-ment reects consistency with the way auto-motive organizations operate.

The focus on product realization andthe process approach is the way we do busi-ness. We think there was legitimacy tothe complaint that the quality system auditwas too oriented to procedures based on anelement-by element assessment, Branskycontinued. What we have in the auto-motive single process approach is anapproach that sets up an audit trail basedon the line of sight from the agreed upon

customer requirements to the operatorinstructions, and back to what was deliv-ered to the customer. Its a better correla-tion with the way a manufacturing productbusiness operates.

Branskys comments give us somestarting points from which to begin our

examination of ISO/TS 16949:2002.It is based upon ISO 9001:2000.It is focused upon product realization

and the process approach.It seeks a line of sight through the

organization that focuses upon the customer.

Based uponISO 9001:2000,not ISO 9001:1994

ISO 9001:1987 (the original issue of thestandard) was aimed at all businesses, fromlarge corporations to the one- or two-person company. The 1994 revision addedsignificant requirements that were com-patible with manufacturing companies, butdid not really fit service organizations.Furthermore, ISO 9001:1994 became socomplex and documentation-oriented thatthe small company was overburdened in itscompliance efforts. For many organizations,ISO 9001:1994 required effort that was notvalue-added.

ISO 9001:2000 returns the standardmodel to one that is exible enough to tall sizes and types of organizations.Signicantly more freedom in several areasencourages adoption of and certication tothe standard.

A number of new and different thingsin ISO/TS 16949:2002 come from thischange of the base ISO document. A sum-

mary of the major changes in ISO9001:2000 from ISO 9001:1994 includes:

Greater focus on the customer andcustomer satisfaction

New focus on the process approachvs. the elemental approach

Clarification of requirements forcontinual improvement

Greater emphasis on the role of topmanagement

Measurable quality objectives New requirements for data collection

and analysisReduced emphasis on documented

proceduresShift in emphasis from training toproviding competent people

Modication in the purpose of inter-nal audits

Lets briey review these changes:(1) Greater focus on the customer and

customer satisfaction. The heart of whatthe organization does is identied in ISO9001:2000 as Clause 7, Product Realization.This begins and ends with the customer.Clause 8, Measurement, Analysis andImprovement, requires measure of customersatisfaction.

(2) A new focus on the processapproach vs. the elemental approach.Most signicant in ISO 9001:2000 is thechange from the 20 elements of the 1994version to the five clauses of the ProcessModel.

(3) Clarification of requirements for continual improvement. Continualimprovement was viewed as a natural out-come of implementing an ISO 9001:1994compliant quality management system.

A helpful guide to understanding the newTechnical Specications revisions and changes.

Whats New (and Different!)in ISO/TS 16949:2002


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QS-9000 brought this requirement intosharper focus. ISO 9001:2000 continuesthis evolution and addresses continualimprovement requirements and actions inClauses 5.3, 5.4.1, 5.6, 8.2, 8.4, 8.5.2, and

8.5.3.(4) Greater emphasis upon the role of top management. The descriptive phrasemanagement with executive responsibil-ity (used in the 1994 version) has becomean elastic term. ISO 9001:2000 changes thisphrase to top management, which isdened in ISO 9000:2000 as a person orgroup of people who directs and controlsan organization (3.3.1) at the highest level.The 2000 version species what actions topmanagement must perform and what canbe delegated to others.

(5) Measurable quality objectives. ISO9001:2000 introduces a new feature calledquality objectives. Quality objectives arebased upon the quality policy and imple-mented at relevant functions and levelswithin the organization. Clause 5.4.2requires that the quality managementsystem is planned so that its effectivenesscan be measured and compared with thequality objectives.

(6) New requirements for data col-lection and analysis. ISO 9001:2000 hasadded requirements for data to be collect-ed and analyzed and the analyses used asthe basis for decisions. This approach isalready part of the automotive industry.

(7) Reduced emphasis on documented procedures. ISO 9001:1987 did not requiremuch documentation. The requirementwas for a system by which actions wereaccomplished. ISO 9001:1994 increasedthe requirements for documented proce-dures. The 2000 revision reduces thisrequirement to six documented procedures:

Control of documents;

Control of records;Planning and conducting internal

audits;Addressing nonconforming products;Corrective action; andPreventive action.

Now, the requirement is for a processthat can be audited. This change in docu-mentation emphasis provides one of thegreat opportunities for organizations imple-menting ISO 9001:2000-based qualitymanagement systems.

Exploring ISO/TS 16949:2002 31

Some New Language

A note on a language change in ISO/TS 16949:2002: The ISO 9001:1994language used to refer to the supply chain has been revised. The newImplementation Guide from AIAG will use the revised language, so thesechanges need to be highlighted:

ISO 9001:1994 Language ISO 9001:2000 Revised Language

Customer Customer

Supplier Organization

Subcontractor Supplier


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(8) Shift in emphasis from training to providing competent people. ISO 9001:1994focused on how to qualify people to per-form their work. Often, the focus was theinitial step of hiring. ISO 9001:2000 broad-ens this focus to how the organization pro-vides competentpeople that do work. Insteadof a gate through which only qualifiedpeople enter, ISO 9001:2000 requires acompetent workforce while work is beingperformed.

(9) Modication in the purpose of internal audi ts. There are three significantchanges in Clause 8.2.2 from Element4.17.1. First, the quality management sys-tem must be audited to the requirements of ISO 9001:2000, not just the plannedarrangements of the organization. Second,the internal audit is to ensure that thequality management system (QMS) is

effectively implemented by the top man-agement. ISO 9001:1994 required that theinternal auditor determine the effective-ness of the QMS. This is clearly the roleof top management in the managementreview. The internal audit checks the QMSimplementation, and the results go to themanagement review. The third change isthat the auditors can now audit in the areain which they workthey may not audittheir own specic work. This gives muchgreater freedom to very small companies.

In ISO/TS 16949:2002, the IATF adopt-ed a concept called Customer OrientedProcesses (COPs). COPs are referred to inthe Checklist to ISO/TS 16949:2002, whereit is stated, The IATF expects ISO/TS

16949:2002 auditors to audit based uponthe Customer Oriented Processes (COP).The COP is a model that was introducedby ISO 9001:2000 and refers to the fact thatany organization needs customer input tocomply to specied and expected needs of the customer (output) in order to achievecustomer satisfaction. This is accomplishedby value adding processes of product real-ization and appropriate support processes,both enabled by management processes andprovided resources.

. . . the Automotive Process Approach toauditing for ISO/TS 16949:2002 must notbe driven by a clause or a section drivenchecklist. Instead, the checklist shall be a toolto verify the completeness of the audit, whichmeans that the auditor shall audit all appli-cable requirements to an identied COP.

What Else isNew and Different?

Lets highlight several of the more sig-nicant items that are new or different inISO/TS 16949:2002:

(1) Clause 8.2.1.1 One of the keyclauses of ISO/TS 16949:2002 is 8.2.1.1 Customer Satisfaction Supplemental,which reads, Customer satisfaction withthe organization shall be monitored throughcontinual evaluation of performance of therealization processes. Performance indica-tors shall be based on objective data andinclude, but not be limited to:

Delivered part quality performance;Customer disruptions including eld

returns;Delivery schedule performance (includ-

ing incidents of premium freight); andCustomer notications related to qual-

ity or delivery issues.The organization shall monitor the

performance of manufacturing processes todemonstrate compliance with customerrequirements for product quality andefficiency of the process.

Customer satisfaction is a key conceptin ISO/TS 16949:2002 and is used by audi-tors (internal and third party) to evaluatethe organizations performance. The four

Product Realization andthe Process Approach

The process model in Figure 1 capturesthe two key points made by Bransky earli-er in this article. First, the organization existsto meet a customer need with a productof some kind. Instead of the QMS beingset upon a pedestal or an internal visionbeing the driver of the QMS, the processmodel claries that the QMS must be con-cerned, first and foremost, with meetingcustomer needs.

Additionally, companies do not operatein a certain number of silos of activity (e.g.,20). Companies must operate dynamical-ly to meet their customers needs. Theprocess model is not a number of verticalsilos with some other number of horizontalmultidisciplinary activities. Rather, it iscircular, with business processes beginning

and ending with the customer.

Line of Sight Throughthe Organization andCOPs

Line of sight refers to the idea that theproduct produced, the product realizationprocess and the management processes under-lying it all should be based upon customerrequirements. Another way of stating thisis that all activities should be value-added,where the customer denes value.

32 Exploring ISO/TS 16949:2002

Figure 1. Model of a Process-Based Quality Management System


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areas of objective data are related to the keymetrics existing on the Web sites of DaimlerChrysler, Ford Motor Company andGeneral Motors. Acceptable performanceon these Web sites is customer satisfaction,

and, per sub-clause 5.6.1.1, demonstratescustomer satisfaction with product supplied.(2) Clauses 4.2 & 7.5.1.2 Documen-

tation Requirements. Each organizationshould examine its own documentationstructure for opportunities such as:

Reducing the size and complexity ofthe quality manual. A compliant qualitymanual needs to have only three areascovered and can be quite short. The areasare (1) the QMS scope, (2) a reference tothe procedures and (3) a description of theinteractions between the QMS processes.

Eliminating non-value added docu-mentation. Many QS-9000-compliant com-panies have built documentation night-mares. The organizations have been askingfor relief from the document everythingsyndrome, and that relief is here withISO/TS 16949:2002. It requires seven doc-umented procedures and a laboratory doc-ument. While there are additional require-ments, the principal requirement is that youhave a process. It need not be documentedin most cases. You can run your shop oorsimilar to how you run your office. In par-ticular, work instructions appear pervasive.The ISO/TS 16949:2002 requirement isnot that every task has a work instruction;rather, it is the employee that must havea work instruction, and even then, only theemployee in the product realization process.

Be careful on how you word theQuality Policy and Quality Objectives.These are not to be visionary statements,but attainable goals with measures.

(3) Clause 7.3 Design andDevelopment Planning. Compared with

Element 4.4 in the 1994-based documents,the major change in this area is the sepa-ration of the product from the process bywhich you manufacture the product. UnderQS-9000, you could exclude all of Element4.4 (Design Control). This registered thesite at the ISO 9002 level. Manufacturingprocesses were then planned and reviewedunder Element 4.2, under APQP.

ISO/TS 16949:2002 allows scope exclu-sion of product design, but requires all of Clause 7.3 be applied to the manufactur-

ing process. This brings a much strongerfocus upon the manufacturing process thanwas present in QS-9000.

(4) Clause 7.4.1.2 Supplier Quality Management System Development. Since

QS-9000 Sanctioned Interpretation C9received so much attention stemming fromits apparent requirement that all suppliersbe third-party registered to an ISO standard-based requirements document (ISO 9001/9002, QS-9000, ISO/TS 16949:1999), organ-izations would naturally turn to the area of supplier development to understand whatrequirements exist for ISO/TS 16949:2002.

The debate is beginning over the mean-ing of the three sentences in this clause.In particular, the meaning of the thirdsentence is generating debate. Clause 7.4.1.2states, The organization shall performsupplier quality management system devel-opment with the goal of supplier conform-ity with this Technical Specification.Conformity with ISO 9001:2000 is the rststep in achieving this goal.

NOTE: The prioritization of suppliersfor development depends upon, for exam-ple, the suppliers quality performance andthe importance of the product supplied.

Unless otherwise specied by the cus-tomer, suppliers to the organization shall bethird-party registered to ISO 9001:2000 byan accredited third-party certication body.

The intent of this clause is that the organ-ization should implement a supplier devel-opment program, and it recommends con-formity to ISO 9001:2000 as the rst step.This conformity should be demonstrated bythird-party registration to ISO 9001:2000.The sentence also states that customerapproval may be otained by the use of analternative program, such as second-partyreviews. Cleary, the third sentence shouldnot be interpreted as requiring all suppli-

ers to be registered prior to an organizationsregistration to ISO/TS 16949:2002. Addi-tionally, the lack of a time requirement inthe third sentence should be understoodas giving the organization the exibility tofocus rst on the subsuppliers most impor-tant to customer satisfaction.

Tripp Martin is director of quality for sinteredvalve train and transmission products and North

American engine bearings for Federal-MogulCorporation.

Exploring ISO/TS 16949:2002 33

lo nuevo y diferente de iso ts 4

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