The absence of a system means that there is neither any provision within the docu-
mented management system nor there is any practice being implemented that com-
plies with the requirement.
A total breakdown of a system means that there is provision within the documented
management system that complies with the requirement but no evidence was found of
its implementation.
If an auditor finds one example in one process where one requirement ISO/TS 16949
is not being implemented but if he or she were to look elsewhere, evidence of conform-
ity would be found; there is no justification for a major nonconformity unless, noncon-
forming product would be shipped. Emphasis is on the word ‘would’ because if there
were stages downstream where the nonconformity would be detected it is simply not
an issue. Apart from the first definition of a major nonconformity, the others quite sen-
sibly regard all the nonconformities as having an impact on the product.
A failure of the quality management system arises where nonconforming product is
shipped. It is not where a signature is missing from a document or some obscure record
cannot be found. The focus should always be on results and capability rather than rules.
Regarding minor nonconformities, if you are doing what you say you will do, a minor
nonconformity would be justified.
In all the cases you will need to submit root cause analysis with the solution for its elim-
ination meaning that the analysis has to go beyond specific incidents.
ISO/TS 16949 and the EU
This is an extract from EU Directive 92/53/EEC of June 18, 1992 amending the
Directive 70/156/EEC governing the type-approval of motor vehicles and their
trailers. It must be assumed that Directive will be amended shortly to address ISO
9001:2000.
“The approval authority of a Member State must verify, before granting type-approval,
the existence of satisfactory arrangements and procedures for ensuring effective con-
trol so that components, systems, separate technical units or vehicles when in production
conform to the approved type. The approval authority must also accept the manufac-
turer’s registration to harmonized standard, EN 29002 (whose scope covers the product(s)
to be approved) or an equivalent accreditation standard as satisfying the requirements
of Point 1.1. The manufacturer must provide details of the registration and undertake to
inform the approval authority of any revisions to its validity or scope”.
Role, origins and application of ISO/TS 16949 109
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