Context of the Organization in IATF 16949 - Determining the Scope

Posted in IATF 16949

dETERMINING THE sCOPE: Comparing the new IATF 16949 and the ISO 9001:2015 Standard with the old ISO/TS 16949:2009 Standard

IATF 16949

ISO/TS 16949:2009

ISO 9001:2015

4.3 Determining the scope of the quality management system

The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider:

3.a) the external and internal issues referred to in 4.1;

3.b) the requirements of relevant interested parties referred to in 4.2;

3.c) the    products    and    services    of    the organization

The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.

The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is notapplicable to the scope of its quality management system.

Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.

4.3.1 Determining the scope of the quality management system — supplemental

Supporting functions, whe
ther on-site

4.2.2 Quality manual

The organization shall establish and maintain a quality manual that includes

2.2.a) the scope of the quality management system, including details of and justification for any exclusions  (see 1.2),

Scope requirements are more explicit

Required Content

Types of products & services Application of all requirements from ISO 9001 that are applicable – if they have

activities/processes they are to be included Boundaries of the QMS

Justification for any exclusions

Scope determined by considering external & internal issues, requirements of interested parties & products & services

Automotive Specific:
Scope must include supporting functions, (remote and on-site).

Only permitted exclusion is product design and development and this

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