ISO/TS16949 audit checklist about documentation requirements
ISO/TS16949 audit checklist about documentation requirements
Clause 4.2
4.2.1 Does the quality management system documentation include the following:
a) documented statements of a quality policy and quality objectives
b) a quality manual?
c) Documented procedures required by ISO/TS16949:2002?
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes?
e) Records required by ISO/TS16949:2002 (see element 4.2.4)
4.2.2 QUALITY MANUAL
Has the organization established and maintained a quality manual that includes:
a) the scope of the quality management system, including details of and justification for any exclusions (see section 1.2 of ISO/TS16949:2002)?
b) The documented procedures established for the quality management system, or reference to them?
c) A description of the interaction between the processes of the quality management system?
4.2.3 CONTROL OF DOCUMENTS
Does the organization control the documents required by the quality management system?
4.2.4 Has the organization established a documented procedure to define controls needed:
a) to approve documents for adequacy prior to issue?
b) To review and update as necessary and re-approve documents?
c) To ensure that changes and the current revision status of documents are identified?
d) To ensure that relevant versions of applicable documents are available at points of use?
e) To ensure that documents remain legible and readily identifiable?
f) To ensure that documents of external origin are identified and their distribution controlled?
g) To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?
4.2.5 Does the organization have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes (including the updating of appropriate documents) based on customer required schedule?
4.2.6 Does the organization maintain a record of the date on which each change is implemented in production?
4.2.4 CONTROL OF RECORDS
4.2.7 Has the organization established and maintained records to provide evidence of conformity to requirements and of the effective operation of the quality management system?
4.2.8 Are records legible, readily identifiable and retrievable?
4.2.9 Has the organization established a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records?
4.2.10 Does the organization treat quality records as a special type of document and control them according to the requirements given in questions 4.2.7 and 4.2.8?
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