Taken from:
ISO/TS16949:2002 Expectations and Guidance for
Certification and Surveillance audits
(a) On-Site Readiness Review (Stage 1 audit):
The readiness review is an on-site audit to determine if the organization is ready for the stage 2 conformance audit. The outcome of the readiness review will be a determination that the organization is or is not ready. No nonconformances will be documented.
To prepare for the readiness review the organization will be requested to complete the Readiness Review form TSF-019-2k. The lead auditor will review the TSF-019-2k to ensure that it is complete prior to the on-site audit.
The following list is summarized in the TSF-019-2k and will be reviewed during the on-site readiness review. If any of this information is not present, then the readiness review will result in the conclusion of not ready.
1) Quality Manual and Procedures for each site audited:
The quality manual must contain the scope of the quality management system, including justification for exclusions. Product design is the only permissible exclusion and can only be taken for non-design responsible organizations.
The quality manual must contain documented procedures OR reference to them.
The quality manual must contain a description of the interaction between the processes of the quality management system. AQA requires a graphical description that includes Core processes, management processes, and support processes.
2) 12 months of evidence of Key indicators & performance trends, including:
· Customer satisfaction
· Customer field returns, complaints, disruptions, and status
· Delivered Part or Service Quality including stop shipment
notifications and warranty issues
· On time delivery
· customer specific performance results
· Employee motivation and awareness
· Continual Improvement issues
· Supplier performance
3) Internal Audits for the past 12 Months including completed audits to TS16949:2002
4) List of Qualified Internal Auditors & Qualification
5) Management Reviews for Last 12 Months. (Note, management review must include a review of the TS16949 internal audit results)
6) Other customer metrics or operational performance trends for Last 12 Months
7) Customer specific requirements (e.g. supplier quality manuals, OEM, contained in purchase orders)
The auditor will review this information to determine if the organization is ready for a conformance audit and that the scope of certification is appropriate.
If the required items are NOT present and complete, then the Stage 1 audit shall judge the organization “not ready.” If during the Stage 1 audit obvious major nonconformances with respect to the organization’s effective implementation of the management system are found, the organization shall be judged “not ready.” A “not ready” determination will result in another readiness review.
No nonconformances will be identified during the readiness review. However, areas of concern that would result in a nonconformance during the stage 2 conformance will be identified.
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