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7 RECORDS All
records generated in this process shall be filed and maintained by MR for a period of five (3) years. 8
ASSOCIATED DOCUMENTS: • Corrective Action Request • Car Status Log 9 REVISION HISTORY REVISION
NO TYPE OF REVISION DATE 0 Initial Issu
We begin the New Year with a review of Clause 4.16 Control of Quality Records.
Four additional ISO Clauses remain and the series will be completed. However,
with the introduction of ISO 9001:2000, the series will continue with
comparisons and updates to help you and your company better understand
QS9000-2000 requirements and conversion from ISO 9000 1994 documentation.
ISO 9001-2000 Second Committee Draft (CD) has been available since February
1999 (see the March 1999 issue of MoldMaking Technology magazine.) The Draft
International Standard ISO 9001-2000 will be available for purchase January 15,
2000.
Introduction
ANSI/ISO/ASQ Q9000-2-1997 states: "The supplier's quality records should give
evidence that quality system elements falling within the requirements of Q9001-2
or 9003 have been implemented. If the results have not proved satisfactory,
quality records should indicate what has been done to correct the situation."
The approach for control of quality records is to identify the records required in
each of your procedures to support or provide objective evidence that the
procedure has been followed. It is suggested that you develop one procedure to
comply with Clause 4.16.
The following list of clauses is provided to identify Clause 4.16 quality record
requirements.
4.1.3 Management Review
4.2.3 Quality Planning
4.3 Contract Review
4.4.5 Design Output
4.4.6 Design Review
4.4.7 Design Verification
4.6.2 Acceptable Subcontractors
4.7 Control of Customer Supplied Product
4.8 Product Traceability
4.9 Process Control
4.10.2.3 Urgent Production Release
4.10.4 Final Inspection & Testing
4.10.5 Inspection and Test Records
4.11.1 Control of Inspection, M & T Equipment
4.11.2.e Control Procedure
4.13.2 Review and Disposition Nonconforming Product
4.14.1 Corrective/Preventive Action
4.14.2 b Results of Nonconforming Work
4.16 Subcontractor Quality Records
4.17 Internal Quality Audits Training
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"The supplier shall establish and maintain documented procedures for
identification, collection, indexing, access, filing, storage, maintenance and
disposition of quality records."