9001-2000 quality manual（pdf 15页）.pdfVIP

Company X Inc. Quality System Manual The following is an example systems manual from a low volume (TE, but not an automotive supplier) company. You will note that this is essentially a copy of ISO 9001:2000. I take this path because long ago I got tired of an auditor picking a phrase or line item out of the standard and ask where that item was addressed. Sometimes it was from a laundry list type of situation. The bottom line is they would mumble about the “…words aren’t there…”. An example is traceability. Many companies do no traceability – no need. But – you still have to address the issue by saying you recognize and understand the requirement and that your company sees no need for traceability. Consider the following from the 1994 version: 4.5.2 Document and data approval and issue The documents and data shall be reviewed and approved for adequacy by authorized personnel prior to issue. A master list or equivalent document control procedure identifying the current revision status of documents shall be established and be readily available to preclude the use of invalid and/or obsolete documents. This control shall ensure that: a) the pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed; b) invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use; c) any obsolete documents retained for legal and/or knowledge-preservation purposes are suitably identified. In one audit the auditor did a minor writeup because although line item ‘c’ was addressed (the system did this) but nowhere were the words: “…any obsolete documents retained for legal and/or knowledge-preservation purposes are suitably identified…” So – why get into a pissing match? Technically your quality manual may be a stat