I have been asked this question tens of times: What are the documents (procedures and records) aside the quality manual that ISO 9001:2000 requires and considers as mandatory? Well, the standard requires 6 procedures and 21 records. Depending on your system, the implementation of some of the records might be not applicable, (exclusions are here a typical example: for instance, if you are excluding Design from your scope, associated records will no longer be mandatory). Here is the complete list with the associated clause number where the standard requires it:
Mandatory procedures:
4.2.3 Document control procedure-
4.2.4 Records procedure -
8.2.2 Internal audit procedure -
8.3 Control of non-conformance procedure -
8.5.2 Corrective action procedure -
8.5.3 Preventive action procedure
Mandatory records:
5.6.1 Management review minutes6.2.2 Records of education, training, skills and experience7.1 Evidence that the realization processes and product fulfill requirements7.2.2 Records of sales activities7.3.2 Design and development inputs7.3.4 Design and development reviews and any related actions7.3.5 Design and development verification and any related actions7.3.6 Design and development validation and any related actions7.3.7 Design and development changes and any related actions7.4.1 Results of supplier evaluations and any actions arising7.5.2 Records to demonstrate the validation of special processes7.5.3 Where traceability is required, the unique identification of the product7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable7.6 Basis used for calibration of measuring equipment where no international or national standards exist7.6 Validity of the previous measuring results when measuring equipment is found to be out of calibration7.6 Results of calibration and verification of measuring equipment8.2.2 Internal audit results and follow-up actions8.2.4 Indication of the person(s) authorizing release of product8.3 Records of the product nonconformities and any subsequent actions8.5.2 Results of corrective action8.5.3 Results of preventive action
See also - Voir aussi :
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it’s worth to mention that exclusions are limited to clause 7!
Yes, we can only address sub clauses of the clause 7 (product realization) for exclusions. Excluded sub clauses should be taken as a ‘Whole’, for example if we choose to exclude design, the whole 7.3 should be addressed and not some of its sub clauses (7.3.1 or 7.3.3 for instance). Exclusions have to be justified, the justifications should be proved.
hi there,
is there any change with version 2008 in these required documents?
Abby, actually there’s not difference in the mandatory documents.
2008 is just a revision of 2000, changes (new requirements) are very few, the rest is only clarifications of 2000′s version.
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Have a look also on The Official Interpretation Sheets of ISO9001:2000
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