C
Chris_Anderson
Re: ISO 9001:2008 Required Procedures
ISO 9001 Six Required Procedures
Clause 4 Documents (2 procedures)
1) 4.2.3 Document Control
2) 4.2.4 Record Control
Clause 8 CAPA (4 procedures)
3) 8.2.2 Internal Audit
4) 8.3 Nonconforming Product Control
5) 8.5.2 Corrective Action
6) 8.5.3 Preventive Action
ISO 9001 21 Required Records
1) 5.6.1 Records from management reviews (minutes, results, actions)
2) 6.2.2 (e) Education, training, skills and experience records/files.
Clause 7 Product Realization (14 records)
3) 7.1 (d) Evidence that the realization processes and resulting product fulfill requirements.
4) 7.2.2 Results of the review of requirements relating to the product and actions arising from the review.
5) 7.3.2 Design and development inputs.
6) 7.3.4 Results of design and development reviews and any necessary actions.
7) 7.3.5 Results of design and development verification and any necessary actions.
8) 7.3.6 Results of design and development validation and any necessary actions.
9) 7.3.7 Results of the review of design and development changes and any necessary actions.
10) 7.4.1 Results of supplier evaluations and actions arising from evaluations.
11) 7.5.2 (d) As required by the company to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement.
12) 7.5.3 The unique identification of the product, where traceability is a requirement.
13) 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use.
14) 7.6 (a) Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist.
15) 7.6 Validity of previous results when measuring equipment is found not to conform with its requirements.
16) 7.6 Results of calibration and verification of measuring equipment
Clause 8 CAPA (5 records)
17) 8.2.2 Internal audit results.
18) 8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product.
19) 8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained.
20) 8.5.2 Results of corrective actions.
21) 8.5.3 Results of preventive actions.
Welcome to the Cove.
There were no substantive changes in the 2008 version, so the documentation requirements are the same. In addition to the six you cite, 4.2.1 says that you must also have "... documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes."
ISO 9001 Six Required Procedures
Clause 4 Documents (2 procedures)
1) 4.2.3 Document Control
2) 4.2.4 Record Control
Clause 8 CAPA (4 procedures)
3) 8.2.2 Internal Audit
4) 8.3 Nonconforming Product Control
5) 8.5.2 Corrective Action
6) 8.5.3 Preventive Action
ISO 9001 21 Required Records
1) 5.6.1 Records from management reviews (minutes, results, actions)
2) 6.2.2 (e) Education, training, skills and experience records/files.
Clause 7 Product Realization (14 records)
3) 7.1 (d) Evidence that the realization processes and resulting product fulfill requirements.
4) 7.2.2 Results of the review of requirements relating to the product and actions arising from the review.
5) 7.3.2 Design and development inputs.
6) 7.3.4 Results of design and development reviews and any necessary actions.
7) 7.3.5 Results of design and development verification and any necessary actions.
8) 7.3.6 Results of design and development validation and any necessary actions.
9) 7.3.7 Results of the review of design and development changes and any necessary actions.
10) 7.4.1 Results of supplier evaluations and actions arising from evaluations.
11) 7.5.2 (d) As required by the company to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement.
12) 7.5.3 The unique identification of the product, where traceability is a requirement.
13) 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use.
14) 7.6 (a) Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist.
15) 7.6 Validity of previous results when measuring equipment is found not to conform with its requirements.
16) 7.6 Results of calibration and verification of measuring equipment
Clause 8 CAPA (5 records)
17) 8.2.2 Internal audit results.
18) 8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product.
19) 8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained.
20) 8.5.2 Results of corrective actions.
21) 8.5.3 Results of preventive actions.
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