The 21 records required by ISO9001:2000

Implementing an ISO9001:2000 quality management system means you’ll be keeping some records that you probably don’t already keep. Some of these records may seem a little confusing until you become more familiar with the quality standard.

Some of these, such as records relating to design and development, may not apply to your organization if you don’t design anything. Maybe you only distribute products, or you’re trying to get ISO certification for your convenience store. (Hey, it could happen.) In this case, you can specifically exclude yourself from section 7.3 Design and Development, and you won’t have to keep the associated records.

And, of course, you might decide to keep more records than are listed here, if you feel your organization needs them. But as I always preach, keep your system as simple as possible. The fewer documents and records you keep, the fewer things that will be audited, and the more time you’ll have to actually run your business.

Also keep in mind that you are free to combine some of these records where it makes sense. For example, I always combine the Corrective Action Request and Preventive Action Request records, with a simple checkbox to note which one it is. I also combine both CAR and PAR’s onto one form, again with a check box to designate if its a Corrective or Preventive action request.

Here then is the list of 21 records required by ISO9001:2000. Please note this is a list of the records you’ll be required to keep. This does not deal with required documents (quality manual, quality procedures, etc.) which is a whole different topic.

Clause Record required
5.6.1 Management reviews
6.2.2 (e) Education, training, skills and experience
7.1 (d) Evidence that the realization processes and resulting product fulfil requirements
7.2.2 Results of the review of requirements related to the product and actions arising from the review
7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions
7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations
7.5.2 (d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
7.5.3 The unique identification of the product, where traceability is a requirement
7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
7.6 (a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product.
8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2 Results of corrective action
8.5.3 Results of preventive action

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2 Responses to “The 21 records required by ISO9001:2000”

  1. bsrao says:

    this is realy very useful for starting of ISO. Hope these records are mandatory for maintaining the system very effectively and efficiently.

  2. dekorasyon says:

    Well designed template thanks for sharing it.

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