The new revision of the ISO 9001 quality management system standard has been simplified so that it is equally applicable to the quality management system of small as well as medium and large organizations. ISO 9001:2008 allows flexibility in the way you document your quality management system.

Clause 4.2.1 General explains that the quality management system documentation shall include:

-    A Quality policy.
-    Quality objectives.
-    A Quality manual.
-    Documented procedures required by the Standard.
-    Documents needed by the organisation to ensure the effective planning, operation and control of its processes, and records required by the Standard.

The quality management system standard ISO 9001 defines the requirements for control of the quality management system documentation in clause 4.2.4. Records should be established to provide evidence of the effective operation of the quality management system and compliance with the ISO 9001 standard.

There should be a documented procedure to define the controls for identification, storage, protection, retrieval, retention and disposition of records. The system should ensure that records are legible, readily identifiable and retrievable.

Records specifically required by ISO 9001:2008 are listed below:

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

Other records will almost certainly be needed to demonstrate conformity of your processes, products and quality management system.