This text is from the second edition of ISO 9001, The Standard Companion. It is based on the now obsolete 1987 version of the ISO 9001 Standard. The third edition, based on the current 1994 standard, is available from Simply Quality.

4.16 Quality Records

Maintain Records of System Use

Establish procedures for collecting, indexing, filing, maintaining and disposing of quality records. Keep records to demonstrate achievement of quality, and operation of the quality system. Be sure to keep records of supplier data.

Records must be legible and identify the product to which they pertain. Store them with retrieval and preservation needs in mind. Establish a policy for the length of time various types of records will be retained. If previously promised, the customer will have access to the records.


The Standard specifically requires (by use of the phrase "See 4.16" in each of the cited sections) retaining the following fourteen types of quality records:

Your procedures may establish the need for additional quality records. These records must be readily accessible during design, development and manufacture of the associated product. Afterwards, they can be archived to reduce storage costs. In either case, retention times must be established.

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