ISO9

In the ISO 9000 Standard, quality records are kept to demonstrate conformance to specified requirements and to the effective operation of the Quality Management System (QMS). The ISO Standard clearly mandates that certain things must be recorded and treated as "quality records." These quality records can be considered the minimum required under any quality system that complies with the standard. Samples of quality records include part specifications, engineering changes, training course descriptions, product specifications, contract reviews, corrective action Requests, nonconformances and others.

When quality records are created as a consequence of a work instruction, the work instruction must list those quality records. A "record,” of any kind, is a document that furnishes objective evidence of activities performed or results achieved. Its nature is to capture something that has already happened. The "specified requirements" are those that apply to the product. The quality record must also demonstrate the effective operation of the QMS.

For example, a newly created test procedure is not a quality record, although generally it is a controlled document. It becomes a quality record when it is used to record the steps executed during a specific test to establish that the product met requirements. Similarly, a design drawing generally is not a quality record, although generally it is a controlled document. However, it becomes a quality record when it is part of a review package that establishes that the design was verified (i.e. evidence of effective operation of the QMS).

In both these cases, when the document in question (e.g. procedure, drawing) becomes a quality record, it loses its active nature and becomes fixed. The procedure or drawing that lives on to serve further purposes is not the same entity as the one that is set aside as a quality record. Similar logic can be applied to other instances.

From the standpoint of ISO audits, registrars may not be in a position to observe compliance with a specific quality procedure. As such, an authentic "quality record" may be the next best form of objective evidence. Any number of employees in an organization may generate quality records, which will need to be retrieved frequently for internal audits and registration audits.

The organization itself has the latitude (and responsibility) to determine which records are the most authentic and most comprehensive for the features that must be documented. For instance, there may be two or three records that may document the satisfaction of a particular requirement. The organization may designate which of the multiple records should be retained as the primary quality record to prove satisfaction of that requirement. The supplemental records need not be retained as the official or designated proof.