Control of ISO 9000 records

Control of ISO 9000 records

The ISO 9000 standard requires records to be established and maintained to provide evidence of conformity to requirements and the effective operation of the quality management system.
A record is defined in ISO 9000 as a document stating results achieved or providing evidence of activities performed.

Although a record is a document, the document control requirement of clause 4.2.3 do not apply to records primarily because records are not issued, neither do they exhibit revision status simply because they are results that are factual when recorded. If the facts change, a new record is usually created rather than the previous record revised. Even where a record is revised and new facts added, the old facts remain identified as to their date. The only reason for revising facts contained in a record without changing the identity of the record or the date when they were collected is where the facts were incorrectly recorded. This subtle difference demands different treatment for documents that are classed as records to those that are classed as informative. As with other types of documents, records result from processes and may be used as inputs to other processes.

Records required by the management system means records used or generated by the management system. There is therefore no requirement to produce records solely to satisfy an auditor. The records required are those for the effective operation of the organization’s processes (see clause 4.1d of ISO 9001). If a record has no useful purpose within the management system there is no requirement that it be established or maintained.

This does not mean that a record is required to prove conformity with every single requirement for every product and service. There are those records required by the standard (see below) that are required for every product and service where applicable and in all other cases, audit records showing compliance on a sample of operations would be sufficient.

Compliance with many requirements can be demonstrated by observation, analysis, interview or examination of documentation. If a result or an activity is not required to be recorded in order to manage the organization effectively nd satisfy the interested parties, it is not necessary to maintain records of it.