Control of ISO 9000 records

The standard requires records to be established and
maintained to provide evidence of conformity to require-
ments and the effective operation of the quality manage-
ment 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
and satisfy the interested parties, it is not necessary to maintain records of it.