Documentation requirements
An important change in the procedural requirements for the ISO 9000 standard is the fact that the number of
specifically required documents procedures have changed as follows:
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4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of non-conforming product
8.5.2 Corrective action
8.5.3 Preventive action
While the number of required documented procedures has reduced, it does not mean that organizations will
be able to forgo documentation or its control. More responsibility is placed on the organization to decide
which documents it will need to ensure the fact of planning, operation, and control of its processes. Also
required is that the organization identify the processes needed for the quality management system and the
application of these processes as well as their sequence and interactions. The documentation system must
also include the documented statements of a quality policy, quality objectives, quality manual, and records
as required by the standard.
When determining the amount of documentation needed, the organization should base its decision on the
size of the organization, the complexity of its activities and the processes as well as the competence of its
personnel. It should also be noted that documentation might be any type of media, including hard copy
or electronic versions. With many organizations moving toward electronic methods, controls must be
established and implemented.