ISO 9001:2008 Documentation Requirements

ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”

Clause 4.2.1 General explains that the quality management system documentation shall include:

a) documented statements of a quality policy and quality objectives;

b) a quality manual

c) documented procedures required by this International Standard

d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and

e) records required by this International Standard;

The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:

− the size of organization and type of activities;

− the complexity of processes and their interactions, and

− the competence of personnel.

All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.

Title: ISO 9001:2008 Documentation Requirements
Article From: ISO/TC 176/SC 2/N 525R2