Iso 9001:2008: Guidance on Documentation Requirements

The ISO 9001:2008 standard is meant to be generic- Quality manual;
and applicable to all kinds of organizations. - Documented procedures required by this
Therefore, organizations from both the public andInternational Standard;
private sectors, including non-governmental- Documents needed by the organization to ensure
organizations can benefit from the ISO 9001 qualitythe effective planning, operation and control of its
management system model, regardless of whetherprocesses, and
they are small, medium or large organizations.  The- Records required by this International Standard.
immediate benefit that can be realized from the 
implementation of ISO 9001 is the collective alignmentThe procedures that are required to be documented
of the activities of internal processes that areare:
focused towards the enhancement of customer- Clause 4.2.3 Control of documents
satisfaction, which in turn will result in many other- Clause 4.2.4 Control of records
benefits, whether internal or external.  The- Clause 8.2.2 Internal audit
magnitude of these benefits are determined by how- Clause 8.3 Control of nonconforming product
effective the processes are in achieving its- Clause 8.5.2 Corrective action
objectives. - Clause 8.5.3 Preventive action
ISO 9001:2008 is not focused on the amount of 
documentation that must be established for theFor an organization who wishes to optimise its quality
quality management system.   The main objectivesmanagement system's documentation, it is sufficient
of an organization’s documentation are toto maintain these six procedures only.  Other
provide a basis for communication of information,processes need only to have records that provide
evidence of conformity and knowledgeevidence of implementation, conformance and
sharing.   Clause 4.1 General requirements requireseffectiveness.  Quality records may come in various
an organization to “establish, document,forms, such as meeting minutes, filled-up forms,
implement, and maintain a quality managementreports, technical drawings, tags, et cetera.  The
system and continually improve its effectiveness inmain purpose of the quality management system is
accordance with the requirements of thisits effectiveness in meeting customer requirements. 
International Standard”.  Clause 4.2.1 General ofAlthough ISO 9001 gives much flexibility to
the ISO 9001:2008 standard explains that the qualitythe documentation aspect of the quality
management system documentation shall include:management system, it is still supportive in nature. 
- Documented statements of a quality policy andIt is not the focal point.
quality objectives;