Guidance on Documentation Requirements

The ISO 9001:2008 standard is meant to be generic and applicable to all kinds of organizations. Therefore, organizations from both the public and private sectors, including non-governmental organizations can benefit from the ISO 9001 quality management system model, regardless of whether they are small, medium or large organizations. The immediate benefit that can be realized from the implementation of ISO 9001 is the collective alignment of the activities of internal processes that are focused towards the enhancement of customer satisfaction, which in turn will result in many other benefits, whether internal or external. The magnitude of these benefits are determined by how effective the processes are in achieving its objectives.

ISO 9001:2008 is not focused on the amount of documentation that must be established for the quality management system. The main objectives of an organization’s documentation are to provide a basis for communication of information, evidence of conformity and knowledge sharing. 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 of the ISO 9001:2008 standard explains that the quality management system documentation shall include:

-Documented statements of a quality policy and quality objectives;

-Quality manual;

-Documented procedures required by this International Standard;

-Documents needed by the organization to ensure the effective planning, operation and control of its processes, and

-Records required by this International Standard.