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Saturday, May 1, 2010

guidance for ISO 9001: Documentation requirements


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Iso 9001:2008: Guidance on Documentation Requirements

05.01.2010 · Posted in Document Management

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.

The procedures that are required to be documented are:

Clause 4.2.3 Control of documents
Clause 4.2.4 Control of records
Clause 8.2.2 Internal audit
Clause 8.3 Control of nonconforming product
Clause 8.5.2 Corrective action
Clause 8.5.3 Preventive action

For an organization who wishes to optimise its quality management system’s documentation, it is sufficient to maintain these six procedures only. Other processes need only to have records that provide evidence of implementation, conformance and effectiveness. Quality records may come in various forms, such as meeting minutes, filled-up forms, reports, technical drawings, tags, et cetera. The main purpose of the quality management system is its effectiveness in meeting customer requirements. Although ISO 9001 gives much flexibility to the documentation aspect of the quality management system, it is still supportive in nature. It is not the focal point.

Ismail Latiff is a management consultant who lives and works in Kuala Lumpur, Malaysia. His field of expertise is in ISO 9001 Quality Management System. He writes extensively on ISO 9001 on his website ISO 9001:2008 | Guidance on documentation requirements. He also provides a fully-compliant documentation suite to complement the ISO 9001:2008 requirements.

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