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4.2.1 General

ISO 9001 require organization to document down the necessary process. Documentation is a tool to help us to run our quality management system and its processes more effectively. In fact, we don’t have to document everything but we should make more effort to keep the number of documents to a minimum level so that we keep only those necessary and import documents to run our business. Always remember, “write what you do and do what you write”. So, don’t just create a set document for ISO audit purpose.  Use it wisely to improve the effectiveness and efficiency of QMS.

The QMS documentation must include:


  1. Organization’s Quality Policy and Quality Objective
  2. Quality Manual
  3. Documented Procedures (note 1) required by ISO 9001 QMS
  4. Work Instruction or Inspection Standard
  5. Quality Records and Forms


Documents and records required by the organization must ensure effective planning, operation and control process.


ISO 9001 Clause 4.2.2 Quality Manual

4.2.2 Quality Manual

To summarize the “Documentation Requirements” in ISO 9001 QMS, please refer to picture shows above. The diagram shows the relationship between different types of documents. The higher level documents have more authority than the lower level documents. This means that, Quality Manual must align to Quality Policy set by Top Management. Procedures must meet the requirements spelled out in the Quality Manual. Work Instruction must follow the procedures’ requirements.


The top level documents are more broad and general in term of contents. In vice versa, lower level documents are more detail and use for daily processes.


Note 1: where the term “documented procedure” appears in the ISO 9001 standard mean that the procedure must established, documented, implemented and maintained by requirement of ISO 9001 standard.


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