Guidance

Plan your management system

The ISO Navigator™ database hyperlinks the ISO 9000 principles and the ISO 9001 requirements; and explains them in plain English with practical guidance.

ISO 9001: Documentation requirements 4.2

Documents and records are an important organizational asset. They provide the primary route for evidence based verification and traceability in order to demonstrate compliance with customer requirements.

There is an urban myth that procedures must spell out everything in minute detail in case someone falls under a bus. This is a hangover from the Defence standards and has NEVER been a requirement of ISO 9001. 

The answers to these questions will influence the amount of documentation required. The modern way of documenting a quality system this is to have lightweight procedures balanced by heavy training records, which demonstrate competence.

Also, think about having flow-charts instead of text. You can draw adequate flow-charts using Word ‘s auto-shapes. Whether you use text or flow-charts, generally aim (in artistic terms) for an impressionist painting, rather than a detailed engineering blue-print.

  1. General requirements 4.2.1
  2. Quality manual 4.2.2
  3. Control of documents 4.2.3
  4. Control of records 4.2.4

Looking for help with your quality documentation? Our quality manual template provides a great foundation for establishing, implementing and documenting the six mandatory procedures that are required by the standard.