ISO 9001 Clause 4: Quality management system

“Management works in the system; Leadership works on the system.”


Stephen R. Covey (Management consultant, Writer of The 7 Habits of Highly Effective People) 





The quality management system requirements are defined in following clause


5. Management responsibility,
6. Resource management,
7. Product realization
8. Measurement, analysis and improvement


while clause 4 of ISO 9001 covers documentation requirement and requirements for control of documents and records.
Clause 4 has two sub clauses:


4.1 General Requirements
4.2 Documentation requirements


Following picture shows how the requirements (processes) of clause 5. Management responsibility, 6. Resource management, 7. Product realization, and 8. Measurement, analysis and improvement are interrelated.


 


Process Interaction





External Document Reference: Documentation Kit


Quality Manual Section: QMS Processes and their interaction

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