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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