The ISO 9001 requirements are broadly separated into eight sections (called ISO 9001 clauses), five of which contain mandatory requirements for a QMS: 1. General Quality Management System requirements (clause 4) 2. Management Responsibility (clause 5) 3. Resource Management (clause 6) 4. Product Realization (clause 7) 5. Measurement, Analysis and Improvement (clause 8).
All elements of these five clauses are mandatory with the exception of the Product Realization section, which allows for a company to exclude portions that are not applicable. Clauses 1 through 3 include no requirements, but instead deal with the scope of the standard, references to understand the standard better, and terms and definitions.
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