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Foreword Introduction 0.1 General0.2 Quality Management Principles0.3 Process Approach 0.3.1 General0.3.2 Plan_Do_Check_Action Cycle0.3.3 Risk-based thinking0.4 Relationship with other MS standardsQMS Requirements 1. Scope2. 3. 4. 4.1 Reference Terms Context4.2 Needs & expect of interested parties4.3 Determine the scope of QMS4.4 QMS and its processes 4.4.14.4.2 documented information for process5. Leadership 5.1 5.1.1 General5.1.2 Customer focus5.2 Policy 5.2.1 Establishing policy5.2.2 Communicating the quality policy5.3 Roles, responsibility & authority6 Planning 6.1.1 Actions to address risk6.2 objectives & planning to achieve6.3 Planning of changes7 Support 7.1 resources 7.1.1 7.1.27.1.4 Environment for the operation7.1.5 Monitoring & measuring resource7.1.5.2 Measurement traceability7.1.6 Organizational knowledge7.2 Competence7.3 Awareness7.4 Communication7.5 Documented information 7.5.17.5 Documented information 7.5.17.5.2 Creating and updating7.5.3 Documented Information Control I7.5.3 Control of Document II8. Operation 8.1 Operation Plan & Contro8.2.1 Customer Communication8.2.2 Determine the Requirements for pro8.2.3 Review8.2.4 Changes8.3.1 General8.3.2 Design and Development8.3.3 Inputs of Design and Development8.3.4 Design and Development Controls8.3.5 Design and Development Outputs8.3.6 Design & Development Changes8.4.1 General8.4.3 Type and extent of Control8.4.3 Information for External Providers8.5.1 Control of Production8.5.2 Identification and Traceability8.5.3 Property of Customer or EP8.5.4 Preservation8.5.5 Post-delivery activities8.5.6 Control of ChangesRelease of Products and Services8.7 Control of NC Outputs8.7.2 Retain Documented Information9. Performance evaluation 9.1.19.1.2 Customer Satisfaction9.1.3 Analysis and Evaluation9.2 Internal Audit
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