50 Main points of ISO 9001-2015 Quality Management Standard

1. Scope: Defines the boundaries and applicability of the standard.

2. Normative References: Lists other standards and documents referenced in the standard.

3. Terms and Definitions: Provides definitions for key terms used throughout the document.

4. Context of the Organization: Requires understanding the organization and its context.

5. Understanding the Needs and Expectations of Interested Parties: Identifies and understands relevant stakeholders.

6. Determining the Scope of the Quality Management System: Defines the scope within the organization.

7. Quality Management System and Its Processes: Establishes, implements, maintains, and continually improves the QMS.

8. Leadership and Commitment: Top management must demonstrate leadership and commitment to the QMS.

9. Customer Focus: Ensures that customer requirements are understood and met.

10. Quality Policy: Establishes and maintains a quality policy.

11. Organizational Roles, Responsibilities, and Authorities: Defines and communicates roles and responsibilities.

12. Actions to Address Risks and Opportunities: Plans and implements actions to address risks and opportunities.

13. Quality Objectives and Planning to Achieve Them: Sets and plans quality objectives.

14. Planning of Changes: Ensures changes are planned in a systematic manner.

15. Resources: Determines and provides necessary resources.

16. People: Ensures competent personnel for the QMS.

17. Infrastructure: Provides and maintains the infrastructure needed.

18. Environment for the Operation of Processes: Determines and maintains a suitable environment.

19. Monitoring and Measuring Resources: Ensures valid and reliable monitoring and measurement.

20. Measurement Traceability: Ensures traceability of measurement equipment.

21. Organizational Knowledge: Maintains and makes available necessary knowledge.

22. Competence: Ensures personnel are competent.

23. Awareness: Ensures personnel are aware of the QMS requirements.

24. Communication: Determines and manages internal and external communications.

25. Documented Information: Controls the documented information required by the QMS.

26. Operational Planning and Control: Plans, implements, and controls the processes needed.

27. Requirements for Products and Services: Determines and reviews requirements for products and services.

28. Design and Development of Products and Services: Establishes, implements, and maintains a design and development process.

29. Control of Externally Provided Processes, Products, and Services: Ensures externally provided processes meet requirements.

30. Production and Service Provision: Controls production and service provision under controlled conditions.

31. Identification and Traceability: Identifies and traces products and services.

32. Property Belonging to Customers or External Providers: Takes care of property belonging to customers or external providers.

33. Preservation: Preserves products during production and service provision.

34. Post-Delivery Activities: Meets requirements for post-delivery activities.

35. Control of Changes: Controls changes during production and service provision.

36. Release of Products and Services: Ensures products and services are released under controlled conditions.

37. Control of Nonconforming Outputs: Identifies and controls nonconforming outputs.

38. Monitoring, Measurement, Analysis, and Evaluation: Monitors and measures processes and products.

39. Customer Satisfaction: Monitors customer perceptions of the degree to which their needs are met.

40. Internal Audit: Conducts internal audits to provide information on the QMS.

41. Management Review: Top management reviews the QMS at planned intervals.

42. Nonconformity and Corrective Action: Reacts to nonconformities and takes corrective actions.

43. Continual Improvement: Continually improves the suitability, adequacy, and effectiveness of the QMS.

44. Control of Documented Information: Controls documented information to ensure it is available and suitable for use.

45. Control and Monitoring of External Providers: Monitors the performance of external providers.

46. Evaluation of External Providers: Evaluates, selects, and monitors external providers.

47. Verification and Validation: Verifies and validates the processes, products, and services.

48. Process Approach: Manages processes using the PDCA cycle and risk-based thinking.

49. PDCA Cycle: Applies the Plan-Do-Check-Act cycle to processes and the QMS.

50. Risk-Based Thinking: Integrates risk-based thinking to manage risks and opportunities. These points summarize the key aspects of the ISO 9001:2015 standard.