ISO 13485 checklist
ISO 13485 audit include checklists as follows:
1. Management commitment
O 13485 audit checklist about Management commitment
Clause 5.1
1. How does top management communicate the importance of meeting customer and legal requirements to the organization?
2. Quality policy
ISO 13485 audit checklist about Quality policy
Clause 5.3
1. How does top management ensure that the quality policy is appropriate to the purpose of the organization?
3. Planning
ISO 13485 audit checklist about planning
Clause 5.4
5.4.1 Quality objectives
4. Responsibility, authority and communication
ISO 13485 audit checklist about responsibility, authority and communication
Clause 5.5
5. Management review
ISO 13485 audit checklist about management review
Clause 5.6
5.6.1 General
6. Resource management
Clause 6.0
6.1 Provision of resources
7. Planning of product realization
Clause 7.1
1. Where are the processes needed for product realization identified?
8. Customer-related processes
Clause 7.2
7.2.1 Determination of requirements related to the product
9. Design and development
Clause 7.3
7.3.1 Design and development planning
10. Purchasing management
Clause 7.4
7.4.1 Purchasing process
11. Management commitment
Clause 5.1
1. How does top management communicate the importance of meeting customer and legal requirements to the organization?
12. Quality policy
Clause 5.3
1. How does top management ensure that the quality policy is appropriate to the purpose of the organization?
13. Planning
Clause 5.4
5.4.1 Quality objectives
14. Responsibility, authority and communication
ISO 13485 audit checklist about responsibility, authority and communication
Clause 5.5
15. Management review
Clause 5.6
5.6.1 General
16. Resource management
Clause 6.0
6.1 Provision of resources
17. Planning of product realization
Clause 7.1
1. Where are the processes needed for product realization identified?
18. Customer-related processes
Clause 7.2
7.2.1 Determination of requirements related to the product
19. Design and development
Clause 7.3
7.3.1 Design and development planning
20. Purchasing management
Clause 7.4
7.4.1 Purchasing process
21. Control of production and service provision
ISO 13485 audit checklist about control of production and service provision
Clause 7.5.1
22. Validation of processes for production and service provision
ISO 13485 audit checklist about validation of processes for production and service provision
Clause 7.5.2
23. Identification and traceability
Clause 7.5.3
7.5.3.1 Identification
24. Customer property
Clause 7.5.4
1. Do you use any customer-owned property? (Product, packaging, drawings, tooling, gages…)
25. Control of monitoring and measuring devices
ISO 13485 audit checklist about control of monitoring and measuring devices
Clause 7.6
26. General of measurement, analysis and improvement
ISO 13485 audit checklist about general of measurement, analysis and improvement
Clause 8.1
27. Monitoring and measurement
Clause 8.2
8.2.1 (Customer satisfaction) Feedback
28. Control of nonconforming product
Clause 8.3
1. How do you ensure that nonconforming products are identified and controlled to prevent unintended use or delivery?
29. Analysis of data
Clause 8.4
1. What data is collected and analyzed to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of its effectiveness can be made?
30. ISO 13485 audit checklist about improvement
Clause 8.5
8.5.1 (Continual improvement) General
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