Quality Manual Mandatory Sops: List of Documents Required For Qms 17025:2017

You might also like

Download as docx, pdf, or txt
Download as docx, pdf, or txt
You are on page 1of 1

LIST OF DOCUMENTS REQUIRED FOR QMS 17025:2017

A. Quality manual
B. Mandatory SOPs
1. Document and Record Control Procedure (Clauses 8.2.1, 8.3 & 8.4)
2. Quality Policy (Clauses 8.2.1 & 8.2.2)
3. Competence, Training and Awareness Procedure (Clause 6.2.5)
4. Externally Provided Products and Services Procedure (Clause 6.6.2)
5. Facilities and Environment Procedure (Clause 6.3)
6. Equipment and Calibration Procedure (Clauses 6.4.3 & 6.5)
7. Customer Service Procedure (Clauses 7.1.1 & 8.6)
8. Test and Calibration Method Procedure (Clauses 7.2.1 & 7.2.2)
9. Quality Assurance Procedure (Clauses 7.7.1 – 7.7.3)
10. Sampling Procedure (Clauses 7.3, 7.5 & 7.8.5, applicable only to laboratories that do
sampling)
11. Handling of Laboratory Test or Calibration Items Procedure (Clause 7.4)
12. Complaint, Nonconformity and Corrective Action Procedure (Clauses 7.9 – 7.10 & 8.7)
13. Testing Report Procedure (Clauses 7.8.2 & 7.8.3, applicable to testing laboratories that
write test reports)
14. Calibration Report and Certificate Requirements Procedure (Clauses 7.8.2 and 7.8.4,
applicable to calibration laboratories that write calibration certificates)
Mandatory records for ISO 17025:2017
15. List of Internal and External Documents (Clauses 8.2.4 & 8.3.1)
16. List of Types of Records (Clause 8.4)
17. Registry of Records for Detention/Central Archive (Clauses 8.3.2f & 8.4.1)
18. Quality Objectives (Clauses 8.2.1 & 8.2.2)
19. Training Program (Clause 6.2.3)
20. Training Record and Performance Monitoring (Clause 6.2.2)
21. Record of Attendance (Clause 6.2.2)
22. Competence Approval and Authorization Record (Clauses 5.6 & 6.2.5e)
23. Supplier Evaluation and Approval Record (Clause 6.6.2a)
24. List of Approved Suppliers of Products and Services (Clause 6.6.2a)
25. Record of Laboratory Environmental Controls (Clause 6.3.3)
26. List of Laboratory Equipment (Clause 6.4.13a)
27. Calibrated Equipment Record (Clause 6.4.13a)
28. Calibration Record (Clause 6.4.13e)
29. Equipment Maintenance Record (Clause 6.4.13g)
30. Customer Order Review (Clause 7.1.1a)
31. Method Verification, Validation and Development Record (Clauses 7.2.1 & 7.2.2)
32. Sampling Plan (Clause 7.3.1) (as applicable)
33. Sampling Report (Clause 7.3.3) (as applicable)
34. Corrective Action Report (Clause 8.7.3)
35. Complaint, Nonconformity and Corrective Action Report Log (Clause 8.7.3)
36. Measurement Uncertainty Record (Clause 7.6.3)
37. Audit Nonconformity Report (Clause 8.8.2d)
38. Internal Audit Report (Clause 8.8.2e)
39. Management Review Record (Clause 8.9.2)
40. Equipment Operations, Calibration And Maintenance procedures and record
Commonly used recommended record ( Non-Mandatory)) ISO 17025 documents and records
1. Addressing Risks and Opportunities Procedure (Clauses 8.5.2 & 8.5.3)
2. Report of Customer Satisfaction (Clause 8.6.2)
3. Internal Audit Procedure (Clause 8.8.2)
4. Management Review Procedure (Clause 8.9)

You might also like