What does the Guide M-17025 contain?
The Guide M-17025 contains the following templates*:
- 1 Quality Manual (49 pages).
This provides a guide to implementing the quality management system ISO/IEC 17025:2017 in your laboratory:
1. OBJECTIVE AND SCOPE.
2. DEFINITIONS AND NOTATIONS.
4. GENERAL REQUIREMENTS.
5. STRUCTURAL REQUIREMENTS.
5.1 Legality of the Laboratory.
5.2 Head of the Laboratory.
5.3 Scope of activities.
5.4 Responsibility for compliance with the standard, customers and authorities.
5.5 Organizational structure.
5.6 Responsible of the management system.
5.7 Responsibility of top management.
6. RESOURCES REQUIREMENTS.
6.3 Facilities and environmental conditions.
6.5 Metrological traceability.
6.6 External products and services.
7. PROCESS REQUIREMENTS.
7.1 Review of requests, tenders and contracts.
7.2 Selection, verification and validation of methods.
7.4 Management of items under testing or calibration.
7.5 Technical records.
7.6 Evaluation of measurement uncertainty.
7.7 Ensuring the validity of results.
7.8 Reporting of results.
7.10 Nonconforming work.
7.11 Management of information and data.
8. MANAGEMENT SYSTEM REQUIREMENTS.
8.2 Documentation of the management system.
8.3 Document control.
8.4 Control of records.
8.5 Risks and opportunities.
8.7 Corrective actions.
8.8 Internal audits.
8.9 Management reviews.
9.1 Procedures of the quality system.
9.2 Forms of the quality system.
- 18 Managerial and technical procedures (190 pages).
These documents conduct the user to satisfy each of the requirements of the standard ISO/IEC 17025:2017:
1. Procedure for personnel management.
2. Procedure for equipment management.
3. Procedure for intermediate checks of measuring equipment.
4. Procedure for purchasing of external products and services.
5. Procedure for review of requests, tenders and contracts.
6. Procedure for calibration.
7. Procedure for testing.
8. Procedure for sampling.
9. Procedure for evaluation of measurement uncertainty.
10. Procedure for verification of calibration methods.
11. Procedure for verification of physical testing methods.
12. Procedure for verification of analytical testing methods.
13. Procedure for validation of calibration methods.
14. Procedure for validation of physical testing methods.
15. Procedure for validation of analytical testing methods.
16. Procedure for management of items under test or calibration.
17. Procedure for monitoring the validity of results.
18. Procedure for nonconforming work.
-46 Managerial and technical forms (256 pages).
These forms provide mechanisms to monitor each procedure and generate objective evidence of their operation (records):
1. Form for code of ethics.
2. Form for organization chart.
3. Form for job descriptions
4. Form for meeting minute.
5. Form for selection of personnel.
6. Form for training of personnel.
7. Form for program of personnel supervision.
8. Form for supervision of personnel.
9. Form for authorization of personnel.
10. Form for authorized positions and signatures
11. Form for inventory of standards and equipment.
12. Form for management of standards and equipment.
13. Form for calibration and verification (check) program of standards and equipment.
14. Form for identification labels of standards and equipment in operation.
15. Form for identification labels of standards and equipment out of operation.
16. Form for metrological traceability chart.
17. Form for intermediate checks of standards and equipment.
18. Form for list of external products and services.
19. Form for evaluation of external providers.
20. Form for purchase order of external products and services.
21. Form for review of requests, tenders and contracts.
22. Form for quotation of services.
23. Form for calibration certificate.
24. Form for testing report.
25. Form for sampling report.
26. Form for verification of calibration method.
27. Form for verification of physical testing method.
28. Form for verification of analytical testing method.
29. Form for development of methods by the laboratory.
30. Form for validation of calibration methods.
31. Form for validation of physical testing methods.
32. Form for validation of analytical testing method.
33. Form for management of items under service.
34. Form for monitoring the validity of results.
35. Form for planning the monitoring of the validity of results.
36. Form for proficiency test plan.
37. Form for complaints.
38. Form for nonconforming work.
39. Form for validation of information management systems.
40. Form for policies and objectives.
41. Form for master list of documents and software.
42. Form for customer feedback.
43. Form for corrective action.
44. Form for internal audit program.
45. Form for management reviews.
46. Form for evaluation of dissemination of the management system.
-6 Spreadsheets (6 files).
These spreadsheets provide a guide to prepare indicators for monitoring and improvement of the quality system:
1. Form for risk management
2. Form for scope of the Laboratory.
3. Form for recording and monitoring of environmental conditions.
4. Form for statistical control chart of measuring standards and equipment.
5. Form for estimation of measurement uncertainty.
6. Form for statistical control chart of customer satisfaction index.
- 1 User manual (14 pages).
This provides instructions for using and modifying documents of the Guide M-17025, and to adapt them to your laboratory.
*These documents can be edited and adapted to any kind of calibration or testing laboratory, independent of its size or activity. They are focused to the implementation of the quality system ISO/IEC 17025-2017 and they do not include specific technical documents regarding the calibration or testing of items, in a particularized way.