ISO 17025 Documentation Kit

Content of Documentation Kit

Documentation Kit is designed by following four Three of documents

• Tier 1 – Manual – This provides the reference to each requirement of the standard. We make the structure of the manual same as the standard, so that you can easily understand and follow requirements.
• Tier 2 – Procedures – This provides additional information referred in the manual that how you are doing specific activities in your organization
• Tier 3 – Formats – These are an actual document that you use to show your compliance with the standard.

We have added many documents for reference and use, however, you can add any additional document which is not part of our documentation kit, or can ignore those document which is not applicable to your activities from our documentation kit.

It is recommended the documentation kit shall be reviewed by senior management, managers, and employees as relevant to them which can help to understand ISO 17025:2017.

Documentation kit contains A Quality Manual that address clause wise details for how ISO 17025:2017 systems are designed and implemented in your organization.

1. [Company] INTRODUCTION
2. AUTHORIZATION STATEMENT
2.1 SCOPE OF WORK
3. ORGANIZATION STRUCTURE
4. GENERAL REQUIREMENTS
4.1 IMPARTIALITY
4.2 CONFIDENTIALITY
5. STRUCTURAL REQUIREMENTS
6. RESOURCE REQUIREMENTS
6.1 GENERAL
6.2 PERSONNEL
6.3 FACILITIES AND ENVIRONMENTAL CONDITIONS
6.4 EQUIPMENT
6.5 METROLOGICAL TRACEABILITY
6.6 EXTERNALLY PROVIDED PRODUCTS AND SERVICES
7. PROCESS REQUIREMENTS
7.1 REVIEW OF REQUESTS, TENDERS AND CONTRACTS
7.2 SELECTION, VERIFICATION AND VALIDATION OF METHODS
7.2.1 SELECTION AND VERIFICATION OF METHODS
7.2.2 VALIDATION OF METHODS
7.3 SAMPLING
7.4 HANDLING OF TEST ITEMS
7.5 TECHNICAL RECORDS
7.6 EVALUATION OF MEASUREMENT UNCERTAINTY
7.7 Ensuring the validity of results
7.8 REPORTING OF RESULTS
7.8.1 GENERAL
7.8.2 COMMON REQUIREMENTS FOR REPORTS (TEST)
7.8.3 SPECIFIC REQUIREMENTS FOR THE TEST REPORTS
7.8.4 SPECIFIC REQUIREMENTS FOR THE CALIBRATION CERTIFICATES
7.8.5 REPORTING SAMPLING – SPECIFIC REQUIREMENTS
7.8.6 REPORTING STATEMENTS OF CONFORMITY
7.8.7 REPORTING OPINIONS AND INTERPRETATIONS
7.8.8 AMENDMENTS TO REPORTS
7.9 COMPLAINTS
7.10 NON–CONFORMING WORK
7.11 CONTROL OF DATA – INFORMATION MANAGEMENT
8. MANAGEMENT SYSTEM
8.1 OPTION
8.1.1 GENERAL
8.1.2 OPTION A
8.1.3 OPTION B
8.2 MANAGEMENT SYSTEM DOCUMENTATION
8.3 CONTROL OF DOCUMENTS (OPTION A)
8.4 CONTROL OF RECORDS (OPTION A)
8.5 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES (OPTION A)
8.6 IMPROVEMENT (OPTION A)
8.7 CORRECTIVE ACTION (OPTION A)
8.8 INTERNAL AUDITS (OPTION A)
8.9 MANAGEMENT REVIEW
ANNEX 1 – QMS POLICY
ANNEX 2 – IMPARTIALITY AND CONFIDENTIALITY POLICY
ANNEX 3 – LIST OF PROCEDURES

17 procedures, which helps you to manage your operations and address requirements of ISO 17025:2017 through the implementation of procedures.

1. Procedure for Context of Organization
2. Procedure for Environment Monitoring
3. Procedure for Evaluation of measurement uncertainty and statistical evaluation
4. Procedure for Internal Audit
5. Procedure for Communication
6. Procedure for Control of Records
7. Procedure for Corrective Action
8. Procedure for Management of Changes
9. Procedure for Management Review
10. Procedure for Control of Documents
11. Procedure for Customer Complaint and Appeal
12. Procedure for Training, Awareness and competence
13. Procedure for Lab Operations
14. Procedure for Purchasing and sub-contracting
15. Procedure for Master Equipment
16. Procedure for Handling of calibration items
17. Procedure for Impartiality Management

39 Formats, which is actually used to implement the system and keep records to provide evidence of the fulfillment of standard requirements.

1. Management of change plan
2. Job Description
3. Skill Matrix
4. Competence Gap Assessment
5. List of Calibrated Equipment
6. Calibration Plan
7. Equipment Inspection Report In-House
8. Approved subcontractor list
9. Employee Training Plan
10. Attendance Sheet
11. Induction Training Report
12. Employee training report
13. Authorization Sheet
14. Technician’s Training & Assessment Process form
15. Employee Trainings record
16. Witness Assessment of technician-Site Activities Report
17. Witness Assessment of technician-Site Activities Plan
18. Equipment log Book
19. Supplier Registration Form
20. Approved Vendor List
21. Supplier Evaluation Form
22. Customer Feedback
23. Complaint Appeal Report
24. Complaint Appeal Register
25. Document Change
26. Minutes of Management Review Meeting
27. List of internal auditors
28. Internal Audit Schedule
29. Internal audit NCs
30. Corrective action report
31. Internal Audit Checklist
32. Internal audit report
33. Terms & conditions of services process
34. Amendment, Change Record Form
35. Sub-Contractor Evaluation Form
36. Non Conformance Log
37. SWOT Analysis Matrix
38. Confidentiality Impartiality Agreement
39. Identification and Assessment of Impartiality