List of Documents Required for Testing and Calibration Laboratories

In this article, we provided the list of documents, records, formats, and procedures required for testing and calibration laboratory according to ISO/IEC 17025:2017.

ISO/IEC 17025:2017 document specifies the general requirements for the competence of testing and calibration laboratories

Full-Form of ISO is International Organization for Standardization

The full form of IEC is International Electrotechnical Commission

2017 Specifies the year the document was published.  I.e., ISO/IEC 17025 was published in the year 2017

This document is applicable to the Testing and Calibration Laboratory.

List of Documents for Testing and Calibration Laboratory

List of Documents Required for Testing and Calibration Laboratories

To get accredited by ISO/IEC 17025:2017 at least the following documents are needed

  1. Quality Manual: 1st level Document
  2. Quality Procedures: 2nd Level Document
  3. Work Instructions/ SOP (SOP is Standard Operating Procedure): 3rd Level Document
  4. Formats:  3rd Level Document (Filled Formats are called Records)
  5. Record of Last Internal Audit
  6. Record of Last NABL Audit (or Similar Organization in the respective country)
  7. Last NABL Application and N.C (Non-Conformity)
  8. Current NABL Application Form
  9. Record of Last Management Review Meeting
  10.  Quality Policy
  11.  Quality Objectives
  12. Calibration Certificates of Master Instruments
  13. ISO /IEC 17025:2017
  14. GST Certificate (or Similar Legal Document in the respective country)
  15.  Master List of below documents
  • Format (Filled formats are called Records)
  • Work Instructions/SOP
  • Procedures
  • NABL Documents
  • International/Indian Standards
  • Equipment

List of Records

List of Records/Formats according to ISO/IEC 17025:2017

Section 4.1 Impartiality
The undertaking of Impartiality and confidentiality
Section 4.2 Confidentiality
The undertaking of Impartiality and confidentiality
Section 6.2 Personnel
Personnel List
Competency Requirement
Training Record
Training Evaluation and Authorization
Section 6.3 Facilities and Environmental Conditions
Environmental Conditions
Section 6.4 Equipment
Master Outward/Inward Register
Master Pre/Post check
Intermediate Checks- Plan
Intermediate Checks- Record
Mater List/ Calibration Schedule
History card
Checklist for Site Calibration
Section 6.6 Externally provided products and services
List of approved vendors
Evaluation of vendor
Section 7.1 Review of requests, tenders, and contracts
Service Request Form (SRF)
Quotation
Section 7.4 Handling of test or calibration items
Service Request Form (SRF)
UUC Inward Outward register
Section 7.5 Technical Records
Raw data sheet Pressure
Raw data sheet Thermal
Section 7.7 Ensuring the validity of results
Replicate calibration- Plan
Inter Laboratory Comparison (ILC) – Plan
Intermediate Checks- Plan
Intermediate Checks- Record
Section 7.8 Reporting of results
Calibration Certificate
Review of Calibration Certificate (Master)
Calibration Label
Section 7.9 Complaints
Customer Complaint Register
Section 7.10 Nonconforming work
Non-Conformity report
Section 8.6 Improvement
Customer Feedback Analysis
Customer Feedback form
Section 8.7 Corrective Actions
Non-Conformity report
Section 8.8 Internal Audit
Non- Conformity report
Internal audit Attendance sheet
Internal Audit Summary
Internal Audit Checklist
Section 8.9 Management Reviews
Customer Feedback Analysis
Management Review Agenda
Management Review meeting

List of Procedures

List of Procedures according to ISO/IEC 17025:2017

Sr. NoProcedure No.Procedure
1QP/6.2Personnel
2QP/6.4Equipment
3QP/6.6Externally Provided Products and Services
4QP/7.1Review of Requests, Tenders, and Contracts
5QP/7.4Handling of Test or Calibration Items
6QP/7.5Technical Records
7QP/7.6Evaluation of Measurements Uncertainty
8QP/7.7Ensuring Validity of Results
9QP/7.9Complaints
10QP/7.10Non-Conforming Work
11QP/8.3Control of Management System Documents
12QP/8.4Control of Records
13QP/8.8Internal Audit
14QP/8.9Management Reviews
15QP/SITESite Calibration

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About the author

Technical Manager | + posts

Myself Completed my Masters's in Physics degree from Mumbai University. Currently working as Technical Manager in Calibration Laboratory.

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List of Documents Required for Testing and Calibration Laboratories

 
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