ISO/IEC 17025:2017 – List of Documents

Posted on: July 20th, 2019  /  By:  /  Posted in: #QUALiTYViVA, ISO/IEC 17025:2017, Laboratory management system  /  Comment: 1

[ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories]

Laboratory management system is always fascinating me from its original version to 2005 and to latest third edition published in 2017, which is made in line with ISO 9001:2015.After going through the standard, it is interesting to furnish list of mandatory documents which Covers ,Manual , Formats , Records ,SOP or Work Instruction and most important mandatory procedures.

To understand about the procedure and what to be included in procedure here explain with example of clause 7.6 as below

Clause 7.6 — Procedure for evaluation measurement uncertainty.

In this clause 7.6 there are three sub clause 7.6.1, 7.6.2 and 7.6.3 and in these sub clauses mentioned as, identify the contribution to measurement uncertainty, what calibration laboratory to carry out and laboratory performing testing shall evaluate measurement uncertainty respectively.

Whereas, it is expected to make procedure which includes formulae for measurement uncertainty, calculation part and results. 

Similarly, I take this opportunity to first explain here the difference between document and record, which is part of clause 8.3 and 8.4, control of document and control of record respectively.

 DOCUMENTS: Information used to support an effective and efficient organizational operation.

Examples: Policy Statements, Procedures, Specifications, Manufacturer’s Instructions, Calibration Tables, Charts, Text Books, Posters, Notices, Memoranda, Drawings, Plans, etc. These can be on various media, such as hard copy or digital.

RECORD: Evidence about a past event(s).

Examples:  evidence of Test results, checked dimension, Temperature data etc.

Secondly, on action to address the risk and opportunity refer my article link as below:

Let us understand, what are procedure and other required documents.

  1. The clause wise list of procedure is as below:
  2. Procedure for safeguard impartiality    —–  Clause 4.1
  3. Procedure for confidentiality    —-  Clause 4.2
  4. Procedure for personnel and training —  Clause 6.2
  5. Procedure for facilities and environmental conditions —– Clause 6.3
  6. procedure for handling, transport, storage, use and planned maintenance of equipment —  Clause 6.4.3
  7. Procedure for intermediate checks — clause 6.4.10
  8. Procedure for  metrological traceability and calibration of equipment —- Clause 6.5
  9. Procedure for externally provided products and services  — Clause 6.6
  10. Procedure for review of requests, tenders and contracts — Clause 7.1
  11. Procedure for  selection and verification of methods   —– Clause 7.2.1
  12. Procedure for  validation of methods —- Clause 7.2.2
  13. Procedure for  transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items  — Clause 7.4
  14. Procedure for evaluation measurement uncertainty  — Clause 7.6
  15. Procedure for monitoring and ensuring  the validity of results — Clause 7.7
  16. Procedure  to receive, evaluate and make decisions on complaints  — Clause 7.9
  17. Procedure for Non- conforming work related to laboratory activity and customer requirement  —- Clause 7.10
  18. Procedure for  control of data and information management  — Clause 7.11
  19. Procedure for control of document —- Clause 8.3
  20. Procedure for control of records  —– Clause 8.4
  21. Procedure for action  to address risks and opportunities  — Clause 8.5
  22. Procedure for opportunities for improvement —- Clause 8.6
  23. Procedure for corrective action —– Clause 8.7
  24. Procedure for internal audit  —-  Clause 8.8
  25. Procedure for management review —  Clause 8.9
  • Other documents are,
  • Manual
  • Records
  • Formats
  • SOP or work instruction
  • Reporting of Results —- Clause 7.8
  • Sampling Plan and Method — Clause 7.3