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Procedure · SOP-13

Selection, Verification and Validation of Methods

Choosing appropriate methods, verifying standard methods, validating non-standard and laboratory-developed methods.

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Purpose

To define how the Laboratory selects the methods and procedures it uses, keeps them current, verifies that it can perform them before use, controls deviations, and validates non-standard, laboratory-developed or modified methods, so that all methods are fit for purpose and results are valid.

What is inside

10 sections, about 4 pages when printed.

  1. 1. Purpose
  2. 2. Scope
  3. 3. References
  4. 4. Definitions
  5. 5. Responsibilities
  6. 6. Procedure
  7. Records generated by this procedure
  8. Monitoring and performance indicators
  9. Assessment readiness notes
  10. Related documents

Records it generates

Applying this procedure produces the following records, which are the evidence an assessor samples.

  • –Method selection basis
  • –Verification and validation plans and reports
  • –Deviation authorisations
  • –Impact assessments of new editions of referenced methods

What an assessor looks for

The document closes with these points, so you can check your own practice before someone else does.

  • –Asking for the verification evidence for a sampled procedure: the repeatability data, the comparison with a reference, and the uncertainty budget at actual conditions.
  • –Checking that the calibration procedure contains enough detail for consistent performance and matches what the engineer actually does at the bench (witnessed).
  • –Confirming the edition of referenced guides is current and that the impact of changes was assessed.
  • –Reviewing how a deviation was authorised and communicated to the customer.

Before you use it

  • Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
  • Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
  • Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
  • Record the document in your own document register and set its review date.
  • Delete the assessment readiness notes if you do not want them in your controlled version; they are guidance for you, not requirements.

Related documents

This is an original template published by ValiTrac. It does not reproduce the text of ISO/IEC 17025 or of any accreditation body publication, and it does not by itself confer or guarantee accreditation. Customise, review and approve it before use.