Method Verification and Validation Report

Purpose

Records the plan, execution and conclusion of method verification (standard methods) or validation (non-standard, developed or modified methods) as required by clause 7.2, including the requirements, performance characteristics, results and the statement of fitness for purpose.

What it covers

• 1. Requirements for intended use
• 2. Performance characteristics and acceptance criteria
• 3. Experiments and results
• 4. Uncertainty
• 5. Statement of validity
• Authorisation

How to complete it

1. 1.Section 1 defines the requirement for the intended use before any testing; the Technical Manager approves the plan.
2. 2.Section 2 lists the performance characteristics to be demonstrated and the acceptance criteria for each; select from SOP-13 section 6.5.
3. 3.Section 3 records the experiments: design, equipment, personnel, environment, data files and results per characteristic.
4. 4.Section 4 records the uncertainty budget evaluated under actual conditions and the comparison with the CMC or target.
5. 5.Section 5 is the statement of validity signed by the Technical Manager, with any restrictions.

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.

Related documents

• QM-01

  Quality Manual

  Top-level description of the management system against every clause of ISO/IEC 17025:2017.

• SOP-13

  Selection, Verification and Validation of Methods

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

• SOP-21

  Temperature Calibration

  Comparison calibration of thermometers, PRTs, thermocouples, indicators and data loggers in baths, dry blocks and chambers.

• SOP-22

  Humidity Calibration

  Calibration of hygrometers, RH probes and loggers against a reference hygrometer in a humidity generator or chamber.

• SOP-23

  Pressure Calibration

  Calibration of gauges, transducers and indicators against pressure balances and reference transducers.

• SOP-24

  Electrical Calibration

  DC and low-frequency calibration of multimeters, calibrators and process instruments.

• SOP-25

  Dimensional Calibration

  Calibration of callipers, micrometers, gauge blocks, dial indicators and rules by comparison to reference standards.

• SOP-26

  Mass and Balance Calibration

  Calibration of weights and non-automatic weighing instruments, aligned with EURAMET cg-18 principles.