ISO 13485 · Basic · 12 min lesson
Clauses 7.5.6 and 7.6 - process validation and measuring equipment (overview)
ISO 13485:2016 clauses 7.5.6, 7.6, 4.1.6 and 4.2.5; GHTF SG3 N99-10 (2004) sections 2, 3 and 5
What you will learn
- Explain when clause 7.5.6 requires process validation and describe IQ, OQ and PQ in overview.
- Describe what clause 7.6 requires for calibration, status, intervals, software and out of tolerance findings.
- Build a calibration record and a validation summary that an auditor can follow, and spot a weak one.
Key takeaways
- Clause 7.5.6: validate processes whose output cannot be, or is not, verified; verification checks units, validation proves the process.
- IQ, OQ and PQ show correct installation, capability across the range and consistent performance, each under an approved protocol.
- Revalidation criteria and approval of changes keep a validation true after moves, material changes and negative trends.
- Clause 7.6: calibrate or verify against traceable standards, show status, protect equipment, and keep records, including as found data.
- An out of tolerance finding requires assessment of earlier results and action on affected product; software is validated before use and after changes.
Free practice question
Tarrow bonds tubing to a connector with solvent. The only test is a pull test that breaks the bond. Today five sets per lot are tested and the lot is released if all pass. A colleague says that five good results mean the process is validated.
What is the correct view under clause 7.5.6?
The colleague is right: five passes validate the process.
Not quite. Five passes verify five units only; clause 7.5.6 requires evidence that the process consistently achieves planned results.
Sampling is verification, and because the bond cannot be fully verified the process needs validation with qualification and challenge.
Correct. Clause 7.5.6 applies where output cannot be fully verified, and validation needs objective evidence of consistency.
Neither validation nor verification is needed for solvent bonding.
Not quite. A bond whose weakness appears only in use is exactly what clause 7.5.6 targets.
Only the supplier of the solvent must validate.
Not quite. Clause 7.5.6 places responsibility on the organization for its own production processes, whoever supplies materials.
Key terms
- process validation: Establishing by objective evidence that a process consistently produces a result meeting its predetermined requirements (GHTF 2.4).
- verification: Confirmation by examination and objective evidence that specified requirements have been fulfilled (GHTF 2.6).
- IQ, OQ, PQ: Installation, operational and performance qualification: the three phases of a process validation (GHTF 2.1 to 2.3).
- calibration: Comparison of an instrument with a traceable measurement standard to determine its error (ISO 13485 clause 7.6).
- as found data: Readings taken before any adjustment, used to judge the validity of earlier measurements.
- traceable standard: A measurement standard linked to international or national standards through an unbroken chain of comparisons (clause 7.6).
- revalidation: Repeating all or part of a validation after a change or negative trend, with criteria set in advance (clause 7.5.6 f).
- GHTF: Global Harmonization Task Force, whose Study Group 3 published the process validation guidance N99-10; guidance, not law.
Official sources
- GHTF SG3 N99-10:2004 (Edition 2), Quality management systems - Process validation guidance
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- FDA - Quality Management System Regulation (QMSR)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.