ISO 13485 · Medium · 12 min lesson
When and why to validate - clauses 7.5.6 and 4.1.6, the GHTF decision tree and the validation master plan
ISO 13485:2016 clauses 7.5.6, 7.5.7 and 4.1.6, GHTF SG3 N99-10 (2004, 2nd edition) sections 2, 3, 5.1 and 6
What you will learn
- Explain when clause 7.5.6 requires a process to be validated and tell verification from validation using the GHTF decision tree.
- Recognise special processes and the software that clauses 4.1.6 and 7.5.6 require you to validate.
- Build a risk-based validation master plan and plan summary, name the roles and spot a plan that fails.
Key takeaways
- Clause 7.5.6: validate a process whose output cannot be, or is not, verified by later monitoring or measurement.
- Verification examines a unit; process validation proves that the process consistently produces conforming output (GHTF 2.4, 2.6).
- The GHTF decision tree asks whether the output is verifiable and whether verification is sufficient; otherwise validate or redesign.
- Software used in production or in the quality system is validated before use and after changes, proportionate to risk (7.5.6, 4.1.6).
- The master plan and plan summary show processes, risk, sample size rationale, owners, schedule and revalidation; protocols are approved before execution.
Free practice question
Lumora bonds catheter hubs with a UV-cured adhesive. Bond strength can only be measured by a pull test that breaks the bond. Today the plant pull-tests five hubs per lot and releases the lot if all five pass. A new engineer asks whether the bonding process needs validation.
What does clause 7.5.6 require?
No validation: five pull tests per lot are verification and are enough.
Not quite. Five tests verify five hubs only; clause 7.5.6 still applies to the rest, and GHTF section 3.1 step A says validate.
Validate only if a customer complaint occurs.
Not quite. Clause 7.5.6 is preventive and applies when output cannot be verified, so waiting for complaints contradicts GHTF section 3.1.
Validate the bonding process, because the output cannot be fully verified and weak bonds would show only in use.
Correct. Clause 7.5.6 requires validation where output is not verified and deficiencies appear after use; GHTF section 3.1 step A leads to step D.
Replace the pull test with a visual check of every hub.
Not quite. A visual look cannot measure bond strength, so the requirement stays unverified under clause 7.5.6 and GHTF section 3.1.
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).
- special process: A process whose output cannot be fully verified afterwards, so that defects appear only in use, such as sterilisation or sealing.
- IQ, OQ, PQ: Installation, operational and performance qualification: the three phases of a process validation (GHTF 2.1 to 2.3).
- validation master plan: The plan that identifies processes to validate, the schedule, interrelationships and revalidation timing (GHTF 5.1).
- plan summary: The project-level page that lists each process, its risk, sample size and the references to its protocols and reports.
- 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
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.