ISO 13485 · Expert · 15 min lesson
Auditing clauses 7.5 and 7.6: production, validation, traceability and calibration
ISO 13485:2016 clauses 7.5.1, 7.5.6, 7.5.8, 7.5.9, 7.5.11 and 7.6, with clause 4.1.6 and ISO 19011 audit practice
What you will learn
- Audit batch records and process validation status.
- Run a traceability test (forward and backward).
- Audit calibration and software for measurement.
Key takeaways
- Clause 7.5.1 requires a batch record showing quantity manufactured, quantity approved and traceability, verified and approved.
- Clause 7.5.6 requires validation of non-verifiable processes with revalidation criteria and approved changes.
- Clause 7.5.9 traceability is proven by a timed forward and backward test chosen by the auditor.
- Clause 7.6 requires traceable calibration and assessment of earlier results when equipment is out of tolerance.
- Software that decides pass or fail must be validated under clause 7.6, 4.1.6 or 7.5.6.
- Maintenance of validated equipment needs verification against validated parameters before return to use.
Free practice question
Halden batch record BR-4410 rev B for titanium bone screws lists: quantity manufactured 600, quantity approved for distribution blank, release initials with no date. The material line reads "titanium bar, supplier A".
What is the most serious gap in this record?
The record does not show the approved quantity or the material lot, so traceability and release cannot be shown.
Correct. Clause 7.5.1 requires quantity approved and traceability to the extent of clause 7.5.9, and neither is recorded here.
The quantity manufactured is too high for a single batch.
Not quite. Clause 7.5.1 sets no batch size limit, so quantity manufactured is not the gap here.
The supplier name is written in the wrong field.
Not quite. Field placement is trivial; the missing material lot is the real traceability gap under clause 7.5.9.
The record is a revision B and should be revision A.
Not quite. Revision letters follow document control under clause 4.2.4 and do not affect the traceability gap.
Key terms
- batch record: The record for each device or batch showing traceability, quantity manufactured and quantity approved for distribution (ISO 13485:2016 clause 7.5.1).
- traceability: The ability to follow a device and its components and materials through production and distribution, to the extent defined by the organisation (ISO 13485:2016 clause 7.5.9).
- calibration: Comparison of measuring equipment against measurement standards traceable to international or national standards at specified intervals or before use (ISO 13485:2016 clause 7.6).
- revalidation: Repeat validation of a process after defined changes or at defined intervals, according to criteria in the validation procedure (ISO 13485:2016 clause 7.5.6).
- consignee: The party to which a device was delivered, whose name and address must be recorded for implantable devices (ISO 13485:2016 clause 7.5.9.2).
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 19011:2026 Guidelines for auditing management systems
- FDA Quality Management System Regulation (QMSR), effective 2 February 2026
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.