ISO 13485 · Expert · 14 min lesson
Auditing clause 6: competence, infrastructure and work environment
ISO 13485:2016 clauses 6.2, 6.3, 6.4.1 and 6.4.2, with links to clauses 7.6 and 8.5.2 and the ISO 14644 series
What you will learn
- Verify competence evidence and effectiveness.
- Audit maintenance and utilities.
- Audit contamination control.
Key takeaways
- Competence needs a written role requirement and an evaluation of effectiveness under clause 6.2; attendance is not evidence.
- Temporary staff in special environmental conditions must be competent or supervised under clause 6.4.1.
- Maintenance under clause 6.3 needs documented intervals, records and an impact assessment when late.
- Calibration belongs to clause 7.6 and is a separate record from maintenance.
- Work environment requirements under clause 6.4.1 need limits, monitoring and records.
- Contamination control under clause 6.4.2 needs limits, trend review and reaction to excursions.
Free practice question
Lumora training record TR-221: twelve operators attended a one hour session on the new pouch sealer. The box effectiveness contains the word yes, signed by the trainer. No test, observation or later review is attached. Four seal checks failed in the following month.
What is the best audit assessment under clause 6.2?
Conforming, because everyone attended and the trainer signed.
Not quite. Clause 6.2 requires evaluation of effectiveness, and attendance with a signature does not show that operators can do the task.
A gap: the effectiveness of the training was not evaluated against a defined method or criterion.
Correct. Clause 6.2 requires evaluating the effectiveness of actions taken, and the failures after training show why a real evaluation matters.
A gap against clause 7.6, calibration of the sealer.
Not quite. Clause 7.6 concerns measuring equipment calibration, which the record does not mention.
An observation only, because the trainer was experienced.
Not quite. The trainer's experience does not replace the effectiveness evaluation that clause 6.2 requires.
Key terms
- competence: Demonstrated ability, based on education, training, skills and experience, to do work affecting product quality (ISO 13485:2016 clause 6.2).
- effectiveness of training: Evaluation, by a defined method and criterion, that actions taken achieved the necessary competence (ISO 13485:2016 clause 6.2).
- infrastructure: Buildings, workspace, utilities, process equipment and supporting services needed for product conformity (ISO 13485:2016 clause 6.3).
- contamination control: Planned arrangements to control contamination of product and the environment, with specific documented requirements for sterile devices (ISO 13485:2016 clause 6.4.2).
- action limit: A defined monitoring value that, when exceeded, requires investigation and a decision on product; part of an environmental monitoring programme (ISO 13485:2016 clause 6.4.2).
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
- ISO 19011 Guidelines for auditing management systems
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.