ISO 13485 Human Resources Process: Your Audit Is Approaching and You Know This Process Is a Watchpoint. How to Address It?

Do you recognise this situation?

A notified body audit is approaching. In the lead-up to the audit during the internal review of practices, documentation and available data, gaps emerge in the human resources process: authorisations not formalised, training plan absent or insufficient, quality procedure to clarify.

And to make things more complicated: a non-conformity on this same process had already been raised during a previous audit, without having been corrected.

This is a more common situation than one might think and it can have serious consequences if not addressed before the audit.

What was at stake

The human resources process is one of the systematic checkpoints during an ISO 13485 audit and one of those most often underestimated in its complexity. Authorisations, qualifications, training plans, training effectiveness evaluation: each element must be formalised, consistent with the company’s actual activities, and demonstrable to an auditor. A gap in this process can quickly become a source of non-conformity, all the more so if an observation had already been raised during a previous audit without having been fully corrected.

What was done

As part of a preparation for a notified body audit, I supported a company across the entire human resources process:

• Remediation of authorisations and qualifications: formalisation of missing documents and alignment with the actual activities carried out by each employee.
• Definition of a training plan: identification of needs, prioritisation and formalisation of a realistic plan given the time constraints.
• Review and update of the associated quality procedure: integrating new tools adapted to the requirements of ISO 13485 §6.2, including a competency matrix that is easy to read and directly usable during audits.
• Implementation of a CAPA: to formally address the non-conformity left uncorrected from the previous audit, with traceability of corrective and preventive actions.
• Coaching of the human resources manager: to enable her to answer the auditor’s questions with confidence and to master the requirements applicable to her scope, as well as support for updating individual personnel files.

What changed

The company presented itself at the audit with a compliant, documented and defensible human resources process. The previous non-conformity had been formally addressed. The HR manager was prepared for the audit and the process put in place allowed her to manage it independently after the intervention.

→ Are you preparing for an audit and have identified gaps in your human resources process? A One Health Compliance Workshop combines analysis of your situation, targeted remediation and team support to approach your audit with confidence, and put in place practices that last.

Sandra Dejean, PharmD – Founder of One Health Compliance

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