ISO 13485 Cl. 6.2 Human Resources - Personnel working within the QMS



In the practical guide, the guidance under 6.2 points to personnel working within the QMS. Does this refer to Regulatory and Quality only? But doesn't everyone have a role in QMS by making change requests and updating documents? If somebody can clarify, that would be appreciated.



Provide your own definition:

A) Working under the QMS
I.E. Everyone following the procedures laid down within the QMS
B) Working in QMS
I.E. Those directly involved in Quality Management such as those who manage the QMS, or have a predominantly Quality orientated task (such as inspectors and auditors).

If your interpretation is incorrect, you'll at least have had a good stab at it, and any certifying auditor will be happy to provide a little guidance if they can see that a reasonable effort has been made to interpret the standard.

Jen Kirley

Quality and Auditing Expert
6.2 includes everyone whose activities are included under your management system scope. That is not limited to Regulatory and Quality.

Sidney Vianna

Post Responsibly
Does this refer to Regulatory and Quality only?
Any business process which can affect product conformity, customer satisfaction and compliance with regulatory requirements is part of the quality system.

For example, anyone who can receive feedback from customers and users of the devices have to be made aware of the regulatory (e.g. FDA) definition of a complaint, so the feedback will be captured and acted upon, as expected by the regulators.
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