AAMI News July 2018

Asked & Answered: Establishing Competence

This regular feature showcases questions and answers from professionals participating in AAMI’s online discussion groups, collectively known as AAMI Connect. AAMI does not endorse specific practices or advice. Participants in these forums are sharing their own experiences and insights.


Q: In the updated ISO 13485:2016 standard, section 6.2 states: “The organization shall document the process for establishing competence, providing needed training, and ensuring awareness of personnel.” My interpretation of this is that a procedure for determining the necessary competence/qualifications for positions affecting quality is required and that it’s no longer sufficient to only have competence/qualifications documented. Does anybody else interpret this differently?


A: I’d say your interpretation is spot on. The element found in ISO 13485:2016, clause 6.2 was added to the standard during the revision of the 2003 version to address the need for a documented process for establishing competence, providing needed training, and ensuring personnel awareness. So yes, we now need a procedure to show how competency is achieved in addition to having the documents (records) to show it has been done.

I’d also add that the revised standard employs the need for a methodology to check the effectiveness that is proportionate to the risk associated with the work for which the training or other action is provided. This relates back to the whole risk-based approach found in clause 4.1.2, which says, essentially, that things that directly impact product safety and effectiveness require a higher level of attention than those that don’t. In my more recent experience, this risk-based approach tends to cause people anxiety as to how it should be employed and demonstrated to an auditor. This need not be the case in this instance if one documents and records that for certain roles and tasks there is a higher level of competency achieved and verified (say through a process requiring a person to read a procedure, then show that he/she can successfully achieve conformity to  the procedure) versus another that only needs to show “read and self-assess for competence” for a process that does not directly impact product safety and effectiveness. It will be up to the organization to establish the process for the various risk-based cases.

The new standard really just makes more explicit  what we all probably are (or should be) doing.

—Rem Siekmann, senior principal engineer for Regulatory and Quality Solutions, LLC based in Pittsburgh, PA, and a member of the U.S. national standards committee for medical device quality systems (QM/WG 01)

A: If you refer to ISO 13485:2016—Medical devices—A Practical Guide, under clause 6.2 you will find a detailed explanation. The “intent” paragraph states: “There is a new requirement for documenting processes of establishing competence, providing needed training, and ensuring awareness of personnel.” Three pages of discussion follow. This document was written by the standards committee that created ISO 13485 and is intended to provide guidance on the implementation of the standard. In the interest of full disclosure, however, there has been controversy in some groups over the information found in the document.

—Edwin Bills, principal consultant for ELB Consulting in Overland Park, KS, and a member of QM/WG 01

A: The section in 13485 you refer to can be interpreted in a few ways—as can many global standards in general, which leaves room for creativity and potentially problems. Having a standard operating procedure (SOP) that reflects a competency process measuring performance is something you might want to consider. It’s a good idea to write both the SOPs and competencies according to published consensus standards, expectations, and internal standards. Sometimes this is challenging because internal controls might be stricter than standards or vice versa. The organization then can consider establishing internal content experts or external vendor/manufacturer experts who are able to verify the competency of staff.

—Jenny Crnkovich, assistant director and educator of sterile processing at NorthShore University HealthSystem in Chicago, IL


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