Interpretation of Clause 5.5.2 in ISO 13485:2016


Involved In Discussions
Hello all

I am currently in the process of transitioning from 2003/2012 to 2016. I have a gap analysis in place that I presented to management and there is a slight disagreement as to the actual requirements of clause 5.5.2.

It is the final sentence in the clause that is causing contention, point C. Which without directly quoting the standard says "The Management Rep will promote awareness of the regulatory and QMS requirements throughout the organisation".

The feeling from management is that our current Training system of assigning relevant procedures to the different roles/employees within the organisation is sufficient to cover this requirement.

My feeling is that this is pushing for something a little more, but during the discussion, I was unable to articulate exactly what that was.

Please, can I have some input as to how others have interpreted this clause and how you have met the requirements?
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Marcelo Antunes

Addicted to standards
Staff member
I think it's easier to understand the few "awareness" requirements if you look at another requirement, the one in 6.2.2 that says: "d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives".

I usually use one anecdote as a basis for this requirement (and I do not remember where it com from):

Imagine 3 stone breakers, ask each one "what are you doing?"
1 - breaking stone - he has no vision beyond the task and therefore does not understand the impact of his work
2 - making a window - sees beyond the task but not where the output fits into the overall context
3 - building a cathedral - he sees himself as part of the process and has a vision of what he is trying to achieve that will influence what he does

In particular, number 3 is the most aware of the relevance and importance of this activities to achieve objective, and thus, more able to contribute (for example, he may note that the stone he is breaking may not be ideal for building a cathedral and would alert his superiors, where 1 and 2 would not understand this).

The idea is the same for the "promote awareness" requirement of the MR, which is to make sure everyone is aware of the regulatory and QMS requirements.

One easy way to verify if this is being done is to ask random employees how they would act in certain simulated situations.

Edward Reesor

Quite Involved in Discussions
I share that vision completely, however I have worked for organizations in the past that treat warehouse workers (for example) as two hands and a heart beat that should have limited knowledge as to what's in the boxes they ship (and even justify it by viewing their importance to the process as being too stressful on them). Personally, I saw that as an impediment to good customer service at the very least and a detriment to the organization.

Fortunately, my current employer has employees with experience in higher level quality control that transfers to our organization and corporate culture.