ISO 13485:2016 Cl. 4.2.3 - Determine QMS Processes, Monitoring, Measuring, etc.

#1
Hi,

I work at a company which manufactures parts for medical devices and we are working on transitioning from 2003 to 2016.

The question we are dealing with right now is determining the processes in the QMS.

Does this include all processes related to meeting the standard?

If so, do all process need to have some kind of performance indicator to meet the requirements in 4.1.3?

Any guidance would be greatly appreciated.
 
Last edited:
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Ronen E

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Staff member
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#2
Hi,

I work at a company which manufactures parts for medical devices and we are working on transitioning from 2003 to 2016.

The question we are dealing with right now is determining the processes in the QMS.

Does this include all processes related to meeting the standard?

If so, do all process need to have some kind of performance indicator to meet the requirements in 4.1.3?

Any guidance would be greatly appreciated.
Hello khourihan and welcome to the Cove :bigwave:

Perhaps the recently issued ISO 13485 handbook has some answers for you (I don’t have it so not sure).

My own answers to your two questions are yes and yes.

Cheers,
Ronen.
 
Last edited:

locutus

Involved In Discussions
#3
The basic answer to the first question is yes, that is how ISO 13485:2016 has now been established based on the scope of the quality system. Read Section - and 1, because the standard has been more written that this can be applied to any type of organisation related to medical devices, i.e. distributors, Authorised Representatives. So you should define the processes that are applicable to your organisation, regulatory requirements, and/or customer requirements.

The answer to the second question is ... probably. At least many NB and Registrars have been expecting more and more monitoring and measuring down of various processes. All processes? Maybe not. But I have seen a couple NB auditors that expected each process defined by the company (Quality Manual) to have monitoring and measuring done. A few other auditors if you have Quality Objectives is enough. The disparity with auditors ... so you may need to apply what is necessary, but Ronen is correct, read the Handbook as it gives a good explanation of monitoring and measuring of processes.
 

LUFAN

Starting to get Involved
#4
The Process Interaction Diagram is a major hot button issue for our auditor. Every one we've drawn up gets critique and the feedback we get seems to change audit to audit. Anyone have experience with an EXTREMELY simply process interaction diagram. Our auditor is convinced that you need a Quality Objective for essentially every arrow on the diagram.
 

Philip B

Involved In Discussions
#5
The Process Interaction Diagram is a major hot button issue for our auditor. Every one we've drawn up gets critique and the feedback we get seems to change audit to audit. Anyone have experience with an EXTREMELY simply process interaction diagram. Our auditor is convinced that you need a Quality Objective for essentially every arrow on the diagram.
Having worked with both ISO 9001 and ISO 13485 for nearly 30 years I am convinced that no-one, alive or dead, knows what a quality objective is. Or, to put it another way, you will get a different opinion from everyone you ask. Are they improvement projects? Monitors? Measures? KPIs? Policy goals? Who knows (or, frankly, cares)?
For our own part I have written our policy in such a way as to be readily transferable into objectives. For each policy goal I have set set one or more objectives which are either monitored or (preferably) measured. Consequently these are our monitors and measures of the product / process. Although there is no link from objectives to monitoring / measuring in the standard which I find bizarre. If my approach doesn't work then I might give up and go and sell doughnuts on the nearby seafront.
 
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