ISO 13485 - Monitoring and Measurement of Processes (Sections 8.2.5 / 8.2.6)

H

HeatherC-S

#1
Hello

I am implementing 13485:2016 in my company and i am a bit confused with section 8.2.5 / 8.2.6 Monitoring and measurement of processes and product. To me this is just a way of flagging up when something has gone wrong with the product or the process, coming from customer complaint, audit, near-miss etc - which then leads on to CAPA. Am I missing something here?

Many thanks
 
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Ronen E

Problem Solver
Moderator
#2
Hello

I am implementing 13485:2016 in my company and i am a bit confused with section 8.2.5 / 8.2.6 Monitoring and measurement of processes and product. To me this is just a way of flagging up when something has gone wrong with the product or the process, coming from customer complaint, audit, near-miss etc - which then leads on to CAPA. Am I missing something here?

Many thanks
Hello Heather and welcome to the Cove :bigwave:

8.2.5 speaks of the QMS as a whole. You need to state the results the processes are expected to produce, then actively monitor them (e.g. trend) to show that the processes are capable, them implement CAPA if they're not.

8.2.6 is more focused on demonstrating that the product meets its specifications and that the prescribed procedures and inspections have been followed as specified. It's quite straightforward so I don't think you're missing anything of essence.

Cheers,
Ronen.
 
#3
Hi Ronen!

I have the same issue. I see that thread is a little bit old, but I hope my question will get back to you. :)

I'm very confused with 8.2.5. How to demonstrate that processes are capable and effective?

Hello Heather and welcome to the Cove :bigwave:

8.2.5 speaks of the QMS as a whole. You need to state the results the processes are expected to produce, then actively monitor them (e.g. trend) to show that the processes are capable, them implement CAPA if they're not.

8.2.6 is more focused on demonstrating that the product meets its specifications and that the prescribed procedures and inspections have been followed as specified. It's quite straightforward so I don't think you're missing anything of essence.

Cheers,
Ronen.
 

Ronen E

Problem Solver
Moderator
#4
Start by listing your QMS processes and the planned results for each.
Then collect and collate information about each of the above processes' performance (in relation to the planned results). This should be an ongoing process.
This should allow you to reach conclusions and take action as necessary.
 
#5
Every process should have a metric or metrics. For example, nonconformity reports should be closed within 30 days. That is just an example. Then, metrics data is periodically reviewed, typically during management review. If the average number of days to close a nonconformity report is actually 90, you need to determine whether a corrective action is required. Let's say you determined that a corrective action is required. You would then initiate the corrective action process and determine the root cause of the issue, i.e., why your nonconformity reports take so long to be closed.
 
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