How to accomplish ISO 13485 Clause 8.2.3 Monitoring and Measuring?

J

Joconnell

#1
I have been viewing the Elsmar Cove website for a while, but never posted. I am at my wits end...I am new to the 13485 scene and my company recently received our certification (January), after dealing with a NC for 8.2.3 Monitoring and measuring. Our auditor said that we needed proof of this being done, I know that this is a "documented procedure not require" but he said we needed one and needed objective evidence this was being completed. We have the verbage, and no matter how much we talked about us doing this he wanted written proof. Does anyone have any suggestions on how to fulfill this clause successfully?

Thank-you!
 
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G

Gert Sorensen

#2
Re: How to accomplish 8.2.3 for ISO 13485?

You need a procedure for Management evaluation of the efficiency of the Quality System, and a procedure for CAPA.

Reviews from the Management meetings clearly adressing the efficiency of the QS, and CAPA's issued as a result of this should be sufficient.

:bigwave:
 

Jim Wynne

Staff member
Admin
#3
Re: How to accomplish 8.2.3 for ISO 13485?

I have been viewing the Elsmar Cove website for a while, but never posted. I am at my wits end...I am new to the 13485 scene and my company recently received our certification (January), after dealing with a NC for 8.2.3 Monitoring and measuring. Our auditor said that we needed proof of this being done, I know that this is a "documented procedure not require" but he said we needed one and needed objective evidence this was being completed. We have the verbage, and no matter how much we talked about us doing this he wanted written proof. Does anyone have any suggestions on how to fulfill this clause successfully?

Thank-you!
Welcome, Joconnell. :D It's helpful to give us the exact wording of the auditor's finding when you have a question about audit NCs. It sounds like what the auditor is looking for is records rather than a written procedure, but it's hard to tell unless we know exactly what was written up.
 
J

Joconnell

#4
Re: How to accomplish 8.2.3 for ISO 13485?

The NC states:
Process monitoring is required by the quality manual but there is no documentation present to demonstrate implementation of this process.

Thanks!
 

Marcelo

Inactive Registered Visitor
#5
Re: How to accomplish 8.2.3 for ISO 13485?

Is it documentation or object evidence? Anyway, i really think it´s difficult to monitor and measure processes without writting something about it. For example, how would you know if the proccess has a "variation" if you don´t plot a graph?? And how could you know the measurement/monitoring result for some time if you don´t write these measurement results down?

Well, in practical terms, you have to know your proccess and to put measurement/monitoring points, sometimes refered as indicators, in your proccess to measure/monitor key points which can be used to demonstrate that the proccess is working. For example, let´s say my procces consists of delivering an water gallon to the kitchen at 10 a.m. every morning and returning to my office in 15 minutes, no more than that. How can i measure/monitor this proccess? Well, i could make myself fill a form in the kitchen with the time i arrive there everyday. Or i could put someone observing me and annotating the time i arrive at the kitchen. Or i could as someone to phone me 10:15 at my office to see if i´m there. These are just funny exampls of ways of monitoring and measuring a proccess. Hope you can see the picture.
 

Doug Tropf

Quite Involved in Discussions
#6
Methods we use to comply with 13485's 8.2.3, Monitoring and Measurement of Processes, include quality assurance activities, internal auditing, management review, and customer complaint processing - plus appropriate CAPAs when planned results are not achieved.
 
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