Is Process Mapping an ISO 13485 Requirement?

D

david_r

#1
Hello All... :)

Just picking the brains of the vast knowledge of the forum with this simple question...

I have been involved in a few recent management discussion with a few fellow RA/QA personnel and it has been mentioned that ISO 9001 and 13485 will be hitting "Process Mapping" hard starting this summer (2012) because it will be part of the standard and as a requirement to be in compliance with the standard.

My question is have I missed something (which would not be the first time) in the standard? Is process mapping required, or will it be mandated in the future for certification?

If it is mandated can someone point me to where in the standard it is stipulated?

We are in the process of mapping on this end and I do know the importance of having this in place, but I wanted to know if this is actually a requirement within the standard that I should be aware of.

Any input would be greatly appreciated :thanx:

Dave :)
 
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Jim Wynne

Staff member
Admin
#2
Hello All... :)

Just picking the brains of the vast knowledge of the forum with this simple question...

I have been involved in a few recent management discussion with a few fellow RA/QA personnel and it has been mentioned that ISO 9001 and 13485 will be hitting "Process Mapping" hard starting this summer (2012) because it will be part of the standard and as a requirement to be in compliance with the standard.

My question is have I missed something (which would not be the first time) in the standard? Is process mapping required, or will it be mandated in the future for certification?

If it is mandated can someone point me to where in the standard it is stipulated?

We are in the process of mapping on this end and I do know the importance of having this in place, but I wanted to know if this is actually a requirement within the standard that I should be aware of.

Any input would be greatly appreciated :thanx:

Dave :)
There is no requirement in ISO 9001:2008. There is a requirement to identify the processes of the QMS and describe their interactions. No quality manual I've ever seen has actually done that (the description of interactions), however. I can't speak for 13485.
 

qusys

Trusted Information Resource
#3
Hello All... :)

Just picking the brains of the vast knowledge of the forum with this simple question...

I have been involved in a few recent management discussion with a few fellow RA/QA personnel and it has been mentioned that ISO 9001 and 13485 will be hitting "Process Mapping" hard starting this summer (2012) because it will be part of the standard and as a requirement to be in compliance with the standard.

My question is have I missed something (which would not be the first time) in the standard? Is process mapping required, or will it be mandated in the future for certification?

If it is mandated can someone point me to where in the standard it is stipulated?

We are in the process of mapping on this end and I do know the importance of having this in place, but I wanted to know if this is actually a requirement within the standard that I should be aware of.

Any input would be greatly appreciated :thanx:

Dave :)
As Jim said, for ISO 9001 it is not absolutely a requirement.
I would only like to add that process mapping is a method and you can select whatever to identify the QMS processes and their relations.
You can select the way that better fit your organization, how you do is only up to you. The important is to be ffective and meet the ISO requirement.
For example, you can also go to identify the QMS process and relations by verbiage, writing a document and briefly explain the input and the output among them.
Probably turtle diagrams, context , swimlane help to see but they are not prescriptive.
I see the process mapping is useful for BMP when you want to improve process and in this case the method helps to organization to improve identifying disconnects and grey areas between an " as-is" situation and "should be", involving process owners and multidisciplinary teams.:bigwave:
 
#4
Hello All... :)

Just picking the brains of the vast knowledge of the forum with this simple question...

I have been involved in a few recent management discussion with a few fellow RA/QA personnel and it has been mentioned that ISO 9001 and 13485 will be hitting "Process Mapping" hard starting this summer (2012) because it will be part of the standard and as a requirement to be in compliance with the standard.

My question is have I missed something (which would not be the first time) in the standard? Is process mapping required, or will it be mandated in the future for certification?

If it is mandated can someone point me to where in the standard it is stipulated?

We are in the process of mapping on this end and I do know the importance of having this in place, but I wanted to know if this is actually a requirement within the standard that I should be aware of.

Any input would be greatly appreciated :thanx:

Dave :)
Hello Dave and welcome!

Wow, there are some interesting myths and legends about what's 'required' by these standards... and it's all in peoples' minds! I'm guessing that you don't have a copy of the standard, but Jim has explained it well, if you don't.

I'd suggest that the best way to put this type of frustration "to bed" is to obtain a copy and have everyone get on the 'same page', as you might say. Sometimes, these legends come from a particular auditor's demands, and that spreads like wildfire to then become a 'requirement'. Sad but true!
 
D

david_r

#5
Hi Everyone :)

Thank you for all the great advice and thoughts. Much appreciated!

We have been ISO 9001 and ISO 13485 since 2005 here with myself being the chief honcho running the system, so I am pretty much up to date on the basics and have the standards.

Like I said with some discussions, I have a staff member from our sister division who are in the process of obtaining their ISO 13485 certification in the upcoming months telling people that as of June of 2012 the ISO auditor(s) are going to be hitting companies hard on having process mapping in place and that it will be a requirement, in which I haven't heard anything coming down the line that stipulates process mapping as being mandated.

I figured that the COVE is the BEST place to obtain answers and input, which it always has been in the past...this site is AWESOME to say the least :)

Again, thanks for the responses!

Dave :thanks:
 
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