Document control ISO 13485:2016

#1
Hi!
Our NB complained that our documents only have new or amended text i red, you can not see all old changes on the current document.. You can see the last amendment on the current document. If you need to see the old text you have to talk to QA who is the only person that have access to old documents. This was not acceptable for the NB.
Text in standard is c) ensure that the current revision status of and Changes to dokuments are identified. I claim that the NB is wrong. I am right. Pls advice!!!
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Seems to be the NB is telling you what they like to see - not what they need to see.
the standard does not specify HOW the changes are to identified or where they actual differences need to be listed - that's up to your organization and it's processes/systems.
 

Jean_B

Trusted Information Resource
#3
You need to identify the changes from the preceding version, and these changes need to be identifiable during the period the documents are maintained. There are two things at play here:
  1. The intent behind changelogs in the documents is to make the people working according to/with the documents aware of the changes, and how it impacts the work and their way of working. For this reason we prefer three in-document, as that can help the people returning after long vacations or similar, but our people can look back to the recent previous versions in system, and QA ensures there's no avalanche of updates so people lose sight of it. But yes, the most recent one being available I would regard as compliant, though not robust (what if you have a really minor update (textual correction) 2 days after a major update: people might not know etc. etc. It should be weighed against the risk, but well, pah)
  2. The intent of retention of all revisions/version of the document is to be able to provide a full picture of the product or process at the various points in its existence, for a period in which it is worthwhile to look back.
For 1: Very dependent on information we cannot presume on. Could be: Show training records of personnel to the document from 2., or how they are instructed in induction to only use the hardcopy in a controlled binder, or how they will always pull the recent one up electronically. Elsmar cannot really know.
For 2.: If each version has its changes from its predecessor identified within itself, then take some document you have with multiple revisions going back a long while and demonstrate that you can still retrieve them and demonstrate them to be readable. (Make it ironic if you have so many changelog entries, that the table can be comically compiled into one big one for 'easy perusal' in the mail towards the auditor.) An additional concern they could express is risk of loss or deterioration, and if you securely store those (i.e. backup arranged with retrieval validated) and demonstrate that as well they'll be hard-pressed to make a case on this point.

I can also state that the 13485 handbook that NB auditors might fall back on does not state anything clearly on this matter, and to my knowledge no other applicable standard or regulation does either. Show you meet the intent, and you should be good.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi!
Our NB complained that our documents only have new or amended text i red, you can not see all old changes on the current document.. You can see the last amendment on the current document. If you need to see the old text you have to talk to QA who is the only person that have access to old documents. This was not acceptable for the NB.
Text in standard is c) ensure that the current revision status of and Changes to dokuments are identified. I claim that the NB is wrong. I am right. Pls advice!!!
One thing I'm not clear about from your post is whether you have a revision table/list in each revision, briefly describing the changes in all revisions from the initial release forward. I mean, in addition to highlighting the changes in the latest revision in red.
If you do have such a table - I believe you are in compliance.
If you don't - maybe you're still compliant, however: (a) this is a widely accepted practice and maybe that's what your NB is looking for (out of habit, if nothing else); (b) it's not a difficult practice so maybe consider adding it; and (c) in my experience it's a very convenient tool when trying to quickly figure out something regarding the evolution of then document's content (if changes are described properly - concisely).
 

James

Involved In Discussions
#5
(b) it's not a difficult practice so maybe consider adding it; and (c) in my experience it's a very convenient tool when trying to quickly figure out something regarding the evolution of the document's content
I have substantially less experience in Quality Management than you Ronen; a small point from a user perspective is that it can be useful also to minimise the amount of information on documents. I have kept a separate change log with specific details of changes for this reason, but highlighting in red any significant changes on re-issued procedures. In addition to this, notifying all users of the changes via email, having them documented in team meeting minutes, etc seems to be effective.

I'm also about to start using an E-QMS which I 'think' will notify users of changes since their last log in automatically - which further helps to reinforce adherence to changes.

Cheers

James
 
#6
Seems to be the NB is telling you what they like to see - not what they need to see.
the standard does not specify HOW the changes are to identified or where they actual differences need to be listed - that's up to your organization and it's processes/systems.
Thank you for your reply. We are ISO 13485, MDD and ISO 9001 since 12 years but due to Brexit were we forced to change the NB. Our old NB have approved our system since 2008 and we have had about 8 different persons acting for the old NB. No body have objected to our system.
I have seen this in other organisations in the last years. The audits are more and more concentrated on small details rather then doing a overall assesment. Anybody else that have the same axperience? We are based in northen europe.
 
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