ISO 13485 Audit help needed

K

Ktrna

#1
Hello,
I am a little overwhelmed. We will be audited (ISO 13485) the first week of January.This is our 3rd audit. I have had the responsibility of regulatory documents since Sept of this year. I am still trying to get things in order but feel like I have barely scratched the surface.
I have a lot to change, revise, update and/or totally redo with our quality manual. Although I have received notice outlining the areas of the audit I am finding it difficult to just "fix" those areas because they obviously relate to other sections in the quality manual.
Can anyone guide me on how to deal with the audit?
Also, the people before me had a "master copy" of the manual and a "working copy", both are exactly the same with all documents being stamped as "control documents". Can someone explain what is the purpose of the "working copy"?
Thank you in advance,
Katrina
 
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pkost

Trusted Information Resource
#2
When you say 3rd audit, is this a pre cert audit, or is it a surveillance audit?

I will assume it is for surveillance
First question:
Why are you making these changes? Is it because you received non conformance in your previous audit, or some other reason....has the system changed but without the relevant documentation being updated with the change?

With regards to master copies and working copies, what they are may be documented in your system somewhere, however I would hazard a guess that the master copy is the original document which is stored away and treated with reverence, the working copy a copy of the master to be handed out to whomever needs it. It's your decision as to whether you think this is necessary/the best way of doing it. I have my own opinions ;). The master is a controlled for obvious reasons, but the working copy is also controlled, so it would suggest to me that you know where all of the working copies are so you can retrieve them if necessary?
 
A

arios

#3
If you have the auditor's agenda you can use it to prepare in advance:

For instance:

1. Make sure your management review file looks complete, and be ready how to answer certain questions, for example if your metrics show a negative trend be ready how to explain the follow-up over that situation. As an auditor typically you can expect find CAPA plans addressing such issue.

2. Check your internal audit files. Where they made on time? By qualified and independent people? Is there evidece of CAPA over the audit non-conformances?

3. For your last Notified Body (3rd party) assessment, make sure you addressed correctly the non-coformances and if applicable even the Opportunities for improvement. Have the documents that show evidence of implementation and effectiveness available so they can be readily available.

4. Make a tour at the process areas that the agenda outlines, fpr example check for status and ID of instruments requiring calibration. Check if visual aids or work instructions are posted where they should be.

5. Check your complaint files, MDR's

Hope this helps
 
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K

Ktrna

#4
What you've said about the working copies makes sense. I will only stamp the master copies.
The reason for making changes are numerous. We have had changes in procedures and processes within the last year and they have not been reflected properly. Some areas of concern and non conformances where brought up in the last audit. Some documents were referred to but did not exist. From what I have been told, the start up of the quality manual was outsourced to someone who "copied and pasted" documents from another company. Some of the processes, procedures are not relevant to our company and as I said some documents have another company's name/ address on them. The responsibility of these documents has changed hands many times without sufficient explanation of procedures, etc. or training given to next person. Needless to say, there are many omissions and mistakes. Each time I try to update something it is like a web as I realize, there are no proper supporting documents or regulations were not previously understood.
Thank you for your quick response
 
I

ILyAS

#5
I have a lot to change, revise, update and/or totally redo with our quality manual. Although I have received notice outlining the areas of the audit I am finding it difficult to just "fix" those areas because they obviously relate to other sections in the quality manual.
Please Ktrna, can You say what change and what point of the standard will be changed.:cool:
 

pkost

Trusted Information Resource
#6
Urm, that certainly sounds like a lot of work and sounds like it is necessary!

In that case I would paint over the cracks and hope the auditor isn't too keen.

The auditor has sent you his/her plan, so focus on these areas along with the ones that they always review such as management review, audits and CAPA/vigilance.

Also make sure you fix all the non-conformances that have been raised before.

With regards to updating the manual and procedures; although it might be a complete mess try to remember that it has been inspected at your initial certification and was acceptable enough then to gain you your certificate. Make only changes that are necessary to ensure it continues to demonstrate compliance with ISO 13485. Worry about making it perfect after the audit, it will probably save you some work.

If you are still in arse covering mode, go over the areas that the auditor is looking at and try to spot what you they will raise as a non conformance, fix that!

I would also recommend you highlight these problems to you manager, it sounds like you have had this dumped on you so point that out! try to get more resource allocated temporarily to fix/gloss over the problems, point out the consequences of losing your certification.
 
K

Ktrna

#7
I guess the major changes would be the addition of a labeling machine and the fact they are now doing QC prior to sterilization. Changes have also been made as to who communicates with customers, how feedback will be handled and by whom, titles and responsibilities of employees have changed (including the addition of an operations manager who has full authority to make decisions) the advisory and recall procedures changed due to Health Canada audit non conformance (these have been changed and accepted by Health Canada so are considered closed). Also there has never been a diagram showing the interaction of processes and as we get bigger, jobs are becoming a bit more defined. It just seems so much to me...Maybe I am trying too hard?
 
B

Boscoeee

#8
I guess the major changes would be the addition of a labeling machine and the fact they are now doing QC prior to sterilization. Changes have also been made as to who communicates with customers, how feedback will be handled and by whom, titles and responsibilities of employees have changed (including the addition of an operations manager who has full authority to make decisions) the advisory and recall procedures changed due to Health Canada audit non conformance (these have been changed and accepted by Health Canada so are considered closed). Also there has never been a diagram showing the interaction of processes and as we get bigger, jobs are becoming a bit more defined. It just seems so much to me...Maybe I am trying too hard?
:caution:You can only get done what you can get done!:2cents:
 

pkost

Trusted Information Resource
#9
:caution:You can only get done what you can get done!:2cents:
Damn good advice that!

That being said, I would certainly look at ensuring the labeling machine and QC prior to sterilisation are adequately covered. These are two highly critical areas which certainly my NB would have a field day over if they spotted any problems.

With regards to the diagram, although it would make life easier - is it necessary? if not forget it for now, it's not a requirement of ISO to have either pretty diagrams or an easy to understand system!

I get a feeling that your system is over constrained, certainly in the future you need to review it to ensure that it works for you and not the other way around e.g

Sarah responds to all customer queries within one day = BAD

The customer service team responds to all appropriate customer queries within one working day = BETTER!
 
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K

Ktrna

#10
I understand what you are saying. Last year we hit a lot of brick walls starting with the words "Well ISO says..." from the previous ISO Coordinator. This worked for a while since no one else here understood ISO nor had the time to research it at all. Now that I have a much clearer understanding I realized what are actual regulations for ISO and how to implement changes. My father was a chemical engineer and Quality Assurance (ISO 1400) for years with the department of national defence up until he passed away last year. Perhaps this is why I want to "succeed" so badly because I know he believed in ISO very much. I remember him telling me ISO wants you to document what you say you do and do what you document.
I will try to take a step back, deep breaths come back and prioritize.....

Thank you for the time you've taken to respond
 
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