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How to add exemption or statement to control of document procedure?

L

love02eat

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#1
#1
We are a ISO13485:2016 reg. company and we have been purchased by a new Company that is corporate in June. I have been asked to write an clause or exemption for all our documents that have not yet been updated to reflect the new company logo and footing details. I am not sure on how to write that and be compliant any examples of statements to use would greatly be appreciated. It will take me and others about 6 months to update all our records. But we will have audits coming up and I just don't want to get dinged. Thank you
 
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William55401

William55401

Quite Involved in Discussions
#2
#2
Here's a suggestion. Raise a nonconformance to capture the issue and keep it open until all impacted documents are updated. This will ensure the Correction is captured within the QMS. Your notified body will want to see that issues are identified and actively being worked. Putting this into a NC is one way to go. There are others.

Alternatively, I suspect there may be an integration plan for your site. Is this document control detail captured as a line item in the plan? If the integration plan is a QS document and there is a closed loop report, you should also be OK.

Bottomline, use your QS to drive resolution. Good luck.
 
L

love02eat

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#3
#3
Thank you for the response but I suggested that manager prefers a statement to be documented and right now the new plan wont take effect until june 2021
 
P

Philip B

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#4
#4
You could also raise a change control programme. If you have been bought then there may multiple things you need to consider eg policy and objectives, top management commitment, roles and responsibilities etc. A change control programme would demonstrate that you have considered all of the impacts and have a plan with timescales for dealing with it. Could even turn a negative into a positive with your auditors.
 
L

love02eat

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#5
#5
Philip B said:
You could also raise a change control programme. If you have been bought then there may multiple things you need to consider eg policy and objectives, top management commitment, roles and responsibilities etc. A change control programme would demonstrate that you have considered all of the impacts and have a plan with timescales for dealing with it. Could even turn a negative into a positive with your auditors.
Click to expand...
Thank you
 
L

levatorsuperioris

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#6
#6
consider when you intend to change the name of the company with your NB. It doesn't matter what the sign says outside, as long as your certs still say xyz company INC, your documentation can refer as such. Chances are your NB only cares about when the label on the product will change and get phased in/out.
 
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