ISO 13485 Scope Reduction

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nowusu

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#1
#1
Hi all
New here but have found these forums useful in the past. Anyway, my question is as follows: My company has an ISO 13485 certification covering design, development and manufacture which was acquired before my time in 2016. Due to delays the company is still at least 3 years from market. My view is that the certification was acquired too soon, so wanted to suspend it but found out that the certification bodies are so busy that they are rejecting new applications so didn't want to put my company at risk so opted to reduce scope instead to just design and development . Anyway my question is can I still leave all the non-applicable SOPs in our system without obsoleting them? Or will need to obsolete them as part of the scope reduction?
 
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Ronen E

Ronen E

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#2
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nowusu said:
can I still leave all the non-applicable SOPs in our system without obsoleting them?
Click to expand...
Of course you can. You can have in your QMS anything that makes sense to you. However, if you are stating in your SOPs that you are doing something or that something needs to be done, and it isn't (because it's N/A at this stage), it may trigger a NC. So make sure to document clearly in your system which parts are currently suspended / "dormant", and why, and make sure that the rest it working in sync and in a way that makes sense. Then be prepared to explain all that to the auditor, defend it as necessary, and even receive and resolve some NCs that you might deem unjustified / illogical. That's the way the world works!...
 
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