Controlled Environment Procedure: Disaster Recovery Plan

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T

TCdavid

#12
Re: Controlled Environment Procedure: Disaster Recovery Plan?

BSI has been unresponsive to my inquiries, so far...:frust:
 
B

badgary

#13
Re: Controlled Environment Procedure: Disaster Recovery Plan?

BSI is still providing companies with the Disaster Recovery Plan listed on their Microbiology Audit Documentation Preparation Assistance Plan. Did you end up creating one for them? My client, small medical device company, is faced with the same situation as you were.

Thanks!
 
R

Reg Morrison

#14
Re: Controlled Environment Procedure: Disaster Recovery Plan?

BSI is still providing companies with the Disaster Recovery Plan listed on their Microbiology Audit Documentation Preparation Assistance Plan.
It would be good if a BSI representative could clarify why anyone seeking certification to QMS standards such as ISO 13485 would have to have a disaster recovery plan. Unless there is some forthcoming clarification, some people might start to get suspicious that BSI is trying to cross sell business continuity services for clients seeking QMS certification. There would be nothing wrong with that, AS LONG AS the clients understand that this is optional and above and beyond ISO 13485 requirements.
 
#15
Re: Controlled Environment Procedure: Disaster Recovery Plan?

Hi,

I am most interested in this thread. We are moving from an ISO9001 based system to an ISO13485 certification. We had the stage I assessment a few weeks ago and we were cited for two concerns related to this thread. "Need a business continuity plan (6.3) and need a pest control plan (6.4)". We are a small build to print manufacturer and have started supplying some analytical medical devices. I checked Elsmar since I couldn't find a "shall" in ISO13485 that required the above two processes. Has there been confirmation on these requirements? Any help would be appreciated.
 
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