T
TCdavid
Hello all,
We are a medical device manufacturer and are preparing for a microbiology audit (seeking ISO certification) to be conducted by BSI. Part of the documentation they will be reviewing, listed under "Controlled environment (clean room) procedures" is "Disaster recovery plan". I haven't been able to find information here specific to that situation. Is it just a misplaced request to see if we have a general business contingency plan prepared (we don't) or are there requirements for recovery plans for clean room disasters (Oops! The HEPA vacuum just exploded!). Any information or example plans (if available) would be greatly appreciated. Thanks in advance!
David
We are a medical device manufacturer and are preparing for a microbiology audit (seeking ISO certification) to be conducted by BSI. Part of the documentation they will be reviewing, listed under "Controlled environment (clean room) procedures" is "Disaster recovery plan". I haven't been able to find information here specific to that situation. Is it just a misplaced request to see if we have a general business contingency plan prepared (we don't) or are there requirements for recovery plans for clean room disasters (Oops! The HEPA vacuum just exploded!). Any information or example plans (if available) would be greatly appreciated. Thanks in advance!
David