M
Hi All,
I introduced myself before the holidays and mentioned that I would be asking questions in the new year. Well, here is the first of many (I'm sure).
Background: Our company (80 employees) manufactures medical imaging software only, and does not sell any hardware (computer, medical or otherwise). We meet ISO 13485-2003, have achieved CE marking and are FDA and Health Canada approved. We are due to have our ISO and CE marking surveilance audit the first week of February.
I recently moved into the position of Quality Systems Manager at our company and have no prior experience in quality systems or regulatory affairs. The previous QMS manager has left the company, so I am flying solo. Luckily I found this site and am hoping to learn as much as I can as quickly as possible.
Question: I am reviewing the operational procedures that we currently have in place, and was wondering if they are all needed. We currently have 26 individual procedures, but I'm thinking (perhaps incorrectly) that some of these can be dealt with simply by mentioning them in the Quality Manual (for example, do we need a documented procedure on how we do project management to deal with 7.2 of ISO 13485?).
I found a list of documentation requrements on this site, but was wondering if it is still valid as it states only 7 procedures are required to be documented.
Several of the OPs are also quite lengthy (15-25 pages). After deciding which OPs are necessary, the next step is to create work instructions from the detailed information in the remaining operational procedures in an effort to reduce them to a more manageable 4-5 pages. Does anyone see a problem with doing this?
Thanks for your help.
MtlGuy
I introduced myself before the holidays and mentioned that I would be asking questions in the new year. Well, here is the first of many (I'm sure).
Background: Our company (80 employees) manufactures medical imaging software only, and does not sell any hardware (computer, medical or otherwise). We meet ISO 13485-2003, have achieved CE marking and are FDA and Health Canada approved. We are due to have our ISO and CE marking surveilance audit the first week of February.
I recently moved into the position of Quality Systems Manager at our company and have no prior experience in quality systems or regulatory affairs. The previous QMS manager has left the company, so I am flying solo. Luckily I found this site and am hoping to learn as much as I can as quickly as possible.
Question: I am reviewing the operational procedures that we currently have in place, and was wondering if they are all needed. We currently have 26 individual procedures, but I'm thinking (perhaps incorrectly) that some of these can be dealt with simply by mentioning them in the Quality Manual (for example, do we need a documented procedure on how we do project management to deal with 7.2 of ISO 13485?).
I found a list of documentation requrements on this site, but was wondering if it is still valid as it states only 7 procedures are required to be documented.
Several of the OPs are also quite lengthy (15-25 pages). After deciding which OPs are necessary, the next step is to create work instructions from the detailed information in the remaining operational procedures in an effort to reduce them to a more manageable 4-5 pages. Does anyone see a problem with doing this?
Thanks for your help.
MtlGuy
