A
I work in a medical device company that has SOP’s according to the QS requirements of ISO 13485, the FDA, Canada and the MDD.
I have seen the SOP’s of other companies and almost every company has a different approach in relation to:
1. The method of numbering the SOP’s.
2. The way in which the SOP’s are written, e.g. some companies quote almost verbatim from a standard or regulation; others use their own terminology.
3. The way of writing SOP’s so as to satisfy the QS requirements of ISO 13485, the FDA and Canada, e.g. some companies have a separate SOP listing some of the Canadian QS requirements; other companies integrate Canadian QS requirements into their “general” SOP’s.
4. The method for referencing other company documents, e.g. some companies include other documents in the body of the SOP; other companies simply make a reference to another document.
Of course, we all have to do what is best for us and what works in practice, and we want to use language that is commonly used in business practice, .e.g. instead of saying “process performance and product conformity” we can say “how well our processes are doing and how often we get it right/wrong”.
So my post really boils down to this: based on our experience and on comments/observations received from external auditors, can we please share with each other "major" pitfalls/mistakes to be avoided when writing SOP’s???
Thanks.
Asherlee
I have seen the SOP’s of other companies and almost every company has a different approach in relation to:
1. The method of numbering the SOP’s.
2. The way in which the SOP’s are written, e.g. some companies quote almost verbatim from a standard or regulation; others use their own terminology.
3. The way of writing SOP’s so as to satisfy the QS requirements of ISO 13485, the FDA and Canada, e.g. some companies have a separate SOP listing some of the Canadian QS requirements; other companies integrate Canadian QS requirements into their “general” SOP’s.
4. The method for referencing other company documents, e.g. some companies include other documents in the body of the SOP; other companies simply make a reference to another document.
Of course, we all have to do what is best for us and what works in practice, and we want to use language that is commonly used in business practice, .e.g. instead of saying “process performance and product conformity” we can say “how well our processes are doing and how often we get it right/wrong”.
So my post really boils down to this: based on our experience and on comments/observations received from external auditors, can we please share with each other "major" pitfalls/mistakes to be avoided when writing SOP’s???
Thanks.
Asherlee