Hi Covers!
Just wanted to start a general discussion thread regarding plagiarism and copyright infringement, specifically when it comes to developing Quality System documents.
In particular, some points of discussion that come to mind:
- When quoting from standards, how much can be quoted? For example, I've seen company compliance or audit "checklists" that quote nearly all clauses in a standard. Is this acceptable, as long a the document isn't shared?
- Similarly, when writing Quality System documents: I've seen Quality Manuals that have requirements pulled pretty much verbatim from the ISO9001 standard. Is this considered plagiarism?
- When we quote clauses from copyrighted standards in these forums, is this acceptable? Some resourceful person could probably re-create most of the ISO 9001 standard by gathering up the quoted clauses...
- When another company's documents are obtained legitimately (e.g. through FCC, FDA or under freedom of information act), what are the restrictions on its use? For example, if I like the concise format of a 510k submission, can I copy the format?
- (Medical Device Specific) If the indications for use and contraindications for a device are the same as that of a predicate, is it acceptable to copy the statements from the predicate company? Or must they be re-worded?
Anyway, as always, looking forward to feedback and discussion!
P.S. Not exactly sure what forum this discussion would best belong to...moderators, feel free to re-locate as appropriate...
Just wanted to start a general discussion thread regarding plagiarism and copyright infringement, specifically when it comes to developing Quality System documents.
In particular, some points of discussion that come to mind:
- When quoting from standards, how much can be quoted? For example, I've seen company compliance or audit "checklists" that quote nearly all clauses in a standard. Is this acceptable, as long a the document isn't shared?
- Similarly, when writing Quality System documents: I've seen Quality Manuals that have requirements pulled pretty much verbatim from the ISO9001 standard. Is this considered plagiarism?
- When we quote clauses from copyrighted standards in these forums, is this acceptable? Some resourceful person could probably re-create most of the ISO 9001 standard by gathering up the quoted clauses...
- When another company's documents are obtained legitimately (e.g. through FCC, FDA or under freedom of information act), what are the restrictions on its use? For example, if I like the concise format of a 510k submission, can I copy the format?
- (Medical Device Specific) If the indications for use and contraindications for a device are the same as that of a predicate, is it acceptable to copy the statements from the predicate company? Or must they be re-worded?
Anyway, as always, looking forward to feedback and discussion!

P.S. Not exactly sure what forum this discussion would best belong to...moderators, feel free to re-locate as appropriate...