C
Hello all,
Generally speaking, documents you'd have under ISO 13485 structure would include Procedures, Forms, Work Instructions, Attachments.
Now I could be understanding this the wrong way, so please feel free to correct me. But I created several Work Instructions for step-by-step instructions on how exactly things are done.
For example: I have a Work Instruction for How to Install Firmware in the Electronic Board. The firmware and associated files will be part of the Attachment. And the document number is WI-02-003, where WI is Work Instruction, 02 is because it is related to Electronics, 003 is the sequential document number.
Anyway, my question is that how should I number the system level documents? So documents such as Program Plan, Risk Analysis, System Design Specifications, etc... because they do not qualify as a Procedure, Form, Work Instruction or Attachment. Or do they?
Any suggestions? (If it is not clear what I am asking, please let me know and I can try to put it differently)
Generally speaking, documents you'd have under ISO 13485 structure would include Procedures, Forms, Work Instructions, Attachments.
Now I could be understanding this the wrong way, so please feel free to correct me. But I created several Work Instructions for step-by-step instructions on how exactly things are done.
For example: I have a Work Instruction for How to Install Firmware in the Electronic Board. The firmware and associated files will be part of the Attachment. And the document number is WI-02-003, where WI is Work Instruction, 02 is because it is related to Electronics, 003 is the sequential document number.
Anyway, my question is that how should I number the system level documents? So documents such as Program Plan, Risk Analysis, System Design Specifications, etc... because they do not qualify as a Procedure, Form, Work Instruction or Attachment. Or do they?
Any suggestions? (If it is not clear what I am asking, please let me know and I can try to put it differently)
