Document Numbering and Hierarchy Requirements for ISO 13485

C

cartman1417

#1
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)
 
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Jim Wynne

Staff member
Admin
#2
Re: Document Numbering

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)
You don't have to have document numbers at all, if there's an easier way of identifying them. You can just give all of your documents a unique sequential number, or identify documents strictly by title or anything else that works for you.
 

sagai

Quite Involved in Discussions
#3
Re: Document Numbering

Welcome :bigwave:

Actually I should admit I agree, you do not have to have a numbering scheme for documents in document control.
I know, there is a temptation to have it, but think about it, numbers ... are only characters having 0-9 values. Nevertheless, with Arabic numbers have little or no use in several languages (for example most of the Asian languages not even considering arabic numbers), and obviously only those are not fulfilling the purpose of having a unique identifiers for ... for example for documents.

I have some doubts about the step by step instructions, but anyway, that was not the subject of this post.

In addition, I am not sure if ISO mandates any particular media to have particularly for the QMS documentation. :cool:

Cheers!
 
C

Chance

#4
Re: Document Numbering

Here is what we use:
XX-NN-WI V1.0
XX- department initials
NN-two running numbers 01 for first WI and 02 and so on
WI - stands for WI
 
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