Document Control - Control of external documents

[mcervantes]

Re: Control of external documents

Here is a question I have regarding ISO 13485 and the requirement for controlling of external documents in Section 4.2.3, (f):
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document
and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to review and approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and

How detailed is the control? My company has 100's of standards but they are not controlled right now. They live in a spreadsheet and they are not in Doc Control. Help or any suggestions?

 

[gmdfharr]

Although these documents are not controlled, you as an organization must keep a list of such documents, how many copies, where are they located. You are controlling where they are and what you have. such as: IPC 610, Military Defense Standard 2167, if your drawings call for this standard or a standard, you must list them.

 

[gmdfharr]

Re: Control of external documents

take your spread sheet, ensure it has number of copies, where located, latest rev. and call the spread sheet, "Documents of External Origin", give the spreadsheet a number/rev. and put it in Doc Control. now except for a 1 page process doc for how you handle these, your done. Sounds like you have most of the work already done.

External documents, such as international and domestic standards, customer drawings and such items are maintained as documents of external origin. These are the documents you need to at least show control by listing them along with the rev. of the doc and location to be found, that's how you control "external document". Nothing to do with safety. The only control is that you know what they are, the rev. and where they are located.

I stand corrected on the 1 page doc, just put my first statement above in your QMS as a paragraph in 4.2.3. This with the list will satisfy the requirement. No other 'control' is necessary.

 

[Geoff Withnell]

Even if the guidelines weren't a reference document, it wouldn't still be required by the 'QMS' since the document pertains to Safety and according to many experts here, anything related to EHS shouldn't form part of the Quality Management System conforming to the requirements of ISO 9001.

The issue has already been discussed in various threads under different thread titles.

It is amazing to me how many people miss the point. It is not whether it is "required" by the QMS to control the document. The issue should be "Do we care if the user has the correct information provided by this document?" If the answer is yes, then the document should be controlled. Since most organizations don't want to have more than one document control system, it will be in the QMS Document Control. If you don't care, why have the document?

Geoff Withnell