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Do we have to have foreign legal documents? (ISO13485 4.2.3 document control)

ugecha

Starting to get Involved
#1
Hello, everyone. Will you kindly let me now about the followings?

ISO13485 4.2.3 requires that manufacturer control the documents required by quality management system.
I assume they include legal documents such as MDD, Part 820, JPAL, etc.

We sell our products in many countries. Here are my questions I would like to know.

Q1. Do we need to have all legal documents (latest version) physically in paper in our office for every country? (If we must have all in paper, our office needs many huge file cabinets!!!)

Q2. For example, we cannot read any written in Spanish, yet do we have to have Mexican legal documents in Spanish? What for?

Q3. How about PDF? Is it possible for us to keep documents in PDF not in paper?

Q4. If yes above, do we need to worry about software validation or PART 11 (security, backup?) ?

Q5. Or is it enough that we just know where to find them online such as URL and we keep a list showing information such as document name, its latest version and URL?

Actually Canadian guideline says we should have their legal documents, ?MDR?.

GD210 4.2.3 says;
Does the Manufacturer have the most recent consolidated version of the MDR including any amendments published in Canada Gazette Part II?
http://laws.justice.gc.ca
http://canadagazette.gc.ca/

Thanks you for your help.
 
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John Broomfield

Staff member
Super Moderator
#2
Hello, everyone. Will you kindly let me now about the followings?

ISO13485 4.2.3 requires that manufacturer control the documents required by quality management system.
I assume they include legal documents such as MDD, Part 820, JPAL, etc.

We sell our products in many countries. Here are my questions I would like to know.

Q1. Do we need to have all legal documents (latest version) physically in paper in our office for every country? (If we must have all in paper, our office needs many huge file cabinets!!!)

Q2. For example, we cannot read any written in Spanish, yet do we have to have Mexican legal documents in Spanish? What for?

Q3. How about PDF? Is it possible for us to keep documents in PDF not in paper?

Q4. If yes above, do we need to worry about software validation or PART 11 (security, backup…) ?

Q5. Or is it enough that we just know where to find them online such as URL and we keep a list showing information such as document name, its latest version and URL?

Actually Canadian guideline says we should have their legal documents, “MDR”.

GD210 4.2.3 says;
Does the Manufacturer have the most recent consolidated version of the MDR including any amendments published in Canada Gazette Part II?
http://laws.justice.gc.ca
http://canadagazette.gc.ca/

Thanks you for your help.
ugecha,

Plug your management system into the online sources of the relevant documents and their updates. Do not rely on hardcopy.

Have your designated competent experts review each update for its impact on your goods, services, processes and management system. Authorize them to invoke the necessary changes per your preventive action process.

Have your designated experts evaluate compliance before closing each PAR.

Of course, your updated management system would then be used, monitored and improved for ongoing assurance of compliance. And internal audits would continue to sample effectiveness of your management system.

You may also need to analyze/design your process and document its procedure for "deploying legal requirements to your management system" per clause 4.1.

John
 

John Broomfield

Staff member
Super Moderator
#4
Thank you for your advice. Yes, we will plug our management system into the online documents. I am wondering how other companies are handling this issue.
ugecha,

You may find the other companies also link their marketing, designing and selling processes to this process (deploying legal requirements) to determine the cost of doing business before selling their product in each new foreign country.

John
 
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