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Scope for ISO 13485 Certification of a Translation Service Provider

#1
Hi,
My company (Translation company) is starting the process of ISO Certification. Would anyone be able to advise what clauses in the standard are out of scope for a Translation company?
Thanks
 
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somashekar

Staff member
Super Moderator
#2
Hi,
My company (Translation company) is starting the process of ISO Certification. Would anyone be able to advise what clauses in the standard are out of scope for a Translation company?
Thanks
Here is an attempt list and you have to provide the due justification for its exclusion / non application based on your nature of business...
Exclusion: 7.3
Non applicable: 6.4 / 7.5.2 / 7.5.3 / 7.5.4 / 7.5.5 / 7.5.7 / 7.5.9.2 / 7.6 / 8.2.3 / 8.3.4 /
 

DannyK

Trusted Information Resource
#3
I agree with the list provided by Somashekar except for 8.3.4. A translation company may be asked to rework a translation job,
I personally would not exclude 6.4 -work environment .
 
#4
Thanks for the replies folks.
One more question, we developed our own software system for translating document. When we get a document from a customer we use this system to translate the document into the language the customer requires. Does this system need to be validated?
 

somashekar

Staff member
Super Moderator
#5
Thanks for the replies folks.
One more question, we developed our own software system for translating document. When we get a document from a customer we use this system to translate the document into the language the customer requires. Does this system need to be validated?
YES
Please read the 7.5.6 of the ISO 13485 for clarity on this.
Thanks and good luck.
 

LUFAN

Involved In Discussions
#7
That's computer system validation. Would fall under framework/guidance of ISO 80002 or future FDA "Computer Software Assurance for Manufacturing and Quality System Software" due out any day now.
 
#8
That's computer system validation. Would fall under framework/guidance of ISO 80002 or future FDA "Computer Software Assurance for Manufacturing and Quality System Software" due out any day now.
I'm a bit confused. Do I need to follow ISO 80002?
 

LUFAN

Involved In Discussions
#9
I'm a bit confused. Do I need to follow ISO 80002?
You don't have to follow any particular document as FDA nor any regulatory agency as far as I am aware specifies to do so. However, it needs to be done in a manner which is structured and is risk based (13485). Sans use of any new documentation, the methodology for validation of most software programs used for QMS activities (under FDA scope) was based on a 2002 FDA Guidance. Of course, a lot has changed in the way of technology since then and while it's still relevant, its not all that practical any more. It essentially tells you to perform an IQ/OQ/PQ without calling it that. The problem with this method if essentially every single aspect of the software needs to be heavily tested and scrutinized with test cases. First one I ever did for eQMS was 130 individual test cases ranging between 5 and 200+ steps each. I want to say we had like 15/20 3" binders full of test cases and reports. Takes forever, extremely resource heavy, and a major burden, given that validation is needed before go-live and any subsequent change.

That's where 80002 came along. It essentially gave us another structure to follow which allowed us to apply risk to more important areas, test those more heavily, and others less. Did it eliminate massive amounts of paperwork? Definitely not, but not an insignificant amount either. 80002 is essentially 14971 for QMS software. This allows future validations to more structured around risk, rather than performing test cases of every single little thing, which would be expected during an OQ. Essentially before if you checked a box, you would need to validate it's performance; now you can perform a risk analysis to determine if checking that box, which might do something trivial, is worth testing at all.

Next up and not yet released is FDA's version of "Computer Software Assurance for Manufacturing and Quality System Software". Which will be essentially the same thing as 80002, formally repealing the 2002 guidance. This has been promised by FDA forever now, but it's allegedly due out this quarter.

Here's the ISO 13485 Practical Guidance document:

The validation of software is covered in different parts of ISO 13485 depending​
on the use to which the software will be put (e.g., for processes in the QMS,​
as an element of the product or as the product itself, for the control of production​
or service provision, or for monitoring and measurement). Throughout​
the standard, the requirements for validation of the application of computer​
software are consistent irrespective of the use.​
For guidance on validation of the application of software used in your QMS,
you can find additional information in ISO/TR 80002‑2.

The too long didn't read version of this is using 80002 will actually save you time and is still an effective way to perform validation. Until FDA's new guidance is published, I would select 80002 every time.
 
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