ISO 13485 sample document or template - Class II medical device

O

orthorumcanada

#1
hi, i've spent the last hour searching the forum db for some 13485 sample document... so far i'm only got this existing discussion thread: Please review my Quality Manual , but i am looking for more example/sample/template. So i have a better idea what exactly i need to put in the huge documentation.

we are trying to get approve by Health Canada and so we are filling the 13485 Class II... we already got the ISO13485:2003 pdf and read through it, and now about to make the documentation. Just need some sample to follow through side by side.

Some links would be appreciated. :)

Thanks
 
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GStough

Staff member
Super Moderator
#2
Re: LF ISO 13485 sample document or template

I'm not sure I understand what kind of 13485 sample document, specifically, you are looking for. Have you checked the Post Attachments List in the upper left hand corner of the screen? There are several documents located there that might be what you're looking for, or at least give you a starting point.

Welcome to the Cove! :bigwave:
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Re: LF ISO 13485 sample document or template

So i have a better idea what exactly i need to put in the huge documentation.
If done right, you shouldn't have "huge" documentation. I hope you're not over complicating the situation or misunderstanding the requirements in some way. Many companies over document.

I echo the question, specifically what type of template are you looking for? A quality manual?
 
O

orthorumcanada

#4
Re: LF ISO 13485 sample document or template

If done right, you shouldn't have "huge" documentation. I hope you're not over complicating the situation or misunderstanding the requirements in some way. Many companies over document.

I echo the question, specifically what type of template are you looking for? A quality manual?
The guy who came to our office told us that we need to produce documentations that is about 3/4 of an inch to 2 inch thick... (that's roughly about 50 to 200 pages) :mg:

I'm not sure I understand what kind of 13485 sample document, specifically, you are looking for. Have you checked the Post Attachments List in the upper left hand corner of the screen? There are several documents located there that might be what you're looking for, or at least give you a starting point.

Welcome to the Cove! :bigwave:
WOW, i thought that was an advertisement... lol, well i did search on Advanced Search with keyword "has attachment" hhehe... but let me check that Post Attachments list. Thanks!
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
Re: LF ISO 13485 sample document or template

The guy who came to our office told us that we need to produce documentations that is about 3/4 of an inch to 2 inch thick... (that's roughly about 50 to 200 pages) :mg:
That's a totally irresponsible request. Requiring specific content is one thing, just asking for x inches of documents is total bull stuff.
 
O

orthorumcanada

#6
Re: LF ISO 13485 sample document or template

Well that was the "guesstimate" he gave us. I am the computer guru here, and i've been digging through google the whole morning lol. Thank god i found this website hehe... i will pass on the message about the content of the document, rather than the length. :)
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#7
Re: LF ISO 13485 sample document or template

Anyone giving you 'guesstimates' like that have no idea what's going on. You should ask:

1. What specific documents are required?
2. Is there some specific content required in any specific document?

I'm *assuming* you've been given the responsibility to implement ISO 13485 in your company - Is that the situation?
 
O

orthorumcanada

#8
Re: LF ISO 13485 sample document or template

Nope, the owner and the secretary are going to type out the whole thing. I'm just helping them looking for documents and samples (ex: some other company's ISO 13485 proposal). So they can follow through.
 

Steve McQuality

Quality Engineer
#9
Re: LF ISO 13485 sample document or template

Nope, the owner and the secretary are going to type out the whole thing. I'm just helping them looking for documents and samples (ex: some other company's ISO 13485 proposal). So they can follow through.
If I may be so bold - be careful "cutting and pasting" someone elses QMS for 13485. It may be the easy way to generate the documentation, but may be difficult to live up to someone elses expectations.

We are a relatively small (in comparison) Medical Device company and have been owned along the way by a couple of the giants. Their documentation doesn't work well for our particular situation and we're still "undoing" some of the pitfalls that come with being associated with a large company. If you're a small company, as it sounds like you are, just be careful you don't "paper yourself into a corner" by over-documenting - which is just what 2-inches of documentation would do come registration time!

Good luck -Steve
 
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