Hi,
My company still has to undergo the transition to ISO13485, 2003. This was a choice made by management earlier and at that time I agreed. I thought I was prepared but when I read the draft quality manual I had prepared earlier I found that I don't like it! I have spent some time looking around and using the search feature in an attempt to see if someone has posted a template or example of a quality manual for a medical device company but I failed to find one.

Would anyone be kind enough to share one? I am not trying to wimp out and find one to copy to get out of writing it, I need to be able to build what my company needs. I feel once I have this in place the rest of the transition should fall into place (or am I fooling myself).

Sorry if I sound so desperate!
Thanks,
Bridget

Try Clinivation (http://clinivation.com/pages/resources/downloads.htm#policies)

Al,
:agree1: Thanks to your previous posts I went to Clinivation first. However I could not find what version of 13485 and other standards they had written it for. I will look at it closer.
Thanks,
Bridget

Bridget,
It appears that Clinivation's manual is aligned with FDA QSR. If it includes the additional ISO 13485 requirements (I haven't scrutinized Clinivation's files fully enought to know) then it essentially complies with ISO 13485, just not aligned the same way. If you are trying to write a manual that complies with both, then you are in for a real treat. There is no simple alignment. There was a thread here that discussed the alignment issue, but I don't recall where it is and I gotta leave right now. I'll try to find it later unless someone else beats me to it.

We had a BSI auditor do a pre-assessement and she said that our manual was just fine (aligned to FDA and ISO 13485:1996) and all we had to do was add the additional requirements and we would be ok. Needless to say, I didn't want to do that because I like the process approach better. The most important thing is to make sure that you have all the elements covered. It also helps if it makes sense to the people who have to use it.

I found a checklist with all the requirements for 13485 listed on the Cove a few weeks ago.

http://Elsmar.com/Forums/attachment.php?attachmentid=1922

Hopefully you can get to it with this link.

--Jodi

Thanks Jodi,
That checklistis a great resource. Wish me luck.
Bridget

Hi 45fan!
I also have to blend in the requirements for CMDCAS and The MDD. How easy was it to write the manual with a process approach? I have created this system where I work in 1996 with little outside exposure so the process approach is new to me and I am having difficulty finding someone to go over it with me. I have used several cove resources and found process articles and powerpoint presentations but until I can apply it to my company I feel inadequate.
Thanks for your input.
Bridget

Here is the link to Mr. Ed Kimmelman's matrix comparing ISO 13485 vs. QSR. He is an FDA Consultant and ISO/TC 210 SC1 Chairman. Originally posted by user SilverHawk to which I owe many thanks for sharing this:

http://Elsmar.com/Forums/attachment.php?attachmentid=1842

The thread is also worth reading, it is:

http://Elsmar.com/Forums/showthread.php?t=6160

As far as setting things up to the process approach, I must admit that I too have been feeling inadequate, and since I'm not done with my system, I don't really want to give too much advice on it, but I will share my system level QMS flowchart. This is patterned after an example in BSI's book "The Route to Registration" which was written for ISO 9001, not 13485, so its close enough. Of course, the system level processes get detailed with other flowcharts and processes. If its good enough for our chosen auditor, it should be good enough for us, I hope. I would appreciate feedback on this from any of you more experienced QA gurus.


I haven't read CDMCAS, but I am under the impression that it is basically 13485 with a few extra twists. MDD approach: QMS in compliance with 13485, add Essential requirements checklist, talk to distributor about any other regional or national requirements, if you are doing clinical trials, compliance with harmonized standard EN 540 "Clinical Investigation of medical devices for human subjects" equals compliance with Annex X, start planning for document translations EARLY-you need 5 languages to sell in all of EU-one is English, and of course technical files, design dossier if needed. Those are the biggies not specifically given in ISO 13485 that I can think of immediately. I'll have to review my procedures and see if I'm done with those.

Dear 45fan:

Thank you for sharing your map and the links, I will review them tomorrow.
You are correct about CMDCAS, we had to only add a few elements into existing procedures. We had CMDCAS for several years now. Fortunately we do not have to do clinical trials, our products are not that serious. With the MDD you need a minimum of 10 languages now plus the 10 new countries that have joined in. We started with 10 languages for the mdd in 1997 and just last week our auditor stated that if you do not sell into those countries then you do not need the translations, however we did so it was not in vain.

I have decided to review and revise all of my procedures and then worry about the manual last. I figure it will come to me in a ball of light one day and fall into place!

Thanks to everyone in this thread for letting me rant and rave about my ignorance. Someone could be making a lot of money if they were holding the right classes in the Indy area right now, I don't think I am the only one that needs a boost.

Bridget

10 languages?!!? That's gotta be expensive! Care to share the approximate costs, per page, word, etc? Any references to good translators would also be appreciated.

Tom

Hi Tom:
Besides our international sales reps who speak some languages we used our customers to translate the remainder of what we needed. We figured they knew the correct usage of the words because they use our products. Then we just offered them 400.00 of free products. Of course by now there are medical device translating company out there. I think our EU rep even offers this
mdi-europa.com and they have a US office, mdi consultants in the east. At least for Canada CMDCAS you only need French translations along with English.

The real fun is trying to get them all of the tranlastions on our product insert and the outside labeling along with the required symbols from EN980!


If I come across further tranlation companies I will let you know.
Bridget

Hi Bridget,

I suggest you use your existing manual then add an appendix containing a chart that harmonizes the standards. My chart consist of ISO 9001:1994, ISO 9001:2000, ISO 13485:1996 and 21 CFR 820, which our third party auditor, BSI accepted. I mention CMDR all over the manual and that satisfies Canada.

With regards to CE Mark, we over directions for use in five languages and the shear bulk is making packaging problematic. I can't imagine ten languages. We did a market analysis to settle before settling on five. CE Mark continues to be a challenge.

Kind regards,
Jeanne




Hi,
My company still has to undergo the transition to ISO13485, 2003. This was a choice made by management earlier and at that time I agreed. I thought I was prepared but when I read the draft quality manual I had prepared earlier I found that I don't like it! I have spent some time looking around and using the search feature in an attempt to see if someone has posted a template or example of a quality manual for a medical device company but I failed to find one.

Would anyone be kind enough to share one? I am not trying to wimp out and find one to copy to get out of writing it, I need to be able to build what my company needs. I feel once I have this in place the rest of the transition should fall into place (or am I fooling myself).

Sorry if I sound so desperate!
Thanks,
Bridget

What exactly you are intrested in knowing about ISO 13485, My company is ISO 13485 and QMS manual is a ditto copy of ISO13485, I dont like it and the funny thing is they started numbering the documents as per the sections of ISO 13485.

Hi, I'm new to the forum and it's been a tremendous resource for me. I was just hired to basically be in charge of "all things ISO" for our company which produces orthodontic equipment. I was handed a generic Quality Manual and generic Procedure Manual which was for 9001:2000 and was told that they had changed their minds and we are actually going to be preparing for the 13485 standards instead. Anyway I gues my point to this little rant is that I've been completely clueless :confused: :bonk: ( I'd never heard of ISO until I was going through interviews for my job) and this forum has helped a lot.

And that our manual is numbered like the standards as well and I hate it as well. So yeah, anyway. I guess I would like to pose one question. What I was given for 9001 was a Quality Manual and a Procedural Manual as two different things, except it looked like all the quality manual was, was a repeat of the standard, is this the right thing to do?? It seemed rather redundant to me. Also does a Procedural manual HAVE to be numbered exactly like the standard???

Thanks for any help, :thanks:

Jina

Hi, I'm new to the forum and it's been a tremendous resource for me. I was just hired to basically be in charge of "all things ISO" for our company which produces orthodontic equipment. I was handed a generic Quality Manual and generic Procedure Manual which was for 9001:2000 and was told that they had changed their minds and we are actually going to be preparing for the 13485 standards instead. Anyway I gues my point to this little rant is that I've been completely clueless :confused: :bonk: ( I'd never heard of ISO until I was going through interviews for my job) and this forum has helped a lot.

And that our manual is numbered like the standards as well and I hate it as well. So yeah, anyway. I guess I would like to pose one question. What I was given for 9001 was a Quality Manual and a Procedural Manual as two different things, except it looked like all the quality manual was, was a repeat of the standard, is this the right thing to do?? It seemed rather redundant to me. Also does a Procedural manual HAVE to be numbered exactly like the standard???

Thanks for any help, :thanks:

Jina
Welcome to the Cove:bigwave:

Short answers:
repeating the Standard in your manual IS silly and stupid. Congratulations for recognizing this. You are already on my list of bright, intelligent people!:D

The numbering can be anything you choose. It is good to make a "cheat sheet" matrix indexing your numbering system with the Standard so that clueless auditors don't wet their pants in frustration when they encounter something out of the oridinary.

Please ensure you do a "Gap Analysis" to compare your organization's present practices with the Standard you wish to follow. You will be pleasantly surprised that you already do most of the stuff in the Standard (good companies usually do.)

Medical concerns itself a lot with Standard Operating Procedures (SOP) and "Good Manufacturing Practices" (GMP) and "Current GMP" (CGMP) - these are the kinds of things you may have in a separate Procedural Manual. Compare this styling with the typical Document levels in regular ISO9k2k (or any good business management system.)

Quality Policy
Quality Manual
Procedures
Work Instructions
Records
In effect, your procedural manual is just binding your procedures together.

One thing I strongly suggest is to get a good handle on the concept of "Process" - once you do, you will find flow charts and similar tools will help folks in your organization keep an eye on the big picture and how each small aspect of the organization contributes to that "big picture."

Short answers:
repeating the Standard in your manual IS silly and stupid. Congratulations for recognizing this. You are already on my list of bright, intelligent people!:D I guess that means I'm on your other list.http://elsmar.com/Forums/images/smilies/omg.gif

I guess that means I'm on your other list.http://elsmar.com/Forums/images/smilies/omg.gif
If you want to repeat the Standard, why not just attach the whole thing as an appendix to your Quality Manual - why bother to retype the darn thing?

That way, you could have a one-line Quality Manual:
"We do everything contained in the Standard attached as Exhibit 1 in the Appendix."http://elsmar.com/Forums/images/smilies/lmao.gif

Seriously - what purpose is served by repeating the Standard? I might even condone paraphrasing, but some I have seen are word-for-word identical to the point of printing something like,"ISO9001:2000 says in "Section 6.4 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements." This organization determines and manages the work environment needed to achieve conformity to product requirements.
Of course, there is no mention of "how" they determine and manage the work environment.
http://elsmar.com/Forums/images/smilies/offtopic-d2.gif I also am constantly amazed that "organizations" do these things, not "people" or persons.http://elsmar.com/Forums/images/smilies/smile-a1.gif

The meat is in the procedures. The manual is a means to get to them.

Ok, I just have to say Thanks for all the help, your answers helped reassure me that I was in the right frame of mind. I have another question :o Ok, am I correct in assuming that a procedure manual should be written in such a way that the people (aka employees) reading it should actually be able to understand it? I've asked around, most of the employees, managers included have not even seen the manual, when I show it to them and ask them if they can understand the first few pages, they can't. It took me reading through it slowly and throughly six or more times before I understood it because it is so dense and technical. I don't feel that it needs to be or should be, so I guess my question is does it need to be that dense and technical to pass an audit? We have a meeting with a BSI consultant on Thursday and I felt safer asking here before asking her and making a fool out of myslef.

:thanx:

Jina

By all means, consider using flow charts, process maps, photographs, cartoons, and native language of the users (even if that means common English versus some rarefied legalese mumbo jumbo.)

When I look back at some of the turgid [drop the "gi"] wording which was common in Procedures 10 years ago, I can't believe we did NOT all gag on the stink.

What were we thinking back then? I remember seeing a Procedure for creating a document which ran 15 pages! If Jefferson was forced to follow that Procedure for the Declaration of Independence, all of North America might still be under fractured control of Great Britain, France, Spain, and the Hudson Bay Company.

The true test of the readability is when a person can summarize the document after reading it once and then holding it behind his back while summarizing.

You do NOT have to "dumb down" every document. It is OK to make assumptions about your audience for each document. A document meant for lawyers on filing a lawsuit does not have to be readable and understandable to the guy who mows your lawn. Similarly, the Procedure for programming a CNC 5 axis machining center does not have to be written so your second grade daughter can produce aerospace products to 50 millionths of an inch tolerances. It is sufficient if the document is readable and understandable to the target audience.

Thank you so much! :D

I've been polling employees and showing them the manual and several have said that it's too dense, others said that it's understandable but reads like an army manual. I just wanted to thank you sooo much for reaffirming my belief that it doesn't need to be like this.

:thanx:

Jina

Technical literature for Canada has to be in two languages (English and French), if the device is meant for public sale.

I am starting on the revision to ISO 13485:2003 and would appreciate any feedback.

My daughter, who is an executive with a Fortune 100 company, says, "North America is STILL under fractured control: Walmart, liberal press, fanatic right wingers, and Big Brother credit reporting companies!"

ISO 13485:2003 quality manual scope question- what is an appropriate scope statement for a medical device manufacturer- (we design, manucturer & service) I realize the old scope statement may be too broad ''The Quality Systems Manual is applicable to all personnel employed, engaged, or in a contractual relationship with xxx" Is there anyone out there who could suggest a different generic scope statement??

Thanks-Pamela

ISO 13485:2003 quality manual scope question- what is an appropriate scope statement for a medical device manufacturer- (we design, manucturer & service) I realize the old scope statement may be too broad ''The Quality Systems Manual is applicable to all personnel employed, engaged, or in a contractual relationship with xxx" Is there anyone out there who could suggest a different generic scope statement??

Thanks-PamelaHow about:
The design, manufacture and servicing of widgets
or
the manufacturing, testing, packaging, storage and distribution of X corporation products and services