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Home > Archive > Electrical code Compliance > February 2006 > ISO 13485, how to ?
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ISO 13485, how to ?
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| rover8898 2006-02-10, 7:21 pm |
| Good day to all,
Can someone offer any advice concerning what documents are required for
an ISO 13485:2003 certification.
I already talked to a company that is responsible for the certification
of ISO 13485:2003.
I already downloaded the ISO 13485:2003 standard.
And I am still confused to as what an ISO 13485:2003 certification's
requires.
What documents does it require?
What has to be done to get ready for the ISO 13485 certification?
If anyone can forward me a link to a completed ISO 13485 documentation,
be it very BAD documentation and be it a first a draft, it will be much
appreciated.
Basically, I want to a gander to what a finalized doumentaion of an ISO
13485 documentaion looks like. I know, I am asking for much.
The point is that I want to avoid any consulting fees. The company
which I work for is small (4 employees, and the scope of the
certification is only 1 product) so I think the ISO 13485 certification
can avoid consultant fees. The company is not ISO 9001 certified
either.
In order to some better insigth, the company is comprised mainly of
engineers more focused on gettings things working than documenting the
steps they took to a given procedure. We have just developped a product
that requires an ISO 13485 certification. So how do I start?
I already got quotes for the certification process, but I can't very
well sit down with the certification inspector without having any idea
of what is it that he requires of me. That is why I wanted to look at
an already finished ISO 13485 documentation; I want to know what is I
must be able to supply in order to get the ball rolling.
Perphaps someone can tell me the first step I should do (aside from
talking to a pro :-) ).
Regards,
Roger
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| Paul E. Bennett 2006-02-11, 11:21 am |
| rover8898 wrote:
> Good day to all,
>
> Can someone offer any advice concerning what documents are required for
> an ISO 13485:2003 certification.
[%X]
> The point is that I want to avoid any consulting fees. The company
> which I work for is small (4 employees, and the scope of the
> certification is only 1 product) so I think the ISO 13485 certification
> can avoid consultant fees. The company is not ISO 9001 certified
> either.
Sometimes hiring a consultant early on in the project can save you more than
his fee. However, you have to look at consultancy hire more in terms of an
investment rather than a cost. You will, of course, have to find the right
sort of consultant.
> In order to some better insigth, the company is comprised mainly of
> engineers more focused on gettings things working than documenting the
> steps they took to a given procedure. We have just developped a product
> that requires an ISO 13485 certification. So how do I start?
> I already got quotes for the certification process, but I can't very
> well sit down with the certification inspector without having any idea
> of what is it that he requires of me. That is why I wanted to look at
> an already finished ISO 13485 documentation; I want to know what is I
> must be able to supply in order to get the ball rolling.
>
> Perphaps someone can tell me the first step I should do (aside from
> talking to a pro :-) ).
Your company will require a significant shift in attitude for a start.
Documentation is all important when preparing to convince the clientele and
the regulatory authorities that you have considered all aspects of the
design, have performed a sound development and that the risks posed by your
equipment are reduced to ALARP (As Low As Reasonably Practical). You should
be able to produce a complete safety case which, at its best, presents the
case for the defence against any incident that might involve your systems
(a bit like fighting any possible court case before you get landed there).
By doing things to that level of detail during design and development and
being able to back it up with documentation that would stand up to scrutiny
against the rules of evidence you are much less likely to end up in a court
of law (a topic extensively discussed at the recent Safety Systems
Symposium in Bristol, UK).
I know that there will be some who are quite cynical about taking such an
approach but, should their systems injure or kill someone, how would they
stand in court if they hadn't used the best possible practice available or
had enough supportive documentation to prove that they had accomplished
their stated aims of providing a safe system.
Without ISO9001, do you have a development process that can stand up to
scrutiny in terms of being able to repeatedly produce compliant systems. If
your engineers are more doers than documenters then I would doubt you even
meet the basic requirements of the medical devices industry. So, the first
thing to do is to sit down and document your current development management
process and to subject it to a very thorough technical review. Test this
documented management process once you have it written to make sure that
everyone follows the process (keeping it as simple as possible will help
here). Once you have done this then gaining ISO9001 accreditation is a
simple step of being audited (an expense but a worthwhile one). You may
find that it takes a couple of rounds of auditing to achieve the
accreditation.
As for understanding what documentation is required under ISO13458 "Medical
devices -- Quality management systems -- Requirements for regulatory
purposes" I expect it mentions that ISO9001 as an underlying requirement
and it may also mention production of documents like:-
A Product Hazard List
A Product Risk Assessment
A Product Quality Plan
A Product Quality Report
A Product Safety Plan
A Product Safety Case
A Product Safety Report
These are, of course, in addition to design rrequiremenst and technical
specifications. Remember that, in writing any of the above, you will also
have to document any assumptions you make about the operating environment
and system interfaces (including the interfaces with your clients at an
organisational level).
Be methodical about your approach and you will save time rather than waste
it. Keep the review meetings as short as practicable (there are good guides
around on running technical reviews) and stay focused on producing a sound
product.
--
********************************************************************
Paul E. Bennett ....................<email://peb@amleth.demon.co.uk>
Forth based HIDECS Consultancy .....<http://www.amleth.demon.co.uk/>
Mob: +44 (0)7811-639972
Tel: +44 (0)1235-811095
Going Forth Safely ..... EBA. www.electric-boat-association.org.uk..
********************************************************************
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