Getting a company to ISO standard

It would be very useful to get my small Ltd company to ISO 13485: 2003

http://www.iso.org/iso/iso_catalogue/catal...?csnumber=36786

This one is normally harmonised with ISO 9001 (it's a step up from ISO 9001 basically).

We are a UK Ltd company but 100% based in Germany, so not even sure if I can undertake the process in English or German. English might be legal but I might also hit instant issues with German staff therefore meeting and understanding the new internal standards etc. So may need to be bi-lingual.

Has anyone here used an outside agency to reach an ISO standard? Has anyone managed to handle this in-house?

Thoughts or advice appreciated.

I've done this twice and on both occasions used an outside agency to create the Quality Manual.

It's a damn sight easier, they know what the true req'ts are and it's cheaper in the long run.

The aim is to make the QM as small as is possible so that audits become easier.

I would suggest doing it in the UK if at all possible as it's an International Standard.

Thanks Dave. Doing it in the UK is not an option. Doing it in English might be - but I am not kidding myself - we are 100% based in Germany, just not a Gmbh.

I have done it in-house (ISO 9001) in the past - with one other colleague, him for the quality management side, me for the sales/marketing/development side. It was a mid-sized company in Germany (about 300 employees spread in three locations)

The biggest hurdle may be the German. I don't know if you can do it in English; even though we were an American company, we did it in German for the German end of the business.

But the actual rules are not really hard and for a small business it shouldn't be too hard to lay them out in writing. Don't know if there's a handbook of steps/processes... but the actual doing is very much just common sense.

ISO 9001 is a waste of time and money. Most companies will spend lots of money and man hours, to which they won't recover anything (Money or time).

You can however do it in German or English, its a standard... So its all the same, no matter where you go, or what ext. company does the audit.
There are companies in Munich that will ISO review/certify you in English. If you really want to go the ISO route I'll PM you their contract info tomorrow.

More red herrings from people who dont understand <sigh>. The second part of your statement is true, the first isnt. If you do it properly it actually saves time and money, which admittedly doesnt stop a lot of people who want to jump the bandwagon without understanding it and doing it wrong.


Part 1 of understanding what ISO9001 etc is supposed to do: - Its an operating system for your company, so its pointless not having it in the native language of most of your employees. Yes you can do it in english and try and get your German employees to work to it, no it wont be very useful or successful.


No it isnt and it matters great deal who does your certification, as there are still cowboys around who will provide a certificate thats not worth the paper its printed on. If you are going to bother, go to a reputable certification company with specific experience in your industry.


If the OP wants ISO 13485 certification, a generic ISO9001 certifier isnt going to be a lot of help. Probably the best first place to go is the local TÜV - They may not be able to do the specific certification themselves, but they may know people who can.

http://elsmar.com/ has a lot of very useful people who might be able to give more specific tips.

Im automotive so Im deeply into TS16949 rather than ISO 13485.

andy M

Be careful with that - Its not a step up but a step sideways. It is harmonised with but does not include ISO9001 and if you want both you'll have to make sure you cover both in your QMS. The extra work is probably so little that it wont be worth NOT going for both.


Youre quite right here. Its well worth going bi-lingual but whetever you do it will need to be in German.


Ive been a quality professional for over fifteen years now and was a plant or company quality manager for nearly ten of those so I have written or introduced QM systems to AQAP4 (the NATO standard pre-dating ISO9001), ISO9001:1994, ISO9001:2000, QS9000 and ISO TS 16949 (all in German or bi-lingual). For ISO9001 Ive always written myself from scratch, for my first outing into TS 16949 I bought a generic handbook, learnt how not to set up a system by reading it,. threw it away and then wrote from scratch. The company I am currently with used an external contractor and had an internal Quality manager who clearly didnt know what he was doing and the system, although certified, is a mess.

If you really are starting from scratch it might be helpful to get a contractor in to help you get off the ground, but dont let him write your QMS alone, aim to pick up what hes doing and do the final write-up yourself. The whole system will end up a lot leaner and more efficient that way. Do you have a quality manager? If not, it may be worth getting one, even if only temporarily, or get someone else to take over the function.

Ive posted the link eleswhere, but the Elsmar Cove website is a rich mine of information and can probably help you with something as specific as 13485.

andy M

'Ol Scott really doenst like ISO 9001 ;-) Theres a whole series of ISO9001 Dilberts but I didnt have this one - Thanks for that.

andy M

Trust me - I will not be doing this for fun. I will only be doing it because I really really have to. I abhor unnecessary regulations, but if I want to manufacture my own Class IIa Medical
Devices it is my only longterm option.

But I have another option for the next 6-12 months whilst I upgrade to the lovely required standards. We are a very small company so the costs and time needed are rather daunting.
Would be OK if we had 100 employees.

I suspect English will be acceptable as in fact my current employees are actually Swiss, Swedish and French so our working languages are English and German (in no particular order).

This one is normally harmonised with ISO 9001 (it's a step up from ISO 9001 basically).

Not sure if this is appropriate, but have you looked at the Professional Contractors Group Scheme. PCG is a trade body for freelancers and small companies, and offers a route to ISO9001 certification. It might be adjustable to your needs. Certainly worth asking the question.

http://www.pcgqs.org.uk/cms/index.php for the quality stuff

http://www.pcg.org.uk/cms/index.php for contact info

Good Luck