EBME Forums Forums Management Medical Equipment Management Easi ISO

Today I received my ISO 9001:2000 certificate and managed it with minimal effort. The company come in, audit the department, go away, write your manual then come back a few weeks later, check you have put in place what they recommend and present you with your certificate and manual.
Anyone interested please let me know your details and I will get them to give you a call.

P.S. it cost £1000 app. with £375 app per year for annual audit.

Darren
Did I understand you to say You had got your ISO Certification?
Congratulations

Darren,
Congrats on your registration.

I deleted the other 5 entries - don't think you wanted it on the forum 6 times

I'm going to have to decrease that floodcheck time

I am new to this ISO certification. Is there a MINIMUM requirements that can be used as a benchmark(sort of) to get this certification? A check list perhaps?

Darren,
Do I gather that you effectively paid a company to do the hard work, i.e. the paperwork and thinking. It seems like a bargin to me.
I spent absolutely ages getting us from the 1994 standard to the 2000 one. I had to have an extra visit from BSI, our auditors, which cost an arm and a leg and we pay much more for our twice yearly audit visits.

Bong,
Have a look at the articles posted by Huw on this very website. The skeleton of a manual is there for you to adapt to your own situation. Well done Huw. Though I am having trouble locating the rest of the articles. Could someone put in an easy link for me...and Bong.
Thanks
Robert

All the hard waork was completed by someone else, and the quality manual is written to what you do, not what someone else thinks you should be doing. The department was previously registered with BSI but i wasn't prepared for to pay them what they wanted to update to 2000.

If people wnat to update or have not registered before and would like more info they can give me a call on 0870 855 2170.

Darren,
Congratulations. I'm sure that you'll find quickly that you can reap all kinds of benefits from having ISO Accreditation, certainly we have over the past few years.

It is a common mis-conception that the QA manual is something that we have to follow, whereas, in truth it follows us (the trick is to have sensible procedures) It's one of the ways forward for all Biomed departments.

On a very slight ISO tangent; I would be interested in hearing of places/cal. houses (other than the manufacturers) who provide Calibration services (ISO traceable) for Medical Equipment such as defib testers, NIBP testers etc.

Where are you sending your 'specialist' test equipment? Perhaps we could do some benchmarking here in the forum?

We use Qados at present for some, but I have been disappointed in the quality of their certificates of late.

Sorry for the delay Robert - The articles have not all been posted yet - but what there is can be found at ISO 9001/2000 Quality Management