ISO 13485

patzx12

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Today my company was quality audited and we attained the Prestigious
ISO 13485 quality standard. We are absolutly over the moon.
 
Not another ISO B0110x accreditation

Only people benefitting from these are the auditors !!!

More paper chasing to 'strangle' a business

Celebrate getting it while you can.... months down the line you'll wonder why you bothered

P.S. this all stems from over 15 years of bitterness around various BS & ISO standards that appear to have popped up as an excuse for poor management to hide behind as they dont tend to understand there own business processes, requirements or legal obligations
 
Iso its all a bit of bull dust is it not, just another way to make money....

"It's alrite guvner, we're ISO certified"

We design and manufacture medical product so the ISO procedures are essential. We have been 9002 and 9001-2000 for 10 years but 13485 is another step to ensure the products we produce and the materials we use conform to the highest possible standard.


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ISO standards are just paper recording to show some sort of traceability from raw material to finished product.

Doesn't make the product perform better or be more reliable.


Military standards piss all over ISO standards anyway.
 
As long as Companies can write their own procedures it's just a paper chase. However, that doesn't undermine the hard work of those whom made it happen...:thumb2
 
We design and manufacture medical product so the ISO procedures are essential. We have been 9002 and 9001-2000 for 10 years but 13485 is another step to ensure the products we produce and the materials we use conform to the highest possible standard.


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well done
 
This once great nation of ours used to be a hub of innovation, enterprise and and manufacturing. Now all it seems to manufacture is overpaid feckin inspectors and auditors producing risk assesments, method statements, pie charts and other such bullshit which costs what's left of our industry an arm and a leg and generally makes the small businessman's life a misery.:spitfire
But well done anyway, Pat.
 
Well done, it takes serious effort and alignment to achieve that, and it is a high commendation of your company, people and the products.

To describe registration / certification as a paper sham is a poor reflection on the people who said it.

Does anyone need me to remind them what B. Behan said about begrudgers?

Bin
 


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