ISO 13485 reassessment - passed with only one OFI

D

Doug Tropf

Quite Involved in Discussions
Passed our 13485 reassessment audit this week with only one OFI related to not properly documenting preventive actions.
 
howste

howste

Thaumaturge
Trusted Information Resource
Re: 13485 reassessment

Doug Tropf said:
Passed our 13485 reassessment audit this week with only one OFI related to not properly documenting preventive actions.
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Congratulations on your recertification! :applause:

You have my permission to take the rest of the week off. ;)
 
D

Doug Tropf

Quite Involved in Discussions
phoexix said:
Good News~~HAHA~~
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Thanks Phoexix. By the way I did discuss steam quality with our auditor, who is a microbiologist. He too had not heard of dry or super heated steam. I checked on the standard you referenced and it is pretty pricey so I did not pursue it any further.
 
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phoexix

Doug Tropf said:
Thanks Phoexix. By the way I did discuss steam quality with our auditor, who is a microbiologist. He too had not heard of dry or super heated steam. I checked on the standard you referenced and it is pretty pricey so I did not pursue it any further.
Click to expand...

Thanks.Doug
Our customer in US also provide us with their requirement about the steam quality which almost is the same as you mentioned except the limits..:thanx:
 
P

phoexix

Doug Tropf said:
Thanks Phoexix. By the way I did discuss steam quality with our auditor, who is a microbiologist. He too had not heard of dry or super heated steam. I checked on the standard you referenced and it is pretty pricey so I did not pursue it any further.
Click to expand...

Yes, it is hard to conduct these tests..

And the steam quality is led by the UK..adopted by Europe

EN 1422
10.2.1 If the sterilizer utilizes steam supplied above atmospheric pressure for humidification, it shall be
designed to operate with steam having a dryness value of not less than 0,9 and the degrees of superheat in
free steam at atmospheric pressure not exceeding 5 K..
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