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EFHSS Questions and Answers - Answer to Question Q00025

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EFHSS - Questions & Answers - Quality Assurance - Q00025
ISO9002 Quality Assurance Certification
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From: Michele Tait (Ireland)   Date: 6 June 2000, 01:47 [GMT]
Subject: ISO9002 Quality Assurance Certification

Dear colleagues

I am trying to source information from other Sterile service departments who may hold the ISO9002 Quality assurance certification (or equivelant). I am in the process of compiling a quality manual but would welcome some help as to the scope I need to include. I hope to make application for registration before the end of the year, I would be very grateful for your help.

Kind regards
Michele Tait
CSSD Manager
Dublin Dental Hospital

From: (United Kingdom)   Date: 1 September 2000, 11:20 [GMT]
Subject: Re: ISO9002 Quality Assurance Certification

I would approach some of the members of the ISSM to give you this info as alot of them have been going or are going through this process for 46002 registration

Robert

From: (India)   Date: 22 September 2000, 13:17 [GMT]
Subject: Re: ISO9002 Quality Assurance Certification

Kindly send me more information on the above subject. I would also appreciate if you could send me information on classification of indicators.

Thanks & Regards,
Anchal Gupta.

From: (Belgium)   Date: 26 September 2000, 08:05 [GMT]
Subject: Re: ISO9002 Quality Assurance Certification

Dear Anchal Gupta,

In the EN 867-1: Non-biological systems for use in sterilisers - Part 1: General requirements (see under CEN Standards on the homepage), you can find the classification of indicators. You will have to check the CEN website for information on how to obtain the standards.
ISO 11140-1, 2, 3:1995 goes also about chemical indicators. Information hereabout you'll find on the ISO website (see under Related Sites and Links).

Kind regards.
Wim Renders

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