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This thread is carried over and continued in the Current Elsmar Cove Forums |
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This thread is carried over and continued in the Current Elsmar Cove Forums |
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 The Old Elsmar Cove Forums
 FDA and Medical Devices
 Continuous Certification
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| Author | Topic: Continuous Certification |
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ISO GUY Forum Contributor Posts: 81 |
posted 25 April 2000 02:52 PM
   
We are ISO 9001 Certified EN46001 and we have to comply with the MDD. Is there anything out there that says we can not be on a Continuous Certification rather than having to be re-certified every three years? IP: Logged |
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WallyBaloo unregistered |
posted 25 April 2000 03:37 PM
I believe that's between you and your registrar. Ours conducts a surveillance audit every six months, and a 'Strategic Review' (more intensive) every two years. As long as we remain in compliance, our registration is continued. IP: Logged |
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barb butrym Forum Contributor Posts: 637 |
posted 26 April 2000 12:25 PM
absolutely registrar dependant. Most will do an off site, invisible to you, review of your audits every 3 years and based on the overall trend( and elements covered), renew the registration..no charge. Have seen some charge, have seen some actually come in and do another full system audit (typically done with surveillance options of 1 per year instead of 2) You would be surprised what options are really available out there..no one seems to want to question the registrars....they are NOT all alike. [This message has been edited by barb butrym (edited 26 April 2000).] IP: Logged |
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ISO GUY Forum Contributor Posts: 81 |
posted 26 April 2000 03:21 PM
No our Registrar said that we can't have a continuous certificate. I called and they said it can't be done because the MDD needs to be re-certified every 5 years and EN46000 needs to be re-certified every 3 years? Is this true? I know all registrars are differnt, what I was looking for was to not have them come in and do a full system audit after 3 years. IP: Logged |
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