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Transition Arrangements for ISO 9001:2000

03.02.2000

Certification Bodies are not to issue accredited certificates against the DIS or the FDIS ISO 9001:2000 standard that will follow in the year 2000.

After the publication (IS) of the standard a three-year grace period will follow during which certificates against the 1994 standards will still be valid. All such certificates will however expire on the third anniversary of the date of publication of ISO 9001:2000.
Read more about the transition arrangements by downloading "IAF standard letter" and "ISO/TC176 Communiqué". You find the documents under "Documents" on this site.

It should be noted that the current harmonized quality standard to the Medical Devices Directives are EN 46001 and EN 46002. Work by CEN on adopting the current standards ISO 13485 and 13488 into harmonized standards, was initiated last year by the EU Commission.




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