Update on ISO 13485. (regulation and standards column).(quality management)

Medical Device Technology, March, 2002 by Donawa, Maria

In December 2000, ISO 9001:2000, Quality Management Systems, Requirements, was issued, which cancels and replaces ISO 9001:1994, EN ISO 9002:1994 and EN ISO 9003:1994. A three-year transition period is in effect during which time companies operating under a certified quality system can choose between the current 1994 editions or ISO 9001:2000. On 15 December 2003, the 1994 editions will be withdrawn and ISO 9001 quality system certificates issued after this date will be based on the new edition. In recent years, considerable progress has been made towards the harmonisation of requirements for medical device quality systems (see Table I). The publication of ISO 9001:2000 has significantly affected the harmonisation work that has been accomplished thus far; some of...

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