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QMI to Perform ISO 13485 Audits

Published: Wednesday, November 3, 2004 - 23:00

QMI recently announced that it has received accreditation to perform ISO 13485:2003 audits. The accreditation, which was issued by the Standards Council of Canada, also allows QMI to offer registrations to ISO 13485:1996 and ISO 13488:1996. To apply for or maintain a valid license for Class II, Class III or Class IV medical devices, all manufacturers will be required by Health Canada to register to ISO 13485:2003 under CMDCAS by March 15, 2006. This new requirement can provide medical device manufacturing companies with advantages. Many ISO 9001:2000 principles addressing specific medical device manufacturing requirements, including adopting the process approach for quality management systems, have been included.

“This achievement further expands QMI’s management systems registration services to medical device manufacturers,” says Randall Boyle, QMI medical devices manager. “Growth in this sector allows QMI to find new ways to bring value to our established customers.”

For more information, visit www.qmi.com.


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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.