Monthly Archives: November 2013

Unlike ISO 9001:2008 revision which was primarily semantic changes, the 2015 revision seems to include some major changes similar to transition from 1994 to 2000 edition. The release of the new 2015 standard probably will not happen until later 2015 or early 2016, but it is worth while to take a look at the proposed changes and try to incorporate some of the changes into revisions of existing ISO 9001:2008 program in preparation to the new standard and also for continual improvement.
Please note that the changes in the draft document is subject to change and the released document may include some major differences to the proposed draft.

http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1633

Starting January 2014 Health Canada will be participating in a pilot program by launching the Medical Device Single Audit Program (MDSAP)together with the Australian Therapeutic Goods Administration of Australia (TGA), the Brazilian Nacional de vigilancia sanitaria (ANVISA) and United States Food and Drug Administration (FDA).
This program is intended to provide similar assessment system as the current (CMDCAS) which has been adopted by Health Canada for number of years now.
Health Canada will continue to operate the current (CMDCAS) as well as the new (MDSAP) for period of three year pilot program. During the pilot the certificates generated by registrars under MDSAP will be used instead of (CMDCAS) until the three year pilot which and successful completion of the pilot the (MDSAP) will replace the (CMDCAS), and (CMDCAS) will no longer will be used for assessment of the quality systems.
Under this program the manufacturers will benefit from a single audit program that meets the requirements of multiple countries. This will reduce the number of inspections faced by medical device manufacturers which a present cause significant disruption and cost to business operations while at the same time maintaining appropriate regulatory oversight.

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/mdsap_pilot_notice_avis-eng.php

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/mdsap_pilot_inter_coal_avis-eng.php

FDA Video Presentation on MDSAP:
http://fda.yorkcast.com/webcast/Viewer/?peid=ae40c79d2479493393241d4a90e586691d

FDA Slide Presentation MDSAP:
http://www.fda.gov/downloads/Training/CDRHLearn/UCM372920.pdf