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Its a Green Light for IS) 13485 .pdf



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It's A Green Light For ISO 13485:
Revised Global Quality Systems
Standard Finally Published
By Shawn M. Schmitt / Email the Author
Regulatory & Policy News / Word Count: 550 / Article # 01160229018 /
Posted: February 26 2016 10:00 AM

Executive Summary
After five years of high-stakes development, ISO 13485:2016 was published
on Feb. 24. The 36-page worldwide quality systems standard carries an
official publishing date of March 1, which means firms have until March 1,
2019, to comply.

There are no current related
articles

Topics Covered in
this Article
Click a keyword for related
articles.
General Topics
quality assurance
SilverSheet
Subjects
Regulatory
Post-Market Regulation
Manufacturing
Manufacturing
Industries
Medical Devices
Companies
3M Co.

The long, twisted path to revision
for international quality systems standard ISO
13485 has come to an end following five years of high-stakes development.
The 36-page ISO 13485:2016
cleared an up-or-down vote from the 37 membercountries of the International Organization for Standardization (ISO), setting the
stage for its Feb. 24 release.
The standard carries an official publishing date of March 1, which means firms have
until March 1, 2019, to comply with its requirements. ISO 13485 was last revised in
2003.
Among the core revisions to the 2003
standard in the new document is an
enhanced focus on how device
companies should manage risk-based
decisions related to purchasing, design,
development, manufacturing, production
control activities and other aspects of the
quality management system. The revised

"It was agreed that we would
not go to the high-level
structure – that the medical
device industry preferred
not to do that, and that we
wanted to stay with our

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standard is also intended to be more
prescriptive.

existing format," 3M's Scott
Sardeson said in an August
interview.

Device manufacturers use ISO 13485 to
ensure quality systems compliance with
regulators in different countries, including
Canada, Japan, Australia and the 28 member-states of the European Union. The
standard's requirements for device manufacturers are similar – but not identical – to
FDA's Quality System Regulation
.
US manufacturers have to comply only with the QSR if they plan to exclusively sell
their devices domestically, but they must meet the requirements of both the FDA
regulation and ISO 13485 if they want to market internationally.
Late in the revision process there were concerns
that the rejiggered standard
would be thrown off the rails by some European countries that wanted ISO 13485 to
follow a so-called "high-level" format.
Adopted by ISO in 2012, the format requires all published standards to be
harmonized in construct, text, terms and definitions. But the group tasked with
revising ISO 13485 – ISO Technical Committee 210
, Working Group 1 (WG1) –
believed it would be troublesome to use such a structure for a device-related
standard.
Therefore, WG1 asked for – and received – a waiver from ISO's Technical
Management Board to revise ISO 13485 based on the 2008 version of ISO 9001,
which does not use the high-level approach.
Originally published in 1987, ISO 9001 underwent its own revision last year that
incorporated ISO's high-level format. ISO 9001 is the general quality systems
standard applicable to all industries and is the base standard of ISO 13485.
"It was agreed that we would not go to the high-level structure – that the medical
device industry preferred not to do that, and that we wanted to stay with our existing
format," Scott Sardeson, an international regulatory manager at 3M Co., told "The
Gray Sheet" last August.
Sardeson, who is also co-chair of WG1, promised that the group would consider the
high-level format when ISO 13485 is next revised in about five years.
Until then, the newly published version of ISO 13485 includes an annex that allows
users to map the standard to ISO 9001.
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200 .
Printed by Mr. Norm Rabin, Maetrics LLC

Copyright (c) 2016 Informa Business Intelligence, Inc., an Informa Company. All rights reserved. No part of this article
may be reproduced in any form or incorporated into any information retrieval system without the written permission of the copyright owner.

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