![]() ![]() We’ve purchased our copy, and here is a quick first glance.Ī quick review shows some dramatic departures from the other ISO standards currently being rushed to print by the media publisher, such as ISO 9001:2015. You can purchase the official release here, from ISO, for $158 (158 CHF). ![]() Surprising a lot of insiders, ISO pushed ahead with publication of its revised medical device quality management system standard, ISO 13485:2016, despite some controversy that many thought would cause ISO to delay its release.
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