ISO Starts Revision Process for Quality Management Systems Guidance

Posted 01 July 2013 | By Alexander Gaffney, RAC 

The International Organization for Standardization (ISO) is preparing to once again overhaul ISO 9001, a quality standard used extensively throughout the medical device industry, it has announced

The standard, known as Quality Management Systems, undergoes  a revision process once every five years, and was last updated in 2008 (ISO 9001:2008). The revision committee has already reportedly reached the draft stage of the revision process, the first step in a consultation process allowing comment from industry and the public.

"During this stage, the countries (ISO members) that have chosen to participate in the development of the standard have between two and four months to form a national position on the draft and comment on it," ISO explained in a statement. "Some members may decide to get input from the public to help form this national position, but this is not the official public comment stage."

Public feedback is expected to be collected in the first half of 2014, and the final revision of the ISO standard is expected to be completed by the end of 2015, ISO said. At that time, a two-year transition period will begin to phase out the ISO 9001:2008 standards.

The ISO 9001 standard is used extensively throughout the medical device industry, and is generally harmonized with a related medical device-focused standard, known as ISO 13485. The standard includes requirements related to the regulatory quality of device products, including the ability to prove that products manufactured at a facility consistently meet statutory and regulatory requirements.

ISO Statement

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