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Regulatory Focus™ > News Articles > Public Comment Period Opens on ISO 9001, Major Device Quality Standard

Public Comment Period Opens on ISO 9001, Major Device Quality Standard

Posted 21 July 2014 | By Alexander Gaffney, RAC

Public Comment Period Opens on ISO 9001, Major Device Quality Standard

The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation.


The standard, which covers Quality Management Systems (QMS), undergoes  a revision process once every five years, and was last updated in 2008 (ISO 9001:2008).

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 began collecting feedback on the standard in 2013, and during that time it solicited feedback from ISO member countries, which had the option of soliciting public feedback to form a national position as well.

ISO Consultation

Now ISO has released the draft 9001 standard for public consultation, albeit at a cost.

The 48-page document is available on the organization's website and is available for purchase for 58 Swiss francs.

"Basically, if you are anyone in the world, from industry, academia, consumers and regulators, here is your chance to have a say on probably the most famous ISO standard," said ISO Secretary General Rob Steele in a prepared statement.

Public comments will be considered by ISO's standards development team, Steele explained.

The standard, which is now at the "Draft International Standard stage" (DIS stage) is expected to be completed by the end of 2015. Once completed, ISO will implement a two-year phase-out period transitioning from the 2008 standard to the new standard.


ISO Statement

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