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What You Need to Know about the ISO 9001:2015 Revision

What You Need to Know about the ISO 9001:2015 Revision
The International Organization for Standardization has released its 2015 revision of the ISO 9001 quality standard. Check out all the major changes here.  

The International Organization for Standardization has released its 2015 revision of the ISO 9001 quality standard. Check out all the major changes here.

Marie Thibault

The ISO 9001 quality management system standard has been revised and published by the International Organization for Standardization. The 2015 version replaces the 2008 version of the standard, and companies who were certified using ISO 9001:2008 have three years to meet the 2015 requirements.

In a press release announcing the publication of the revision, Kevin McKinley, acting ISO secretary-general, said,

“The world has changed, and this revision was needed to reflect this. Technology is driving increased expectations from customers and businesses. Barriers to trade have dropped due to lower tariffs, but also because of strategic instruments like International Standards. We are seeing a trend towards more complex global supply chains that demand integrated action. So organizations need to perform in new ways, and our quality management standards need to keep up with these expectations. I am confident that the 2015 edition of ISO 9001 can help them achieve this.”

For a quick overview of the major revisions to the standard, this infographic from Advisera's 9001 Academy is a useful resource.

Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference , November 4–5, 2015.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie 

[Infographic courtesy of ADVISERA. Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

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