ISO 9001:2015 Part 1: Introduction & Overview

In this first of a three-part series, Walt Murray and Peter Knauer give a brief overview of the new ISO 9001:2015 standard. ISO traditionally alternates between major and minor revisions, and both Walt and Peter point out that this is a major revision. Not only that, it’s the version that’ll be used for the next decade.

After giving us some background on the standard, Walt and Peter talk about how the standard is taking on a truly global approach. Companies are increasingly likely to do business internationally, so the new version is taking a more global approach and is designed to work in harmony with other regulations and standards.

There are some dramatic changes in ISO 9001:2015, including an emphasis on risk-based thinking and performance as opposed to documented procedures. In fact, a quality manual is no longer required in this version of the standard and there are no requirements for documented procedures. While there are a lot of changes, Walt and Peter want to reassure viewers that they can adapt with enough preparation.

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ISO 13485:2016 Part 3: Getting Ready for Changes
ISO 13485:2016 Part 3: Getting Ready for Changes

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ISO 9001:2015 Part 2: New QMS Structure
ISO 9001:2015 Part 2: New QMS Structure

The second part of Walt Murray and Peter Knauer’s ISO 9001:2015 series focuses on the QMS. Primarily they d...

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