ISO 9001 and Risk - Based Thinking

The latest edition of ISO 9001, ISO's flagship quality management systems standard, has been published during September 2015. This concludes over three years of revision work by experts from nearly 95 participating and observing countries to bring the standard up to date with modern needs. Watch my comments recorded by ASQ at the ISO TC 176 TAG meeting in Washington, DC, August 8, 2014. This video is featured on the ASQ Standards Channel (along with video comments by many ISO 9001 experts) which are accessible to ASQ members.

According to the ISO website:

The 2015 edition features important changes, which Nigel Croft, Chair of the ISO subcommittee that developed and revised the standard, refers to as an evolutionary rather than a revolutionary process. We are just bringing ISO 9001 firmly into the 21st century. The earlier versions of ISO 9001 were quite prescriptive, with many requirements for documented procedures and records. In the 2000 and 2008 editions, we focused more on managing processes, and less on documentation.

We have now gone a step further, and ISO 9001:2015 is even less prescriptive than its predecessor, focusing instead on performance. We have achieved this by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization. Knowing that today's organizations will have several management standards in place, we have designed the 2015 version to be easily integrated with other management systems. The new version also provides a solid base for sector-quality standards (automotive, aerospace, medical industries, etc.), and takes into account the needs of regulators.

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