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ISO 9001:2015 published on 9/23/15

9/23/2015

2 Comments

 
From http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2002

by Maria Lazarte on 23 September 2015

"The latest edition of ISO 9001, ISO's flagship quality management systems standard, has just been published. 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.

With over 1.1 million certificates issued worldwide, ISO 9001 helps organizations demonstrate to customers that they can offer products and services of consistently good quality. It also acts as a tool to streamline their processes and make them more efficient at what they do. Acting ISO Secretary-General Kevin McKinley explains: “ISO 9001 allows organizations to adapt to a changing world. It enhances an organization’s ability to satisfy its customers and provides a coherent foundation for growth and sustained success.”

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.”

As the much anticipated standard comes into being, Kevin McKinley concludes, “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.”

The standard was developed by ISO/TC 176/SC 2, whose secretariat is held by BSI, ISO member for the UK. “This is a very important committee for ISO,” says Kevin, “one that has led the way in terms of global relevance, impact and utilization. I thank the experts for their hard effort.”

ISO 9001:2015 replaces previous editions and certification bodies will have up to three years to migrate certificates to the new version.

ISO 9000, which lays down the concepts and language used throughout the ISO 9000 family of standards, has also been revised and a new edition is available."
2 Comments
Ted
9/23/2015 09:35:53 pm

If hospitals can effectively integrate risk based thinking with a robust process management system, the effect will be a safer environment for patients.

Reply
LoadX link
5/18/2020 05:03:21 am

nice work, keep up the good work.
excellent

Reply



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  • Home
  • ABOUT
    • About You
    • About Us >
      • Twitter Feed
    • About DNV GL Healthcare
  • Services
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  • Resources
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      • Quality/Quality Tools >
        • ISO 9001:2015 FAQ's
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      • HBR article- Hospitals can't improve without better management systems
      • Becker's- 3 Ways hospitals can improve profitability in 2016
    • Past Newsletters (Progress Notes-PRN)
  • Tools
    • Prioritization Matrix
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    • Preliminary Risk Assessment
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