29. Sep 2017

A report from the ISO TC 176 meeting in Indonesia for QM users

New Quality Standards

From 11 to 15 September 2017, the global meeting of quality experts in the relevant Technical Committee 176 took place in Bali, Indonesia. About 150 experts from all around the world met to proceed with working on the Standards. The experts worked on different Standards from the portfolio of the quality-related ISO 9000 and 10000 series in various meetings. What are the most important news and outcomes and what is especially relevant to ISO 9001-users?

The transition to ISO 9001:2015 is still in progress

The Standardization Committee is working with foresight and thus work on this Standard has already been completed for more than two years. Right now, the aim is to define what will be with ISO 9001 in future!

In 2020, the Standard will be assessed in terms of its topicality and then – depending on the result – another revision with a 3 year period of validity might be carried out.

In the meantime it is considered whether the common framework for management systems, i.e. “Annex SL” with its High-Level-Structure, is still suitable or whether there are changes. At the same time, the work on “Future Concepts” for further development of ISO 9000 and 9001 is incorporated.  The aim is to analyze what issues will have to be taken into account in the field of quality management in future, so that Standards will continue to be highly relevant to users. This work is not primarily focused on the development of a future ISO 9001 but rather could be used as a guideline for any related Standards.

The „Auditing Practice Group” is also interesting for ISO 9001 users. Here, “Best Practice” examples are developed and published.

Right now this group is working on articles about outsourcing, development or audit planning for process-oriented auditing. These should be completed by the beginning of 2018.

Finally, a working group has been established to deal with questions of credibility of ISO 9001 and communication towards the users. This task is in close collaboration with ISO CASCO (responsible for the accreditation standards) and representatives of the accreditation bodies (IAF).

The largest working group was concerned with the completion of ISO 9004, which addresses the quality of an organization. This “guidance to achieve sustained success in an organization” is expected to be published in April 2018. The guideline contains useful concepts and practical guidance on how to bring quality management to the corresponding high level of maturity, how to maintain this level and how to achieve the intended effect.

Various working groups also worked on the revision of the ISO 10000 Standards. These are, inter alia, adapted to ISO 9001:2015 and deal with e.g. customer satisfaction, application of statistical methods, quality plans, project management, commitment of persons and other specific facets within the quality management.

One workshop has covered questions of terminology to raise awareness among the Standardization experts for correct and unambiguous use of terms and/or communication in the development of Standards, so that the content is clear and comprehensible to users.

An overview of ongoing projects and their status can be found on the ISO homepage

The representatives of the German, Austrian and Swiss delegation „DACH“ have consistently voted and united their efforts for achieving the best results; also, they have written this short report together.

The representatives of the German, Austrian and Swiss delegation „DACH“

Contact Person Quality

Team

Ms. Dr. Anni Koubek

Executive Vice President Sector Management Medical Devices

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