The most important ISO clause

It is not a trick question. The most important clause in ISO 9000:2005 was clause 2.3 but they didn’t include it in ISO 9000:2015. TC 176 merged the systems approach and the process approach principles and with it they threw the baby out with the bath water by omitting to make ISO 9001:2015 clause 4.4.1 mirror ISO 9000:2005 clause 2.3.

ISO 9000 clause 2.3 stated: (Note the comments in Red are ours)

2.3 Quality management systems approach

An approach to developing and implementing a quality management system consists of several steps including the following:

  1. determining the needs and expectations of customers and other interested parties; (The starting point)
  2. establishing the quality policy and quality objectives of the organization; (These need to align with ‘a’)
  3. determining the processes and responsibilities necessary to attain the quality objectives; (These need to align with ‘b’))
  4. determining and providing the resources necessary to attain the quality objectives; (Note the focus is always on objectives)
  5. establishing methods to measure the effectiveness and efficiency of each process; (Note that it is the process that needs to be measured not simply the process outputs or whether tasks have been performed)
  6. applying these measures to determine the effectiveness and efficiency of each process; (Note that it is both efficiency and effectiveness that should be determined)
  7. determining means of preventing nonconformities and eliminating their causes; (This means reducing risks)
  8. establishing and applying a process for continual improvement of the quality management system. (Improving the QMS is the same as improving the business because of where ‘a’ comes from)

Such an approach is also applicable to maintaining and improving an existing quality management system.

An organization that adopts the above approach creates confidence in the capability of its processes and the quality of its products and services, and provides a basis for continual improvement. This can lead to increased satisfaction of customers and other interested parties and to the success of the organization.


© Transition Support Last edit  12/12/2022 







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