IS0 9001:2015

Clause 4.4 Quality Management System and its processes

ISO 9001:2015 specifically requires the adoption by the organisation, of a process approach when developing, implementing, and improving the effectiveness of its management system.

There are several additional references throughout the standard to emphasise the point that improved performance (quality) is more likely when activities are understood and managed as interrelated processes.

Specifically, the organisation is required to:

  1. Determine the inputs required and the outputs expected from these processes
  2. The sequence and interaction of these processes
  3. Application of the criteria and methods (including monitoring, measurements, and related performance indicators) needed to ensure the effective operation and control of these processes
  4. Establishing the resources needed for these processes and ensure their availability
  5. Assignment of responsibilities and authorities for these processes
  6. Address the risks and opportunities as determined in accordance with the requirements detailed in article 6.1 (Actions to address risks and opportunities.)
  7. Evaluate the processes and implement any changes needed to ensure that they achieve the intended results
  8. Improve the processes and the quality management system.

Organisations are required to maintain and retain documented information to support the operation of its processes and to have confidence that the processes are being carried out as planned.


“Documented information” may include operational procedures and associated work instructions for example. The use of process diagrams/ flow charts or turtle diagrams can be used to great effect to map and improve processes.IE verify the interrelation of sub-process inputs and outputs and that monitoring and measuring in place is appropriate and effective. They can also then be used to document the process in the management system if required – much easier to follow when imparting organisational knowledge (See later article 7.1.6) during induction or training for example, rather than wordy process instructions.

Audit Check:

Given the explicit emphasis placed on the process approach within the standard, we can expect auditors to specifically challenge organisations to demonstrate that they have considered and acted on the interaction of processes. Organisation will also need to retain documented evidence (records) that shows processes are performing in line with requirements. (IE: Key Performance Indicators to monitor the process in line with targets and expected process Inputs & Outputs can be demonstrated.)

This article is the property of David Barker Consulting © and is free for you to use. If you wish to reproduce elsewhere, please be so kind as to ask permission first and credit me as your source. If you need any further assistance, feel free to use my contacts page to get in touch and let me know how I can help!

David Barker CQP MCQI

ISO 9001:2015

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