ISO 9001 The Basics Explained: Clause 4.4 Quality Management System and its Processes

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Clause 4.4 is broken into two sub-clauses:

Clause 4.4.1

Clause 4.4.1 requires you apply a process-approach to your QMS. The process approach is referred to in clause 0.3, as well as the PDCA cycle.

To implement the QMS and the relevant processes, you need to determine the required process and its application. This includes:

  1. The process inputs and expected outputs, the order of the processes, resources involved and availability;
  2. Specifying the criteria and methods to control the processes and ensure they are effective. This includes monitoring, measurements and related performance indicators;
  3. Assigning responsibilities and authorities for each process, ensuring that the risks and opportunities are addressed;
  4. Evaluating the processes and make changes to them where necessary to demonstrate continual improvement.

When you have identified and applied those processes and interactions, you must ensure it is maintained and continually improved upon.

Clause 4.4.2

Clause 4.4.2 specifies that the documented information must be maintained to continually support the process operations.

Document requirements

The standard specifies documented information must be retained to the point that your organisation is confident the process outputs are as expected.

Retained documented information may be records of customer service feedback, employee reviews, procedures, regulatory standards, evidence of emails and so on.


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Sam Kinch



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