ISO 9001 mandatory documents
As per ISO 9001, is it mandatory to prepare quality plan? Or which clause I can refer?
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ISO 9001:2015 does not require as mandatory a document called quality plan. However, planning quality is of paramount importance.
- Second paragraph of clause 8.4.1 of ISO 9001:2015 states “The organization shall determine the controls to be applied”
- Clause 8.5.1 c) of ISO 9001:2015 states “the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met”
- First paragraph of clause 8.6 of ISO 9001:2015
Slide 11 of this free webinar on demand - Measurement, analysis, and improvement according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/measurement-analysis-and-improvement-according-to-iso-9001-2015-free-webinar/ - includes an example of what can be used as a template for a quality plan. Remember, these days many organizations do not use paper even digitally, the rules from quality planning can be distributed through internet applications, machine software and many other ways.
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Mar 12, 2020