- In segment 4.1 "NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.”
- In segment 4.2.1 “NOTE 3 The documentation can be in any form or type of medium."
There has been discussion in some circles about whether or not the standard should contain notes at all, or whether the standard requires that all notes be complied with. In fact some external auditors believe (wrongly) that these notes must be complied with.
ISO 9001 segment clarifies the use of notes. It states “Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement."
When reading the standard, the key word that identifies a requirement which must be complied with is the word ‘shall’. In the standard, the word shall can be interpreted to mean the word ‘must’.
For example, in segment 4.2.3 Control of documents, the sentence “Documents required by the quality management system shall be controlled” can be interpreted to mean Documents required by the quality management system MUST be controlled in order to conform to the standard.
When reading through the standard, keep in mind the words shall and NOTE. Be sure to meet the requirements found to contain the word shall and use those sentences identified by the word NOTE for guidance and clarification only.
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