Identifying Mandatory vs. Optional Documents in ISO 9001

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Each clause of the ISO 9001:2015 standard is clear on what your organisations responsibilities are. You can identify where actions are required by spotting the following terminology:

“Shall” indicates a requirement;

“Should” indicates a recommendation;

“May” indicates a permission; 

“Can” indicates a possibility or a capability.

Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement. 

ISO 9001:2015

These terms are very important to understand whilst making notes of what is mandatory and what is optional for you to do.

Fortunately, the standard doesn’t require an excessive amount of documentation. You will only need to create/hold documented information where the standard says; “the organisation shall retain/ maintain documented information…”.  

However, you may wish to document certain policies and procedures if you feel it would be beneficial to the working of your QMS.

Just remember, any additional documented information will need to be maintained or preserved properly, so its only worth doing where absolutely necessary or if you feel you have the resources to manage this. 

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