ISO 9001:2015 Clause 7.5.1 General
The opening line of clause 7.5.1 defines two requirements that 'shall' be met to embrace the requirements of ISO 9001-2015
The statement includes a key word 'shall', meaning a command, an obligation required to be met.
With regards to the quality management system it 'shall' have documented information (meaningful data)
•as specified by ISO 9001-2015
•determined as being necessary by the organisation for the effectiveness of the quality management system
These were clauses 4.2.1c and 4.2.1d for the documentation requirements of ISO 9001-2008.
Here the clause is making it clear that organisations are going to have to ensure the standard is read, interpreted, and understood. This, so as to identify the requirements for meaningful data prescribed within the standard that will show the effectiveness of the quality management system. Meaningful data can be in any medium that the organisation prefers.
Note: The extent of documented information for a quality management system can vary from one organisation to another due to:
•the size of organisation and its type of activities, processes, products and services;
•the complexity of processes and their interactions;
•the competence of persons. (ability to apply knowledge and skills to achieve intended results)
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