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Top management are now required to demonstrate The terms ‘documented procedure’ and ‘record’ used in
‘leadership’ rather than just management of the QMS. ISO 9001:2008 have both been replaced throughout ISO
9001:2015 by the term ‘documented information’.
Other QMS requirements Structure and terminology
• Specific requirements in relation to the execution of a ISO 9001:2015 adopts the clause structure specified in
process approach Annex SL, which is now the required framework for all new
• Requirements relating to the identification of required and revised ISO Standards.
personnel competence
• Identification and maintenance of the any organization’s
critical operational ‘knowledge’
• A risk-based approach to the controls applied to
external providers
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