ISO 9001:2015 employs the process approach which incorporates the Plan - Do - Check - Act cycle and risk based thinking.
The process approach enables an organization to plan its processes and their interactions. Understanding and managing interrelated processes as a system (business system) contributes to the organizations effectiveness and efficiency in achieving its intended results.
The process approach involves the systematic definition and management of processes and their interactions, as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. The application of the process approach in a quality management system enables
understanding and consistency in meeting requirements
consideration of processes in terms of added value
the achievement of effective process performance
improvement of processes based on the evaluation of data and information
Requirements of ISO 9001
The organization shall determine the processes needed for the QMS and and their application throughout the organization and shall
Determine the inputs required and the outputs expected from these processes
Determine the sequence and interaction of the processes
Determine and apply criteria and methods needed to ensure the effective operation and control of these processes
Determine the resources needed for these processes and ensure availability
Assign the responsibilities an authority for these processes
Address risk and opportunities as determined
Evaluate the processes and implement changes needed to ensure the processes achieve their intended results
Improve the processes and QMS
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