OMNI QMS: ISO9001
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This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.
|ISO9001 PDF Page #6|
The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.
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|0.3.2 Plan-Do-Check-Act cycle||
The PDCA cycle can be applied to all processes and to the quality management system as a whole.
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|7.5.2 Creating and updating||
When creating and updating documented information, the organization shall ensure appropriate:
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|8.3.6 Design and development changes||
The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.
The organization shall retain documented information on:
|ISO9001 PDF Page #22|