Risk-based thinking, the process approach and plan-do-check-act are all inherent features within our implementations when designing your management system.

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Risk-based thinking.

​One of the key changes in the 2015 revision of ISO 9001 is to establish a systematic approach to considering risk, rather than treating “prevention” as a separate component of a quality management system.

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Risk is inherent in all aspects of a quality management system. There are risks in all systems, processes and functions. Risk-based thinking ensures these risks are identified, considered and controlled throughout the design and use of the quality management system.

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The Process approach.

​All organisations use processes to achieve their objectives.

​A process:

• Set of interrelated or interacting activities that use inputs to deliver an intended result.

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Plan-Do-Check-Act.

​The plan-do-check-act cycle can be applied to all processes and to the quality management system as a whole. PDCA stands for:

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• Plan: establish objectives and build processes necessary to deliver results.

• Do: implement what was planned.

• Check: monitor and measure processes and results against the objectives.

• Act: take actions to improve results.

 

PDCA operates as a cycle of continual improvement, with risk-based thinking at each stage.

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Risk based thinking, the Process approach and Plan-Do-Check-Act.

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These three concepts together form an integral part of the ISO 9001:2015 standard. Risks that may impact on objectives and results must be addressed by the management system. Risk-based thinking is used throughout the process approach; below shows the typical hierarchy of a management system design:

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• Policy.

• Processes.

• Procedure.

• Forms/templates.

• Technology/digital e.g. workflow (if applicable)