ISO 9001:2015 - Risk Based Thinking (6.1)
Risk-based thinking is something we all do automatically and often sub-consciously to get the best result. The concept of risk has always been implicit in ISO 9001 – the 2015 edition makes it more explicit and builds it into the whole management system. Risk-based thinking ensures risk is considered from the beginning and throughout.
While Clause 6, Planning, is an obvious reference to risks and opportunities, the concept of risk-based thinking is present throughout the Standard. Where is risk addressed in ISO 9001:2015?
Introduction - the concept of risk-based thinking is explained.
Clause 4 – the organization is required to determine its QMS processes and to address its risks and opportunities.
Clause 5 – top management is required to
· Promote awareness of risk-based thinking
· Determine and address risks and opportunities that can affect product /service conformity.
Clause 6 – the organization is required to identify risks and opportunities related to QMS performance and take appropriate actions to address them.
Clause 7 – the organization is required to determine and provide necessary resources (risk is implicit whenever “suitable” or “appropriate” is mentioned).
Clause 8 – the organization is required to manage its operational processes (risk is implicit whenever “suitable” or “appropriate” is mentioned).
Clause 9 – the organization is required to monitor, measure, analyze and evaluate effectiveness of actions taken to address the risks and opportunities.
Clause 10 – the organization is required to correct, prevent or reduce undesired effects and improve the QMS and update risks and opportunities.
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