In ISO 9001:2015, addressing risks and opportunities is a fundamental part of the quality management system (QMS), aiming to increase the effectiveness of the QMS, achieve improved results, and prevent negative effects. The standard requires an organization to integrate a risk-based thinking approach into its overall processes. Here's how an organization can address risks and opportunities according to ISO 9001:
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Understanding the Context: The organization needs to understand its internal and external context, including any factors that can impact its QMS objectives. This understanding helps in identifying potential risks and opportunities.
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Planning: Once the risks and opportunities are identified, the organization should plan actions to address these. This includes deciding how to:
- Mitigate or eliminate the risks.
- Enhance opportunities to achieve the intended outcomes of the QMS.
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Integration into the QMS Processes: The actions to address risks and opportunities are integrated into the organization's QMS processes. This integration ensures that risk-based thinking is embedded in the planning and execution of all QMS processes.