ISO 9001:2015 Clause 6.1.2, part of the section on planning for the quality management system (QMS), focuses on "Actions to Address Risks and Opportunities." This clause requires organizations to take a proactive approach to identify and address potential risks and opportunities that could impact (positively or negatively) the QMS's ability to deliver its intended results, including meeting customer requirements and enhancing customer satisfaction. Here's a brief overview:
Objective
The objective is to ensure the QMS is capable of achieving its intended results, enhance desirable effects, prevent or reduce undesired effects, and achieve improvement.
Process
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Identify Risks and Opportunities: Organizations must determine the risks and opportunities that need to be addressed to:
- Assure the QMS can achieve its intended results.
- Enhance customer satisfaction.
- Prevent, or reduce, undesired impacts and potential failures in processes.
- Achieve continual improvement.
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Plan Actions: Once risks and opportunities are identified, the organization must plan actions to address these. This includes deciding on strategies to mitigate risks and seize opportunities.
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Integrate and Implement Actions: The actions to address risks and opportunities must be integrated into the QMS processes and implemented into its practices.
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Evaluate the Effectiveness: Organizations must evaluate the effectiveness of these actions. This step ensures that the measures taken were suitable and sufficient to address the risks and opportunities identified.
Documentation
While ISO 9001:2015 does not specify detailed documentation requirements for this clause, it implies that organizations should keep records of the risks and opportunities identified, actions planned and taken, as well as the evaluations of their effectiveness, as part of its QMS documentation.
This clause is pivotal in pushing organizations towards a more systematic approach to risk management, aligning the QMS with the strategic direction of the organization and ensuring a foundation for continual improvement.