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The purpose of this sub-clause is to ensure that the organisation identifies and addresses the risks and opportunities that could affect the quality management system’s ability to achieve its intended outcomes, based on the risk identification methodology.
The organisation must determine the risks and opportunities that need to be addressed by considering internal and external factors that could impact the quality management system’s performance determined (Clause 4.1).
To address risks and opportunities, the organisation must take appropriate actions.
These actions may include implementing preventive or corrective measures, establishing contingency plans, or pursuing opportunities to improve the quality management system’s performance. The organisation must also monitor and review these actions to ensure their effectiveness and adjust them as necessary (Clause 4.4).
Requires to establish quality objectives at relevant functions, levels, and processes, consistent with the quality policy.
These objectives must be:
To achieve these objectives, the organisation must develop plans that include;
The plans must be reviewed and updated as necessary to ensure their effectiveness in achieving the quality objectives.
The organisation must also ensure that its quality objectives are consistent with the organisation’s overall strategic direction and that they support the continual improvement of the quality management system.
When an organisation determines a change, the nature and extent of the change and the potential consequences, and opportunities of the change must be determined, including internal and external factors.
Resources needed to implement the change and develop a plan for implementing the change must be identified.
The organisation must also consider the impact of the change on the organisation’s stakeholders, including customers, suppliers, employees, and regulators, and communicate the change to these stakeholders as appropriate.
To ensure the effectiveness of the change, this should be monitored, reviewed, and adjusted as necessary.