Clause 6.1.1 of the ISO 9001 standard, titled "Actions to Address Risks and Opportunities - General," focuses on the organization's requirement to determine and address risks and opportunities that could impact the Quality Management System (QMS) and its ability to achieve intended outcomes.
Firstly, organizations must establish processes to identify risks and opportunities that are relevant to the QMS. This includes considering internal and external issues, the needs and expectations of interested parties, and the context of the organization.
Once risks and opportunities are identified, organizations must assess their potential impact on the QMS and its ability to achieve its objectives. This involves evaluating the likelihood of occurrence and potential consequences of each risk or opportunity.
Based on the assessment, organizations must determine the need for action to address identified risks and opportunities. This may include implementing preventive actions to mitigate or eliminate risks, as well as taking advantage of opportunities to improve the QMS and enhance performance.
Actions taken to address risks and opportunities should be proportionate to their potential impact and aligned with the organization's overall strategic direction and objectives. Organizations must integrate risk-based thinking into their decision-making processes to ensure that risks and opportunities are considered in planning and implementing QMS activities.
Additionally, organizations must evaluate the effectiveness of actions taken to address risks and opportunities, monitoring their impact on the QMS and its performance over time.
Overall, Clause 6.1.1 emphasizes the importance of proactive risk management and opportunity identification to ensure the effectiveness and continual improvement of the QMS. By systematically addressing risks and opportunities, organizations can enhance their ability to achieve desired outcomes and meet the needs of customers and other interested parties.
(See Clauses 4.1 and 4.2 – This helps to keep you focused)