ISO 9001:2015 Clause 6.1.1

What is ISO 9001:2015 Clause 6.1.1?

ISO 9001:2015 is an international standard for quality management systems (QMS). Clause 6.1.1 is part of Section 6, which focuses on planning. Specifically, Clause 6.1.1 is titled “Actions to address risks and opportunities.”

Key points outlined in Clause 6.1.1 include:

In Clause 6.1.1, organizations are required to determine the risks and opportunities that need to be addressed to ensure that the QMS can achieve its intended outcomes, prevent or reduce undesired effects, and continually improve. The organization is expected to plan actions to address these risks and opportunities, integrate them into the organization’s management system processes, and evaluate their effectiveness.

The purpose of addressing risks and opportunities is to enhance the likelihood of achieving the intended results of the QMS, prevent or reduce the likelihood of undesirable effects, and achieve continual improvement. This clause emphasizes the importance of a proactive approach to risk management within the context of the organization’s quality management system.

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Other ISO 9001:2015 Clauses:

• The Complete Clause 6
• Clause 6.1
• Clause 6.2
• Clause 6.2.1
• Clause 6.2.2
• Clause 6.3

How do you comply with Clause 6.1.1?

Complying with Clause 6.1.1 of ISO 9001:2015 involves a systematic approach to identifying, assessing, and addressing risks and opportunities within the context of your organization’s quality management system (QMS).

Here are the steps that a company typically takes to comply with this clause:

Establish the Context:

• Understand the internal and external issues that can affect your QMS.
• Identify interested parties and their relevant requirements.

Determine the Scope of the QMS:

Clearly define the boundaries and applicability of your QMS.

Identify Risks and Opportunities:

• Identify potential risks that could affect the achievement of your QMS objectives.
• Identify opportunities for improvement and enhancement of the QMS.

Assess Risks and Opportunities:

• Evaluate the significance of each identified risk and opportunity.
• Consider the likelihood and potential impact on achieving objectives.

Plan Actions:

• Develop plans to address the identified risks and opportunities.
• Consider how to integrate these plans into your existing QMS processes.

Implement Actions:

• Put the planned actions into practice.
• Integrate them into relevant processes and workflows.

Evaluate Effectiveness:

• Monitor and measure the effectiveness of the actions taken.
• Assess whether the desired results are achieved and if the QMS performance improves.

Review and Adjust:

• Regularly review and update your risk and opportunity assessments.
• Adjust actions and plans as necessary based on changing circumstances.

Document and Communicate:

• Document your risk and opportunity management processes.
• Communicate relevant information to relevant stakeholders.

Integration with QMS:

Integrate risk and opportunity considerations into other QMS processes, such as strategic planning, operational processes, and performance evaluation.

Training and Awareness:

• Ensure that employees are aware of the risks and opportunities relevant to their roles.
• Provide necessary training on risk management principles.

Continuous Improvement:

Use the information gathered from risk and opportunity assessments for continual improvement of the QMS.

It’s important to note that the approach to compliance may vary based on the size and complexity of the organization. Documentation of the process is necessary, but the level of documentation can be tailored to the organization’s needs and the significance of the risks and opportunities involved. The key is to have a systematic and proactive approach to managing risks and opportunities within the QMS.

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