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ISO 9001 6.1 Actions to address risks and opportunities




In ISO 9001 6.1 actions to address risks and opportunities, this section aims to ensure that an organization’s Quality Management System is capable of achieving the intended outcomes and prepared to handle both positive and negative impacts that could influence quality objectives. Focusing on identifying, assessing, and addressing risks and opportunities is a big part of the QMS planning process and encourages a proactive approach to quality management.


The 2 main areas that 6.1 requires organizations to address are Risks and Opportunities. The clause ensures that any factors that influence the QMS are considered, planned for, and managed appropriately.

 


In this blog post we will be discussing the following:


·       Understanding risks and opportunities

·       Risk and opportunity assessment

·       Integration into QMS process

·       Evaluating the effectiveness of actions

·       Benefits of Risk and Opportunities

 

 

 

International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:

 

6.1 Actions to address risks and opportunities

6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

a) give assurance that the quality management system can achieve its intended result(s);

b) enhance desirable effects;

c) prevent, or reduce, undesired effects;

d) achieve improvement.

 

6.1.2 The organization shall plan:

a) actions to address these risks and opportunities;

b) how to:

1) integrate and implement the actions into its quality management system processes (see 4.4);

2) evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.


NOTE 1  Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.


NOTE 2  Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.

 


 

Understanding risks and opportunities

Risks: These potential risks may stem from both internal and external issues, such as:

1.      Supply chain interruptions

2.      Process inefficiencies

3.      Regulatory changes

4.      Shifts in customer needs


These risks could potentially hinder the achievement of quality objectives or lead to non-conformities in products and services.

 

Opportunities: These potential opportunities can include:

1.      Technological advancements

2.      Process improvements

3.      Untapped markets


These opportunities are situations or factors that, if leveraged, could enhance or improve customer satisfaction, productivity, efficiency, or competitiveness.

 

 


Risk and opportunity assessment

As for Planning actions based on risk and opportunity assessment, organizations need to plan actions proportionate to the significance of identified risks and opportunities. Having a thoughtful approach that aligns with the complexity and context of the organization is important. Key steps of this process include:


1.      Determine the Potential Impact: This is about assessing how each identified risk or opportunity could affect the organization’s ability to deliver quality products or services.

 

2.      Decide on Proportionate Actions: The organization should prioritize and allocate resources based on the level of impact. Not all risks require extensive action.

 

3.      Documenting Action: Maintaining records helps ensure actions are traceable, communicated effectively, and reviewed over time.

 

 


Integration into QMS process

The Integration into the QMS process for ISO 9001 requires that actions to address risks and opportunities be integrated into the QMS process and not to be handled as standalone activities. Embedding risk-based thinking throughout the organization to support consistency and reliability. Some key areas where integration is critical include:

 

1.      Process Design and Control: Designing and implementing processes that anticipate and control risks. Such as redundant checks or automated alerts.

 

2.      Supplier Management: Mitigating risks with suppliers, including material quality, lead times, and compliance.

3.      Customer Feedback and Complaints: Improving satisfaction or identifying recurring risks by using customer insights.

 

4.      Training and Competency: Ensuring employees are equipped through training to be able to identify risks and opportunities related to their roles. 

 

 


Evaluating the effectiveness of actions

Evaluation of the effectiveness of actions is crucial as the organization should periodically assess whether the actions taken to address risks and opportunities have been effective. There are different ways this evaluation can be done through including:

 

1.      Internal Audits: Internal audits help assess how well the risk and opportunity actions are working within the QMS.

 

2.      Management Reviews: Reviewing the effectiveness of actions to address risks and opportunities is an important topic for management meetings.

 

3.      Continual Improvement: Organizations should adjust their strategies accordingly to support ongoing improvement if actions are found to be ineffective or if new risks/ opportunities arise. 

 

 


Benefits of Risk and Opportunities

Some benefits of addressing these risks and opportunities include:


1.      Organizational Resilience: Having a risk and opportunity QMS helps organizations anticipate challenges and adapt more readily to change. 

 

2.      Competitive Advantage: Enhancing competitiveness through leveraging opportunities such as improvements or new markets. 

 

3.      Improved Process Efficiency: Addressing risk reduces downtime, errors, and rework, leading to more efficient and effective operations. 

 

4.      Enhanced Customer Satisfaction: By being proactive and managing risks that could lead to quality issues, organizations can meet customer requirements consistently.

 


 

In conclusion, 6.1 ISO 9001 Actions to address risks and opportunities encourages organizations to implement a structured approach to identifying and addressing risks and opportunities, helping to secure consistent quality performance. Organizations will be better prepared to deliver reliable outcomes and sustain continuous improvement by embedding risk-based thinking into QMS. In the next blog post we’ll be discussing 6.2 Quality objectives and planning to achieve them.  

 

 

 


Related blog posts -

ISO 9001 – Planning Overview Clause 6: 6.1 – 6.3

 

How to determine your QMS Scope of Certification

 

Improvement- The Seven Quality Management Principles

 

4 Steps to Achieving ISO 9001 Quality Management System Certification

 


 

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