In current day industries and the rapidly evolving global landscape, organizations everywhere should be learning to adapt to new technologies, policies, challenges, and more. There is no business that shouldn’t try to keep up with major changes; if you can’t adapt, you fall behind in terms of performance and growth.

 

This is why your organization requires a game plan, a way to manage or prepare for any changes that could impact your operations or processes. Change management is the key to maintaining your ISO 9001 Quality Management System while evolving with your industry.

 

Let’s discuss: what is change management, and why is it critical to your organization’s success?

 

 

Defining Change Management

What is Change Management?

 

Change management is a structured approach to planning, implementing, and overseeing organizational change, ensuring a smooth transition from start to finish. Its primary goal is to develop strategies that facilitate the change, manage its impact, and support employees in adapting effectively.

 

Whether introducing new technology or restructuring the organizational hierarchy, change management provides greater control over the process, enabling you to track progress and measure the success of the initiative.

 

There are many factors that can trigger a change in your organization or management system. Some of these potential triggers include:

 

• Customer feedback or surveys
• Employee feedback
• Product or service failure
• Technological innovations
• Determined risks or opportunities
• Internal audit results
• Management review results
• Identified nonconformities

 

A variety of changes can occur as a result, impacting multiple processes or objectives. Your organization must consider that the change can influence documentation, equipment, supply chain, and more.

 

Change Management & ISO 9001

 

Managing Changes with Your QMS

 

When it comes to change and change management, ISO 9001 has a few requirements that specifically address these topics. Here are some notable instances of the ISO 9001 standard that discuss these core requirements of controlling change in a Quality Management System:

 

6.3 Planning of Changes

When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner.

 

Examples:

⦁ Change to a process (inputs, activities, outputs, controls, measurements, resources, information, responsibility, procedures, etc.)
⦁ Change related to external providers
⦁ Changes in communication with customers
⦁ Develop documented information
⦁ Improve employee competence

 

8.1 Operational Planning and Control

The organization shall control planned changes and review the consequences of unintended changes, taking action to prevent or mitigate any adverse effects, as necessary.

 

Examples:

⦁ Additional inspection
⦁ Outsource a process

 

8.3.6 Design and Development Changes

During design and development, changes that are identified shall be reviewed and controlled to ensure there is no adverse impact to the conformity of the product or service.

 

Example:

⦁ Changes in communication with the supply chain

 

8.5.6 Control of Changes

The organization shall review and control changes for products ion or service provision, to the extent necessary to ensure continuing conformity with requirements.

 

Examples:

⦁ Implement a new process
⦁ Change existing documented information

 

When implementing organizational changes, it’s crucial to plan carefully to prevent unintended consequences and address potential risks. Organizations should monitor changes post-implementation to evaluate their effectiveness and identify new risks or opportunities. Managing the change process effectively helps mitigate risks and ensures that objectives are met. However, it’s important to remember that not all changes require the same level of oversight.

 

Prioritizing changes based on their impact and risks is also key to effective management. Organizations can adopt a methodology that evaluates factors such as risk levels, customer and stakeholder impact, alignment with quality objectives, and the influence on critical processes. This prioritization ensures that resources are focused on changes with significant potential consequences.

 

To successfully implement changes, organizations should define the specifics of what needs to change, develop a detailed plan, engage relevant stakeholders, and communicate effectively. Utilizing cross-functional teams for planning and feedback, providing training, and measuring the change’s effectiveness are also vital steps. Finally, reflecting on lessons learned helps improve future change management processes.

 

 

Conclusion: Use Change Management to Succeed

 

Effective change management is essential for organizations hoping to remain competitive and maintain the integrity of their ISO 9001 Quality Management System. By strategically planning, implementing, and monitoring changes, businesses can mitigate risks, seize opportunities, and ensure alignment with quality objectives.

 

Prioritizing changes and adopting a structured approach helps organizations navigate transitions while fostering adaptability and growth. Ultimately, a well-executed change management process empowers organizations to embrace innovation, enhance performance, and sustain long-term success.

 

The ISO 9001 Group offers expert management system consulting services for ISO 9001.

 

Contact us today to learn more about how our professional consultants can help your organization achieve certification and improve their management systems over time.