How To Transform Your ISO Management System With Change Management
Your business will continuously go through change – it is inevitable, it could be due to external pressures, internal improvements, or advancements in technology. Managing change effectively becomes even more important in an ISO-certified organisation, where continual improvement is a core principle.
ISO management systems, such as ISO 9001, ISO 14001, and ISO 45001, require a structured approach to change.
ISO 9001 and ISO 45001 explicitly address management of change, with specific clauses like ISO 9001’s 6.3 Planning for changes and 8.5.6 Control of changes, and ISO 45001’s 8.1.3 Management of change.
While ISO 14001 doesn’t have a section titled “management of change,” it emphasises in 6.1.2 Environmental aspects that organisations must consider changes, including planned developments and new or modified activities, products, or services.
Effective change management can help businesses maintain conformity, reduce disruption, and achieve growth.
Table of Contents
What Is Change Management?
Change management refers to a structured approach to transitioning individuals, teams, and organisations from a current state to a desired future state. This discipline focuses on limiting disruption and ensuring successful adaptation to changes, whether they are driven by internal needs or external factors.
The roots of Change management can be traced back to organisational psychology, with Kurt Lewin’s Change Management Model being one of the earliest frameworks. This model laid the groundwork for other methodologies by introducing the stages of Unfreeze, Change, and Refreeze to describe how organisations transition and stabilise new practices. While Lewin’s model is a great starting point for addressing human change and organisational culture shifts, it primarily focuses on people.
For more technical changes, such as those involving processes, products, raw materials, or supply chains, a more specialized approach is needed—yet it’s essential to address both aspects to ensure successful change management.
Why change management Is important within ISO Management Systems
ISO management system Standards use the concept of change management to ensure the integrity and effectiveness of your management system are maintained during transitions. ISO standards are built around the idea of continual improvement, and managing change ensures that improvements are sustainable and aligned with the strategic goals of the company.
Unmanaged changes can lead to non-conformity, compromised product quality, environmental issues, or health and safety risks. In other words, when we want to make adjustments to a process, equipment, infrastructure, policy, or operation, we want the updates to be implemented smoothly. We want to ensure that there are no disruptions to ongoing operations and we don’t want any changes to compromise or impact our ISO certification status.
Download our FREE GUIDE “7 Steps to Change Management with a Risk-Based Approach for ISO Management Systems,” to implement changes effectively while minimizing risks.
What is a change management strategy?
A change management strategy is a plan that outlines how an organisation will handle change in a controlled and efficient manner. This will typically include:
- Clear objectives that define the purpose of the change.
- Stakeholder identification to understand who will be affected by the change.
- Communication plans to keep everyone informed.
- Training programs to prepare employees for new roles or systems.
- Risk assessments to identify potential challenges and opportunities and to allow for the development of detailed plans.
A well-developed change management strategy reduces uncertainty, minimises resistance, and ensures that the business conforms to ISO standards throughout the change process.
What are the four elements required by ISO for change management?
ISO Management System Standards typically define change management as addressing four key elements:
1. The purpose of the change and its effects
Define what the change is, why the change is necessary and what the expected outcomes are. Evaluate the risks of the outcomes, remembering to consider both positive and negative effects.
2. Maintaining the integrity of the management system
Identify which part/s of the management system will be affected by the change. Consider what steps are required to ensure that the management system’s core objectives (such as quality, environmental sustainability, or health and safety) are not compromised during the change. This often involves ongoing evaluations throughout the transition process.
3. Resource requirements
Effectively plan out required resources, with clear specifications and details on how they will be obtained. Resources that support the change can include personnel, training, or technology. Without identifying and planning for these, even the best-planned changes can fail to deliver the desired outcomes.
4. Clear roles and responsibilities
Everyone involved in the change should have a clearly, defined understanding of their specific roles, including responsibilities and authority. Clear accountability around planning, executing, and reviewing the change will help ensure the change is implemented as intended.
It’s important to understand ISO 45001’s approach to managing change. Clause 8.1.3 requires organisations to implement a process for managing both temporary and permanent changes that affect occupational health and safety (OH&S). This includes changes to products, services, workplace conditions, equipment, legal requirements, and knowledge of hazards.
The organisation must also review unintended changes and take action to mitigate any adverse effects on OH&S performance.
Change management in different ISO Standards
ISO 9001:2015 - Quality Management Systems
Change Management in ISO 9001:2015 focuses on maintaining the effectiveness of the Quality Management System (QMS) when changes are made.
To the best of the organisation’s ability, every change should be deliberate and planned for.
They must also consider the potential effects of unplanned changes, ensuring they don’t compromise processes, product quality, and customer satisfaction.
Planning should take a proactive approach, including risk assessments and documentation of changes, although they are not a specified requirement, ensuring that the integrity of the QMS is preserved.
The ISO 9001:2015 standard emphasizes a proactive approach to change management through several key clauses:
Clause 6.3 emphasises planning changes, ensuring alignment with quality goals.
Clause 8.1 mandates strategic control over planned changes, such as equipment upgrades.
Clause 8.3.6 emphasizes the need to review and control design changes to ensure they do not result in unintended consequences during production or use. This process helps maintain product compliance, ensuring that any modifications align with quality requirements and do not negatively impact performance or customer satisfaction.
Clause 8.5.6 stresses the need for documenting and communicating changes to ensure consistency throughout the process. Before implementing any changes to production processes, services, or systems, they must be thoroughly reviewed to ensure they continue meeting organisational or customer requirements, such as quality, safety, or legal standards. The organisation must document the review, including the assessment results, authorisation of the change, and any required actions, like updating procedures or re-training employees, to maintain conformity.
Overall, ISO 9001:2015 integrates change management to continually improve quality and operational control.
ISO 14001:2015 - Environmental Management Systems
ISO 14001:2015 focuses on managing changes that may affect an organisation’s environmental performance. This includes changes to products, services, processes, operations, or infrastructure. The standard ensures that risks are mitigated, and opportunities to improve environmental improvements are maximised.
While it lacks a specific “Planning of Changes” clause, change management is integral across several areas of the ISO 14001:2015 standard:
Clause 4.4 addresses the need for updates to the Environmental Management System when changes are introduced, such as adopting new chemicals or production methods.
Clause 6.1.2 requires continuous assessment of environmental aspects, ensuring that changes in operations or compliance obligations are factored into environmental management.
Clause 8.1 focuses on maintaining operational control by reassessing existing controls in response to new regulations.
Clause 9.3 mandates that management reviews consider internal and external changes, ensuring the Environmental Management System is updated as necessary.
Together, these clauses help organizations respond effectively to environmental changes and maintain compliance with ISO 14001.
ISO 45001:2015 - Occupational Health and Safety Management Systems
In ISO 45001:2015, managing change is critical for maintaining a safe and healthy workplace. It ensures that any changes affecting occupational health and safety (OHS) are carefully planned to ensure that hazards are controlled and that the safety management system remains effective.
The standard integrates change management to proactively address and mitigate OHS risks, through the following clauses:
Clause 6.1.1 calls for risk assessments whenever changes, such as shifts in operations or legal requirements, occur.
Clause 6.1.2.1 emphasizes the identification of new hazards that may arise from changes in work processes, ensuring safety measures remain effective. Management reviews (Clause 9.3) are essential for monitoring and adjusting OHS performance in response to internal and external changes.
Clause 8.1.3 mandates a process for managing both planned and unplanned changes that impact OHS performance, requiring evaluations of health and safety risks before introducing new equipment or work conditions.
Clause 10.2 ensures corrective actions addressing nonconformities are integrated into the change management process to enhance workplace safety.
Overall, ISO 45001 fosters a culture of safety by systematically managing changes and minimizing health and safety risks, even in high-risk environments.
Change management terminology
Change management procedure
A formalised process is used to plan, communicate, implement, and review changes within an organisation. This procedure ensures that changes are executed systematically, minimising the risk of failure or disruption. It typically includes steps like a change request submission, impact assessment, stakeholder approval, implementation, and post-change evaluation.
Change management strategies
Defines the methods and tactics an organisation will use to manage change effectively. These strategies can range from top-down leadership-driven initiatives to collaborative, employee-driven approaches.
Change management principles
The guiding beliefs that underpin successful change initiatives. These normally include:
Effective communication
Ensuring that everyone affected by the change understands the why, what, and how of the transition.
Leadership engagement
Leaders must actively sponsor and support the change effort.
Employee involvement
Engaging those who are impacted by the change helps to reduce resistance and ensure a smoother transition.
Change management models
Change management models are structured frameworks used to guide the implementation of change. Read on further, to learn about some of the more widely used models.
Change management vs. risk management
While both change management and risk management aim to reduce uncertainty and improve outcomes, they have different focus areas.
Change management deals with the transition from one state to another, focusing on managing people, processes, and technology. The idea is to mitigate and/or effectively manage disruptions to existing arrangements in the organisations during any moment of change.
Risk management, on the other hand, looks at identifying, assessing, and mitigating risks that could impact the organisation, whether they are related to the change or not. They could have either a positive or negative outcome on the organisation.
Change management vs. project management
Project management focuses on delivering specific objectives such as building a new system or launching a product within a set time, scope, and budget.
Change management complements project management by focusing on how changes are communicated, accepted, and sustained by people, ensuring that the project’s outcomes are successfully adopted.
Opportunity Identification
In addition to managing risks, a change management approach also helps organisations identify potential growth opportunities. For instance, changes to processes can lead to more innovative methods, which in turn enhance competitiveness and increase customer satisfaction.
Planning for opportunities in Change Management for ISO Standards
Incorporating opportunities into change management for ISO Management System Standards can significantly enhance organisational performance and resilience.
When planning for changes, businesses should not only focus on mitigating risks but also identify and capitalise on opportunities that arise during transitions. Opportunities in change management may include:
- Process improvement: Changes can lead to more efficient processes, reducing waste, improving quality, or increasing productivity.
- Innovation: New technologies or methods introduced during change can foster innovation, enabling the business to stay competitive.
- Enhanced compliance: Proactively addressing changes can help organisations stay ahead of evolving legal, regulatory, and customer requirements.
- Employee engagement: Engaging employees in the change process can lead to a more motivated workforce, with better acceptance of new practices.
- Sustainability gains: Changes aligned with ISO 14001 can offer environmental benefits, reducing the organisation’s ecological footprint and enhancing its reputation.
- Safety improvements: For ISO 45001, managing change can introduce opportunities to improve workplace safety, reducing incidents and enhancing employee well-being.
By planning for these opportunities, organisations can not only ensure conformity but also drive continuous improvement and business growth.
Models and methodology in change management
What models or methodologies are available?
Change models, like Lewin’s or Kotter’s, are highly relevant for macro-level organisational changes, such as restructuring or cultural shifts. However, they become less applicable when dealing with smaller, more technical changes.
Overapplying these models to minor adjustments—such as changes in equipment or processes—can lead to unnecessarily complex systems. It’s important to tailor your approach to the scale and significance of the change to avoid over-engineering solutions for less impactful changes.
Kotter’s 8-Step Model
A comprehensive step-by-step framework that focuses on building urgency, creating a coalition of change agents, and embedding the change in the organisation’s culture. The model guides organisations through eight steps, from creating urgency to embedding new behaviours into the culture.
Lewin’s Change Model
A simple three-phase approach focused on preparing for change, making the change, and stabilising it. This model consists of Unfreeze (preparing for change), Change (implementing new processes), and Refreeze (solidifying the new state).
ADKAR Model
A people-centric framework that focuses on supporting individuals through change. The model emphasises building awareness, desire, knowledge, ability, and reinforcement.
McKinsey 7-S Model
Focuses on seven key elements (strategy, structure, systems, shared values, skills, staff, and style) to align an organisation during a change process.
Choosing the right change management model
Choosing the right model depends on the nature of the change, the business’s culture, and the complexity of the transition.
For example, Kotter’s 8-Step Model is ideal for large-scale, transformational change. Lewin’s Change Model is more suitable for small, incremental changes and ADKAR is effective when the primary challenge is getting individuals and teams to adopt new behaviours or processes.
Download our FREE GUIDE “7 Steps to Change Management with a Risk-Based Approach for ISO Management Systems,” to implement changes effectively while minimizing risks.
Change management in your organisation
What are the benefits of change management?
Sustainability
Ensures that changes are not only successfully implemented but also maintained over time, preventing a return to old habits or ways.
Risk management
Reduces the risk of failure during transitions by identifying potential problems early and taking proactive steps to mitigate them.
Corporate governance
Promotes organisational transparency and accountability, ensuring that leadership is engaged, and stakeholders are informed throughout the change process.
How can change management be managed effectively in the workplace?
- Engage leadership to support and champion the change.
- Develop a clear communication plan that keeps all stakeholders informed.
- Provide training and resources to help employees adapt to the new processes.
- Monitor the progress of the change and adjust as needed to ensure successful adoption.
ISO certification's relationship with change management
Change management is crucial for maintaining conformity with ISO standards. ISO certification relies on the principle of continual improvement, and managing change effectively is integral to achieving this. Auditors will look for evidence that changes have been managed in a way that upholds the integrity of the management system and aligns with the requirements of the ISO standard.
What would be considered during an audit?
During an ISO audit, auditors will examine how changes have been planned, communicated, and implemented. They will usually look for documented evidence that outlines the change process. This could arise in the form of risk assessments, management reviews, and mitigation strategies. Additionally, they will need records showing that changes have been monitored and reviewed for effectiveness.
During an audit, the following would typically be considered:
ISO 9001:2015 - Quality Management Systems
Change planning and control
Does the business have management arrangements in place to ensure that any changes to the QMS are planned and controlled?
Auditors will check if the changes are documented, communicated, and implemented with minimal disruption to operations. This is only a requirement of 8.5.6 after a change has been implemented.
Impact on product or service quality
How does the business assess potential impacts on product quality?
Auditors will check if the changes are documented, communicated, and implemented with minimal disruption to operations. This is only a requirement of 8.5.6 after a change has been implemented.
ISO 14001:2015 - Environmental Management Systems
Environmental aspects
Has the organisation considered how these changes affect energy usage, waste generation, or emissions?
Auditors will look at how the company assesses and manages the potential environmental impact of changes (e.g., new processes, equipment, or materials).
Regulatory conformance
Are there legal registers? Is there evidence that they have been maintained and updated?
Auditors will assess whether the organisation has management arrangements in place to identify legal requirements during planned changes, ensure compliance throughout the implementation process, and verify that compliance is maintained after the changes are made.
ISO 45001:2015 - Occupational Health and Safety Management Systems
Risk identification and control
Are there adequate hazard identification and risk assessment processes in place?
Auditors will evaluate how the business identifies, assesses, and controls health and safety risks associated with changes (e.g., changes in workplace design, equipment, or procedures).
Consultation with workers
How are workers involved in the change process?
Auditors will check if the organisation involves workers or their representatives in discussions around changes that could affect their health and safety.
Emergency preparedness
Has the business updated its emergency preparedness plans to account for changes?
Auditors will check if new risks associated with changes (such as new processes or materials) have been considered in emergency response planning.
Download our FREE GUIDE “7 Steps to Change Management with a Risk-Based Approach for ISO Management Systems,” to implement changes effectively while minimizing risks.
Change management is a powerful tool that can strengthen your ISO management system, ensuring that changes are successfully implemented and aligned with the goals of your organisation.
By adopting effective change management strategies, organisations can not only maintain ISO certification but also drive continuous improvement and long-term business success.
Get in touch with us at +44 (0) 203 926 6507 or +27 (0) 31 941 4790, or email us at info@wynleigh.com to lead your company’s change management efforts and obtain ISO certification.
