Today’s organizations face constant challenges arising from digital transformation, economic crises, changes in consumer behavior, technological disruption and competitive pressure. In the midst of this reality, change management, more than a long-term strategic option, constitutes an imperative need to ensure sustainability, competitiveness and relevance in the market.
In this context, ISO 9001:2015, the international standard for quality management, incorporates elements that make it possible to address change from a structured, strategic perspective, aligned with continuous improvement. This article aims to explore how organizations can effectively address change management within the framework of ISO 9001:2015 quality management systems, not only to comply with the standard, but to achieve authentic, sustainable organizational transformations aligned with strategic objectives.
Change management and organizational transformation
Change management is defined as a structured approach to prepare, support and help individuals, teams and organizations to make a transition from a current state to a desired one (Hiatt, 2006). However, it is essential to keep in mind that it is not only about implementing new methodologies, tools or processes, but also about actively managing the human, cultural and strategic implications that accompany any significant change within an organization.
In this sense, change management is an aspect prior to organizational transformation, which represents a deep and systemic process of cultural, structural and strategic evolution that helps organizations reinvent themselves to face the challenges emanating from the environment.
It is important to keep in mind that organizational transformation does not happen spontaneously. It demands breaking with inertia, challenging existing paradigms and aligning multiple wills. These transformations bring with them a natural resistance to change, especially when they affect consolidated beliefs, routines and comfort zones. Therefore, structured change management is not only advisable, it is indispensable.
Change as a systemic phenomenon
Any transformation has an impact on processes, technological and organizational systems, but above all on people. Without a systemic and planned approach, change presents the risk of generating undesired effects such as:
- Demotivation or stress among personnel.
- Loss of efficiency during the transition.
- Rejection of new tools or methodologies.
- Confusion in roles and responsibilities.
- Failure in the implementation of new processes.
Change management: from the tactical to the strategic
Change management is not simply isolated communication or training actions. Rather, it is a strategic discipline that seeks to facilitate organizational transition, guarantee the adoption of change and ensure the sustainability of the expected results.
Recognized models such as Kotter’s (1996) or Prosci’s ADKAR (Hiatt, 2006), highlight the importance of key stages such as creating a sense of urgency, engaging leaders, generating early wins and reinforcing change over time.
The role of change management in the digital era
In today’s world, changes are much more frequent and disruptive than years ago, especially due to digital transformation. Highlights of this transformation include: automation, artificial intelligence (AI), remote work and new business models, all of which force organizations to constantly adapt. Structured change management enables companies to:
- Respond with agility to uncertain environments.
- Reduce the technology adoption curve.
- Minimize risks in transformation projects.
- Maximize the return on investment in innovation.
- Foster a resilient and adaptable organizational culture.
In order to have an overview of the change management process, below is a video with the steps that compose it.
5 steps in change management process
From the above, it is clear that integrating the change management process in the scope of ISO 9001 quality management systems multiplies its impact, since it aligns change with key processes, the organizational context and continuous improvement.
What does ISO 9001:2015 require regarding change?
The latest version of ISO 9001 brought with it a much more strategic view of quality management systems. One of its key contributions is to recognize that organizational changes, whether they come from internal or external demands, must be managed in a planned and systematic manner, while being in line with the strategic direction.
Change in ISO 9001:2015
In Chapter 6.3 “Planning for change”, ISO 9001: 2015 states that when an organization determines the need for changes to its quality management system, these should be carried out in a planned manner. To do so, organizations should consider:
- The purpose of the changes and their possible consequences.
- The integrity of the quality management system.
- The availability of resources.
- The assignment or reassignment of responsibilities and authorities.
The purpose of the above is not only to avoid undesired negative impacts, but also to ensure that the changes are harmoniously integrated into the management system, maintaining the consistency of the processes and compliance with customer requirements.
From planning to active change management
Complying with chapter 6.3 of ISO 9001: 2015 involves much more than documenting or recording changes. It requires adopting a structured approach that considers technical, human and cultural aspects. That is why it is essential to integrate a change management strategy aligned with the quality management system.
An effective strategy must:
- Anticipate resistance to change and address it through empathy and communication.
- Involve leaders as promoters of change, reinforcing the desired vision with their example.
- Develop capabilities in the people affected by the change, through training and accompaniment.
- Monitor the impact of the change on the processes and results of the management system.
- Foster a culture of continuous improvement, where change is seen as an opportunity and not as a threat.
An integrated vision
When change management is implemented within the scope of a quality management system, it enhances strategic alignment, staff participation and change sustainability. In this way, organizations not only comply with the standard, but are prepared to lead transformations with agility and confidence.
Key tools for managing change in ISO 9001:2015
According to these considerations, change management is a fundamental requirement within the quality management systems conceived in accordance with ISO 9001:2015, particularly in clause 6.3 (“Planning of changes”), which states that any modification must be planned and executed in a controlled manner.
To respond to these requirements, a number of tools are available to help provide a structured approach, reduce resistance and ensure that changes do not negatively affect the quality of the product or service. Some of the most useful and recommended tools are described below:
1. FMEA (Failure Mode and Effects Analysis)
This tool helps to identify possible failure modes that may arise as a consequence of the change, while facilitating the study of its effects and causes. It is useful in the impact assessment phase, as it helps to prioritize risks according to their severity, occurrence and detection. Within the framework of ISO 9001:2015 quality management systems, applying FMEA strengthens risk management and ensures that decisions on change are based on an objective and preventive analysis.
2. Change Control Checklist
This tool helps to ensure that critical steps are not excluded when implementing changes within an organization. It includes elements such as review of regulatory requirements, validation of procedures, document updating and resource evaluation. This tool is key in the planning and implementation phase, ensuring traceability and compliance with management system standards.
3. Change impact matrix
Through this matrix, the impact level of the change on business processes, resources employed, relevant stakeholders, customer requirements or management indicators can be observed. Its use focuses on the prior evaluation of the impact, facilitating the strategic decision making process, anticipating adverse effects and prioritizing from there.
4. Change management meetings
Holding specific meetings with process leaders, quality managers and key stakeholders helps to align criteria, share information on risks and coordinate actions. They are essential in the planning and acceptance phases, as they foster commitment, promote a culture of positive change and avoid misunderstandings or operational overlaps.
5. PDCA cycle (Plan-Do-Check-Act)
This cycle provides a management structure that allows the planning of change, its subsequent implementation, the verification of its effects and the subsequent action based on the reality presented. It is applicable throughout the entire change management cycle, and is consistent with the continuous improvement approach embodied in ISO 9001:2015.
6. Kanban or visual boards
This management tool allows visual tracking of change-related tasks: what is being done, who is doing it and what is pending. Kanban boards are particularly useful when implementing and monitoring, as they improve collaboration between teams, promote transparency and reduce bottlenecks.
7. SWOT Analysis
This strategic analysis tool allows the identification of the Strengths, Opportunities, Weaknesses and Threats of the organizational system in the face of change, which makes it possible to establish realistic and contextualized strategies. It is mainly applied in the strategic planning phase of change.
8. Change communication plan
Designing a structured communication plan is essential to properly manage the perception and expectations of staff and other stakeholders. Define key messages, channels, responsible parties and frequency. This tool is central in the communication and change acceptance phase, avoiding rumors, unnecessary resistance and improving cultural and operational alignment.
The aforementioned tools, when applied in an integrated and consistent manner, strengthen an organization’s ability to manage complex changes without compromising its performance or commitment to quality. Incorporating them as part of the ISO 9001:2015 management system not only ensures regulatory compliance, but also enhances resilience, innovation and continuous improvement.
The following table summarizes the usual tools for change management in ISO 9001: 2015 Quality Management Systems.
Table. Useful tools for managing change in ISO 9001:2015 systems.
| Tool | Primary purpose | Phase of the change where it is applied | Key benefit |
|---|---|---|---|
| FMEA (Failure Mode and Effects Analysis) | Identify and prioritize risks associated with change | Impact assessment | Reduces uncertainty and enables risk-based decisions |
| Change control checklist | Verify compliance with mandatory steps and documentation | Planning and implementation | Ensures traceability and compliance with requirements |
| Change impact matrix | Analyze consequences of change in processes, resources and customers | Impact assessment and planning | Facilitates communication and prevents collateral effects |
| Change management meetings | Bringing together key stakeholders to assess change | Planning and acceptance | Generates commitment, reduces resistance and improves governance |
| PDCA cycle (Plan-Do-Check-Act) | Structuring the implementation of change in a cyclical manner | The entire change management cycle | Promotes continuous improvement and control over results |
| Kanban or visual boards | Monitoring tasks, responsible parties and status of change actions | Implementation and follow-up | Improves visual management and team collaboration |
| SWOT analysis | Assess strengths, weaknesses, opportunities and threats to change. | Planning | Helps to define realistic and context-oriented strategies |
| Change communication plan | Define messages, channels and frequency of communication | Communication and acceptance | Prevents rumors, maintains alignment and improves organizational climate |
Conclusions
In the midst of today’s business reality, where the only constant is change (Drucker, 2002), it is essential to integrate effective change management into the Quality Management System according to ISO 9001:2015, which is much more than a regulatory obligation, but rather a vital strategy for survival and success. Organizations that master this art not only adapt, but also lead innovation, improve their competitiveness and build committed and resilient teams.
Adopting a systematic approach to managing change within the QMS is a commitment to the continuity of value delivered to customers and other relevant stakeholders, while contributing to continuous improvement.
References
- Drucker, P. (2002): La Gerencia en la Sociedad Futura. Bogotá, Colombia. Editorial Norma.
- International Organization for Standardization (ISO). (2015). ISO 9001:2015 — Quality management systems — Requirements. ISO.
- Hiatt, J. (2006). ADKAR: A Model for Change in Business, Government and Our Community. Prosci Research.
- Kotter, J. P. (1996). Leading Change. Harvard Business Review Press.
- Prosci. (2020). Best Practices in Change Management – 2020 Edition. Prosci Inc.
- Cameron, E., & Green, M. (2019). Making Sense of Change Management: A Complete Guide to the Models, Tools and Techniques of Organizational Change. Kogan Page.
- Lewin, K. (1947). Frontiers in Group Dynamics: Concept, Method and Reality in Social Science; Social Equilibria and Social Change. Human Relations, 1(1), 5–41.
- Dweck, C. S. (2017). Mindset: The New Psychology of Success. Random House.
