Change Management in ISO 9001:2015

Addressing Change In ISO 9001:2015

ISO 9001 2015 focuses on change management at many places of the standard. Any change maybe it is in process, manpower, machinery, instruments, technology, raw materials, suppliers, customer requirements, legal requirements, etc shall go through a defined change management process. One of the goals of ISO 9001:2015 is to enhance the requirements for addressing changes at the system and operational levels. The ISO 9001:2015 requirements provide a strong basis for a management system for business that supports the strategic direction of the organization. Once the organization has identified its context and interested parties and then identified the processes that support this linkage, addressing changes becomes an increasingly important component of continued success. Once processes are determined, an organization will need to identify the risks and opportunities associated with these processes. To achieve the benefits associated with the determination of risks and opportunities, changes may be needed. These changes can be related to any element of the process, such as inputs, resources, persons, activities, controls, measurements, outputs, etc. Change  process would include

  • the change to be done
  • changes initiated by
  • reason for change
  • changes reviewed by
  • evaluation of change for consequences/effects on the overall performance of the quality system and further actions to be taken to resolve such effects
  • resources required to make change
  • skills required to make change
  • the final decision for change approval
  • change in documents as per change to be implemented.

Changes are intended to be beneficial to the organization and need to be carried out as determined by the organization. In addition, consideration of newly introduced risks and opportunities needs to be taken into account. To achieve the benefits associated with changes, the organization should consider all types of changes that may need to occur. These changes may be generated, for example, in:

  • Processes
  • Documented information
  • Tooling
  • Equipment
  • Employee training
  • Supplier selection
  • Supplier management
  • and many others

The successful management and control of these changes have become a core requirement within the organization’s QMS. These new requirements are referenced in ISO 9001:2015 as outlined below.

4.4.1 g)  The organization shall establish, implement, maintain and continually improve a quality management system. including the processes needed and their interactions. in accordance with the requirements of this International Standard. The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;

5.3 e)  Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization. Top management shall assign the responsibility and authority for ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

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 and systematic manner (see 4.4).
The organization shall consider the:
a) purpose of the changes and their potential consequences;
b) integrity of the quality management system;
c) availability of resources;
d) allocation or reallocation of responsibilities and authorities.

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

 8.3.6 Design and development changes
The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services. to the extent necessary to ensure that there is no adverse impact on conformity to requirements. The organization shall retain documented information on:
a) design and development changes;
b] the results of reviews;
c) the authorization of the changes;
d] the actions are taken to prevent adverse impacts.

 8.5.6 Control of changes
The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. The organization shall retain documented information describing the results of the review of changes, the persons authorizing the change, and any necessary actions arising from the review.

9.2.2 a) The organization shall plan, establish, implement and maintain an audit program (s) including the frequency, methods, responsibilities, planning requirements, and reporting. which shall take into consideration the importance of the processes concerned. changes affecting the organization. and the results of previous audits

9.3.2 b) The management review shall be planned and carried out taking into consideration changes in the external and internal issues that are relevant to the quality management systems.

9.3.3 b) The outputs of the management review shall include decisions and actions related to any need for changes to the quality management system;

10.2.1 f) When a nonconformity occurs, including any arising from complaints, the organization shall make changes to the quality management system, if necessary. 
Corrective actions shall be appropriate to the effects of the nonconformities encountered.

Things to consider when implementing the new requirement for Change

There are many triggers that can cause a change in the Quality Management System:

  • Customer feedback
  • Customer complaint
  • Product failure
  • Employee feedback
  • Innovation
  • Determined risk
  • Determined opportunity
  • Internal audit results
  • Management review results
  • Identified nonconformity
  •  Many others

These recommendations are not necessarily applicable to every type of organization. Some changes need to be carefully managed while others can be safely ignored. In order to sort through this, the organization should consider a method to prioritize. To determine the priority, the organization should consider a methodology that allows them to take into account: Consequences of the change

  • Likelihood of the consequence
  • Impact on customers
  • Impact on interested parties
  • Impact on quality objectives
  • Effectiveness of processes that are part of the QMS
  • others

Typical steps to Implement changes

  • Define the specifics of what is to be changed
  • Have a plan (tasks, timeline, responsibilities, authorities, budget, resources, needed information, others)
  • Engage other people as appropriate in the change process
  • Develop a communication plan (appropriate people within the organization, customers, suppliers, interested parties, etc. may need to be informed)
  • Use a cross-functional team review the plan to provide feedback related to the plan and associated risks
  • Train people
  • Measure the effectiveness
  • What changes may need to be made?
  • Change to a process (inputs, activities, outputs, controls, etc.)
  • Communication with customers
  • Communication with the supply chain
  • Additional controls for processes
  • Inspection
  • Employee training
  • Implement a new process
  • Provide documented information
  • Change existing documented information
  • Improve employee competence
  • Outsource a process
  • Many others

Other considerations:

  • Prior to making a change, the organization should consider unintended consequences
  • After making a change the organization should monitor the change to determine its effectiveness and to identify any additional problems that might be created
  • Records of some changes may be needed as part of the Quality Management System

Here are some tips and techniques to help you plan and implement your change in an effective, efficient and timely manner:

1. Change Must Be Realistic, Achievable, and Measurable
These aspects are especially relevant to managing personal change. Before starting organizational change, ask yourself: What do we want to achieve with this change, why, and how will we know that the change has been achieved? Who is affected by this change, and how will they react to it? These aspects also relate strongly to the management of personal as well as organizational change.

2. Start At The Top But Involve Every Layer
As change is unsettling for employees across all organizational levels, the introduction of ISO 9001:2015 will place a focus on the CEO and leadership team for strength, support, decisiveness, and direction. Initialising the changes must include plans for identifying leaders throughout the company and pushing responsibility for the design and implementation of the organization so that change systematically flows through the organization. At each layer of the organization, those managers and employees identified and trained must be aligned to the company’s vision, equipped to execute their specific mission, and motivated to make change happen.

3.  Risk Thinking through Change Management
Within ISO 9001:2015, many QMS managers and coordinators have faced the challenge of how to implement risk thinking and risk assessment in their Quality Management System. The answer is easy – Your Risk Management Will Be Included In Your Change Management! Firstly, you need to evaluate any planned changes by identifying the consequence and likelihood of potential risk related to every change. So in addition to identifying the benefit of every change, why not identify the risk involved with the change.
Some typical risks of the changes are:

  • Resistance – Active and Passive
  • Change Put On Hold
  • Resources Not Made Available
  • Costs / Time Runs Over Budget
  • Obstacles Appear Unexpectedly
  • Change Fails to Achieve Expected Results
  • Side Effects of The Change

4. Make You Change Management Integrated
Due to continuous organizational changes in the life cycle of businesses, there will always be a basis for uncertainty within the businesses.  Why not bring these changes under one umbrella?
There are different internal and external sources initiating the change throughout the organization. Change management tool as a platform enables you to plan, control and manage every change need in the organization such as:–

  • Strategic Business Changes
  • Changes in Product, Processes or System
  • Decisions Made (Management review meetings, board meeting, etc.)
  • Objective and Targets (Quality, Safety or and business goals)
  • Corrective (or preventive) Actions
  • Respond to Customer Complaints or undesired situations
  • Respond to Accidents, Incidents
  • Suggestions and Recommendations for Improvement

Change Management in easy steps

Prepare a change register to address and keep control of every change. This register can be easily made by an excel sheet addressing the below items:

  • What needs to be changed?
  • Why is the change needed? Investigate causes in case of an incident or customer complaint.
  • Existing Situation? What is the environment telling you prior to beginning implementation of the change?
  •  Who is doing what? – Individuals & Teams
  • What are the Resources Required? This includes cost, infrastructure, and human resources
  • What are the Timings and Deadlines?
  • What are your end objectives?
  • What Are The Potential Risks?

Identifying and evaluating potential risks through determining the consequence and likelihood and contingency plan for each risk (See  9001:2015 Clause 6.1)

  • Who / when / how will effectiveness and efficiency of change be monitored?
  • Current and additional required knowledge (See ISo 9001:2015 Clause 7.1.6)

Implementing the Change Management tool will help you with every single change suggested in ISO 9001:2015 and will be good practice for any other change such as business needs and daily decisions. Effective change management will support a smooth transition from the old Quality Management system to the new one and will be a good practice to manage all the other changes in your organization in the future.


The change management process is the sequence of steps or activities that a change management team follows to apply change management to a change in order to drive individual transitions and ensure the project meets its intended outcomes.



Assessments are tools used by a change management team or project leader to assess the organization’s readiness to change. Readiness assessments can include organizational assessments, culture and history assessments, employee assessments, sponsor assessments, and change assessments. Each tool provides the project team with insights into the challenges and opportunities they may face during the change process. What to assess:

Assess the scope of the change:
  • How big is this change?
  • How many people are affected?
  • Is it a gradual or radical change?
Assess the readiness of the organization impacted by the change:
  • What is the value-system and background of the impacted groups?
  • How much change is already going on?
  • What type of resistance can be expected?

You will also need to assess the strengths of your change management team and change sponsors, then take the first steps to enable them to effectively lead the change process.


Many managers assume that if they communicate clearly with their employees, their job is done. However, there are many reasons why employees may not hear or understand what their managers are saying the first time around. In fact, you may have heard that messages need to be repeated five to seven times before they are cemented into the minds of employees.

Three components of effective communication

  1. The audience
  2. What is communicated
  3. When it is communicated

For example, the first step in managing change is building awareness around the need for change and creating a desire among employees. Therefore, initial communications are typically designed to create awareness around the business reasons for change and the risk of not changing. Likewise, at each step in the process, communications should be designed to share the right messages at the right time. Communication planning, therefore, begins with a careful analysis of the audiences, key messages, and the timing for those messages. The change management team or project leaders must design a communication plan that addresses the needs of frontline employees, supervisors, and executives. Each audience has particular needs for information based on their role in the implementation of the change.


Business leaders and executives play a critical sponsor role in times of change. The change management team must develop a plan for sponsor activities and help key business leaders to carry out these plans. Research shows that sponsorship is the most important success factor.

Avoid confusing the notion of sponsorship with support

The CEO of the company may support your project, but that is not the same as sponsoring your initiative. Sponsorship involves active and visible participation by senior business leaders throughout the process, building a coalition of support among other leaders, and communicating directly with employees. Unfortunately, many executives do not know what this sponsorship looks like. A change manager or project leader’s role includes helping senior executives do the right things to sponsor the project.


Managers and supervisors play a key role in managing change. Ultimately, the manager has more influence over an employee’s motivation to change than any other person. Unfortunately, managers can be the most difficult group to convince of the need for change and can be a source of resistance. It is vital for the change management team and executive sponsors to gain the support of managers and supervisors. Individual change management activities should be used to help these managers through the change process. Once managers and supervisors are on board, the change management team must prepare a strategy to equip managers to successfully coach their employees through the change. They will need to provide training and guidance for managers, including how to use individual change management tools with their employees.


Training is the cornerstone for building knowledge about the change and the required skills to succeed in the future state. Ensuring impacted people receive the training they need at the right time is a primary role of change management. This means training should only be delivered after steps have been taken to ensure impacted employees have the awareness of the need for change and the desire to support the change. Change management and project team members will develop training requirements based on the skills, knowledge, and behaviors necessary to implement the change. These training requirements will be the starting point for the training group or the project team to develop and deliver training programs.


Resistance from employees and managers is normal and can be proactively addressed. Persistent resistance, however, can threaten a project. The change management team needs to identify, understand and help leaders manage resistance throughout the organization. Resistance management is the processes and tools used by managers and executives with the support of the change team to manage employee resistance.


Managing change is not a one-way street; employee involvement is a necessary and integral part of managing change. Feedback from employees as a change is being implemented is a key element of the change management process. Change managers can analyze feedback and implement corrective action based on this feedback to ensure full adoption of the changes.


Early adoption, successes, and long-term wins must be recognized and celebrated. Individual and group recognition is a necessary component of change management in order to cement and reinforce the change in the organization. Continued adoption needs to be monitored to ensure employees do not slip back into their old ways of working.


The final step in the change management process is the after-action review. It is at this point that you can stand back from the entire program, evaluate successes and failures, and identify process changes for the next project. This is part of the ongoing, continuous improvement of change management for your organization and ultimately leads to change competency. These elements comprise the areas or components of a change management program. Along with the change management process, they create a system for managing change. Good project managers apply these components effectively to ensure project success, avoid the loss of valued employees and minimize the negative impact of the change on productivity and a company’s customers.

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