Anda di halaman 1dari 11

Addressing Change ISO 9001:2015

Addressing Change In ISO 9001:2015

ISO 9001 2015 focuses on change management at many places of the standard. ISO
9001 2008 standard was also has this element. However 2015 version is emphasizing
on change management more than earlier version. Any change may be it is in process,
manpower, machinery, instruments, technology, raw materials, suppliers, customer
requirements, legal requirements etc shall be go through a defined change
management process. One of the goals of the ISO 9001:2015 is to enhance the
requirements for addressing changes at 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

change to be done
changes initiated by
reason for change
changes reviewed by
evaluation of change for consequences / effects on overall performance of quality
system and further actions to be taken to resolve such effects
resources required to make change
skills required to make change
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 new introduced risks
and opportunities need 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:

Documented information
Employee training
Supplier selection
Supplier management
and many others

The successful management and control of these changes has become a core
requirement within the organizations 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
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 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 programme(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

Things to consider when implementing the new requirement for Change

There are many triggers that can cause a change to the Quality Management
Customer feedback
Customer complaint
Product failure
Employee feedback
Determined risk
Determined opportunity
Internal audit results
Management review results
Identified nonconformity
Many others
These recommendations not necessarily applicable for 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
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
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
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
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

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

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 organisational 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 organisational change.
2. Start At The Top But Involve Every Layer
As change is unsettling for employees across all organisational 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 design and implementation down the organisation 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
companys 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 mangers 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 organisational changes in the life cycle of businesses, there will
always be a basis for uncertainty within the businesses. Why not to 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, Process 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 below items:

What needs to be changed?

Why is the change needed? Investigate causes in case of an incident or customer
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
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 Change Management tool will help you with every single change
suggested in ISO 9001:2015 and will be a 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 of your organization in the future.


The change management process is the sequence of steps or activities that a change
management team follow 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 organizations 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


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 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 leaders 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 employees 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


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 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

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 companys customers.