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:

Processes

Documented information

Tooling

Equipment

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 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 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
encountered.

Things to consider when implementing the new requirement for Change

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

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

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
prioritize.

To determine the priority, the organization should consider a methodology that

allows them to take into account:
o Consequences of the change
o Likelihood of the consequence
o Impact on customers
o Impact on interested parties
o Impact on quality objectives
o Effectiveness of processes that are part of the QMS
o others

Typical steps to Implement changes

o Define the specifics of what is to be changed
o Have a plan (tasks, timeline, responsibilities, authorities, budget,
resources, needed information, others)
o Engage other people as appropriate in the change process
o Develop a communication plan (appropriate people within the
organization, customers, suppliers, interested parties, etc. may need to be
informed)
o Use a cross functional team review the plan to provide feedback related to
the plan and associated risks
o Train people
o 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 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:
o Resistance Active and Passive

o Change Put On Hold

o Resources Not Made Available
o Costs / Time Runs Over Budget
o Obstacles Appear Unexpectedly
o Change Fails to Achieve Expected Results
o 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:
o Strategic Business Changes
o Changes in Product, Process or System
o Decisions Made (Management review meetings, board meeting, etc.)
o Objective and Targets (Quality, Safety or and business goals)
o Corrective (or preventive) Actions
o Respond to Customer Complaints or undesired situations
o Respond to Accidents, Incidents
o 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

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 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.

CHANGE MANAGEMENT PROCESS

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.

1. READINESS ASSESSMENTS
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 process.
2. COMMUNICATION & COMMUNICATION PLANNING
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.
3. SPONSOR ACTIVITIES & SPONSOR ROADMAPS
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.
4. CHANGE MANAGEMENT TRAINING FOR MANAGERS
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 employees.
5. TRAINING DEVELOPMENT AND DELIVERY
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.
6. RESISTANCE MANAGEMENT
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.
7. EMPLOYEE FEEDBACK AND CORRECTIVE ACTION
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.
8. RECOGNIZING SUCCESS REINFORCING CHANGE
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.
9. AFTER-PROJECT REVIEW
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.