Introduction:

In my first post I had written about the Eight principles of qualitymanagement on

which the standard of ISO 9001:2008 was based. As we are all aware that fifth
edition of ISO 9001( ISO 9001:2015) was published in month of september 2015.
This fifth edition (ISO 9001:2015) cancels and replaces the fourth edition( ISO
9001:2008). This document was being prepared by Technical committee of ISO
“ISO/TC 176/SC 2-Quality Management and Quality Assurance/ Quality
Systems” also know as ISO/TC 176 in short. The process of preparing the ISO
9001:2015 went through a six stage process. Organisations have been granted a
three-year transition period after the revision has been published to migrate their
quality management system to the new edition of the standard.
The key changes in the standards are

1. There is no quality manual.

2. It emphasis on organization context and risk based thinking,
3. There is no requirement of management representative
4. The standard does not include a specific clause for “Preventive Actions”.
5. The terms “document” and “records” have been replaced with the term
“documented information”. Documented procedure in iso 9001:2008 have been
replaced by maintained documented information and Documented record in iso
9001:2008 have been replaced by retained documented information.
6. In 2008 version of the standard the term “product” was used. This term also
included services. This term has been changed to Product and Services
7. In addition to the term “continual improvement” another term “improvement” have
been introduced
8. Outsourcing is now an external provision.The term “purchased product” has been
replaced with “externally provided products and services”.The term “supplier” has
been replaced with “External provider”.Control of external provision of goods and
services address all forms of external provisions.
9. The new standard does not make any reference to the exclusions which was for
only for clause 7 in ISO 9001:2008, but in ISO 9001:2015 after proper justification
any of the requirement of this international standards may not be included in the
scope, provided it does not affect the organization’s ability or responsibility to
ensure the conformity of its product and services and the enhancement of
customer satisfaction
10. The term “work environment” used in ISO 9001:2008 has been replaced with
“Environment for the operation of processes”.
The ISO 9000:2015 and ISO 9001:2015 standard is based on the following
Seven principles of Quality management.

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1 – Customer Focus
The primary focus of quality management is to meet customer requirements
and to strive to exceed customer expectations.
Rationale
Sustained success is achieved when an organization attracts and retains the
confidence of customers and other interested parties on whom it depends. Every
aspect of customer interaction provides an opportunity to create more value for the
customer. Understanding current and future needs of customers and other interested
parties contributes to sustained success of an organization
Explanation:
This is the first of the Seven principles of Quality management and there is no
change in the heading of this principle. The Eight principle definition stated
“Organizations depend on their customers and therefore should understand current
and future customer needs, should meet customer requirements and strive to
exceed customer expectations.” The Seven principle definition states “The primary
focus of quality management is to meet customer requirements and to strive to
exceed customer expectations.“. Customer focused means putting your energy into
satisfying customers and understanding that profitability comes from satisfying
customers.There should be researching ,establishing and understanding current
and future customer needs and expectations. The organization should ensure that
the objectives of the organization are linked to customer needs and expectations.
The top Management should communicate customer needs and expectations
throughout the organization. There should be measuring customer satisfaction and
acting on the results. the organization should ensure a balanced approach between
satisfying customers and other interested parties.
2 – Leadership
Leaders at all levels establish unity of purpose and direction and create
conditions in which people are engaged in achieving the quality objectives of
the organization.
Rationale
Creation of unity of purpose, direction and engagement enable anorganization to
align its strategies, policies, processes and resources to achieve its objectives.
Explanation:
This is the second of the Seven principles of Quality management and there is no
change in the heading of this principle. The Eight principle definition stated “Leaders
establish unity of purpose and direction of the organization. They should create and
maintain the internal environment in which people can become fully involved in
achieving the organization’s objectives.” The Seven principle definition states
“Leaders at all levels establish unity of purpose and direction and create conditions
in which people are engaged in achieving the quality objectives of the
organization.“Leadership is providing role model behaviors consistent with the values
of the organization. Behavior that will deliver the organizations objectives. Internal
environment includes the culture and climate, management style, shared, trust,
motivation and support. The leadership should Consider the needs of all interested
parties including customers, owners, employees, suppliers, financier, local
communities and society as whole. The leadership should establish a clear vision of
the organization’s future. The leadership should set a challenging goals and
targets. The leadership should create and sustain a shared values, fairness and
ethical role models at all levels of the organization. The leadership should Establish
trust and eliminate fear. The leadership should provide people with the required
resources training and freedom to act with responsibility and accountability. The
leadership should Inspire, encourage and recognize people contributions.
3 – Engagement of People
It is essential for the organization that all people are competent, empowered
and engaged in delivering value. Competent, empowered and engaged people
throughout the organization enhance its capability to create value.
Rationale
To manage an organization effectively and efficiently, it is important to involve all
people at all levels and to respect them as individuals. Recognition, empowerment
and enhancement of skills and knowledge facilitate the engagement of people in
achieving the objectives of the organization.
Explanation:
This is the third of the Seven principles of Quality management and the term
“Involvement of People” has been change to “Engagement of People“. The Eight
principle definition stated “People at all levels are the essence of an organization and
their full involvement enables their abilities to be used for the organization’s benefit.”
The Seven principle definition states “It is essential for the organization that all
people are competent, empowered and engaged in delivering value. Competent,
empowered and engaged people throughout the organization enhance its capability
to create value.” Engaging people means employees are committed to their
organisation’s goals and values, motivated to contribute to organisational success,
and are able at the same time to enhance their own sense of well-being.An engaged
employee experiences a blend of job satisfaction, organisational commitment, job
involvement and feelings of empowerment. When we talk of engagement of people it
means that all the employees are competent, empowered and they are delivering
value. An engaged employee will have a better perception of job importance. An
engaged employee will have better clarity of job expectation. There will be more
improvement opportunities. There will be regular feedback and dialog with
supervisors. The Quality of working relationships of an engaged employee with
peers, superiors, and subordinates is much improved. There is effective employee
communication.
4 – Process Approach
Consistent and predictable results are achieved more effectively and
efficiently when activities are understood and managed as interrelated
processes that function as a coherent system.
Rationale
The quality management system is composed of interrelated processes.
Understanding how results are produced by this system, including all its processes,
resources, controls and interactions, allows the organization to optimize its
performance.
Explanation:
This is the fourth of the Seven principles of Quality management and there is no
change in the heading of this principle. The Eight principle definition stated “A
desired result is achieved more efficiently when activities and related resources are
managed as a process.” The Seven principle definition states “Consistent and
predictable results are achieved more effectively and efficiently when activities are
understood and managed as interrelated processes that function as a coherent
system.” Processes are dynamic-they cause things to happen.processes within an
organization should be structured in order to achieve a certain objective in the most
efficient and effective manner.It helps us in systematically defining the activities
necessary to achieve/obtain desired results.It helps us in establishing clear
responsibility and accountability for managing key activities.It helps us in analyzing
and measuring of the capabilities of key activities. It helps us in identifying the
interfaces of key activities within and between the functions of the organization.It
helps us in evaluating risks,consequences and impacts of activities on
customers,suppliers and other interested parties. Quality Management System are
constructed by connecting interrelated processes together to deliver the system
objectives which is the satisfaction of the interested parties. This helps us in
structuring a system to achieve the organizations objectives in the most effective and
efficient way and understanding the interdependencies between the processes of the
system. It also helps us in providing a better understanding of the roles and
responsibilities necessary for achieving common objectives and thereby reducing
cross functional barriers and targeting and defining how specific activities within a
system should operate.
5 – Improvement
Successful organizations have an ongoing focus on improvement.
Rationale
Improvement is essential for an organization to maintain current levels of
performance, to react to changes in its internal and external conditions and to create
new opportunities.
Explanation:
This is the fifth of the Seven principles of Quality management and can be mapped
to the sixth of the Eight Quality principle which is “Continual Improvement”. The
term “Continual Improvement” has been change to “Improvement“. The fifth
principle of the Eight Quality principle “System approach to management” no
longer exist in the Seven principle of quality management.The Eight principle
definition stated “Continual improvement of the organization’s overall
performance should be a permanent objective of the organization.” The Seven
principle definition states “Successful organizations have an ongoing focus on
improvement.” Improvement is the improvement in organizational efficiency and
effectiveness. The organization should Employ a consistent organization-wide
approach to improvement of the organizations’ tools of improvement. The
organization should Provide people with the training in the methods and tools of
improvement. The organization should Make improvement of products,
processes,and the system an objective for every individual in the organization. The
organization should Establish the goals to guide and lead.
6 – Evidence-based Decision Making.
Decisions based on the analysis and evaluation of data and information are
more likely to produce desired results.
Rationale
Decision-making can be a complex process, and it always involves some
uncertainty. It often involves multiple types and sources of inputs, as well as their
interpretation, which can be subjective. It is important to understand cause and effect
relationships and potential unintended consequences. Facts, evidence and data
analysis lead to greater objectivity and confidence in decisions made.
Explanation:
This is the sixth of the Seven principles of Quality management and can be mapped
to the seventh of the Eight Quality principle which is “Factual approach
to decision making “. The term “Factual approach to decision making “ has
been change to “Evidence-based Decision Making“. The fifth principle of the Eight
Quality principle“System approach to management” no longer exist in the Seven
principle of quality management.The Eight principle definition stated “Effective
decisions are based on the analysis of data
and information.” The Seven principle definition states “Decisions based on the
analysis and evaluation of data and information are more likely to produce desired
results.” Evidence is information that shows or proves that something exists or is
true. Evidence can be collected by performing observations, measurements, tests, or
by using any other suitable method. Any decision making should away be based on
evidences. The organization should ensuring that data/information is sufficiently
accurate and reliable. The organization should make data accessible to those who
need them. The organization should analyze data using appropriate tools.The
organization should make decision and take actions based on analysis of
data,balanced with experience and intuition.
7 – Relationship Management
For sustained success, organizations manage their relationships with
interested parties, such as suppliers.
Rationale
Interested parties influence the performance of an organization. Sustained success
is more likely to be achieved when an organization manages relationships with its
interested parties to optimize their impact on its performance. Relationship
management with its supplier and partner network is often of particular importance
Explanation:
This is the seventh of the Seven principles of Quality management and can be
mapped to the eighth of the Eight Quality principle which is “Mutually beneficial
supplier relationships “. The term“Mutually beneficial supplier relationships
“ has been change to “Relationship Management“. The fifth principle of the Eight
Quality principle “System approach to management” no longer exist in the Seven
principle of quality management.The Eight principle definition stated “An organization
and its suppliers are interdependent and a mutually beneficial relationship enhances
the ability of both to create value“ The Seven principle definition states “For
sustained success, organizations manage their relationships with interested
parties, such as suppliers.“An interested party is a person or group that has a
stake in the success or performance of an organization.Interested parties may be
directly affected by the organization or actively concerned about its
performance. Interested parties can come from inside or outside of the organization.
Examples ofinterested parties include customers, suppliers, owners, partners,
employees, unions, bankers, or members of the general public.Interested
parties are also referred to as stakeholders. Relation management with interested
parties meaning sharing knowledge,vision,values, understanding and suppliers are
not treated as adversaries.The organization establishes a relationships that balance
short-term gains with long term considerations. There is pooling of expertise and
resources with partners. The Organization identifying and selecting key suppliers.
There is clear and open communication with the stake holders. There is sharing of
information and future plans. The organization establishes a joint development and
improvement activities. The organization inspiring,encourages and recognize
improvements and achievement by suppliers.