Professional Documents
Culture Documents
Introduction:
In my first post I had written about the Eight principles of quality management 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.
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 Documented procedure in iso 9001:2008 have been
replaced by maintained documented information and Documented record in iso
9001:2008 have been replaced by retained documented information.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 organizations 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.
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
Key Benefits (As per ISO 9000:2015)
Some of the possible actions that an organization can take to increase Customer Focus
can include:
1. To identify and recognize the direct and indirect customer of the organization who
receive value from the organization.
2. To understand customers current and future needs and expectations;
3. The organization must link its objectives to customer needs and expectations;
4. It must communicate customer needs and expectations throughout the
organization;
5. It must plan, design, develop, produce, deliver and support products and services
to meet customer needs and expectations;
6. It must measure and monitor customer satisfaction and take appropriate actions;
7. It must determine and take action on relevant interested parties needs and
appropriate expectations that can affect customer satisfaction;
8. It must actively manage relationships with customers to achieve sustained
success.
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.. First and
foremost the organization must have a clear understanding of who are its direct customer
and who are its indirect customers. 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
It develops and improves the capability of the organization and its people to
deliver desired results.
It can create and sustain shared values, fairness and ethical models for behaviour
at all levels of the organization;
It can ensure that leaders at all levels are positive examples to people in the
organization;
It can provide people with the required resources, training and authority to act
with accountability;
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
organizations 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 organizations 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
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 organizations 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 organisations 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
It can define objectives of the system and processes necessary to achieve them;
It can ensure the necessary information is available to operate and improve the
processes and to monitor, analyse and evaluate the performance of the overall
system;
It should manage risks which can affect outputs of the processes and overall
outcomes of the QMS.
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
There is enhanced ability to anticipate and react to internal and external risks
and opportunities;
There is improved use of learning for improvement; There is enhanced drive for
innovation.
It can educate and train people at all levels on how to apply basic tools and
methodologies to achieve improvement objectives;
It can track, review and audit the planning, implementation, completion and
results of improvement projects;
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
It should ensure that data and information are sufficiently accurate, reliable and
secure;
It can analyse and evaluate data and information using suitable methods;
It should ensure people are competent to analyse and evaluate data as needed;
It can make decisions and take actions based on evidence, balanced with
experience and intuition.
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 Evidencebased 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
It can gather and share information, expertise and resources with relevant
interested parties;
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