1. AWARENESS PROGRAM
Quality Management System
ISO 9001:2008
BY
ANKUR DHIR
CERTIFIED LEAD AUDITOR FOR ISO 9001:2008, 14001:2004,ISO 22000:2005;ISO
27001:2005

2. INTRODUCTION
 In a highly competitive environment, managing
performance poses the greatest challenge for managers
within the context of continual change in customer
needs, requirements, and expectations that shape
performance requirements. To overcome this
challenge, management practices need to be based on
established principles.
 Developing a principle-based management system is
therefore crucial to good management practices that
can lead to desired performance.

3. INTRODUCTION
 After many years of quality assurance practices, the
International Organization for Standardization, or
commonly referred to as the ISO, has evolved eight key
management principles as the basis for standardizing
management system practices that meet the specified
requirements. This resulted in the ISO 9001:2000
International Standard, and now the revised ISO
9001:2008 version of this International Standard.

4. QUALITY - CUSTOMER DEFINATION
 Customers define quality, they quality they want,
need, expect or dream of. So much has been said on
this point that it will be pointless to discuss it any
longer. However, let’s not forget that there is an
“explicit” quality and an “implied” quality: explicit
quality goes along with “quality standards” (see
principle below) – implied quality is specified
nowhere, it’s quality that must just be there! A fridge
is supposed to cool well, a book is supposed to be
printed without spelling mistakes. Finite. That’s just
given for granted.

5. PRINCIPLES OF QMS
 The eight key guiding principles to establish an integrated
management system for achieving organizational
performance are:
 1. Leadership,
 2. Customer focus,
 3. Process approach,
 4. System approach to management,
 5. Involvement of people,
 6. Factual approach to decision making,
 7. Continual improvement, and
 8. Mutually beneficial supplier relationships.

6. PRINCIPLE 1 LEADERSHIP
 Leadership is about establishing unity of purpose
and direction in an organization. It also involves
creating and maintaining an environment where
people can be fully involved in achieving the
organization's objectives. As such, someone has
to get this started, to set the direction, to
strategize and to plan the implementation of the
business idea, to find the means and to provide
the resources.

7. “Quality” means those features of products which meet customer needs and
thereby provide customer satisfaction. In this sense, the meaning of quality is
oriented to income. The purpose of such higher quality is to provide greater
customer satisfaction and, one hopes, to increase income.
However, providing more and/or better quality features usually requires an
investment and hence usually involves increases in costs. Higher quality in this
sense usually “costs more.”
WHAT IS QUALITY ?
“Quality” means freedom from deficiencies—freedom from errors that require doing
work over again (rework) or that result in field failures, customer dissatisfaction,
customer claims, and so on. In this sense, the meaning of quality is oriented to
costs, and higher quality usually “costs less.”

8. LEADERSHIP IN ISO 9001:2008
 Under the ISO 9001:2008 requirements, the leadership
role is def ined as management responsibility in
Clause 5,“Management Responsibility”.
 The standard requires that top management
“provide evidence of its commitment to the
development and implementation of the quality
management system and continually improving
its effectiveness by…”

9. RESPONSIBILTIES
Herein top management holds five key responsibilities:
 a) communicating to all employees on the importance
of meeting customer and other requirements,
 b) setting direction through a quality policy,
 c) defining expectations and monitoring results
through the established quality objectives,
 d) reviewing the organization's overall performance by
conducting management reviews, and
 e) providing resources to achieve desired outcomes.

10. LEADERSHIP- QUALITY POLICY
 A leader must be passionate about the purpose
(objective) of the organization and what the leader has
to do to achieve the desired outcomes. This
requirement is categorically stated in Clause 5.3,
“Quality Policy”, that the top management is
responsible to establish, document and
communicate to all employees and other interested
parties.

11. PRINCIPLE 2 CUSTOMER FOCUS
 In customer focus, the ISO 9001:2008 requirement is
inclined towards the underlying concept of customer
responsiveness, which is defined as giving customers
what they have contracted to receive. This is defined in
Clause 5.2, “Customer focus”, as “Top management
shall ensure that customer requirements are
determined and are met with the aim of enhancing
customer satisfaction

12. CUSTOMER FOCUS ISO CLAUSES
 Conformance to customer requirements and achieving customer
satisfaction are crucial concepts in managing performance. The
whole performance management of the business idea is focused on
these two concepts in the ISO 9001:2008 Standard. This is defined
in Clause 7.2 as “Customer-related processes” under the main
Clause 7 on “Product realization”. The requirements of product
realization are all focused on meeting customer requirements and
achieving customer satisfaction, starting with Clause 7.2.1,
“Determination of requirements related to the product”. This
requirement covers specified and implied requirements of the
customer and also covers other requirements including statutory and
regulatory requirements and “additional requirements as determined
by the organization”.

13. Applying Principle of Customer focus
 Organizations depend on their customers and
therefore should understand current and future
customer needs and should meet customer
requirements and strive to exceed customer
expectation. (ISO 9004:2000)

14. REQUIREMENTS- Customer Focus
1. Meeting customer requirements.
2. Product/service requirements.
3. Customer communication.
4. Customer satisfaction.
5. Other customer-focused activities

15. PRINCIPLE 3 THE PROCESS
APPROACH
 To respond to a customer request, the organization has
to be concerned with processes within the
organization. A work process is a series of operations
(steps) or activities that transform input into
intermediate output at each step until the final output
that meets the customer specified requirements.

16. ISO CLAUSES- PROCESS APPROACH
 It is the responsibility of management to identify
processes needed to produce and deliver the products
or services to satisfy the requirements of the customers
and other interested parties (suppliers, employees and
other affected parties).
 In the ISO 9001:2008 Standard, Clause 4.1(a) requires
the organization to “determine the processes needed
for QMS and their application throughout the
organization”. The requirements for the core business
processes of the organization are defined under
Clause 7, “Product realization”.

17. Requirements
a) identifying work process titles,
b) creating a standard method for carrying out the work
and for monitoring process performance over time,
c) addressing problems that arise,
d) continually improving the work operations,
e) identifying opportunities for continual improvement,
f) disseminating work process information, and
g) facilitating the training of new personnel.

18. PROCESS APPROACH - MRM
 The review on the performance of the processes and the actions
taken to improve them are specified in the requirements for
management review as defined in Clause 5.6, “Management
review”.
The review of the processes covers:
 Status and results of quality objectives,
 Results of audits and self-assessment of the organization,
 Feedback and satisfaction of customers and other stakeholders,
 Process performance and product nonconformities,
 Status of corrective actions and preventive actions,
 Continual improvement initiatives, and
 Unresolved issues relating to meeting customer requirements.

19. Applying the process approach
 A desired result is achieved more efficiently when
activities and related resources are managed as a
process. (ISO 9004:2000)
 The ISO 9001:2008 also identifies six mandatory
procedures to manage the integrity of QMS. These
processes are:
a) Control of documents used in QMS, including
documents of external origin. These documents can be
in any medium,

20. PROCEDURES REQUIREMENT
b) Control of records. Records are generated to provide evidence of
implementation, monitoring and control of QMS processes,
c) Internal audits. Audits carried out at planned intervals to ensure
the maintenance, improvement and integrity of QMS and its
processes,
d) Control of non-conforming product. This ensures that product
which does not conform to product requirements is identified
and controlled to prevent its unintended use or delivery,
e) Corrective action. This is action taken to eliminate the causes of
nonconformities in order to prevent recurrence, and
f) Preventive action. This is action taken to eliminate the
causes of potential nonconformities in order to prevent their
occurrence.

21. PRINCIPLE 4 SYSTEM APPROACH TO
MANAGEMENT
 A system is an organization of resources to achieve an
intended objective. Within a large system, there are
sub-systems with their own objectives which are
aligned to the overall objective of the organization.
A system itself is a sub-system of a larger system.
One can conceptually view a system as an interaction
of several elements.

22. SYSTEM APPROACH TO MANAGEMENT IN ISO
9001:2008
 The system approach is a crucial concept for
maintaining the integrity of the management system
when improvement changes are made to QMS, as it
can provide the mental picture on the interactions of
the parts in the system.
 The ISO 9001:2008 Standard requires that an
organization establishes, documents, implements and
maintains a quality management system and
continually improves its effectiveness, as reflected in
Clause 4.1, “General requirements” of a QMS.

23. REQUIREMENTS
 The QMS documented to meet the requirements in Clause 4.1
“General requirements”, will preserve the integrity of QMS
and facilitate communication of policies, procedures and
instructions. Typically, as defined in Clause 4.2,
“Documentation requirements", the system requirements are
documented at four levels:
a. Documented statements of quality policy and quality objectives,
b. A quality manual,
c. Documented procedures and other documents needed to ensure
effective planning, operation and control of processes, and
d. Quality records.

24. Applying the principle of system approach to
management.
 Identifying, understanding and managing
interrelated processes as a system contribute to
the organization's effectiveness and efficiency in
achieving its objectives.
1) Determined Processes.
2) Relationships of Processes.
3) Requirements of ISO 9001:2008.
4) System Concept.
5) Resources and Information.

25. PRINCIPLE 5 INVOLVEMENT OF PEOPLE
 Communication is particularly crucial to ensuring
involvement of all employees. Under Clause 5.5.3,
“Internal communication”, top management must
“ensure that appropriate communication channels are
established within the organization and that
communication really takes place regarding the
effectiveness of QMS”.

26. ISO CLAUSES for Involvement of People
 The activities for communication encompass:
 Top management-led meetings at functional areas and levels,
 Team briefings and other meetings at various levels,
 Notice-boards, in-house journals/magazines,
 Audio-visual, electronic media, such as e-mail and websites, and
 Employee satisfaction surveys and suggestion scheme.

27. CLAUSES Contd
 Under Clause 5.5.1, “Responsibility and authority”, the
top management has to define and communicate the
responsibility and authority to implement and maintain
QMS. Only then will the employees be clear about their
involvements and how they are expected to contribute to
the organization's overall mission and objectives.
 Under Clause 6.2.2 “Competence, training and
awareness”, it is the responsibility of management to
determine the necessary competence of personnel
performing work that will affect product quality, and to
provide the necessary training to achieve the necessary
competence.

28. Applying Involvement of people
 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 following are required.
 Top-down communication.
 Responsibility and authority.
 Training.
 Empowerment and involvement.
 Communication.

29. Principle 6 Factual Approach to
decision making.
 A QMS that meets the requirements of the ISO
9001:2008 Standard is established to be results-
oriented. In other words, the system must be able to
evaluate and monitor the planned results and to take
necessary actions to ensure its achievement.
 Under Clause 8, “Measurement, analysis and
improvement“, the organization must plan and
implement the monitoring, measurement, analysis
and improvement processes to ensure that QMS is
effectively implemented and continually being
improved.

30. ISO CLAUSES – Factual Approach to decision making.
 QMS focuses on three key areas:
a) to ensure that the product meets customer specified
requirements,
b) to ensure discipline in implementing QMS, and
c) to ensure continual improvement of the effectiveness of
QMS. This calls for the use of data and analysis for
decision-making and for initiating actions to achieve
planned results and improvements.
On the performance management of QMS, the system
audits, particularly the internal quality audits as in Clause
8.2.2, “Internal audit“, will provide objective evidence
for decisions on improvement of QMS and its processes.

31. Clauses Contd
 Besides, there must be evidence records of statistical
analysis to monitor the stability of processes, and
actions initiated to prevent potential causes of
nonconformity. This requirement is defined in Clause
8.4, “Analysis of data”.

32. Applying the principle of factual approach to decision making
 Effective decisions are based on the analysis of
data and information.
The following are required
 Management Reviews.
 Quality objectives.
 Use of Data Analysis.
 Monitoring and measurement of production.
 Maintaining and improving QMS.

33. PRINCIPLE 7- Continual Improvement
 In the ISO 9001:2008 Standard, the requirement for
continual improvement (CI) is defined in Clause 8.5.1,
“Continual improvement”. CI can be initiated
through the use of quality policy, quality objectives,
audit results, analysis of data, corrective and
preventive actions and management review. This
requirement covers both the reactive and proactive
actions of improvement.

34. Continual Improvement
 In process management, the basis for CI is in the managing
of variation. Variation is the fluctuation of the output of a
process, sometimes called noise. Every repeatable process
exhibits variation. Improvement of any process is to reduce
variation so that the process can consistently meet
expectations of either the internal customers (employees
responsible for the subsequent processes) or the external
customers. Studying variation leads to managing it, as this
will help to identify the source of a problem and to
establish the action most likely to resolve it.
 CI drives the organization to continually address ways to
reduce costs, improve organizational performance and
customer satisfaction.

35. CONTINUAL IMPROVEMENT- ISO CLAUSES
 The systematic approach to CI is based on the Plan-
Do-Check-Act cycle (PDCA). The PDCA cycle
ensures rigour that is necessary to understand all
aspects of the improvement opportunities and for
considering multiple options. Apart from the data
analysis tools, CI tools include creativity tools, quality
function deployment, and what-if analysis. In the
context of CI, it is necessary to focus on customer
wants and needs in more depth in order to be able to
develop improvement options.

36. Applying the principle of continual improvement
 Continual improvement (CI) is applied in Clause 8.5 of the
Standard
CI is achieved from three different actions;
1) CI projects,
2) corrective actions taken to eliminate causes of
nonconformity, and
3) preventive actions taken to eliminate the causes of potential
nonconformity.
 The opportunities for continually improving QMS can be identified
through the use of the quality policy, quality objectives, audit results,
analysis of data and management review.
1.Continual improvement.
2. Corrective Action.
3. Preventive Action.

37. Principle 8 mutually Beneficial supplier relationships
 The role of the supplier constitutes a crucial relationship in the
value creation chain in QMS. The ISO 9001:2008 Standard
defines this relationship under Clause 7.4, “Purchasing”. In
dealing with suppliers, the standard is focused on the control of
the purchased items and the reliability and capability of the
supplier in relation to the requirements of the customers.
 The first element of control is to ensure that the supplier has the
capability to supply and deliver to the specified requirements of
the organization. This calls for the assessment of the supplier or
sub-contractor on many criteria, including the relevant
experience for the job, the performance of the supplier against
other competing suppliers, the product quality, price, delivery
performance,

38. ISO CLAUSES
 The second element of control is the purchasing
process control, from the request for purchase and the
issuance of the purchase order to the delivery and
receipt of the inputs.
 Clause 7.4.3, “Verification of purchased product”
clearly specified the requirement for this control.
 The tendering process will look at all the requirements
specified under Clause 7.4, “Purchasing”, and will
include the development of the project quality plan
for implementation after the award of the tender.

39. Applying the principle of Mutually beneficial supplier relationships
 An organization and its suppliers are interdependent
and a mutually beneficial relationship enhances the
ability of both to create value.
 The following requirements provide the opportunities to
build mutually beneficial supplier relationships:
 Supplier evaluation.
 Supplier re-evaluation.
 Outsourcing.
 Information requirements.
 Improvement opportunities.

40. Conclusion
 Several shortcomings are apparent in the applications of
these eight principles in many organizations which have
implemented the ISO 9001:2008 Standard. The most
obvious is that the principle of CI of product, process and
service is not pervasive in this field of performance
practice. Organizations are more concerned with achieving
conformance to requirements, and once that is achieved
there is no motivation for further improvement.
 These shortcomings undermine the ability of managers to
exploit the potentials of their established QMS. Managers
must continue to study these eight principles of
performance management to be able to appreciate the
strength and potential that can be harnessed from the
application of the ISO 9001:2008 Standards.