ISO 9001:2008

REFRESH TRAINING

QUALITY CONCEPT AND PROCESS

APPROACH
WHAT IS QUALITY?
FOR MANUFACTURED PRODUCT:
Performance : basic operating characteristics of a product
Durability: How long product lasts before replacement
Quality of design: Designing quality characteristics into a product or service
Features: Extra items added to basic features, such as a stereo CD or a
leather interior in a car.
Reliability: Probability that a product will operate properly within an
expected time frame.
Fitness for use: how well product or service does what it is supposed to
Serviceability: ease of getting repairs, speed of repairs
Aesthetics: how a product looks, feels, sounds, smells or tastes
Cost effectiveness
Perfection
Zero defect

For Service:

Time and timeliness: How long must a customer wait for service, and is
it completed on time?
Completeness: Is everything customer asked for provided?
Courtesy: How are customers treated by employees?
Consistency: Is the same level of service provided to each customer each
time?
Accessibility and convenience: How easy is it to obtain service?

Definitions:
Quality: Degree to which a set of build in characteristics fulfills
requirement
System: Set of interrelated or interacting element. A system may or
not have sub system.

may

Management System: System to establish policy and objectives and to

achieve those objectives.
Quality Management System: Management system to direct and control
an organization with regard to quality.
Quality Control: Part of quality management, focused on fulfilling quality
requirements.
Quality Assurance: Part of Quality Management, focused on providing
confidence that the quality requirements will be fulfilled.

-continued
Defect: Non-fulfillment of a requirement related to intended or specified
use.
Correction: Action to eliminate a detected non-conformity. e.g. rectification
or replacement.
Corrective Action: Action to eliminate the cause of a detected nonconformity or other undesirable situation.
Preventive Action: Action to eliminate the cause of a potential Nonconformity or other undesirable potential situation.
Effectiveness: Extend to which planned activities are realized and planned
results achieved.
Efficiency: Relationship between the result achieved and resources used.

Quality Management Principles:

ISO 9001:2008 is based on QMS Principles. This QMS

Principles are stated in ISO 9000 and ISO 9004.They have
been taken into consideration during the development of ISO
9001:2008 standard.

This Principles are blended in ISO 9001:2008 requirements.

Eight QMS Principle

Customer
Focus
Mutual
beneficial
supplier
relationship

Factual
Approach to
decision making

Leadership

Eight
Quality
Management
Principles

Continual
Improvement

Involvement of
People

Process
Approach
System
Approach to
Management

Continual Improvement

Continual improvement of the organizations overall performance

should be a permanent objective of the organization.

Defined as RECURRING activity to INCREASE ability to FULLFILL

requirements.

It could be MACRO (strategic breakthroughs) to MICRO (small-step

on-going) level improvement.

Refer: ISO 9001:2008 CL: 4.1,5.3,5.6.3,6.1,8.1,8.4,8.5

Factual Approach to Decision

Making

Effective decisions are based on the analysis of Data and Information.

Analysis of Data is an integral part of ISO 9001:2008 requirements.

Refer: ISO 9001:2008 CL: 8.4,5.6,8.2.3

Mutual Beneficial Supplier

Relationships

An organization and its suppliers are independent and mutually

beneficial relationships enhances the ability of both to create value.

Refer: ISO 9001:2008 CL: 7.4

Customer Focused Organization

Organization depends on their customers and therefore should

understand current and future customer needs, should meet
customer requirements and strive to exceed customer expectations.

Refer: ISO 9001:2008 CL:

5.1(a),5.2,5.3,5.4,5.5.2(c),5.6.2(b),7.2.1(b),7.2.3,7.5.4,8.2.1

Leadership

Leaders establish unity of purpose and direction in the organization.

They should create & maintain internal environment in which people
can become fully involved in achieving organizations objectives.

Refer: ISO 9001:2008 CL: 5.1,5.2,5.3,5.4.1,5.4.2,5.5.1,5.5.3,5.6

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 organizations
benefit.

Refer ISO 9001:2008 CL: 5.5.1,5.5.3,6.2.2.(d)

System Approach to Management

Identifying understanding and managing interrelated processes as a

system which contributes to organizations effectiveness and
efficiency in achieving the goals or objectives.

The output of one process is the input to one or more subsequent

processes.

It interfaces between processes to ensure that the overall system is

effective.

Refer ISO 9001:2008 CL: 4.1,5.4,7.1,8.2.3

- continued

Applying the principle of system approach to management leads to

the following actions:
Defining the system by identifying or developing the processes that affect a
given objective.
Structuring the system to achieve the objective in the most efficient way.
Understanding the interdependencies among the processes of the system.
Continually improving the system through measurement and evaluation,
and
Establishing resource constraints prior to action.

Process Approach

A desired result is achieved more efficiently when activities and

related resources are managed as a process.

Systematic identification and management of the various processes

employed within an organization, & particularly the interactions
between such processes, is referred to as the process approach to
management.

Refer ISO9001:2008 CL: 4.1,7.1,8.2.3