What is ISO 9000?

• Written set of rules (a “Standard”) published by an international

standards writing body (International Organization for
Standardization).

 Rules define practices that are universally recognized and

accepted for assuring that organizations consistently understand
and meet the needs of their customers.

Principles that can be applied to any organization providing any

product or service anywhere in the
world.

Often called a quality system or a quality management system

What is ISO 9000?
“A set of universally understood and accepted
quality practices which, when well implemented,
give customers confidence that suppliers can
consistently meet their needs and requirements”.

 Requirements include

◦ meeting customer specifications

◦ system is consistently implemented and verifiable.
◦ support continuous improvement
◦ practices that measure the effectiveness of various aspects of
the system.
Goal and Scope
 The ultimate goal of the standard is customer satisfaction.
 How to achieve customer satisfaction?

◦ Applying the system : using it and putting it a the heart

of organization.
◦ Continually improving the system
◦ Prevention of nonconformity.
 Its scope is universal.

 The requirements “are generic and applicable to all

organizations, regardless of type and size.”
 implemented by any organization, producing any product
or service, anywhere in the world.
 What are the elements of the standards?
 Management responsibility
 Resource management
 Quality System
 Contract Review
 Design Control
 Document Control
 Purchasing
 Purchaser-Supplied Product
 Product Identification and
Traceability
 Process Control
 Inspection and Testing
 Inspection, Measuring and
Test Equipment
 Inspection and Test Status
 Control of Non-conforming
product
 Corrective Action
 Quality Records
 Internal Quality Audit
 Training
 Servicing
 Statistical Techniques
ISO 9000
 What are the parts of ISO 9000?
ISO 9000 is composed of 5 different, but related parts:
ISO 9000, 9001, 9002, 9003 and 9004
ISO 9000 and 9004 are guidelines, while ISO 9001, 9002,
and 9003 are the categories in which a company may apply
for certification
−ISO 9000: Quality Management and Quality Assurance Standards
– Guidelines for Selection and Use
−ISO 9001: Quality Systems – Model for Quality Assurance in
Design/Development, Production, Installation, and Servicing
−ISO 9002: Quality Systems – Model for Quality Assurance in
Production and Installation
−ISO 9003: Quality Systems – Model for Quality Assurance in Final
Inspection and Test
−ISO 9004: Quality Management and Quality System Elements –
Guidelines
Obtaining ISO Certification
In-depth analysis of the company’s
quality procedure
An external consultant is hired to access
the original procedure and take the
necessary steps to match with ISO 9000
standards
Assessment process by the third pary
Third party registration agency will issue
certification
Cost of obtaining ISO certification
The cost of obtaining an ISO certification will
vary from among companies. An estimate of
the implementation cost can be found by
brining into account factors such as
Employee size
Multiple locations
Degree of “closeness” to ISO 9000 standards
Needed steps to re-engineer quality
procedures (Cost)
Advantage and Disadvantage
Advantage:
Improves customer focus and process
orientation within the organization
Facilitates continuous improvement
Creates consistency throughout organization
Strengthens relationship & provide confidence
Improves management decision making
Institutionalizes training & add value
 Ten Steps to ISO Registration
10. Registration!

9. Final assessment by registrar

8. Take corrective actions

7. Pre-assessment by registrar

6. Submit quality manual for approval

5. Perform self-analysis audit

4. Select a third-party registrar and apply

3. Develop and implement the quality system

2. Select the appropriate standard

1. Set the registration objective

ISO 9000
ISO Nepal
 Real World Examples (cont.)
 “AtIBM, the ISO 9000 standards have proven to be a
template for the creation of a sound quality system,
regardless of whether the target market is located in the
United States or overseas. By embarking on the ISO
9000 journey, it is reasonable to expect lower costs,
improved customer satisfaction, greater brand loyalty,
and stronger market performance associated with this
quality effort. The ISO 9000 quality process can be an
important step on the road to total quality
management.” - IBM Director of ISO 9000
Dr. Jack E. Small
List of ISO certified firm