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ISO 9000 refers to a group of quality assurance standards

established by the International Organization for
Standardization.This group, which is made up of representatives
from 91 countries,adopted the standards in 1987.
ISO 9000 standards are aimed at quality systems,not at the quality
systems, not at the quality of goods and services. ISO certification
means that a company has a detailed, documented approach to
achieving consistency of output. It doesnt mean that they can be
made as durable as specified, and that the level of defects will be
While ISO 9000 can be an integral part of a TQM program, its important to
recognize the distinction between the two ideas.
The ISO 9000 standards are mainly concerned with quality assurance;
TQM focuses on quality management.
The ISO 9000 approach sets minimum standards for guaranteeing quality. It
does not go beyond those minimums to promote customer awareness, team
activities,or continuous improvement,all of which are essential to TQM.
TQM almost always requires some changes in a companys structure & culture.
With ISO 9000, the emphasis is not on change .Preparation may require only
careful documentation of systems already in place.
TQM promotes the types of practices, such as focusing on the internal
customer, that assure quality.Once you have successfully adopted TQM, you
will have the systematic approach to quality that the ISO 9000 standards call
TQM improves internal operations it facilitates cost cutting, improves employee
moral, and provides a focus for revolutionary, as well as incremental, leaps in
The ISO 9000 concept
The idea behind the ISO 9000 concept is quite simple. Every
customer wants to buy high-quality goods and services-products
which consistently conform to expectations or to contractual
How does the customer know that suppliers are capable of providing
consistent quality ? One way is to audit each suppliers quality
systems. Many firms now perform such audits of their suppliers.
In Europe, the idea was proposed to establish a uniform standard for
quality systems. This would give every company a well- defined
model for its quality program.It would also mean that a company
could be certified by a third-party auditor. Each of its customers
would then be assured of consistent quality without having to audit
the supplier independently.
The ISO 9000 standards

The ISO 9000 series actually consists of categories. A company
seeking registration will choose one of three levels represented by
ISO 9001, 9002, or 9003.

All the ISO standards are generic. They can be adapted to any
industry, and to both product and service firms.

The ISO 9000 certification process is usually applied to individual
sites. If a company wants complete certification, it proceeds on a
site-by-site basis.
ISO 9000
It provides guidelines for selection and use, definitions and concepts
regarding the ISO 9000

Its a quality management and quality assurance standards

It provide the basis for the implementation of quality system and their
assessment and verification. In establishing a quality system it is essential that
the organization clearly defines the personnel who are responsible for functions
affecting quality.

The quality system will generally be codified in a series of documents which
are commonly known as Quality Manual. All aspects relating to quality should
be identified in these documented procedures which would include all reference
to work instructions and records. The manual should also contain procedures
for specific actions which need to be taken as part of the quality control

ISO 9001
The most comprehensive standard. It assures all aspects of quality
from the design stage through production and servicing.

This standards specifies quality system requirements for use where
a contract between two parties requires the demonstration of a
supplier capability to design and supply product. The requirements
specified in this international standard are aimed primarily at
preventing non-conformity at all stages from design through to
Summary of ISO 9001 Standards
4.1 Management Responsibility
4.2 Quality System
4.3 Contract Review
4.4 Design Control
4.5 Document Control
4.6 Purchasing
4.7 Purchaser Supplied Product
4.8 Product Identification & Traceability
4.9 Process Control
4.10 Inspection & Testing
4.11 Inspection , Measuring and Test equipment
4.12 Inspection and Test Status
4.13 control of Nonconforming Product
4.14 Corrective Action
4.15 Handling ,Storage,Packaging, and Delivery

Summary of ISO 9001 Standards
4.16 Quality Records
4.17 Internal Quality Audits
4.18 Training
4.19 Servicing
4.20 Statistical Techniques

Note :- Various sections of the standards are interrelated.
For example, training is covered in paragraph 4.18. But training
procedures will have an impact on almost every other category. The
same is true for concepts like document control (4.5) or quality records
ISO 9002
This Standard leaves out the design phase of ISO 9001.It focuses on
production and delivery.It is used mainly by commodity
companies, such as chemical or paint producers.

This standard is applicable in contractual situations when

1. The specified requirements for products are stated in terms of
an established design or specifications;

2. Confidence in product conformance can be attained by
adequate demonstration of a certain suppliers capabilities in
production and installation.
ISO 9003
This standard is less detailed than the two above. It does not
include a comprehensive quality system, but focuses on testing
and inspection. It is useful for companies like equipment

This standards specify quality system requirement for use where
a contract between two parties requires demonstration of a
suppliers capability to detect and control the disposition of any
product non-conformity during final inspection and test.
ISO 9004
This is not a standard that applies to relations with outside
customers, but suggests internal methods for meeting the quality
measurements in the other standards. It describes methods for
approaching areas such as procurement , corrective action , and the
use of statistical process controls.

This standards provides guidelines on the technical, administrative
and human factors affecting the quality of products or services, at all
stages of the quality loop system. In this standard, emphasis is laid
on the satisfaction of the customers need the establishment of
functional responsibility and the importance of assessing the
potential risks and benefits
The Growth of ISO 9000
ISO 9000 registration has become a fundamental marketing
tool,particularly for companies doing business internationally.
It gives assurance of quality and provides a competitive
The ISO 9000 standards are meeting with widespread
acceptance. They are scheduled, for example, to replace
similar standards in the U.S. military market.
The European Community (EC) already requires ISO 9000
registration for certain products (e.g., toys, personal
protection devices, gas appliances) and planned to widen
this list to items such as medical devices and lifting

ISO is the International Organization for Standardization, set up with the
objective to promote the developments of standards and related activities
for facilitating international exchange of goods and services.

ISO 9000 series of standards developed in 1987, relate to quality systems.
It has evolved from the standardization of quality assurance system
standards of several nations all over the world.

The standards allow a wide flexibility, but, at the same time are rigid too.

They permit a supplier to formulate his own quality policy and write the
quality manual, procedures and instructions in his own way, within the
framework of the system elements, but does not allow rendering of non-
conforming products or services.