INTRODUCTION
A
quality system is a series of checks and
balances that ensure quality of product if implemented properly. There are many
reasons for implementing a quality system in a company. Major reasons include
(i) increased demand from customers for a firm’s compliance with a quality
system; (ii) improvement in processes or systems; (iii) worldwide hyper competition
in the markets; (iv) firm’s desire for global deployment of resource; and (v)
accelerating product life cycles. This chapter examines the universally
acceptable and widely used worldwide quality certification program, namely, ISO
9000 Certification Program.
INTERNATIONAL
ORGANISATION FOR STANDARDISATION (ISO)
ISO
stands for International Organization for Standardization. This international
organization is headquartered in Geneva,
Switzerland.1 ISO is a network of the National Standards Institutes
of 148 countries, on the basis of one member per country. It was established in
1947 to promote the development of international standards for quality ststems.2
ISO develops voluntary technical standards which add value to all types of
business operations. The ISO Technical Committees carry out the work of
preparing international standards. It circulates the draft standards adopted by
the technical committees to the member bodies for voting. A draft standard is
published as an international standard when it is approved by at least 75% of
the member bodies casting vote.
ISO
is a non-governmental organization. Its members are not delegations of national
governments. Many of its member institutes are part of the governmental
structure of their countries or are mandated by their government. Other members
have their roots uniquely in the probate sector, having been set up by national
partnerships of industry associations.
EMERGENCE
OF ISO
ISO
coordinates the international standards system all over the world. International
standardization initially began in the electro technical field under the
tutelage of the International Electro technical Commission (IES), which was
established in 1906. Pioneering work in other fields was carried out by the
International Federation of the National Standardizing Associations (ISA),
which was set up in 1926. The emphasis within ISA was laid heavily on
mechanical engineering. ISA’s activities came to an end in 1942. ISO officially
began operations on 23
February 1947 based on the decision of the delegates of 25
countries in a meeting in 1946 in London.
This new international organization was created to facilitate international
coordination and unification of industrial standards.
MEMBERSHIP
OF ISO
Membership
of ISO is open to national standards institutes or similar organizations most
representative of standardization in their country. A country has only one
membership. There are three categories of members in
(a)
Member
Bodies : Full members are known as Member bodies. Each member-body has one vote
to cast.
(b)
Correspondent
Members : Correspondent members are usually organizations in countries, which
do not have a full developed national
standards activity. Correspondent members do not take an active part in the
technical work, but are entitled to be kept fully informed about the work of
interest to them.
(c)
Subscriber
Members : Subscriber members are institutes from countries with very small
economies that nevertheless wish to maintain contact with international
standardization.
ISO
STANDARDS
An
ISO standard is a documented international standard that carries the ISO logo
and the designation “international Standard”. In most cases, it is published in
A4 format-which is itself one of the ISO standard paper sizes. It is also
available electron ally.
BENEFIT
OF ISO STANDARDS
Various
parties are beneficiaries of ISO standards. They include business houses,
customers, governments and trade officials.
Business
Houses :
Adoption of international standards facilitates suppliers to base the development
of their products and services on specifications that have wide acceptance in
their sectors. This, in turn, it means that businesses using international
standards are increasingly free to compete on many more markets around world.
Customers
:
When products and services are based on international standards, it becomes
possible to achieve compatibility of technology globally, Thus, international
standards bring them an increasingly wide choice of offers. They also benefit
from the effects of competition among suppliers. Furthermore, conformity of
products and services to international standards provides assurance about their
quality, safety and reliability.
Governments
:
International standards provides the technological and scientific bases
underpinning health, safety and environmental legislation.
Trade
Officials :
Different national or regional standards can create technical barriers to
trade. International standards can create a level playing field for the
competitors in the regional and international markets. International Standards
are the technical means by which political trade agreements can be put into
practice.
DEVELOPMENT
OF STANDARDS BY ISO
When
an industry or business sector feels the need for a standard, it communicates
the requirement to one of ISO’s national members. The member-country then
proposes the new work item to ISO. If accepted, the work item is assigned to an
existing technical committee. The focus of the technical committees is
specialized and specific. Based on the recommendation of the technical
committee, ISO launches the development of new standards for which there is
clearly an market requirement.
In
addition to the technical committee, ISO has three general policy development
committees. They provide strategic guidance for the standards’ development work
on cross-sectoral aspects. They are : CASCO (Conformity Assessment); COPOLCO
(Consumer Policy), and DEVCO (Developing Country Maters). These committees help
to ensure that the specific technical work is aligned with broader market and
stakeholder gro
up.
We
will
discuss the ISO quality systems under two headings:
ISO
9000 Quality Standards Series
ISO
14000 Environmental Management Systems
ISO
9000 QUALITY STANDARDS
ISO
published a series of international standards in 1987. The standards are: ISO
9000, 9001, 9002, 9003, 9004, and 14000. ISO 9000 series, comprised of five
standards, is a subset of total quality, although ISO standards and total
quality are not same. However, a total quality organization needs to apply the procedures
required by ISO 9000.3
Any
legal entity having production or service operations can apply for ISO 9000
certification. Examples incude manufacturers, Service organizations, banks,
insurance companies, trading houses, software firms, hospitals educational
institutions
, etc.
In
1987, s
ome member countries of ISO came to an agreement for the harmonization
of quality standards throughout the world. Accordingly, they decided on an
international quality standard system. This resulted in the formulation and
universal acceptance of ISO 9000 quality standards. These standards were
revised in 1994, followed by another revision in 2000. This has led to ISO
9000:2000 certification. The original ISO 9000 series included ISO 9000, ISO
9001, ISO 9002, ISO 9003 and ISO 9004. The original ISO 9002 and ISO 9003 were
dropped which the standards were revised in the year 2000. in fact, ISO 9000
was replaced i 2000 by the new version, namely, ISO 9000:2000. An organization
aspiring to obtain ISO certification
must now fulfill the requirements specified by ISO 9000:2000 standards.
ISO
9000: What is it?
ISO
9000 is a set of standards governing the requirements for documentations of a
quality program. In other words, ISO 9000 is a collection of international
standards which are independent of any specific industry or economic sector.
When a company complies with ISO 9000, it indicates to customers that the
company would be able to provide documentation to support whatever claims they
make about the actual quality of a product nor specify how a firm should
implement the elements of quality systems. The ISO 9000 family simply describes
what elements quality systems should contain.
Classification
of ISO 9000
ISO
9001
It
is related to design, development, production, installation and servicing. It
is applicable to companies which are involved from designing of products to its
final production.
ISO
9002
It
is related to production and installation. It is applicable to those companies
that produce products on the basis of customers’ specifications. Apparel
manufactures which are export-oriented follow this standard.
ISO
9003
It
is related to final inspection and test.
ISO
9004
It
is related to guidelines in quality management that should be considered in
establishing and maintaining an effective quality system.
ISO
9001
ISO
9001 specifies requirements for a quality management system that an
organization can use for internal application or for certification or for
contractual purposes. It focuses on the effectiveness of the quality management
system in meeting customer requirements. This comprehensive standard focuses on
20 aspects of a quality program for companies that design, produce, install and
service product. They specify requirements for a component of the quality system.
Preparing a quality Manual and Documented Procures is a requirement of ISO
9001. These are needed to define the organization and operation of the quality
system. Overall, preventing nonconformity form the design stage to servicing
stage is the primary aim of this standard. The emphasis is on defect
prevention, rather than on defect detection.
The
20 elements of ISO 9001 are as follows :
1.
Management
responsibility
2.
Quality
systems
3.
Contract
review
4.
Design
control
5.
Document
control
6.
Purchasing
7.
Customer-supplied
materials
8.
Product
identifications and tractability
9.
Process
control
10.
Inspection
and testing
11.
Inspection,
measuring and test equipment
12.
Inspection
and test status
13.
Control
of nonconforming product
14.
Corrective
action
15.
Handling,
storage, packaging and delivery
16.
Quality
records
17.
Internal
quality audits
18.
Training
19.
Servicing
20.
Statistical
techniques
ISO
9002
It
contains standards for quality assurance in production, installation and
servicing. It contains 19 sections/requirements, which are exactly as those of
ISO 9001. The exception is that it does not include requirements for design
control.
ISO
9003
It
addresses only the production processes. It contains quality systems for
quality assurance in final inspection and testing of product. It contains about
half of the requirements from ISO 9001 but does not include design or
production. It modifies some of the requirements to suit the inspection and
final test application.
ISO
Certification : What to be Done by a Company?
The
first thing to be done by a company is to develop a quality management system
that meets the new Quality Standard. The company must develop the Quality management system in such a way that it meets
the requirements specified by ISO 9001:2000. In the course of doing so, the
managers of the company may consult the ISO 9000:2000 and ISO 9004:2000
guidelines. We should, however, remember that the company’s quality management
system must meet ISO’s requirements, not its guidelines.
The
managers may face a question: how can they develop a quality management system?
There are at least two approaches: They can do either a Gap Analysis or follow
a detailed System Development Plan, already prepared by expert consulting
firms.
If
the company has already got a quality management system and the managers are
happy with the way it operates, then they can use a Gap Analysis will help
managers to understand exactly what they need to do to meet the ISO 9001:2000
Quality Management Standard. It will help them identify the gaps that exist
between the new ISO Standard. It will help them identify the gaps that exist
between the new ISO Standard and the company’s processes. Once they know where
the gaps are, they can take steps to fill the gaps. By following this
incremental approach, they will not only comply with the new ISO 9001 Standard,
but they will also improve the overall performance of their organization’s processes.
Once
the company’s quality management system has been fully developed and
implemented, it needs to carry out an Internal Audit to ensure that the company
could meet every single ISO 9001:2000 requirement.
When
the company is ready, it then asks a Registrar to audit the effectiveness of
the company’s quality management system. If the auditors like what they see,
they will certify that the company’s quality system has met ISO’s requirements.
They will then issue an official certificate to the company and they will
record the company’s achievement in their registry. With this the company will
become ISO 9001:2000 certified. Having been ISO-certified means that the
quality of its products and services is managed, controlled, and assured by a
registered ISO 9001 Quality Management System.
ISO
Certification Procedure in Bangladesh
In
Bangladesh TUV is the only authorized organization to issue ISO certificate
directly to any organization under the member body TGA, Germany. To achieve ISO certification by an organization
working in Bangladesh, it needs to communicate with various consultancy firms
working on behalf of accreditation bodies like United Kingdom Accreditation
Services (UKAS), RVA, Hongkong Accreditation Services (HOKAS), TGA etc. These
firms advise the applicant organization to comply with the guidelines of ISO.
When the organization communicates the consultancy firm about its fulfillment
of criteria, the firm then invites the audit teams of the Accreditation Body
for which the company is applying. After satisfactory findings on the
investigation, the team issues ISO certificate in favor of the organization.
The member body audits the firm thereafter on a continuous basis. In case of
any minor non-compliance findings, the team suggests the way of eliminating the
deviations. In case of major deviation from standard, the certification is
cancelled or the firm is suggested to improve the matter within a time frame.
ISO
14000 Series of Standards:
Environmental
Management Systems
The
ISO 14000 family consists of standards relating to environmental management
systems and others which are specific tools for realizing environmental policy
and achieving objectives and targets. After the success of the ISO 9000 series
of quality standards, the International Organization for Standardization
developed, in 1996, a comprehensive set of standards for environmental
management, known as ISO 14000 standards. This series of standards is designed
to cover the whole area of environmental issues for organizations in the global
marketplace. The purpose of this standard is to provide industries with a
structure for a universal & international environmental management system
of standards and guidelines.
History
of ISO 14000
The
ISO 14000 series emerged primarily as a result of the Uruguay round
of the GATT negotiations and the Rio Summit on the Environment held in 1992.
While GATT concentrates on the need to reduce non-tariff barriers to trade, the
Rio Summit generated a commitment to protection of the environment across the world.
The environmental field has seen a steady growth of national and regional
standards.
After
assessing the need for international environmental management standards, ISO
formed the Strategic advisory Group on the Environment (SAGE) in 1991 to
consider whether such standards could serve to :
Promote
a common approach to environmental management similar to quality management;
Enhance
organizations’ ability to attain and measure improvements in environmental
performance; and
Facilitate
trade and remove trade barriers.
The
Reasons for Using the ISO 14000 Standards
A
set of international standards brings a worldwide focus to the environment,
encouraging a cleaner, safer, healthier world for us all. The existence of the
standards allows organizations to focus environmental efforts against an
internationally accepted criterion.
At
present many countries and regional groupings are generating their own
requirements for environmental issues and these vary between the groups. A
single standard will ensure that there are no confliction to compete in the
global marketplace could easily overshadow all ethical reasons for
environmental management. Within Europe, many
organizations gained ISO 9000 Registration primarily to meet growing demands
from customers. ISO 9000 quality registration has become necessary to do
business in many areas of commerce. Similarly, the ISO 14000 management system
registration may become the primary requirement for doing business in many
regions or industries.
Principles
of ISO 14000
·
A
company should define an environmental policy and ensure commitment to EMS;
·
A
company should formulate a plan to fulfill its environmental policy
·
A
company should develop capabilities and support mechanisms necessary to achieve
its environmental policy, objectives and targets
·
A
company should measure, monitor and evaluate its environmental performance
·
A
company should review and continually improve its EMS
with the objective of improving its overall environmental performance The
Process of Preparing Environmental Management Systems.
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