Unit - V

Introduction to IS / ISO 9004 : 2000

ISO 9000

The ISO 9000 Series, issued in 1987 by the International Organization for Standardization (ISO), is a set
of international standards on quality and quality management. The standards are generic and not specific
to any particular product. They were adopted by the American Society for Quality Control (ASQC), now
American Society for Quality, and issued in the United States as the ANSI/ASQC Q90 Series (revised in
1994 as the ANSI/ASQC Q9000 Series).
ISO 9000:2000 is the most recent revision of the standards.

ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the
International Organization for Standardization and is administered by accreditation and certification
bodies. For a manufacturer, some of the requirements in ISO 9001 (which is one of the standards in the
ISO 9000 family) would include:

a set of procedures that cover all key processes in the business;

monitoring manufacturing processes to ensure they are producing quality product;

keeping proper records;

checking outgoing product for defects, with appropriate corrective action where necessary; and

regularly reviewing individual processes and the quality system itself for effectiveness.

A company or organization that has been independently audited and certified to be in conformance with
ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered." Certification to an
ISO 9000 standard does not guarantee the compliance (and therefore the quality) of end products and
services; rather, it certifies that consistent business processes are being applied.

Although the standards originated in manufacturing, they are now employed across a wide range of other
types of organizations. A "product", in ISO vocabulary, can mean a physical object, or services, or
software. In fact, according to ISO in 2004, "service sectors now account by far for the highest number of
ISO 9001:2000 certificates - about 31% of the total"

History of ISO 9000

Pre ISO 9000

During World War II, there were quality problems in many British high-tech industries such as munitions,
where bombs were going off in factories. The adopted solution was to require factories to document their
manufacturing procedures and to prove by record-keeping that the procedures were being followed. The
name of the standard was BS 5750, and it was known as a management standard because it did not
specify what to manufacture, but how to manage the manufacturing process. According to Seddon, "In
1987, the British Government persuaded the International Standards Organisation to adopt BS 5750 as an
international standard. BS 5750 became ISO 9000."

Certification
ISO does not itself certify organizations. Many countries have formed accreditation bodies to authorize
certification bodies, which audit organizations applying for ISO 9001 compliance certification. It is
important to note that it is not possible to be certified to ISO 9000. Although commonly referred to as
ISO 9000:2000 certification, the actual standard to which an organization's quality management can be
certified is ISO 9001:2000. Both the accreditation bodies and the certification bodies charge fees for their
services. The various accreditation
bodies have mutual agreements with each other to ensure that certificates issued
by one of the Accredited Certification Bodies (CB) are accepted world-wide.

The applying organization is assessed based on an extensive sample of its sites, functions, products,
services and processes; a list of problems ("action requests" or "non-compliances") is made known to the
management. If there are no major problems on this list, the certification body will issue an ISO 9001
certificate for each geographical site it has visited, once it receives a satisfactory improvement plan from
the management showing how any problems will be resolved.

An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended
by the certification body, usually around three years. In contrast to the Capability Maturity Model there
are no grades of competence within ISO 9001.

Fundamentals of ISO 9000

ISO 9000 represents an evolution of traditional quality systems rather than a technical change. Whereas
traditional quality systems rely on inspection of products to ensure quality, the ISO 9000–compliant
quality system relies on the control and continuous improvement of the processes used to design, produce,
inspect, install, and service products. In short, ISO 9000 represents a systemic tool for bringing quality
processes under control. Once processes are controlled, they can be continuously improved, resulting in
higher-quality products.

ISO 9000 represents a significant step beyond ensuring that specific products or services meet
specifications or industry standards. It certifies that a facility has implemented a quality system capable of
consistently producing quality products. That is, ISO 9000 does not certify the quality of products; it
certifies the processes used to develop them.

Thus ISO 9000 is a process-oriented rather than a results-oriented standard. It affects every function,
process, and employee at a facility, and it stresses management commitment to quality. But above all, it is
customer-focused: It strives to meet or exceed customer expectations.

ISO 9000 is not a prescriptive standard for quality. The requirements section (ISO 9001), which covers all
aspects of design, development, production, test, training, and service, is less than 10 pages long. For
example, when addressing the product design process, ISO 9000 focuses on design inputs, outputs,
changes, and verification. It is not meant to inhibit creative thinking.

ISO 9000 is a system quality standard that provides requirements and guidance on all aspects of a
company's procedures, organization, and personnel that affect quality—from product inception through
delivery to the customer. It also provides significant requirements and guidance on the quality of the
output delivered to the customer. Pertinent questions are: What benefits will the proposed changes to the
procedures, organization, and personnel provide to the customer? Will the proposed changes help to
continuously improve product delivery schedules and product quality and reduce the amount of variance
in product output?

ISO 9000 does not require inspection to verify quality, nor is it the preferred method. ISO requires that
the output be verified according to documented process-control procedures. ISO 9000 does not mandate
that specific statistical processes be used; it requires the user to implement appropriate statistical
processes. ISO 9000 mandates product-control methods such as inspection only when process-control
methods are neither practical nor feasible.
ISO 9000 does not provide industry-specific performance requirements. It provides a quality model that
can be applied to virtually every industry procurement situation and is being used worldwide for
commercial and, recently, government procurements.

Many suppliers already have a quality system in place, be it simple or elaborate. ISO 9000 does not
require a supplier to add new or redundant requirements to an existing quality system. Rather, it requires
that the supplier specify a basic, common-sense, minimal quality system that will meet the quality needs
of the customer. Thus, many suppliers find that their operative quality system already meets some or all
of the ISO 9000 requirements. They only need to show that their existing procedures correspond to the
relevant sections of ISO 9000.

ISO 9000 provides suppliers with the flexibility of designing a quality system for their particular type of
business, market environment, and strategic objectives. It is expected that management, aided by
experienced internal quality personnel and, if necessary, external ISO consultants, will determine the
exact set of supplier quality requirements. To ensure the overall success of the quality program, however,
the specific work procedures should be created by those actually doing the work rather than by
management or ISO consultants. Although an organization's documentation of work procedures may be
ISO 9000 compliant, if employees do not follow the procedures, the organization may not attain ISO
9000 certification. Drawing upon employee expertise and keeping employees involved in the process
when improving and controlling procedures are critical to attaining ISO 9000 compliance.

Developing a quality system is not a sprint, but a journey, and because processes are continuously being
improved, it is a journey without an end. ISO 9000 does not mandate the use of short-term motivational
techniques to foster employee enthusiasm for a supplier's quality system program. Attempting to motivate
employees by promising lower overhead or greater market share is not likely to be successful. Instead, it
is recommended that employees be educated on how ISO 9000 standards will help them perform their
jobs better and faster.

ISO 9000 emphasizes that for any quality system to be successful, top management commitment and
active involvement are essential. Management is responsible for defining and communicating the
corporate quality policy. It must define the roles and responsibilities of individuals responsible for quality
and ensure that employees have the proper background for their jobs and are adequately trained.
Management must periodically review the effectiveness of
the quality system. It should not back the effort to comply with ISO 9000 during its inception and then
back down when the scope and cost of the effort is fully realized. When employees sense that
management commitment has diminished, their own commitment slackens. Employees typically want out
of a costly project not backed by management.

ISO 9000 does require that an organization have documented and implemented quality procedures that
ensure personnel understand the quality system, that management maintain control of the system, and that
internal and external audits be performed to verify the system's performance. Because ISO 9000 affects
the entire organization, all employees should be given at least basic instruction in the ISO 9000 process
and its specific implementation at their facility. Training should emphasize goals, benefits, and the
specific responsibilities and feedback
required of each employee. ISO 9000 uses customer satisfaction as its benchmark. But the "customers" of
ISO 9000–compliant processes include not only the obvious end-users of the product, but also an
organization's product designers, manufacturers, inspectors, deliverers, and sales force.

Improving the processes that produce a quality product can provide an additional benefit: When the
processes are well defined and constant and when employees are well trained to perform these processes,
employee safety typically improves significantly. Also, during the course of improving its processes, a
company often finds after close inspection that many of its processes and procedures are ineffectual and
can be eliminated. Thus, while ISO 9000 requires preparation and maintenance of a formidable set of
documents and records, the total paperwork of a company implementing ISO 9000 may decrease
significantly in the long run. Other benefits of ISO 9000 compliance are a decrease in product defects and
customer complaints and increased manufacturing yields. A final but very important by-product of
implementing ISO 9000 is a heightened sense of mission at a company and an increased level of
cooperation between
departments.

ISO 9000 is not product-quality oriented. It does not provide criteria for separating acceptable output
from defective output. Instead, it is a strategy for continuous improvement where employees meet and
exceed customer quality requirements and, in doing so, continuously improve the quality of the product.

ISO 9000 recognizes that when a customer is looking at a specific part of a product (e.g., car, stereo
system), he is often looking at an item (e.g., engine, stereo cabinet) provided by a subcontractor. Hence,
ISO 9000 requires that a company verify that its subcontractors are providing quality items. Today,
organizations with excellent quality systems often partner with their subcontractors. ISO 9000 provides
an excellent framework for such a relationship, with subcontractors providing the raw materials and
components of the final product.

The ISO 9000 family is a set of "quality system management" standards, the first in a set of evolving
management system standards. Standards for environmental management are in place; standards for
occupational safety, health management, and energy management will soon follow. These new standards
will affect the space and aircraft industries just as they affect other industries.

In summary, ISO 9000 compliance provides customers with the assurance that approved raw materials for
a product have been purchased and that the product has been manufactured according to the correct
specifications, assembled by trained employees, properly inspected and tested, adequately packaged for
preservation, and transported in a manner that prevents damage to it en route. Overall, ISO 9000
compliance helps generate quality awareness among a company's employees, an improved competitive
position for the company, an enhanced customer quality image, and increased market share and profits.

Components of the ISO 9000 Series

The ISO 9000 Series includes three standards:

ISO 9000:2000 Quality Management Systems—Fundamentals and Vocabulary

ISO 9001:2000 Quality Management Systems—Requirements
ISO 9004:2000 Quality Management Systems—Guidelines for Performance Improvement

ISO 9000 family

ISO 9000 includes the following standards:

ISO 9000:2005, Quality management systems - Fundamentals and vocabulary. Covers the basics
of what quality management systems are and also contains the core language of the ISO 9000 series of
standards.

ISO 9001:2000 Quality management systems - Requirements is intended for use in any organization
which designs, develops, manufactures, installs and/or services any product or provides any form of
service. It provides a number of requirements which an organization needs to fulfill if it is to achieve
customer satisfaction through consistent products and services which meet customer expectations. This is
the only implementation for which third-party auditors may grant certifications.

ISO 9004:2000 Quality management systems - Guidelines for performance improvements. covers
continual improvement. This gives you advice on what you could do to enhance a mature system. This
standard very specifically states that it is not intended as a guide to implementation.
ISO 9002:1994 and ISO 9003:1994 were discontinued in the ISO 9000:2000 family of standards.
Organizations that do not have design or manufacturing responsibilities (and were previously certified
using ISO 9002:1994) will now have to use ISO 9001:2000 for certification. These organizations are
allowed to exclude design and manufacturing requirements in ISO 9001:2000 based on the rules for
exception given in Clause 1.2, Permissible Exclusions.

ISO Facts
The International Organization for Standardization (ISO), founded in 1946, is a global federation of
national standards organizations that includes some 130 member nations:

ISO is based in Geneva, Switzerland.

ISO's mission is to develop standards that facilitate trade across international borders.
In 1979, the Technical Committee 176 (ISO/TC 176) was established to create international
standards for quality assurance.
Representatives from the United States and many other countries served on the committees
responsible for developing ISO 9000.
Early in the 1990s, the chair of the consortium was a U.S. citizen from American Telephone &
Telegraph (AT&T).
The U.S. standards organization within ISO is the American National Standards Institute
(ANSI).
The American Society for Quality (ASQ) has published a U.S. version of the ISO 9000
standards under the name Q9000.
ISO serves only as a disseminator of information on system quality.
ISO 9000 certificates are not issued on behalf of ISO.
ISO does not monitor the activities of ISO 9000 accreditation bodies.
Monitoring is done by accreditation boards within member nations.

Philosophy of ISO 9000

ISO 9000 places the responsibility for the establishment, performance, and maintenance of a quality
system directly with a company's top management:

ISO requires the top management to define a quality policy, provide adequate resources for its
implementation, and verify its performance.
Top management must demonstrate how its employees acquire and maintain awareness of its
quality policy.

The ISO 9000 process strives for generic applicability:

No specific methods, statistical processes, or techniques are mandated.
Emphasis is on the overall objective of meeting customer expectations regarding the output of
the system quality process.
ISO has said that it will never issue industry (product-specific) quality guidelines. ISO 9000
strives to achieve a quality system by employing the following practices for continuous
improvement:
Prevention rather than detection by inspection
Comprehensive review of critical process points
Ongoing communication between the facility, its suppliers, and its customers
Documentation of processes and quality outcomes
Management commitment at the highest levels ISO 9000 provides a clear definition of the
management style required to achieve a "world- class" quality system:
Formal organization that delineates responsibilities
Documented, authorized, and enforced procedures for all key activities
Full set of archived but periodically analyzed quality outcome records
 Set of periodic reviews to track system quality performance and plan and implement corrective
actions
Philosophy of regulating, but not eliminating, individual initiative in achieving system quality
ISO 9000 provides a facility with a formal management style leading to system quality. The measure of
success in implementing system quality is determined by well-organized, well-planned, and well-
executed periodic internal and external audits of the processes and quality outcomes of the facility. The
majority of ISO member nations will not mandate the adoption of the ISO 9000 standards in the
foreseeable future. To date, only Australia mandates
adoption of the standards. How well the ISO standards facilitate trade in the international marketplace
will determine how widespread their use becomes.

Advantages
According to the Providence Business News , implementing ISO often gives the following advantages:

1. Create a more efficient, effective operation

2. Increase customer satisfaction and retention
3. Reduce audits
4. Enhance marketing
5. Improve employee motivation, awareness, and morale
6. Promote international trade

Problems
A common criticism of ISO 9000 is

the amount of money

time
paperwork required for registration

According to Barnes, "Opponents claim that it is only for documentation. Proponents believe that if a
company has documented its quality systems, then most of the paperwork has already been completed."

The ISO 9004:2000 standard

ISO 9004:2000 goes beyond ISO 9001:2000 in that it provides guidance on how you can continually
improve your business' quality management system so that it benefits not only your customers but also:
employees
owners
suppliers
society in general

By measuring these groups' satisfaction with your business, you'll be able to assess whether you're
continuing to improve.

Read about ISO 9004:2000 at the British Standards Institution (BSI) website.
The ISO 9000 series, which includes 9001 and 9004, is based around eight quality management principles
that the senior managers should use as a framework to improve the business:

Customer focus - they must understand and fulfil customer needs.

Leadership - they should demonstrate strong leadership skills to increase employee motivation.

Involvement of people - all levels of staff should be aware of the importance of providing what the
customer requires and their responsibilities within the business.

Process approach - identifying your essential business activities and considering each one as part of a
process.