ISO 9000:2000 is a series of thee International Standards for Quality Management System.

They specify requirements and recommendations for the design and assessment of
management systems. ISO 9000 is not a product standard. None of the standards in the family
contain requirements with which a product or service can comply.

Purpose of ISO 9000

The purpose of these standards is to assist organizations of all types to implement and
operate effective quality management systems. These standards provide a vehicle for
consolidating and communicating concepts in the field of quality management that have been
approved by an international committee of representatives from national standard bodies.
The primary users of the standards are intended to be organizations acting as either
customers or suppliers.

ISO 9000 Family of Standards

There are three standards in the family:

ISO 9000 Quality management systems – Fundamentals and vocabulary

ISO 9001 Quality management systems – Requirements

ISO9004 Quality management systems – Guidelines for performance improvements

Purpose of Standards
Each standard fulfils a different purpose.

ISO 9000

Provide an appreciation of the fundamental principles of quality management systems and

an explanation of the terminology used in the family of standards.
ISO 9001
Provide requirements which if met will enable organizations to demonstrate they have the
capability to consistently provide product that meets customer and applicable regulatory
requirements. ISO 9001 states that the standard can be used to assess the organization’s
ability to meet customer, regulatory and the organization’s own requirements.

ISO 9004
Provide guidance for improving the efficiency, effectiveness and overall performance of an
organization.

Reasons for using these Standards

It is imperative that all three standards are studied for the following reasons:

ISO 9000 contains the definitions of terms used in the family of standards. Without an
understanding of the terms, the standards are prone to misinterpretation. ISO 9000 also
contains the general concepts and principles that apply to quality management and quality
management systems in particular.

ISO9001 contains requirements for a quality management system. This standard should be
used in contractual situations where the customer requires its suppliers to demonstrate they
have the capability to consistently produce products that meets customer requirements. If
suppliers can show they do all the things in ISO 9001, only conforming product would be
shipped to customers. This would in theory reduce the need for customers to verify product
on receipt. Third parties can also use the standard to assess the capability of organizations to
provide product that meets customer and regulatory requirements. Organizations can use
ISO 9001 as a model in designing their management systems providing they also use ISO9000
and ISO9004. ISO 9001 on its own does not define everything an organization needs to do to
satisfy its customers.
ISO 9004 contains guidance on developing and improving a quality management system. This
standard should be used as guidance in designing, operating and improving a management
system. It is not intended for contractual or assessment purposes but when used internally
there may be benefits in using the standard as a basis for assessing current capability.

Why was ISO 9000 created?

The standards were created to facilitate mutual understanding of quality management
system requirements in national and international trade. The associated certification
schemes that are not a requirement of any of the standards in the ISO 9000 family were
launched to reduce costs of customer sponsored audits performed to verify the capability of
their suppliers. The schemes were born out of a reticence of customers to trade with
organizations that had no credentials in the market place.

The standard was primarily intended for situations where customers and suppliers were in a
contractual relationship. It was not intended for use where there was no contractual
relationship. In non-contractual situations, there is usually no need to demonstrate potential
capability. Customers normally purchase on the basis of recommendation or prior knowledge.
Even in contractual situations, demonstration of capability is often only necessary when the
customer cannot verify the quality of the products or services after delivery. The customer
may not have any way of knowing that the product or service meets the agreed requirements
until it is put into service by which time it is costly in time, resource and reputation to make
corrections. In cases where the customer has the capability to verify conformity, the time and
effort required is an added burden and its elimination help reduce costs to the end user.

It is clear that customers need confidence in the quality of products supplied and would
require some evidence that addressed this need. ISO 9000 was a neat solution to this problem
as it embodied most of the requirements customers needed to obtain an assurance of quality.
Any additional requirements could be put into the contract. Standardization in this case
improved efficiency in getting orders out.
What does ISO 9000 apply to?
The ISO 9000 family of standards can be applied to all organizations regardless of type, size
and product provided. The 1994 versions were particularly focused on the manufacturing
sector, but this has largely been remedied in the 2000 version. They are standards that apply
to management of an organization and only the management can and should decide how it
will respond to these standards and recommendations.

History of ISO 9000

Formalised quality assurance originally came from the Defence Industry’s need for standards.
The idea of quality assurance spread beyond the military and in 1966, the UK government led
the first national campaign for quality and reliability with the slogan “Quality is everyone’s
business.” However, by this time, suppliers were being assessed by any number of their
customers and it was widely recognised that such duplication of effort was a chronic waste
of time and money. Progress was finally made in 1969, when a UK government committee
report on the subject recommended that suppliers’ methods should be assessed against a
generic standard of quality assurance.

In 1971, the British Standards Institute (BSI) published the first UK standard for quality
assurance (BS 9000), which was developed for the electronics industry. Then, in 1974 the BSI
published BS 5179 – Guidelines for Quality Assurance. This led to a shift in the burden of
inspection from the customer to the supplier, as quality assurance could be guaranteed by
the supplier to the customer through third-party inspection.

Through the 1970’s, the BSI organised meetings with industry to set a common standard,
which culminated in the BS 5750 standard in 1979. Key industry bodies agreed to drop their
own standards and use BS 5750 instead. The purpose of BS 5750 was to provide a common
contractual document, demonstrating that industrial production was controlled.
The ISO 9000 certification standard has evolved over several revisions. The initial 1987 version
had the same structure as the UK standard BS 5750, with three models for quality
management systems, the selection of which was based on the scope of activities of the
organisation. The language of this first version of the standard was influenced by existing US
and other Defence Military Standards, so it was more accessible to manufacturing and was
well suited to the demands of a rigorous, stable, factory-floor manufacturing process. With
its structure of twenty elements or requirements, the emphasis tended to be overly placed
on conformity with procedures rather than the overall process of management.

The 1994 version (ISO 9000:1994) was an attempt to break from the practices which had
somewhat clouded the use of the 1987 standard. It also emphasised quality assurance via
preventive actions and continued to require evidence of compliance with documented
procedures. Unfortunately, as with the first edition, companies tended to implement its
requirements by creating shelf-loads of procedure manuals and become burdened with ISO
bureaucracy. Adapting and improving processes could be particularly difficult in such
environment.

The 2000 version of the standard (ISO 9001:2000) sought to make a radical change in thinking.
It placed the concept of process management at the heart of the standard, making it clear
that the essential goals of the standard – which had always been about a documented system.
The goal was always to have management system effectiveness via process performance
measures. This third edition makes this more visible and so reduced the emphasis on having
documented procedures if clear evidence could be presented to show that the process was
working well. Expectations of continual process improvement and tracking customer
satisfaction were also made explicit in this version.

The fourth edition of the standard ISO 9001:2008 arrived on November 14th 2008. This
revision contains minor amendments. This aim of this revision is to clarify existing
requirements and to improve consistency of approach with other management standards.
During September 2015, a revised version ISO 9001:2015 was launched to bring the standard
up to date, reflecting latest quality management good practice. Whilst some requirements
have been tightened, the standard is now far less prescriptive and has even greater
integration with other ISO management standard.