ISO 9001:2008 specifies requirements for a quality management system where an organization

needs to demonstrate its ability to consistently provide product that meets customer and applicable
statutory and regulatory requirements, and

aims to enhance customer satisfaction through the effective application of the system, including
processes for continual improvement of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.

All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations,
regardless of type, size and product provided.

Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization
and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these
exclusions are limited to requirements within Clause 7, and such exclusions do not affect the
organization's ability, or responsibility, to provide product that meets customer and applicable statutory
and regulatory requirements.

ISO 9000 essentials

This section concisely describes the essential features of the ISO 9000 family.
The ISO 9000 family of standards represents an international consensus on good quality management
practices. It consists of standards and guidelines relating to quality management systems and related
supporting standards.

ISO 9001:2008 is the standard that provides a set of standardized requirements for a quality
management system, regardless of what the user organization does, its size, or whether it is in the private,
or public sector. It is the only standard in the family against which organizations can be certified – although
certification is not a compulsory requirement of the standard.

The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance
improvements, documentation, training, and financial and economic aspects.

Why an organization should implement ISO 9001:2008

Without satisfied customers, an organization is in peril! To keep customers satisfied, the organization needs
to meet their requirements. The ISO 9001:2008 standard provides a tried and tested framework for taking
 a systematic approach to managing the organization's processes so that they consistently turn out product
that satisfies customers' expectations.

How the ISO 9001:2008 model works

The requirements for a quality system have been standardized - but many organizations like to think of
themselves as unique. So how does ISO 9001:2008 allow for the diversity of say, on the one hand, a "Mr.
and Mrs." enterprise, and on the other, to a multinational manufacturing company with service components,
or a public utility, or a government administration?

The answer is that ISO 9001:2008 lays down what requirements your quality system must meet, but does
not dictate how they should be met in any particular organization. This leaves great scope and flexibility for
implementation in different business sectors and business cultures, as well as in different national cultures.

Checking that it works

1. The standard requires the organization itself to audit its ISO 9001:2008-based quality system to verify
that it is managing its processes effectively - or, to put it another way, to check that it is fully in control of its
activities.
2. In addition, the organization may invite its clients to audit the quality system in order to give them
confidence that the organization is capable of delivering products or services that will meet their
requirements.
3. Lastly, the organization may engage the services of an independent quality system certification body to
obtain an ISO 9001:2008 certificate of conformity. This last option has proved extremely popular in the
market-place because of the perceived credibility of an independent assessment.

The organization may thus avoid multiple audits by its clients, or reduce the frequency or duration of
client audits. The certificate can also serve as a business reference between the organization and potential
clients, especially when supplier and client are new to each other, or far removed geographically, as in an
export context.

Quality management standards

What are quality management system standards and how can they benefit you?

Quality management system (QMS) standards establish a framework for how a business manages its key
processes. They can help whether your business offers products or services and regardless of your size or
industry. They can also help new businesses start off on the right foot by ensuring processes meet
recognised standards, clarifying business objectives and avoiding expensive mistakes.

To achieve a standard you'll first need to implement a QMS. Implementing a QMS can help your business to:

• achieve greater consistency in the activities involved in providing products or services

• reduce expensive mistakes
• increase efficiency by improving use of time and resources
• improve customer satisfaction
• market your business more effectively
• exploit new market sectors and territories
• manage growth more effectively by making it easier to integrate new employees
• constantly improve your products, processes and systems

For example, the quality system of a manufacturing business might include looking at more efficient
manufacturing processes or speeding up distribution.

The ISO 9000 series of standards is the main set of International Standards applying to the management
of quality systems. It includes ISO 9001, the key internationally agreed standard for a QMS. Businesses can
be certified against this standard when they meet its requirements.

Achieving ISO 9001 certification could lead to new business. Not only can it help distinguish you from
competitors, but many large businesses and public sector organisations require suppliers to be ISO 9001
certified. It's a globally recognised achievement, so may lead to a higher profile and increased business
overseas.

You can read about the ISO 9000 quality standards on the British Standards Institution (BSI)
website - Opens in a new window.

There are standards to help you achieve best practice in a wide range of business activities as well as quality
management. These include health and safety, environmental and information management standards. For
more information on how standards can improve different aspects of your business, see our guide on how to
make best use of standards.

Quality management standards

How to implement a quality system
There are five key steps involved in implementing a quality management
system (QMS):

1. Analyse your business by breaking it down into key areas. These will tend to be those that are
crucial to customer satisfaction. Senior staff should determine the needs of the business and
design the system around these.
2. Plan your approach by deciding which resources you need and discussing the effectiveness of
existing processes with staff.
3. Decide if new processes are necessary and tell staff about them - provide training if necessary.
 4. Check that the processes are working by appointing someone to be responsible for the system
and ensuring proper procedures are followed. Targets need to be set for how each process
contributes to the success of business goals.
5. Revise processes where necessary and continue to review them regularly.

It's essential that senior managers are committed to the implementation of a

QMS. Without this support it will be very hard to convince employees of the
benefits.
You are also required to create a quality manual containing documentation
on how processes should be followed. It should specify how the QMS will be
observed and emphasise the business' commitment to quality and
continuous improvement.
Having a QMS in place can help you to introduce and maintain wider
changes to your business. Unlike an ISO 9000 initiative, which will usually be
restricted to specified business processes, a Total Quality Management
System applies to the whole business. It addresses work culture, the
working environment and the ethics of the business. It aims to ensure
complete customer satisfaction.
You can obtain help with implementing a system from a Business Link
adviser or from a consultant registered with the Chartered Quality Institute
(CQI) - find a registered consultant on the CQI website - Opens in a new
window.
The CQI also offers training and education courses and has developed a
Small Business Standard aimed at businesses taking the first steps to a
quality management system