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A brief overview of ISO 9000 and
Quality Management
The ISO 9000 family of standards
addresses various aspects of Quality Management. The standards
provide guidance and tools for organisations of any size who want
to ensure that their products and services consistently meet
clients' requirements, and that quality of service or product is
consistently improved.
ISO 9000 was first
published in 1987. It was based on the BS 5750 series of
standards from British Standards Institute that were proposed to
ISO in 1979. However, its history can be traced back some twenty
years before that, to the publication of the United States
Department of Defence MIL-Q-9858 standard in 1959. MIL-Q-9858
was revised into the NATO AQAP series of standards in 1969,
which in turn were revised into the BS 5179 series of guidance
standards published in 1974, and finally revised into the BS
5750 series of requirements standards in 1979 before being
submitted to ISO.
Standards currently included in the ISO
9000 family include:
- ISO 9000:2015 - covers the basic
concepts and language
- ISO 9001:2015 - sets out the
requirements of a quality management system
- ISO 9004:2018 - focuses on how to
make a quality management system more efficient and
effective
- ISO 19011:2018 - sets out guidance
on internal and external audits of quality management
systems.
The ISO 9000 family is based on eight key areas of
focus (or Principles). These Principles should be used as a framework by
which an organisation measures and improves performance. Full detailed
definitions of these Principles can be found in ISO 9000:2015 (Quality
Management Systems – Fundamentals and vocabulary), and in ISO 9004:2018
(Managing for the sustained success of an organization – A Quality
Management approach).
These Principles can be briefly described as:
Customer focus
- Any organisation depends on its clients
and therefore should fully understand those clients' needs, both current
and future, should consistently meet their clients' requirements and
constantly strive to exceed their clients' expectations.
Leadership -
Leaders establish
unity of purpose and direction within an organisation. Leaders should
create and maintain an environment in which people can become fully
involved in achieving the organisation’s objectives.
Involvement of people -
People at all levels are the essence of
any organisation and ensuring their full involvement enables their
abilities to be used for the organisation’s benefit.
Process approach - Documented processes are
used to efficiently define and manage
all activities within an organisation in
order to achieve a consistent and desired result.
System approach to management -
Identifying, understanding and managing
interrelated processes as an integrated system helps an organisation
efficiently achieve its objectives.
Continual improvement
- Fostering a culture of continual
improvement within an organisation will increase overall performance,
provide a medium for innovation and help prevent "resistance to change".
Factual approach to decision making -
Effective decisions are based on the
analysis of data and information.
Mutually beneficial supplier relationships -
An organisation and its suppliers are
interdependent and a mutually beneficial relationship enhances the
ability of both to succeed.
ISO 9001:2015 - Quality
Management Systems
ISO 9001:2015 sets out the
criteria for implementing and maintaining a compliant Quality Management
System and is the only standard in the family that can be certified to
(although this is not a requirement). It can be used by any
organisation, large or small, regardless of its field of activity. In
fact ISO 9001:2015 is implemented by over one million organisations in
over 170 countries.
A Quality Management System (QMS),
working in conjunction with the Quality Policy, Manual and Objectives, is central to ISO 9001:2008.
The QMS is the managed repository for all documentation used by the
organisation. This includes (but is not limited to) the following document
types:
-
The Quality Policy, Manual
and Objectives for the organisation (can be combined into one
Quality Plan)
-
Master Document Index
-
Process Documentation
-
Local Work Instructions
-
Strategic Plans
-
Key Policies
-
Business Critical Forms and
Records
-
Organisation Charts
-
Disaster Recovery Plans
-
Risk Management and
Mitigation Plans
-
Change Management Plans
-
Test and Regression Plans
-
Training and Development
Plans
-
Training Records
-
Training Material
A properly implemented QMS is
therefore the de facto Document Library for the organisation,
however the QMS can only be correctly managed and maintained if the
Quality Plan is up to date, constantly reviewed and correctly
version controlled.
To this end, ISO 9001:2015
specifically requires the organisation to have "documented procedures" for
the following six activities:
- Control of documents
- Control of records
- Internal audit
- Control of nonconforming product
- Corrective action
- Preventive action
A compliant Quality Plan will
thus define the lifecycle of all documentation, including the review
intervals and triggers and the archiving strategy. It will also
standardise naming conventions and version control throughout the owning
organisation.
ISO 9004:2018 - Managing
for the sustained success of an organisation
ISO 9004:2018 provides guidance
to organisations to support the achievement of sustained success by a
quality management approach. It is applicable to any organisation,
regardless of size, type and activity.
ISO 9004:2018 is however not
intended for certification, and is not designed for contractual or
regulatory use
ISO
19011:2018 - Guidelines for auditing management systems
ISO 19011:2018
provides guidance on auditing management systems,
including the principles of auditing, managing an audit
programme and conducting management system audits, as
well as guidance on the evaluation of competence of
individuals involved in the audit process, including the
person managing the audit programme, auditors and audit
teams.
ISO 19011:2018
is applicable to all organisations that need to conduct
internal or external audits of management systems or
manage an audit programme.
Burdikin.com can advise and assist in all
aspects of Quality Management to ISO 9000 standard. We will also offer stand alone guidance
on implementing best practice in Document Management, Control and Storage for those
organisations unwilling or unable to seek full compliance with ISO
9001:2008. Return to top
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