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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 9000:2005 - covers the basic concepts and language
  • ISO 9001:2008 - sets out the requirements of a quality management system
  • ISO 9004:2009 - focuses on how to make a quality management system more efficient and effective
  • ISO 19011:2011 - 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 9000:2005 (Quality Management Systems – Fundamentals and vocabulary), and in ISO 9004:2009 (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 9001:2008 - Quality Management Systems

ISO 9001:2008 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 9001:2008 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 9001:2008 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 9004:2009 - Managing for the sustained success of an organisation

ISO 9004:2009 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 9004:2009 is however not intended for certification, and is not designed for contractual or regulatory use

ISO 19011:2011 - Guidelines for auditing management systems

ISO 19011:2011 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 19011:2011 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.

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