ISO 9000 Family

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What is the ISO 9000 family?

The ISO 9000 family consists of a core of three International Standards plus many associate quality standards, technical reports and guides, two of which are included here as having very close ties with the family.

The family consists of:

ISO 9000: 2000 Quality management systems - Fundamentals and vocabulary
ISO 9001: 2000 Quality management system - Requirements
ISO 9004: 2000 Quality management system - Guidelines for performance improvement.

Associated with the above are:

ISO 10012 Quality assurance requirements for measuring equipment- Metrological confirmation system for measuring equipment; and
ISO 19011 Auditing quality and environmental management systems

The meaning of ISO

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from 130 countries. ISO is not only an acronym but also a word, derived from the Greek 'isos', meaning 'equal'. From 'equal' to 'standard', the line of thinking that led to the choice of ISO as the name of the organisation. ISO administers over 11,000 standards covering 97 categories (one of which covers management). The ISO 9000 family is in subcategory 03.120.

ISO 9001: 2000 - the requirements

This is the key standard of the family. The requirements for quality management systems are contained in ISO 9001. This 2000 year edition of the standard covers all three of the levels hitherto met by ISO 9001, ISO9002 and ISO 9003. The quality assurance standard lays down the requirements that a quality system should meet, but does not dictate how they should be achieved.

The original so called twenty elements in the standard have been replaced by five clauses. The clauses are:

1. Quality management system
2. Management responsibility
3. Resource management
4. Product realisation
5. Measurement analysis and improvement.

There are over 250 individual requirements in ISO 9001 that can be condensed into five key statements.

The organisation shall:

• Determine the needs and expectations of customers and other interested parties
• Establish policies, objectives and a work environment necessary to motivate the organisation to satisfy these needs
• Design, resource and manage a system of interconnected processes necessary to implement the policy and attain the objectives
• Measure and analyse the adequacy, efficiency and effectiveness of each process in fulfilling its purpose and objectives and
• Pursue the continual improvement of the system from an objective evaluation of its performance.

The requirements are applicable to any kind of organisation: profit, or non-profit, manufacturing, hardware or software, service, commercial or community (government)

ISO 9000: 2000 Fundamentals and vocabulary

Some of the terms used in the 9000 family of standards are common English words but have acquired a particular meaning in the context of quality management and therefore need to be defined. Because these standards are international it is also necessary to ensure that the terms used can be translated into other languages and in so doing retain their meaning.

ISO 9000 has two sections:

The fundamentals of quality management systems present a good general approach to the subject and provide, in plain language, a description of the 'system' approach, the 'process' approach and many of the features dealt with in the other standards, illustrating why the requirements are necessary. It also contains the quality management principles, which were derived from earlier editions and used as a basis for developing the requirements and guidance provided in the current family of standards. An appreciation of these principles is vital to the interpretation and implementation of the requirements and guidelines contained in ISO 9001 and ISO 9004.

The vocabulary defines the terms used in the 9000 family of standards in such a manner that they can be used in any language but retain common roots. There have been some changes in the way some terms are defined, notably:

Quality: degree to which a set of inherent characteristics fulfils requirements.
Requirement: need or expectation that is stated, generally implied or obligatory.
Customer satisfaction: customers' perception of the degree to which the customer's requirements have been fulfilled.

ISO 9004: 2000 Guidelines for performance improvement

This standard replaces ISO 9004: 1994 and was written to be consistent with ISO 9001 but is not a guide to implementing the requirements of ISO 9001. The addition of the requirement clauses from ISO 9001 placed in boxes followed by guidance dealing with the same subject gives the impression that the guidance is 'how to' meet the requirements whereas it is meant to show how to improve on the minimum requirements given in ISO 9001.

ISO 10012: 1992 Part 1: Metrological confirmation system for measuring equipment

This standard is an essential document for those organisations using measuring equipment to determine the acceptability of product. In order to ensure the quality of the product, product characteristics need to be measured using equipment that is of the intended accuracy. The standard contains requirements and guidance for ensuring all measuring equipment performs as intended and addresses calibration, measurement uncertainty, traceability of standards, documentation and other issues relating to measurement accuracy. ISO 9001: 1994 contained detail requirements on measuring equipment but this is replaced in the 2000 edition, as it did not apply to all organisations.

ISO 19011: 2001 Guidelines on auditing management systems

This standard is a revised and amended text of ISO 10011 Quality system auditing standard. It has been substantially amended to be used as a guide to auditing quality and environmental management systems to meet the demand by many organisations for reduced external auditing activity.

What the 9000 family is not

The ISO 9000 family is not a series of product standards - it contains no product requirements. The family is not a quality management system and does not describe a quality management system - it is a series of generic standards for quality management systems. The standards in the family are not a guarantee of product or service quality. Customer focused leadership produces satisfied customers not standards An ISO 9001 audit will demonstrate that an organisation has the minimum requirements for a quality management system that give assurance of its capability to meet specified and implied requirements that will satisfy the customer.

Implementation of the 1994 series resulted in many people claiming that the standards did not prevent organisations producing substandard product. The 2000 edition clearly requires organisations to satisfy their customers and undertake continual improvement of their quality management systems therefore compliance with ISO 9001: 2000 should result in significant benefits to organisations and their customers.

Is ISO 9001 of any use?

Impact on business results

Implementing these standards helps an organisation achieve better business results by ensuring that:

• top management direct the organisation to achieve customer and regulatory requirements in a manner that satisfies all interested parties
• the right capabilities and resources are in place to achieve the organisation's objectives
• it does not enter into commitments it is unable to meet
• processes are designed to achieve the organisation's objectives
• processes are implemented as designed and their performance continually evaluated
• deviations from requirements are promptly detected
• problems are promptly resolved and prevented from recurring
• nonconforming products or services are not supplied
• continual improvement in performance becomes a routine
• evidence of performance is available and used to make decisions
• customer needs and expectations are continually assessed to ensure high customer satisfaction.

Multiple assessments

Customers often carry out assessments of their suppliers to obtain confidence of the quality of supplies. Until ISO 9000 emerged, customers employed various standards to do this. Now that suppliers' quality systems are assessed regularly by independent bodies to a recognised international standard, there is less need for system audits to be carried out by customers. This saves time and cost.

Honouring commitments

An organisation survives because of its reputation for meeting customer needs and expectations. In regions of the world where an organisation is unknown, ISO 9000 is a passport which signals to others that it is committed to meeting customer requirements and therefore can be trusted to honour its commitments.

When should ISO 9001 be used?

To gain competitive advantage

Like all ISO standards, their use is voluntary, unless a specific business sector makes them a market requirement or a government issues regulations making their use obligatory. Not having ISO 9001 certification does not mean that an organisation will not be able to do business. However, if an organisation does not have ISO 9001 certification it may give its customer a reason to choose a competitor because of the assurance of quality that that competitor can provide.

To confirm we are taking the right approach

The original ISO 9001 was designed to be used when customers placed orders on suppliers for products and services through a contract. Therefore, the requirements of ISO 9001 used to reflect an order-driven organisation. However, the standards are being used increasingly for situations outside this field, e.g. law practices, schools, government departments and many service industries in which the customer does not seek a demonstration of capability but needs to ensure that the organisation has a systematic approach to the fulfilment of requirements that will create and retain satisfied customers.

ISO 9001 is not a panacea for turning around a troubled company. ISO 9001 is a model - a series of requirements which experience has shown would prevent failure. It is not a prescription of everything that an organisation must do and should be used as a framework to confirm that all the right things are being done to ensure customer satisfaction. There has to be good management, professionalism and genuine desire to satisfy customers for it to work.

How should the ISO 9000 family be used?

Put simply, a company should use: