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ISO 9001:2000

from The Quality 75, by John Bicheno. Available from PICSIE in Britain.

ISO 9001:2000 is the new international standard on quality assurance, applicable to manufacturing and service. The new standard was published in December 2000. The previous version had accumulated some 350k registrations in 150 countries by January 2000. The 2000 version represents a considerable advance on the previous 1994 version which set down 20 clauses that organisations seeking accreditation had to demonstrate. ISO 9001 can be used by an organisation to both demonstrate its ability and to asses its ability to meet customer requirements. ISO 9001 sets the quality system standards, not the product standards. Quality is defined as the “degree to which a set of inherent characteristics fulfils requirements.”

The 2000 version is based on eight Quality Management Principles that are an excellent guide to modern thinking on quality. The principles are:

Customer Focused Organisation. It is customers, not the organisation that defines quality, so look outward rather than inward. Survival ultimately depends upon understanding customer needs.

Leadership - is necessary to drive the organisation to meet customer needs and to improve.

Involvement of People. It is the people in the organisation that makes for high quality products and services.

Process Approach. It is linked (horizontal) processes, transforming inputs into outputs, which produce the requirements of customers. It is not functional departments or (vertical) ‘silos’. (This is perhaps the most fundamental change to the previous standard which emphasised the responsibilities of functions). The continuous improvement process involves establishing objectives (a management responsibility), resource management, realising the product or service, and measurement and analysis.

Systems Approach: The organisation is a system: it has inputs, outputs, information flows, goals, controls, and interactions. Processes come together to form purposeful systems.

Continual Improvement - is necessary for sur­vival. Everyone needs to participate. (This links with Kaizen.)

Fact-based Approach. As Deming said, ‘In God we trust; all others must bring data.” (This links with “Gemba.”)

Supplier Relationships. A well known and valid saying is that "companies don’t compete, supply chain compete." Ultimately quality depends upon the company and its suppliers.

The new standard has core sections which are broadly similar to the Deming PDCA cycle. Management must plan the system in relation to customers, the resources must be provided, the activities carried out, and then measured, analysed and improved. The standard provides fairly specific guidelines and advice on each. In the overview below, some important points are highlighted. For people not involved in quality certification, it is instructive to read through the following section to gain an impression of an integrated view of quality.

General requirements. 
Like the previous version, the phrase “say what you do and do what you say” still applies. You make up the rules for your own organisation following the guidelines. Then you are expected to follow them and be audited upon them. The organisation must identify the necessary processes, determine criteria, ensure the availability of resources, monitor and measure, and implement to achieve results and continual improvement. (In short, PDCA.)

Management responsibility. 
Management must establish the quality policy, the policy must be communicated, and management must demonstrate and give evidence of its commitment. Senior management must ensure that customer needs and expectations are determined, and ensure that the organisation is able to fulfil the requirements. Processes must be identified. A quality management system must be established, documented, maintained, and improved. A management representative must promote an awareness of customer requirements. And a review process must take place to ensure that the quality system remains effective.

Resource management. 
This covers human resources, facilities, and the work environment. Management must determine and provide the necessary resources and facilities to implement the system and to address customer satisfaction. Records must be kept of experience, training, and qualifications. Training must be evaluated.

Product (or service) realisation. 
This is a mini PDCA cycle within the broader quality system. The emphasis is on process. The steps of the process must be determined, say by flowcharts. Customer requirements must be clearly understood and orders not accepted until there is the ability to meet the requirements. Communication with the customer must take place. The process must be designed, reviewed, verified, and measured, all in relation to the customer. ISO requires a system for suppliers to be identified, selected, communicated with, and evaluated. Then the entire process needs to be controlled by having acceptance criteria, work standards, capable processes, and procedures for release, delivery and service. ISO also gives guidelines on traceability, customer property, preservation of product, process validation (for example SPC), and the control of measuring devices

Design and development. 
These requirements ensure that the process of design is planned and controlled. The organisation is expected to design the stages, review and validate, and clarify responsibilities.

Purchasing and production and service provision. 
Purchased products must conform to requirements and suppliers must be chosen and evaluated in relation to criteria that must be established. Production must be carried out under controlled conditions, including work standards, equipment, and monitoring and measurement. In short using standard operations and capable equipment.

Measurement, analysis, improvement. 
Finally the system needs to be measured, monitored and controlled, and improved. Non-conformities need to be controlled. The pew standard is more specific on improvement and on customer satisfaction which needs to be included in any performance measurement system. Processes and products need to be monitored. Importantly feedback needs to be given to Management Review, thereby closing the loop.

ISO 9001 includes reduced requirements for docu­mentation in comparison with the old standard. The organisation has greater freedom to specify its own documentation, but must nevertheless have documentation for the effective planning, operation and control of its processes. Six types of documentation are specifically required, for:

- control of documents,
- control of nonconforming products,
- corrective actions,
- preventive actions,
- control of records,
- internal quality audits.

Criticisms of the old standard cited its cost to imple­ment, excessive “red tape”, its unsuitability for particular kinds of industry (witness the emergence of the auto industry standard QS9000), and the possibility of management attention being diverted from real quality issues. On the positive side certification gives credibility, a reduction in the necessity for supplier audits, and may bring order to an undisci­plined company. Hopefully the problems have been reduced, whilst benefits remain.

Further reading and notes

ISO 9001:2000 Quality Management Systems: Requirements. This is the standard for demonstrating conformity of a quality management system.

ISO 9004:2000. Guidelines for performance improvement. This is not for certification purposes but provides guidelines for both meeting customer re­quirements and improving performance.

ISO 9000:2000. This discusses the fundamental concepts and sets out definitions.

Charles Cianfrani, Joseph Tsiakals, John West. ISO 9001:2000 Explained. (Second edition), ASQ Quality Press, Milwaukee, 2001. This book contains the entire standard.

ISO website: www.iso.org 

British Standards Institution website: www.bsi-global.com

The Quality Certification Bureau at www.qcbinc.com provides several comprehensive implementation and assessment guides on the standard which can be downloaded.