ISO 9000
- a set of procedures that cover all key processes in the business;
- monitoring manufacturing processes to ensure they are producing quality product;
- keeping proper records;
- checking outgoing product for defects, with appropriate corrective action where necessary; and
- regularly reviewing individual processes and the quality system itself for effectiveness.
A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered." Certification to an ISO 9000 standard does not guarantee the compliance (and therefore the quality) of end products and services; rather, it certifies that consistent business processes are being applied.
Although the standards originated in manufacturing, they are now employed across a wide range of other types of organizations, including colleges and universities. A "product", in ISO vocabulary, can mean a physical object, or services, or software. In fact, according to ISO in 2004, "service sectors now account by far for the highest number of ISO 9001:2000 certificates - about 31% of the total"
ISO 9000 family
ISO 9000 includes the following standards:
- ISO 9000:2000, Quality management systems - Fundamentals and vocabulary. covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards.
- ISO 9001:2000 Quality management systems - Requirements is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides any form of service. It provides a number of requirements which an organization needs to fulfill if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. This is the only implementation for which third-party auditors may grant certifications.
- ISO 9004:2000 Quality management systems - Guidelines for performance improvements. covers continual improvement. This gives you advice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation.
There are many more standards in the ISO 9001 family (see "List of ISO 9000 standards" from ISO), many of them not even carrying "ISO 900x" numbers. For example, some standards in the 10,000 range are considered part of the 9000 family: ISO 10007:1995 discusses Configuration management, which for most organizations is just one element of a complete management system. ISO notes: "The emphasis on certification tends to overshadow the fact that there is an entire family of ISO 9000 standards ... Organizations stand to obtain the greatest value when the standards in the new core series are used in an integrated manner, both with each other and with the other standards making up the ISO 9000 family as a whole".
Note that the previous members of the ISO 9000 family, 9001, 9002 and 9003, have all been integrated into 9001. In most cases, an organization claiming to be "ISO 9000 registered" is referring to ISO 9001.
Contents of ISO 9001
ISO 9001:2000 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national quality organization in each country. Outline contents are as follows:
- Page iv: Foreword
- Pages v to vii: Introduction
- Pages 1 to 14:
Requirements
- Section 4: General Requirements
- Section 5: Management Responsibility
- Section 6: Resource Management
- Section 7: Product Realization
- Section 8: Measurement, analysis and improvement
- Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
- Page 23: Bibliography
The standard specifies six compulsory documents:
- Control of Documents (4.2.3)
- Control of Records (4.2.4)
- Internal Audits (8.2.2)
- Control of Nonconforming Product / Service (8.3)
- Corrective Action (8.5.2)
- Preventive Action (8.5.3)
In addition to these, ISO 9001:2000 requires a Quality Policy and Quality Manual (which may or may not include the above documents).
Summary of ISO 9001:2000 in informal language
- The quality manual is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality manual is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards.
- Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.
- You need a documented procedure to control quality documents in your company. Everyone must have access to up-to-date documents and be aware of how to use them.
- To maintain the quality system and produce conforming product, you need to provide suitable infrastructure, resources, information, equipment, measuring and monitoring devices, and environmental conditions.
- You need to map out all key processes in your company; control them by monitoring, measurement and analysis; and ensure that product quality objectives are met. If you can’t monitor a process by measurement, then make sure the process is well enough defined that you can make adjustments if the product does not meet user needs.
- For each product your company makes, you need to establish quality objectives; plan processes; and document and measure results to use as a tool for improvement. For each process, determine what kind of procedural documentation is required. (Note: a “product” is hardware, software, services, processed materials, or a combination of these.)
- You need to determine key points where each process requires monitoring and measurement, and ensure that all monitoring and measuring devices are properly maintained and calibrated.
- You need to have clear requirements for purchased product. Select suppliers appropriately and check that incoming product meets requirements.
- You need to determine the skills required for each job in your company, suitably train employees and evaluate the effectiveness of the training.
- You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.
- When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs.
- You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness. (Note: you need a documented procedure for internal audits.)
- You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem and keep records to use as a tool to improve the system.
History of ISO 9000
Pre ISO 9000
During WWII, there were quality problems in many British high-tech industries such as munitions, where bombs were going off in factories. The adopted solution was to require factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The name of the standard was BS 5750, and it was known as a management standard because it did not specify what to manufacture, but how to manage the manufacturing process. According to Seddon, "In 1987, the British Government persuaded the International Standards Organisation to adopt BS 5750 as an international standard. BS 5750 became ISO 9000."
1987 version
ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization:
- ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
- ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
- ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
ISO 9000:1987 was also influenced by existing US and other Defence Military Standards ("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management — which was likely the actual intent.
1994 version
ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system.
2000 version
ISO 9000:2000 combines the three standards 9001, 9002, and 9003 into one, now called 9001. Design and development procedures are required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and centre. ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product.) The 2000 version also demands involvement by upper executives, in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal is to improve effectiveness via process performance metrics — numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.
