This paper I have written contains a lot of information about ISO 9000 and Quality Management Systems. I will first talk about some of the history and origins of the ISO phenomenon. I will also mention some of the changes and elements of the Quality Management Systems, financial issues, pros and cons of being certified, and the relationship ISO 9000 has with ISO 14000.
The International Organization for Standardization was founded shortly after the end of World War II to bring commonality and uniformity to products as well as to a number of critical quality areas. Development of the ISO 9000 series was a natural step for the International Organization for Standardization. According to Donald Sanders (1997, p.6), “As its other standards brought uniformity to products throughout Europe and the world, so the ISO 9000 series was designed to bring uniformity to the area of quality systems” Quality standards grew as quality became more important to consumers and as each country often instituted its own quality standards. This large number of standards posed a hardship for many companies as they tried to keep track of the wide range of requirements and regulations. Multinational firms found it particularly difficult because they often had to juggle a number of often-conflicting regulations or face the fact that they might not be able to sell products designed for one country in another nation because they did not meet that country’s unique standards. It was also becoming obvious that quality products and services demanded company wide commitment instead of just the efforts of the quality department.
The ISO 9000 series standards that we know today were developed by committees of quality experts selected from member bodies around the world. These members began meeting in 1979 as Technical Committee 176. The ISO member body in the US is the American National Standards Institute (ANSI), which has worked through the American Society for Quality Control to contribute to the development and ongoing improvement of the standards. The letters ISO in ISO 9000 is taken from the Greek isos, meaning “equal”. “ISO” was chosen in an intentional effort to inform users that the standards apply to all users equally, regardless of a company’s size, products, services, or the country in which it is located. The term ISO 9000 refers to a dynamic and comprehensive set of standards for a companywide quality system that is “built in,” not “inspected in.” These ISO standards are revised and reissued roughly about every six years (Sanders 1997). The first set of standards was published in 1987, and the first revision appeared in 1994. And now the latest updated version in 2000. These new standards are referred to as the “ISO 9000 2000 Standards”. ISO 9000 currently includes three quality standards: ISO 9000:2000 (fundamentals and vocabulary), ISO 9001:2000 (requirements), and ISO 9004:2000 (guidelines).
When you compare ISO 9001:1994 and ISO 9001:2000 you’ll notice a lot of different changes that have been undergone. ISO has abandoned the 20-clause structure of the old standard. Instead of 20 sections, the new standard now has 5 sections. ISO reorganized the ISO 9001 standard in order to create a more logical structure, and in order to make it more compatible with the ISO 14001 environmental management standard. ISO 9001:2000 is more customer-oriented than the old standard. While the old standard was also oriented towards meeting customer requirements and achieving customer satisfaction, the new standard addresses this in much greater detail. In addition, it expects you to communicate with customers and to measure and monitor customer satisfaction. In the past, organizations that wished to be certified were referred to as “suppliers” because they supplied products and services to customers. Since many people were confused by this usage, ISO standards focus on the “organization,” not the “supplier.” The term “supplier” now refers to the organization’s supplier. The new redefined term “supplier” replaces the old term “subcontractor”. Also, under the new standards, you may ignore or exclude some requirements. Requirements that may be ignored under special circumstances are known as exclusions. According to ISO, you may ignore or exclude any of the requirements found in Section 7 Product realization as long as you meet certain conditions.
The main clauses that make up the QMS are continual improvement; management responsibility; resource management; product/service realization; and measurement, analysis, and improvement.
General requirements for having a QMS is that the organization shall establish, document, implement, and maintain a QMS and continually improve its effectiveness. The organization shall (a) identify needed processes such as management activities, provision of resources, product or service realization, and measurement, (b) determine their sequence and interaction, (c) determine criteria and methods for effective operation and control of these processes, (d) ensure the availability of resources and information necessary to support and monitor these processes, (e) monitor, measure, and analyze these processes, and (f) implement actions to achieve planned results and continual improvement of these processes.
Top management shall provide evidence of its commitment to the development, implementation, and continual improvement of the QMS by (a) communicating the need to meet customer, legal, and regulatory expectations, (b) establishing a quality policy, (c) ensuring that quality objectives are established, (d) conducting management reviews, and (e) ensuring the availability of resources.
The organization shall determine and provide the resources needed (a) to enhance customer satisfaction. Resources may be people, infrastructure, work environment, information, suppliers, natural resources, and financial resources. Resources can be aligned with quality objectives.
The organization should also plan and develop the processes needed for product or service realization. Planning of product or service realization shall be consistent with the requirements of the other processes of QMS. In planning product or service realization, the organization shall determine the following, as appropriate: (a) quality objectives and requirements for the product or service; (b) the need to establish processes, documents, and provide resources specific to product or service; (c) required verification, validation, monitoring, inspection, and test activities specific to the product or service and the criteria for its acceptance; and (d) records needed to verify this clause.
The organization shall plan and implement the monitoring, measurement, analysis, and improvement processes needed (a) to demonstrate conformity of the product for service, (b) to ensure conformity of the QMS, and (c) to continually improve the effectiveness of the QMS. This process shall include determination of applicable methods, including statistical techniques. (Besterfield, 2004)
The primary value of having ISO 9000 certification is being able to consistently deliver a product or service to a defined standard and improved bottom line performance. ISO registration also has a significant bearing on market credibility as well. Your certification opens the door to untapped domestic and international business opportunities. An ISO 9000 certified quality system helps to establish common language and expectation levels between businesses. Also, since an ISO certified quality system promotes continuous improvement in your products and processes, many clients see fewer errors, returns and customer complaints. Your ISO 9000 investment can pay dividends in the form of lower costs per transaction. (ISO 2004) It is important to recognize that while the cost of achieving certification may appear to be high, it will only represent a small part of the overall costs of quality as measured in terms of prevention, appraisal and failure costs. The cost of achieving certification has to be seen as a prevention cost, an investment towards the establishment and future maintenance of an effective quality management system (Business Link, 2003)
A disadvantage that some companies might see in being certified is that it is too costly. The return on investment in an ISO 9000 Quality System roughly happens in about 2 years while equipment investment has a typical return on investment of 3 – 10 years. Another disadvantage is that it is very time consuming to document and maintain. The ISO 9000 certification process can take months or years, depending on a manufacturer’s original state of compliance and the commitment of the people involved. Also, it requires employee buy-in, which is unfavorable for some employees.
ISO 9000 is concerned with quality management and meeting customer quality requirements, achieving control of processes, and encouraging continuous improvement while ISO 14000 is concerned with environmental management. Both standards outline a solid, traditional management approach. The ISO 14001 standard uses the same fundamental systems as ISO 9000 such as document control, management system auditing, operational controls, recordkeeping controls, management policies, audits, training, and corrective and preventive actions. ISO 9000 and ISO 14000 require senior management support and commitment for success, and require organizations to have a system for establishing and reviewing objectives and targets, whether they are quality or environmentally related. Both require organizations to provide on-going management review of the management system and its objectives (Lamprecht, 1996).
Because of the close relationship between ISO 9000 and ISO 14000, ISO commissioned a year-long study to investigate the compatibility between the two standards. Technical advisory group 12 (TAG 12) was established to investigate how a better interface can be achieved for users who wish to implement both standards. TAG 12 recommended the following actions to enhance standards compatibility: 1) Relevant terms and definitions should be identical, and there should be consistent use of terminology in both families of standards. 2) Management system standards in the two families should be compatible and, as far as possible, aligned. 3) Auditing standards in the two families should be integrated to consist of a common core document with separate modules on quality and the environment.
In conclusion, ISO 9000’s quality management standards are rapidly becoming the most important quality standard. Thousands of companies in over a hundred countries are using it because it controls quality, saves money, customers expect it, and competitors use it. “If you want to have a quality attitude you must have a quality system” (ISO, introduction section, page 6, 2004).” ISO 9000 recognizes this and realizes its importance.
Besterfield, D (2004) Quality Control. Upper Saddle River, NJ. Pearson Ed. Inc.
International Org. for Standardization. (2004, October 6). ISO 9000. Retrieved March 8, 2005, http://www.iso.org
Lamprecht, J (1996) ISO 9000. Implementaion for business. Milwalkee, WI: ASQL Quality Press
Praxiom Reasearch Group (2005, March 7). ISO Standards. Retrieved March 7, 2005, http://praxio.com
Sanders, D (1997) Passing your ISO 9000 audit. Boca Baton, FL: St. Lucie Press.
The Business Link (2003, March 11). What is ISO 9000? Retrieved March 7, 2005, http://www.cbsc.org