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ISO 9000 The International Organization for Standardization (ISO) is a worldwide federation of 111 national standards bodies. The organization's primary objective is to promote the development of manufacturing, trade and communication among business organizations worldwide through the development of generic standards. The most widely recognized of these international standards is the ISO 9000 series, released in 1987 which describe a basic quality management system that can be used by any industry, of any size, anywhere in the world. Organizations can register to either the ISO 9001, ISO 9002 or ISO 9003 standards, depending on their scope of business. Registration provides objective proof that an organization has implemented an effective quality system, and that it is satisfying all requirements of the applicable standard. An external and impartial expert called a registrar conducts an on-site audit to determine if an organization's quality management system conforms to the standard. A to Z Complete Implementation Program for ISO 9000
ISO 14000, released in 1996, is a global series of Environmental Management System (EMS) standards, providing a framework for organizations to demonstrate their commitment to environmental responsibility. Like the ISO 9000 quality standard series, ISO 14000 is a product of the International Organization for Standardization (ISO). This series of international environmental standards is expected to transcend the vast popularity of ISO 9000. Experts say market forces will drive acceptance of these environmental standards, with many companies requiring their suppliers to register to ISO 140010. ISO 14000 is expected to become a prerequisite for doing business worldwide. Officials from the U.S. Environmental Protection Agency (EPA) and Occupational Safety and Health Administration (OSHA) have indicated that certification may lead to a reduction in the amount of inspections required for permitting. A to Z Complete Implementation Program for ISO 14000
QS-9000 In 1994, Chrysler, Ford and General Motors unveiled QS-9000. This quality system model for automotive suppliers places great emphasis on customer satisfaction and promises to lay the foundation for exceptional products. Under the guidelines of QS-9000 and TE Supplement, suppliers must adapt their quality systems to meet the expectations of the automakers. The majority of this standard is based on ISO 9000, the international standard for quality, and its essential elements for an effective quality system. In addition, auto suppliers must conform to automotive sector-specific and customer-specific requirements in the QS-9000 quality system model. If you are a Big Three supplier, you must conform to QS-9000. Both GM and Chrysler have mandated registration to the standard for their supplier base. A to Z Complete Implementation Program for QS-9000
TE SUPPLEMENT The TE (Tooling and Equipment) Supplement to QS-9000, released in 1996, sets forth quality system requirements for Big Three tooling and equipment suppliers. Developed by the Chrysler/Ford/General Motors Supplier Requirements Task Force, it fully embraces ISO 9000, includes many of the QS-9000 sector-specific requirements, and contains sector- and customer-specific requirements for manufacturers of tools, dies, molds, plating, robotics and assembly, along with some coolants and lubricants. Big Three tooling and equipment suppliers must conform to the TE Supplement. Chrysler has mandated that its tooling and equipment suppliers register to this standard. A to Z Complete Implementation Program for TE Supplement
VDA 6.1, released in 1991, is the quality system standard of the German automobile industry. It was developed by the Verbrand der Automobilindustrie e.V. (VDA), with input from major manufacturers and suppliers. The majority of VDA 6.1 is based on the ISO 9000 quality management systems standards, but is organized into a distinct set of elements in two areas: Management, and Product and Process. These elements incorporate portions of the ISO 9001 quality system model and the ISO 9004-1 quality system guidelines, along with automotive sector-specific requirements. VDA 6.1 has also incorporated requirements from QS-9000 and the French EAQF automotive quality standard. In addition, suppliers with design responsibility must comply with German Road Traffic Law. This standard affects companies that manufacture or supply components and other products to such German automotive manufacturers as Volkswagen, Audi, Mercedes-Benz, BMW, Porsche, Adam Opel and Ford-Were. The Volkswagen Group, consisting of Volkswagen, Audi, Seat and Skoda, requires all of its production and service parts suppliers to register to VDA 6.1. A to Z Complete Implementation Program for VDA
6.1
AS9000 AS9000, Aerospace Basic Quality System Standard, released in 1997, is a quality system model for the aerospace industry which is derived from ISO 9000. Developed by 11 prime US aerospace contractors, the Aerospace Industries Association (AIA) and the American Society for Quality (ASQ), AS9000 contains ISO 9001 in its entirety, along with 27 clarifications or qualifiers and eight notes to the 20 ISO 9001 elements. AS9000 is designed to reduce defects in the supplier chain, continuously improve quality and boost customer satisfaction. Prime contractors involved in its development were McDonnell-Douglas Corp., The Boeing Co., Lockheed-Martin, Northrop-Grumman, Allison Engine Company, AlliedSignal Aerospace, Pratt & Whitney Aircraft, General Electric Aircraft Engines (GEAE), Rockwell-Collins, Sikorsky Aircraft and Sundstrand. Currently there is no AS9000 registration, only qualification. An aerospace supplier seeking AS9000 qualification should also pursue ISO 9000 registration. Both GEAE and AlliedSignal require their suppliers to become AS9000 qualified or ISO 9000 Seminar Seminar registered
CE Marking is required to sell any product manufactured or distributed under European Union (EU) New-Approach Directives in the European Economic Area (EEA). The EEA consists of the 15-nation EU and the four-nation European Free Trade Association (EFTA). The New-Approach Directives, designed to eliminate technical barriers to trade in Europe, set product safety technical requirements. The most important of these apply to medical devices. Other directives include low voltage, simple pressure vessels, toys, construction products, electromagnetic compatibility, machinery, personal protection equipment, telecom terminal equipment, boilers, explosives and recreational craft. CE Marking is affixed to products after they are successfully tested for conformity to applicable directives.
CURRENT GOOD MANUFACTURING PRACTICES (CGMP) U.S. Food and Drug Administration (FDA) Current Good Manufacturing Practices (CGMP) are designed to make medical devices safe and effective. CGMP covers quality assurance programs and organization, buildings, equipment, components, production and process controls, packaging and label control, distribution and installation, device evaluation and records. Medical device manufacturers must follow CGMP and establish a quality assurance Seminar program in order to distribute products in the U.S.
OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEMS (OHSMS) Occupational Health and Safety Management Systems (OHSMS), designed to create a safer workplace, is an area where standards development is just beginning. Currently, there is no international standard, with the International Organization for Standardization (ISO) deciding against developing one in 1996. OHSMS standards development is occurring at the national level, however. The British Standards Institution (BSI), which previously developed precursors to ISO 9000 and ISO 14000, has released BS 8800. Other proposals are being developed by the US Occupational Safety and Health Administration (OSHA), the American Industrial Hygiene Association (AIHA), and standards bodies in Australia and New Zealand. Debate over developing an international OHSMS standard continues, and ISO may revisit the matter in the future.
HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP) Hazard Analysis and Critical Control Points (HACCP), enforced by such agencies as the US Department of Agriculture's Food and Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA), is a scientific process control system for eliminating contaminants at critical areas in the food production and distribution process. HACCP helps to prevent, as close to 100 percent as possible, harmful contamination in the food supply. To ensure safer food, the HACCP system is designed to conduct biological, chemical and physical hazard analysis; identify preventive measures and critical control points; establish critical limits; monitor critical control points; establish corrective action when deviations occur; and establish a record-keeping system and verification procedure. HACCP requirements, endorsed by the United Nations Codex Alimentarius, European Union, Canada, Australia, New Zealand and Japan, apply to meat, seafood and poultry plants; grocery stores; restaurants; and other food processing and handling facilities.
ISO/IEC Guide 25, General Requirements for the Competence of Calibration and Testing Laboratories, most recently revised in 1990, is used to develop and implement laboratory quality systems. Both in-house and stand-alone laboratories meeting Guide 25 requirements comply, for calibration and testing activities, with the relevant ISO 9000 requirements. Guide 25 covers such matters as the scope of calibrations and/or tests; equipment and reference measurement standards; calibration, verification and maintenance of equipment; internal audits and corrective action; checks; training and qualification of personnel; laboratory accommodation and environment; equipment and reference materials; measurement traceability and calibration; calibration and test methods; handling of calibration and test items; records, certificates and reports; sub-contracting; outside services and supplies; and complaints. Countries other than the United States have designated an accredited national laboratory to certify laboratories to Guide 25. Because there is no formal registration process in the U.S., laboratories comply to Guide 25. For in-house laboratories, this compliance can be part of ISO 9000 or QS-9000 registration.
BS 7799, Information Security Management, released by the British Standards Institution (BSI) in 1995, and revised in 1998 and 1999, provides a comprehensive set of controls comprising the best information security management system (ISMS) practices. BS 7799 applies to information systems used by organizations in industry and commerce, including information processing technology in the area of networks and communications. Organizations complying with BS 7799 should assess security risks, select controls and develop guidelines. This standard may be used for ISMS audits and as a basis for a registration scheme. It covers such areas as document control, security policy and organization, asset classification and control, physical and environmental security, communications and operations management, access control and compliance with legal requirements.
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