ISO 9000 Standards, A Baseline for Excellence Companies, like Durace// and Foxboro, that move rapidly today and get registered will find they have asignificant edge. Asbj0rn Aune and Ashok Rao As the European Community (EC) lurches happened when mandatory standards related toward its January 1993 unification deadline, it to health, safety, and environmental issues are "Some customers let us skip is requiring each member country to adopt a not satisfied. These standards are in the process the audit because we are single national quality standard, ISO 9000, as of being written for a variety of products. Some ISO certified. We hope some­ a baseline for excellence. In 1987 the Euro­ of the products for which they have already day to have a list ofthose pean Committee for Standardization (ECS) been written are toys, some pressure vessels, adopted the ISO 9000 standards, renaming gas appliances, electro-medical deVices, and certified companies ­ them EN29000 standards. construction products. When toys not meeting Foxboro might be able to Atruly international organization, ISO these standards were admitted by British Cus­ skip their audit. We could (The International Organization for Standard­ toms, the Local Trading Standards Officers cut down on everybody's ization) is made up of representatives from the were able to ban distribution. work. " standards boards of 91 countries, including the American companies planning to do Dick Anderson, The Foxboro Company United States. business in the EC and those already involved The ECS objective? The patchwork of need to understand these standards and the each country's multiple technicai standards certification process. hindered the free flow of goods. Sometimes the Even companies not exporting to the EC intent was to protect the national industry will be affected by the ISO 9000 standards if from foreign competition. But requiring each they supply a company that does. AT&T uses country to consolidate its standards into one ISO 9000 as a tool to evaluate suppliers. The national standard would still cause companies reason stated in the AT&T Quality Manager's wishing to do business in the EC to negotiate Handbook: International customers reqUire 12 sets of standards. The ECS acknowledged a confonnance to this standard. need for a common standard for quality in order to facilitate the flow of goods between the Why PUlSue Registration? 12 member countries. There are several reasons for a company John Kirchenstein, a University of Ten­ to become ISO-registered: nessee quality consultant, points out this has • By the end of 1992 the EC will represent a 23 SeptemberlOClober 1992 ISO/TC 176 Architecture 8402 Terms and Definitions T ISO 9000 "Road Map" standards guidelines for selection and use. ~ ~ • ISO-9OO1 Quality systems model for quality assurance Contractual Non-Contractual in desiguldevelopment, production, installation, and ISO 9001/2/3 ISO 9004 servicing. Quality Assurance Quality Management • ISO-9OO2 Quality systems model for quality assurance Figure 1. in production and installation. unified market of 350 million people. Potential cus­ • ISO-9003 Inspection and test. tomers are likely to select suppliers from a registry of • ISO-9004 Quality Management and quality system ele­ companies whose quality level is acceptable for con­ ments guidelines. tractual requirements. Failure to obtain registration In addition there is: will result in losing business to companies that are • IS0-8402 Quality terminology and definitions. registered. The ISO 9000-series is intended to be used both in • European countries are lining up to register. Already contractual and non-contractual situations. Figure 1 more than 10,000 British companies have been regis­ provides an overview of the different elements. tered as meeting ISO 9000 requirements. ISO 9004 gives gUidance to all organizations for • Supplying customers doing business in the EC will be establishing a broad-based quality management pro­ easier. One of the requirements of ISO 9000 is to ensure gram. It can be viewed as a short textbook and is consid­ purchased product conforms to specifications. This is ered non-contractual. to be done through assessments of the supplier. ISO 9001/2/3 are intended for external quality assurance purposes in contractual situations between two • Government organizations, notably the Department of parties. They reflect the interests of the buyer. While these Defense (DoD) are considering replacing MIL-Q-9858A standards could be adopted as described, frequently they with ISO 9000 plus supplements. Over 50 countries will need to be tailored for specific contractual situations. have adopted ISO 9000 standards as national standards ISO-9OOO provides guidance on such tailoring. In and purchasers within those countries are requiring addition, some industries are developing their own sup­ registration. plements. For example, the Chemical Industry Associa­ • Once the certification process is completed, the regis­ tion provides guidelines for its industry. tering agency has to perlorm periodic evaluations. The Figure 2 shows the relationship between the four advantage is that the company will have far fewer elements 9001 through 9004. The table shows that man­ audits from individual customers and if there is an agement responsibility is covered in section four of ISO Acompany certified to ISO 900 I would meet the audit itwould be more focused. 9004. most stringent reqUirements. But to get ISO 9002 certifi­ • Although ISO-registration does not protect a manufac­ cation the requirements would be less demanding. And, turer from lawsuits, not being registered in any indus­ for ISO 9003 certification the requirements would be fur­ try where that practice has been adopted may prejudice ther relaxed. the case if a lawsuit is brought against a manufacturer. RegUlated Products Tho Status of ISO 9000 Before these standards can be universally respected, The standards were constructed as a generic basic a uniform set of certification bodies must be formed in set of requirements for any quality assurance system. each country. The Global Approach to Certification and They are intended to apply to any industry in any of the Testing (adopted in December 1989) established several 91 countries represented on the ISO, but they do not stan­ objectiVes for fostering confidence in the safety of prod­ dardize quality systems implemented by businesses. ucts and in manufacturers, testing laboratories, and cer­ Presently, the standards include: tification bodies. One of the main elements is a modular • ISO-90oo Quality management and quality assurance system of testing and certifying products to assess their 24 Target Comparing the ISO Standards Non­ Contract Topic Contractual ISO 9004 ISO 9001 ISO 9002 ISO 9003 Clause Cia... Cia... Cia••• conformity to a standard. The system of modules ranges 4 Management responsibility 4,1 4,1' 4.1** from a manufacturer's declaration of conformity, 5 Quality system principles 4.2 4,2 4.2' through the operation of (independently) approved qual­ 5,4 AUditing the quality system (internal) 4.17 4.16' ity systems, to independent testing and certification. 6 Economics - quality related costs For regulated products, the required method of 7 Quaiity in marketing (contract review) 4,3 4,3 8 Quality in spec. and design (design control) 4.4 demonstrating conformity is defined in the applicable 9 Quality in procurement (purchasing) 4,6 4.5 directive. Each member state must allow any products so 10 Quality in production (process control) 4,9 4.8 designated (usually by the "CE" mark) to be marketed as 11 Control of production 4.9 4,8 being in conformance with the requirements of the direc­ 11.2 Material control and traceability 4.8 4.7 4.4' tive. The same rules apply regardless of the product's ori­ 11.7 Controi of verification status 4.12 4,11 4.7" gin. (inspection and test) So, when French customs officials began to stop 12 Product verification (inspect and test) 4,10 4.9 4.5' 13 Control of measuring and test equipment 4,11 4.10 4.6' every shipment of toys for inspection and asked exporters 14 Nonconformity (control of nonconformity) 4.13 4.12 4.8' to provide translated documents, the EC Commission 15 Corrective action 4.14 4.13 took the side of the exporters. The Commission told the 16 Handling and post-production functions 4.15 4.14 4.9' French they were in violation of directives, if the French 16.2 After-sales servicing 4,19 had not complied, formal complaint procedures would 17 Quality documentation and records 4.5 4,4 4,3' have been initiated under Article 169 of the Treaty of 17.3 Qual ity records 4,16 4,15 4.10' Rome. 18 Personnel (training) 4,18 4.17' 4.11' 19 Product safety and liability In conformance with the principles of the GATT 20 Use of statistical methods 4.20 4,18 4,12' Agreement on Technical Barriers to Trade, non-EC prod­ Purchaser supplied product 4.7 4,6 ucts have the same access to the certification systems laid , Less demanding than ISO 9001 down in EC Directives as EC products. .. Less demanding Ihan ISO 9002 The Registration Process Figure 2. First the company will want to compare its existing quality system to the standards, which are available Several U.S. companies are now able to certify com­ through the American National Standards Institute and panies. Some companies, such as En Testing Laborato­ through the American Society for Quality Control ries, Intertek Services, and Underwriters Laboratory have (ASQC). After documenting the existing system and cor­ agreements with other accreditation groups. recting any deficiencies, the next step is to contact a cer­ ETL and Intertek have an agreement with the tification registrar. This body checks the existing quality Lloyds Register Quality Assurance Ltd. to prOVide regis­ system against the appropriate ISO 9000 standard. In tration services. Underwriters has an agreement with about three months it delivers a quality system supple­ the British Standard Institution.