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. Four organizations ment report showing how the standard maps to the exist­ have been recently authorized by the Registered Accredi­ ing quality system, tation Board of the ASQC - ABS Quality Evaluators, Afew European nations have already established AT&T Quality Registrar, Quality Systems Registrars, and third-party registration schemes and government-spon­ BBQI. sored accreditation councils. The leader in these initia­ Several European certification groups have locat­ tives has been Great Britain. There the Department of ed in the United States. Acomprehensive list of quality Trade and Industry has established a National Accredita­ system registrars is available through the Registration tion Council for Certification Bodies (NACCB). This body Accreditation Board of the ASQC (phone: 414/272­ has authorized 30 accreditation groups to certify compa­ 8575). nies as meeting standards. The smaller groups certify An assessment team performs an in-depth exami­ companies in specific industries such as electrical equip­ nation, documenting their findings as Non-Compliance ment. Groups such as Lloyd's Register Quality Assurance Notes. This examination typically involves a two- to Ltd. handle a broader range of companies. four-day site visit. Some registrars show two categories 25 StipIemberIOcIober 1992 ISO gOOD Model

I Organizalion I

Quality Control Management External QA luyer same time, they were concerned that written procedures I I Internal QA could create red tape which might alienate some employees I and stifle creativity. The DWTC solution was to create three levels of docu­ Systems I mentation. Level I is the New Products and Technology Division's Quality Policy Manual, addressing each of the items considered in ISO 9001 (see Figure 2). Figure 3. Level II, Quality Assurance Procedures for DWTC, pro­ of non-compliance: "hold point" deficiencies which vided significantly more detail. Level II formed the bridge must be fixed before a certificate can be issued, and between Levell and Level III documents. The Level III documents controlled methods, specifi­ ongoing system improvements which will not delay the cations, and drawings. Documentation at this level was spe­ issuance of a certificate. cific to each department and in several instances was for­ Preparation for registration takes about 16 months. mally written for the first time. Following registration, system reviews occur twice a yeat; The three levels of documentation were issued on a with some registrars reassessing every three years. preliminary basis. Employee training and internal audits were conducted on a weekly basis by the quality team. The registration process certifies the company as During the internal audits the auditors checked to verify having a satisfactory quality program. This does not whether employees were complying with established proce­ mean the company can place the CE mark on all its dures. products. As described earlier, there are several advan­ DWTC strategy was to specifically address four major tages in affixing the CE mark to a regulated product concerns: when marketing it in the European Community. 1. Employee commilment The team and the consultant repeatedly stressed they Two U. S. Companies' Registration were as sensitive about red tape as the research scien­ Experiences - Ouracell and Foxboro tists and design engineers. They emphasized their intent to document procedures to assure ISO 9001 certification Both companies recently received ISO 9001 regis­ and their commitment to customer needs and to not tration, Duracelllnc. at its Worldwide Technology Center exceed reasonable limits. However, it took several (DWTC) and The Foxboro Company. months for employees to understand this and to actively take part in the development of the new quality system. Duraeell 2. Documentation control Duracelllnc.'s New Products and Technology Division The Quality Policy Manual (Level I) and the Quality deveioped aquality management system to comply with ISO Assurance Procedures (Level II), were initially written in 9001. Other Duracell divisions are now working on similar hard-copy form and distributed to all department man­ quality systems to meet ISO requirements. agers. However, revision control is an essential require­ To Carl Davis, DWTC Management Representative for ment of ISO 9001, and it became clear that maintaining Quality, being project leader on the ISO 9001 team has been photocopies throughout the facility would be difficult. extremely rewarding. ISO is the foundation for DWTC's qual­ The quality team, with help from the Computer Ser­ ity management system. vices Department, significantly reduced hard-copies by The DWTC effort started in early 1990 with senior distributing them electronically to all computers in the management's decision to implement acorporate quality ini­ facility. Now, DWTC only needs to control revisions to tiative called "Duracell Xcells." Registering DWTC to ISO the computer database. 9001 was one part of the Xcells program. ISO registration was championed by senior management, including vice­ 3. Design control president Dr. H.F. Gibbard. AEuropean consulting organiza­ Specifications, drawings, and methods are critical to the tion experienced in ISO 9000 certification assisted. design process. Project leaders and team members were Aquality team formed of three project leaders- frequently audited to verify the revision currency of Frank Ciliberti and Ed Sczepanski from the Standards, Per­ product drawings, specifications, and test methods. formance, and Quality Department in Bethel, CT, and Carl Today, project teams routinely maintain accurate infor­ Davis from OWTC in Needham, MA - worked with the con­ mation and provide traceability to critical documents sultant and with employees. Due to the magnitude of the during the entire design and development process. project, atop-down commitment was essential. 4. Instrument calibration The team was aware that it had to document quality To support Duracell's worldwide operations, DWTC has procedures in order to meet ISO 9000 standards. At the 26 Target hundreds of test and evaluation instruments, all of which tors made sure the procedures were in the area where the were inventoried. Nearly two-thirds were identified as work was being performed. They confirmed that opera­ Acomprehensive critical and entered into a calibration database. A sched­ tors were collecting all of the statistics required by pro­ list ofquality ule for recalibration had to be constructed and a process cedures. system registrars instituted to notify the department manager. 2. Special processes In March ot 1991, the team notitied Underwriters Lab The auditors classified processes such as welding and is available (UL) they were ready for aRegistration Audit. The consultants brazing as special processes, all of which were examined through the completed apre-assessment audit in June. In July, a team of in detail. For example, in welding they looked for aflow Registration three people from UL conducted a three-day audit. Twenty­ chart of the process, written documentation that included one relatively minor action requests required corrective the qualifications of the operator, the type of machine, Accreditation action. Following the resolution of these action requests and the type of welding rod. Board ofthe DWTC received its ISO 9001 registration in September 1991 3. Documentation ASQe (phone: trom UL. DWTC also received dual registration from BSI in They checked all functional areas for documentation. December. They checked the marketing plan. They asked how mar­ 414/272-8575). Meanwhile, internal audits are conducted monthly by keting provided input to design and then looked for doc­ the quality team. UL and BSI will conduct routine surveillance umentation of these procedures. They checked the audits every six months. design function for documentation. They would pick a job on the factory floor and go back to development to The Foxboro Company see if the package with it was current. The Foxboro Company started its push towards certifi­ During this same period, The Foxboro Company cation in January, 1990. An ISO 9000 Steering Committee was implementing statistical process control (SPC) and was formed consisting of senior managers from several func­ a formal Quality Improvement Process (QIP). This tions including manufacturing and marketing. At an opera­ involved 115 teams and 900 people; each team having tional level a Manufacturing Quaiity Council was formed quality indicators. The DnV auditors used what they under the direction of the corporate director of quaiity assur­ observed in SPC and QIP to fulfill the requirements of ance. Concurrently, the senior quality engineer, Richard element 20 of ISO 9000 - statistical techniques. Anderson, took on the job of rewriting the corporate quaiity 4. Training. manual to align it with the ISO 9001 standards. The revised The auditors checked the documentation to establish the manual was distributed to each factory on afloppy. required qualifications a person needed for each task. In Next a presentation was made to each of the divisions individual interviews they would check if the person's describing the importance of certification and requiring each qualifications matched. They also checked plans for past to create a manual of procedures. The manuals had to be and future training. written by the manufacturing people, not just by the division's quality engineer. Typically, the plant manager and the prod­ Foxboro Results uct line manager would also be involved in the rewrite. Once Foxboro passed the audit. Each plant had at least 95 a plant felt ready, Corporate Quality Assurance would con­ percent of the procedures implemented and 100 percent in duct an intense audit followed by informal audits to ensure place. But there still were findings. As the DnV team left each changes were made to manuals to fit the ISO standards. plant they performed an exit interview. One deticiency related Finally, in October of 1990, the company felt it was to document control. ready for certification and contacted DnV. The DnV auditors All people receiving the document had to be listed on arrived with a checklist of 400-500 items and pertormed the the control listing. These people could not circulate copies of toughest audit the company had since dealing with the audit the documents to people not on the list. Also, they were by the Nuclear Procurement Issue Committee. The team responsible for keeping the document and could not throw it spent three weeks at the company from mid-February through out. the first week of March, interviewing people in sales, R&D, The company did obtain certification in April, 1991 ­ service, order entry, marketing, and personnel in addition to 16 months after it had started. A follow-up audit took place manufacturing. Their aim was to see if 100 percent of the in July to review the open findings; the first six-month audit procedures were in place, with at least 75 percent implement­ took place in September. ed. At the follow-up audit, DnV told the company they would be examining eight specific elements. The auditors The auditors targeted these areas for checks: spent a week reviewing these at each plant. The company 1. Implementation ofprocedures passed the audit. The next audit on another eight elements Implementation of procedures was checked by talking took place in March, 1992. directly to the people working in each function. The audi- Meanwhile, Shanghai Foxboro Company ltd. in China

27 !iep/ember/Odober 1992 also decided to seek ISO certification. They were able to •Ahigh degree of commonality of architecture and con­ transfer several of the procedures from the American plants. cepts in the updated ISO 9001 and ISO 9004. With help from the Corporate Quality group in America and the European quality manager for The Foxboro Company, • No need for industry-specific standards. they achieved certification in December, 1991. Asingle Community mark, CE-mark, will be adopt­ According to Dick Anderson, Foxboro's senior corpo­ ed for all future Community legislation. The CE-mark rafe quaiity assurance engineer, certification has been a help with the multitude of certification forms - "Some customers will not indicate that a particular procedure has been fol­ lef us skip fhe audif because we are ISO certified. We hope lowed. However, when a third party is involved in one of someday to have a list ot those certified companies ­ the modules of the production phase of a conformity Foxboro might be able to skip their audit. We could cut down assessment procedure, it should affix its stamp/ on everybody's work." Mr. Anderson is frequently asked how difficult the pro­ mark/seal next to the CE-mark. cess was. He replies that "anyone with a 9858A Milspec Other groups - CEN (European Committee for quality system, or 10CFR50 Appendix Bshould have very lit­ Standardization) and CENELEC (European Committee tle trouble with ISO 9000 - fhey're almost there." Foxboro for Electrotechnical Standardization) - have been did it wifh the resources in place; the people doing the job charged with determining the basis for regulating and wrote the procedures. harmonizing certification, accrediting, and testing activi­ Will ISO 9000 Guidelines Change? ties. They developed an extensive series of standards During the next decade we will see revisions of the termed EN 45000. The implementation of these standards existing standards and the development of new ones. Sev­ within the 18 EC and EITA countries will be the back­ eral committees are charged with creating new specifica­ bone of a system of mutual recoguition of ISO certifica­ tions and standardizing the certification activities in each tion: country. • EN 45001 (the operation of testing laboratories) In 1990, an ad hoc task force ofTC 176 suggested a • EN 45002 (the assessment of testing laboratories) new framework of "Generic Product Categories:" • EN 45003 (laboratory accreditation bodies) • Hardware: Products consisting of manufactured pieces • EN 45011 (certification bodies operating product certi­ and parts, or assemblies thereof; fication) • Software: Products, such as computer software, consist­ • EN 45012 (certification bodies operating quality sys­ ing of written, or otherwise recordable information, tem certification) concepts, transactions, or procedures. • EN 45013 (certification bodies operating certification • processed Materials: Products (final or intermediate) of personnel) consisting of solids, liqUids, gases, or combinations thereof, including particulate materials, ingots, fila­ • EN 45014 (suppliers' declaration of conformity). ments, or sheet structures. (Processed materials typi­ CDnclusiDn cally are delivered [packaged] in containers such as Becoming ISO-registered does not imply the com­ drums, bags, tanks, cans, pipelines, or rolls.) pany has a world-class quality system in place. Editor's • Services: Intangible products which may be the entire note: In Europe, being ISO registered means you have or principal offering, or incorporated features of the a license to drive, hut it doesn't mean the bearer is a offering, relating to activities such as planning, selling, good driver! directing, delivering, improVing, evaluating, training, In order to realize the full benefits of lower costs operating, or servicing for tangible product. and productivity improvements, the quality system would The task force's "Vision 2000" was formulated as follows: have to be developed beyond the requirements laid down by ISO 9000. There is a danger that companies might •Asingle QM standard, an updated ISO 9004 for all four view getting certified as a destination when it is only a categories. signpost on the road. These standards merely serve to •Asingle QA standard, an updated ISO 9001 for all four document the status quo. With continuous improvement categories. being a necessity for survival it is imperative that man-

28 Target agement continue to evolve the quality system. Asb Roo is a professor ofmanagement and quantilaJive analysis The use of ISO 9000 standards and third party certi­ at Babson College in Wellesley, MA. He earned a Pb.D. in fication of products is accelerating in Europe. France, industrial engineering and an M.S. in electrical engineering Germany, and the Netherlands have followed Great from /be University ofIowa. His industry experience includes an appointment as Director ofBusiness Systems at Northern Telerom, Britain and organized accreditation councils for certifica­ Canada. He is also a member ofMIT's Center for Quality tion groups. Non-European countries such as China are Management. also adopting these standards. The momentum will cause AsbjfJrn Aune is an associate professor in the Division of the United States to accept the standards. As this happens, Production Engineering, and senior scientist at SINTEF it is highly likely the certification bureaucracy will grow ProducIiQn Engineering - The Foundation for ScientIfic and and there will be a lack of qualified assessors. This could Industrial Research, both at the University ofTrondbetm. He is mean the time required to obtain certification will extend also Visiting Professor at Babson College, Vice President to longer than two years. Companies that move rapidly International Academyfor [Juality, Coundl member ofEuropean OrganIZation for [Juality, anda member ofthe Sdentijlc Coundl today and get certified will find they have a significant for /be [Juality Academyfor Managers in Prague, competitive edge. 1banks to Richard Anderson, senior quality engineer Illoeh1ln~ W.H. "Europe 1992, 10 _tou lnlematioual Standanls," Quality at the Foxboro Company, and Carl Davis ofDuracelt I'rogms,June,199O. Inc. s Worldwide Technology Center, for sharing thei, 2 AT&T Quality Steering Committee,!}ualiJy Manager's Handbook, AT&T Cll'itomer Infonnation Center. Indianapolis, IN, 1990. experiences witb ISO 9000. 3 Kendrick, JJ. "Certi/ying QualIty Management S"lems", Quality, Augus~ 1:>199200 1990. For information on reprints, contact: 4 Klock, JJ., "How to Manage 3500 (or Fewer) Supplie~," Quality I'rogms, Association for Manufacturing Excellence June, 1990. 380 West Palatine Road Wheeling, lL 60090 7Q&1520-3282 5Ferguson, K.H. "lnlemational Quality Standanls May Affect Industry" EfforlS In Europe," Pulp & Paper, Man:h, 1991. a