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*See footnote (8) **ISO 9000 standards are in the process of being adopted by the Saudi Arabian Standards Organization (SASO). Return to CONTENTS
WHAT ARE THE NUMBERING SYSTEMS USED BY COUNTRIES TO DESIGNATE THE ISO STANDARD SERIES?Countries adopting the ISO 9000 standards assign numbers to the standards based on their own national standards numbering systems. As noted in the following examples, these numbers may be very different from those numbers assigned by ISO to the Series, even though the standards are identical. In the United States, the ISO 9000 Standard Series has been adopted as the ANSI/ASQC Q90 Series (soon to be changed to the ANSI/ASQC Q9000 Series). In Europe, it has been adopted by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) as the European Norm (EN) 29000 Series. In the U.K., it is BS 5750 Parts 0 to 3. In Pakistan, it is the PS 3000-3004 Series. In Tanzania, they are TZS 500-504; while in China, they are GB/T 10300.1 - 10300.5. Return to CONTENTSWHAT IS NEW WITH THE ISO 9000 FORUM?ISO 9000 Forum symposia have recently been held in a number of countries on issues related to quality assurance and quality management. In addition, the Forum has begun issuing a newsletter, the ISO 9000 News. Subscriptions are available from ANSI. The ISO Forum was established to serve the needs of ISO 9000 users by: providing information; facilitating international discussions on new developments and issues affecting the application of the ISO 9000 standards; promoting the exchange of experience in such areas as training, promotion and operation of relevant schemes; harmonizing practices in the application and interpretation of the ISO 9000 standards; and providing advice to ISO TC 176 or the relevant ISO decision making body. Return to CONTENTSWHAT ARE "NEW APPROACH" DIRECTIVES?The Commission of the European Community (EC) has established a conformity assessment scheme for EC-regulated products.(9) The EC has specified conformity assessment methods in terms of eight "modules," such as the supplier's declaration of conformity (formerly known as self-certification), type testing, quality system approval, or final product verification by a third party. Each "new approach" directive specifies the alternative means (set of modules) that suppliers may use to certify their products as being in conformance with the "essential requirements" spelled out in each directive. The distinction between "old approach" and "new approach" directives is that "old approach" directives defined all the required technical characteristics of a product within the directive, while the "new approach" directives specify only the more generalized "essential requirements" necessary to protect consumer health and safety and the environment. The task of actually writing the specific technical requirements is left to the three European standards-setting organizations - CEN, the European Committee for Standardization; CENELEC, the European Organization for Electrotechnical Standardization, and ETSI, the European Telecommunications Standards Institute. Return to CONTENTS
WHAT IS QUALITY SYSTEM REGISTRATION/APPROVAL AND HOW DOES IT RELATE TO CONFORMITY ASSESSMENT?Quality system registration or approval involves the assessment and periodic audit of the adequacy of a supplier's quality system by a third party, known as a quality system registrar. When a supplier's system conforms to the registrar's interpretation of an ISO 9000 or other appropriate standard, the registrar issues the supplier a "certificate of registration." Note that the supplier's quality system is registered, not an individual product. Consequently, quality system registration does not imply product conformity to any given set of requirements. Conformity assessment, a more comprehensive term, is the systematic evaluation of a product, process, or service to determine the extent to which it complies with specified requirements. Conformity assessment activities include: quality system registration; product or service testing and/or certification; and laboratory, certification body or quality system registrar accreditation.(10) Return to CONTENTS
WHAT IS THE DIFFERENCE BETWEEN QUALITY SYSTEM CERTIFICATION AND QUALITY SYSTEM REGISTRATION?These terms are frequently used interchangeably; however, confusion arises when "quality system" is not placed in front of the term "certification." If these two words are missing, it is easy to confuse the assessment and approval of a manufacturer's quality system with product certification (11) -- two entirely different activities! For that reason, ISO/IEC Guide 48 (see Appendix C), the international document which governs the third- party assessment and registration process for quality systems, refers throughout to "registration," not to "certification. The Directory of Quality System Registration Bodies, published by ISO, confirms the Guide 48 terminology. Return to CONTENTSWILL QUALITY SYSTEM APPROVALS BE MANDATORY IN THE EC?Having an approved quality system will not be a blanket requirement for all products. However, approval of a supplier's quality system will be a key component of the EC's legal requirements for product certification in these areas: construction products (9002 or 9003); active implantable medical devices (9001 or 9002); personal protective equipment (9002 or 9003); telecommunications terminal equipment (9001 or 9002); gas appliances (9002); non-automatic weighing instruments (9002); medical devices (9001 or 9002); elevators (9001 or 9002); pressure equipment (9001 or 9002); recreational craft (9001 or 9002); cable ways equipment (9001); measuring and testing instruments (9001, 9002, or 9003); equipment for use in potentially explosive atmospheres (9001 or 9002); and furniture flammability (9002). For most of these regulated products, quality system approval is one approach to proving compliance, not an absolute requirement. Other methods, not involving quality system approval, may also be allowed under these directives. For example, under the telecommunications terminal equipment directive, a manufacturer has three options for proving conformity to the essential requirement contained in the directive: (1) EC type examination/approval of the product by a notified body plus manufacturer's declaration of conformity to type (whereby a notified body carries out product checks at random intervals); (2) EC type examination of product by a notified body plus approval by a notified body of a manufacturer's quality system according to ISO 9002 (EN 29002); and (3) approval by a notified body of a manufacturer's quality system according to ISO 9001 (EN 29001) with no type approval required.(12) Method 1 does not require any type of quality system approval, while methods 2 and 3 do. It should be noted that manufacturer compliance with ISO 9002 or ISO 9003 is usually combined with some type of product testing for full product certification to EC requirements. The full quality assurance (ISO 9001) option includes an assessment of the product's design to assure that it conforms to the applicable "essential requirements." In other directives, such as the Council Directive dated June 14, 1989 on machinery (89/392/EEC), manufacturers of some products are permitted to self-declare that their product conforms to the requirements of the directive and to place the European Community (CE) mark on the product. However, such machinery manufacturers must maintain a file on the manufacture of those products, including information on "the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive" -- in other words, on the manufacturer's quality system. It is possible that the ISO 9000 (EN 29000) Standard Series could be used within the European Community to evaluate the adequacy of such quality systems. However, at the present time, no requirement is included in the manufacturer self-declaration for third party review/approval of the manufacturer's quality system. Manufacturers need to review all relevant EC directives for specific requirements applicable to their products. Each directive requires the use of different methods for proving conformity. It may be that some conformity assessment options, while meeting the requirements of one directive, will not meet the requirements of other relevant directives covering a product. A product must meet the conformity assessment requirements of all applicable directives for suppliers to be able to apply the CE mark to that product. For some products, specific conformity assessment methods, such as product type testing combined with having an approved quality system, could end up being the only method that will comply with all requirements contained in all applicable directives. Return to CONTENTS
HOW DOES THE EC PRODUCT SAFETY DIRECTIVE RELATE TO ISO 9000?The EC Directive on General Product Safety 92/59 (commonly known as the Product Safety Directive) was approved by the EC Council on June 29, 1992. This directive covers all products placed on the EC market -- whether regulated by the EC or not. The directive becomes fully operational in June 1994 and applies to the safety of products from the time that they are first placed on the EC market and extends throughout the product's foreseeable life. This requires that the safety of a marketed product be monitored by member states over the product's entire life. The directive covers both new and reconditioned products, though not secondhand products clearly identified as antiques or in need of repair or reconditioning. The objective of the directive is to impose a general requirement on producers to introduce only safe products into the EC market. A "safe product" is defined as "a product that does not present, in particular in respect of its design, composition, execution, functioning, wrapping, conditions of assembly, maintenance or disposal, instructions for handling and use, or any other of its properties, an unacceptable risk for the safety and health of persons, either directly or indirectly, in particular through its effect upon other products or its combinations therewith." The Directive requires that products intended for consumers not present any unacceptable risks and that potential users of such products are adequately warned of any remaining risks. Some guidance on what is a safe product is contained in the directive. For that reason, it is probably advisable to read this directive in conjunction with the EC Product Liability Directive discussed below. In general, the Product Safety Directive will not apply to those safety aspects of a product or category of products already covered under an EC directive. When read in conjunction with the Product Liability Directive, this directive may have some implications for suppliers regarding their quality systems. In the event of legal claims, some legal opinion has suggested that ISO 9000 registration combined with other appropriate technical documentation related to product safety and adequate product labeling/user instructions could prove useful in a legal defense.(13) Return to CONTENTS
HOW DOES THE EC PRODUCT LIABILITY DIRECTIVE RELATE TO ISO 9000?On July 25, 1985, the EC Council ratified a Directive Concerning Liability for Defective Products 85/374 (generally known as the Product Liability Directive).(14) Under this directive, products are considered to be defective when they do not provide the level of safety that the public has a right to expect. That level of safety is more clearly defined for some products in other EC directives, such as the Medical Device Directive and the Machine Safety Directive. Under the Product Liability Directive, an injured consumer must show the damage experienced, the product defect responsible for the problem, and the relationship between them, although negligence does not have to be proved if the manufacturer could have reasonably foreseen the problem. It is not necessary to prove that a product is unreasonably defective. The directive creates a strict liability and introduces a uniform concept of product liability in some EC nations where such a view did not previously exist. As a result, this directive will affect almost every company doing business in the EC to some degree. Again, some legal opinion has indicated that while ISO 9000 registration will not protect a company from being sued for a defective product, quality system documentation creates a technical record that could be useful in such prospective product liability suits.(15) Return to CONTENTS
HOW DOES THE ISO 9000 STANDARD SERIES APPLY TO THE EC SERVICES SECTOR?There is no reference to ISO 9000, or to "quality management systems," in EC legislation related to private sector procurement of services, such as accounting, engineering or legal services. The proposed EC directive on procedures for the award of public service contracts does note that some government-owned, operated or controlled contracting entities in the public works and supplies sectors do impose quality management system requirements in their qualified supplier programs. However, ISO 9000 registration is not mandatory under this directive. The EC Commission noted that "quality control certification... exists at the national level in particular service sectors such as the field of engineering. It has been observed that contracting authorities tend to require such certificates whenever a quality assurance body exists in their country. This may have the effect of discriminating against foreign suppliers... The directive should therefore recognize the existence of quality assurance schemes, and reconcile the way in which they are used with the need to grant a fair chance to suppliers from other countries." Return to CONTENTS
WHO WILL BE ABLE TO CONDUCT MANDATORY EC QUALITY SYSTEM APPROVALS?When EC directives require the use of a third party in the conformity assessment process, each member country government must provide the EC government with a list of third parties (referred to as "notified bodies") which the member country has determined to be competent to declare that a regulated product conforms to the "essential requirements" spelled out in a particular directive. Member states notify bodies by both conformity assessment method or module (listed in the directive) and by directive to the EC Commission, which then compiles and publishes a list of all such bodies. For example, a quality system registrar could be notified by an EC member country as being competent to conduct quality system approvals in accordance with ISO 9002 (EN 29002) under a specific directive. However, such a body may not be a "notified body" for purposes of other conformity assessment modules or methods listed in the directive or for other directives. Mandatory quality system approvals or registrations must be conducted by notified bodies. At the present time, notified bodies must be physically located within the geographical boundaries of the European Community. EC member countries can only notify bodies located within their geographical borders. On September 21, 1992, the EC Council approved a guidance document, "Communication to the Council on the Negotiation of the Agreements between the European Economic Community and Certain Third Countries on Mutual Recognition in Relation to Conformity Assessment," which provides guidelines for the establishment of mutual recognition agreements with third countries. Notified bodies can only exist in the United States under the provisions of a mutual recognition agreement between the U.S. government and the EC. A mutual recognition agreement (MRA) would allow U.S. entities to perform all required conformity assessment procedures included within the scope of the agreement. Formal discussions between representatives of the U.S. government and the EC on establishing MRAs began on October 20, 1992 in Brussels. There remains the possibility that some conformity assessment tasks, including quality system audits, may be subcontracted by notified bodies to bodies outside the EC, including organizations in the United States. Such subcontracting would be done at the discretion of the notified body, which would continue to be responsible for audit assessment. Subcontractors must comply with all applicable requirements of the EN 45000 Standard Series. In the case of subcontractors involved in quality system audits, the appropriate European standard is EN 45012. Return to CONTENTS
HOW CAN I FIND MORE INFORMATION ON NOTIFIED BODIES AND WHAT WILL I LEARN?A document entitled, "Notified Bodies", which accompanied the EC Mandate, "Communication to the Council on the Negotiation of the Agreements between the European Economic Community and Certain Third Countries on Mutual Recognition in Relation to Conformity Assessment" provides further details on the responsibilities of notified bodies. These requirements will most likely be placed on any U.S. notified bodies. There are several points to note in these documents: "The notified bodies are, almost by definition, taking on the responsibilities of their national notifying authorities and therefore should remain answerable to them." It is therefore unlikely that the U.S. government will be permitted to notify a body located outside of its territory. Likewise, gaining accreditation from an EC country's accreditation system does not mean that a U.S. or other non-EC conformity assessment body can become a notified body. EC member governments may also choose to notify only some of the bodies they have accredited. Notified bodies must be notified for specific directives and for at least one complete module and any supplementary requirements, though they may be notified for a subset of the products covered by a directive. Since market surveillance activities are aimed at ensuring the compliance of all involved in placing a product on the market (including the notified bodies), market surveillance activities will probably not be carried out by notified bodies, or at least not by those involved in the original assessment. Notified bodies must be independent of their clients or other interested parties. However, a manufacturer's laboratory, for example, might be notified if it is completely independent from the production and commercial department of the firm and if it services production other than just that of the firm. Notified bodies may also be called on to provide technical guidance on how to apply the provisions of the directives, such as how often quality audits should be conducted. However, such technical clarifications should be discussed between member governments to achieve consensus. Under certain conditions, the notified bodies can also assist the surveillance authorities. Return to CONTENTS
WHERE CAN I FIND OUT MORE ABOUT THE EC'S SUBCONTRACTING GUIDELINES?As an interim step pending the establishment of U.S.-EC MRAs or as an alternative to MRAs, some U.S. based registrars are taking advantage of the EC's subcontracting provisions. These provisions allow some conformity assessment tasks, including those in the quality system registration area, to be subcontracted by notified bodies to bodies outside the EC, including organizations in the United States. Subcontracting with EC notified bodies represents an attractive option for a number of U.S. based registrars. However, such subcontracting is done at the discretion of the notified body, which continues to be responsible for the final assessment of product conformity. U.S. and other subcontractors must comply with all applicable requirements contained in the EN 45000 Standard Series. The EC document, Guiding Principles for Subcontracting by "Notified Bodies" pursuant to the Council Resolution of 13 December 1990 Concerning the Modules for the Various Phases of the Conformity Assessment Procedures provides information on the types of tasks that can be subcontracted and the conditions under which subcontracts may be established. Return to CONTENTSWILL THE U.S. BE ESTABLISHING MRAS WITH THE EC?On September 21, 1992, the EC Council approved a guidance document, "The Negotiation of the Agreements Between the European Economic Community and Certain Third Countries on Mutual Recognition in Relation to Conformity Assessment," on seeking mutual recognition agreements with third countries, including the United States. Negotiations for such agreements between the United States and the European Community are being planned in a number of areas based on requests from U.S. industry. Preliminary negotiations began on October 20, 1992. Additional product/industry specific negotiations are planned for 1993. Return to CONTENTSWHAT IS CASE or NVCASE?At a June 21, 1991 meeting between then Secretary of Commerce Robert Mosbacher and EC Commission Vice-President Martin Bangemann, the Secretary proposed that the National Institute of Standards and Technology (NIST) provide the EC with any assurances it might require regarding the competence of U.S. based testing, certification and quality system registration bodies to conduct conformity assessment activities mandated by the EC under one or more U.S.-EC MRAs. NIST has proposed a program to deal with this responsibility, originally identified as the Conformity Assessment System Evaluation (CASE) program, but now entitled the National Voluntary Conformity Assessment System Evaluation (NVCASE) program. The proposal was published in the Federal Register on March 27, 1992, with a closing date for comments of September 30, 1992. NIST is preparing to publish a proposed rule in the Federal Register on the NVCASE program for public comment in the near future. The original proposal included the following key concepts:
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IS QUALITY SYSTEM REGISTRATION LIKELY TO BE REQUIRED FOR NON- REGULATED PRODUCTS IN THE EC AND ELSEWHERE?The demand for ISO 9000 registration in Europe and elsewhere seems to be coming primarily from the marketplace as a contractual rather than a regulatory requirement. As conformity to the ISO 9000 standards becomes recognized and required by foreign and domestic buyers and used by manufacturers as a competitive marketing tool, the demand for ISO 9000 compliance is expected to increase in non-regulated areas. It is therefore critical for manufacturers to determine what are their buyers' requirements regarding ISO 9000 compliance. The degree of interest and pressure specific manufacturers are experiencing from their buyers to seek registration currently varies significantly by industry. In many of the "high tech" or "high safety and health risk" product areas where product reliability is crucial (such as electronic components, aerospace, autos, test equipment and health care products), the market pressure on manufacturers to seek registration is likely to increase. The U.S. Aerospace Industries Association in its April 1992 Study, Impact of International Standardization and Certification on the U.S. Aerospace Industry, noted that in its industry "...(s)ome RFPs for European and other foreign customers are now including a requirement that potential bidders be ISO 9000- compliant." This growing demand from buyers for registration is being noted by many other industries as well. Procurement authorities and buyers are increasingly including ISO 9000 registration requirements in their purchase contracts. Suppliers desiring to sell to such entities will have to be audited and registered as being in compliance with an ISO 9000 standard under terms acceptable to those buyers. Return to CONTENTSWHAT IS EAC?EAC stands for European Accreditation of Certification, an association of the European national accreditation bodies. The overall objective of the EAC is to create a single European system for recognizing certification/quality system registration bodies that will provide the marketplace with adequate assurance that certification/registration is equivalent in all European countries. A Memorandum of Understanding (MOU) was signed by Belgium, Denmark, Ireland, the Netherlands, U.K., Germany, Greece, Italy, Portugal, Iceland, Norway, Sweden, and Switzerland on May 22, 1991. Specific objectives of the EAC, as defined in the MOU, are to: (1) maintain and strengthen market confidence in certificates issued by accredited bodies; (2) establish mutual confidence between participating bodies and promote collaboration and agreements as a means towards a European system of assessment and accreditation; (3) provide the means for a continuous flow of knowledge relevant to assessment and accreditation between participating bodies and other relevant bodies; (4) work towards a multilateral agreement on the equivalence of the operations of the participating bodies and a declaration of their commitment to foster general acceptance of the equivalence of certificates issued by the certification bodies they accredit; and (5) promote the harmonization of the operations of participating bodies. Return to CONTENTSWHAT IS THE EOTC AND HOW DOES IT FIT INTO THE PICTURE?The European Organization for Testing and Certification (EOTC) was created by the EC in April 1990 under a memorandum of understanding with the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Free Trade Agreement (EFTA) (16) countries. The EOTC was formed to promote the mutual recognition of test results, certification procedures, and quality system assessments and registrations in non-regulated product areas throughout the EC and EFTA countries. The EOTC is also responsible for providing technical assistance to the EC Commission in the implementation of some EC legislation, especially in the preparation of mutual recognition agreements with non-EC countries. It is anticipated that there will be a Specialized Committee of the EOTC in the area of Quality Assurance. However, this committee will not be established until after 1992. Nevertheless, the need for expert advice in this area was recognized by the EOTC in July 1991. The European Organization for Quality (EOQ) (17) and the EQS (see below) have been offered observership status in EOTC to fill this need. The EOTC is expected to be fully operational in 1993. (18) Return to CONTENTSWHAT IS EQS?EQS, the European Committee for Quality Systems Assessment and Certification, was established in 1989 with membership from both the EC and EFTA countries. The purpose of the EQS is to avoid multiple quality system assessments and registrations of companies or suppliers by harmonizing the rules and procedures used for quality system assessment and registration among members, particularly through the effective implementation of the European Standard, EN 45012 - General Criteria for Certification Bodies Operating Quality System Certification. EQS promotes methods to develop confidence in quality system assessments and registrations carried out by competent quality system registrars. EQS is also responsible for harmonizing the rules for quality system assessment and registration. EQS is currently an advisor to the European Organization for Testing and Certification (EOTC) and is a candidate for serving as a specialized (functional) committee of the EOTC in the quality assurance area. Return to CONTENTSWHAT IS EQNET?EQNET, the European Network for Quality System Assessment and Certification, is a business agreement established in early 1990 by eight quality system registration bodies - AFAQ (France), AIB- Vincotte (Belgium), BSI Quality Assurance (U.K.), DQS (Germany), DS (Denmark), N.V. KEMA (the Netherlands), SIS (Sweden), and SQS (Switzerland). The purpose of EQNET is to establish close cooperation among members leading to mutual recognition of each other's quality system registration certificates. Each signatory agrees to: (1) promote the recognition of quality system certificates issued by EQNET members; (2) coordinate the work to be performed for quality systems registration of an organization having subsidiaries in several EC/EFTA countries to help such an organization to obtain appropriate quality system (QS) certificates; (3) issue several QS certificates simultaneously after performance of a joint audit; (4) promote bilateral agreements between EQNET members; (5) contribute to the development of operating procedures and promotional materials; and (6) to present information on EQNET. A number of mutual recognition agreements have been established between EQNET members. Because EQNET's membership is limited to one not-for-profit quality system registration body per country, it is not a likely candidate for an EOTC agreement group. Return to CONTENTSWHAT ELSE IS NEW IN THIS AREA IN THE EC?Manufacturers should note that some countries have developed additional guidelines for the application of the ISO 9000 standards to specific product sectors, such as medical devices (EN 46000) and aerospace products (EN 2000 and EN 3042). Some quality system registration programs have also based registration requirements on documents other than ISO 9001, 9002 and 9003. For example, The U.K.'s Department of Trade and Industry (DITI) has developed a scheme, called TickIT, specifically for software companies which incorporates many of the recommendations in ISO 9000-3: Guidelines for the Application of ISO 9001 to the Development, Supply and Maintenance of Software (the guidance document developed by ISO for software suppliers) into its requirements for registration. The U.K.'s National Accreditation Council for Certification Bodies (NACCB) is offering accreditation to U.K. registrars in the software area under the TickIT scheme. The U.S. Registrar Accreditation Board (RAB) has set up a committee on the use of ISO 9000-3 in registration and intends to look at issues such as whether there is a need for a similar type of program for software companies in the United States. Return to CONTENTSWHAT'S HAPPENING WITH NON-EC EUROPEAN COUNTRIES?On May 2, 1992, the ministers from the twelve EC and seven EFTA countries signed a treaty designed to establish a nineteen nation free trade area, referred to as the European Economic Area (EEA). While the EC/EFTA countries must still ratify the EEA Treaty, most EFTA countries (19) can be expected to follow the EC's example in encouraging or requiring compliance to the ISO 9000 standards. Former Eastern Bloc countries may also follow the EC lead as they seek and form closer ties with the European Community. The EC has entered into bilateral Association Agreements with Poland, Hungary, and Czechoslovakia and is negotiating similar agreements with Bulgaria and Romania. These agreements will gradually establish bilateral free trade areas between the EC and each of the associated countries, with the understanding that the ultimate goal is eventual EC membership for these countries. The EC has also signed Trade Cooperation Agreements with Albania and with the Baltic States. While not as far-reaching as the Association Agreements, these agreements are expected to contribute to the objective of eventually concluding Association Agreements with these countries in the future. Return to CONTENTSIS THE U.S. GOVERNMENT PLANNING TO USE THE ISO 9000 STANDARDS?The U.S. government is beginning to recognize the potential applicability of the ISO 9000 standards to some of its regulatory and procurement activities. U.S. federal government agencies are in the early stages of reviewing the applicability and usefulness of the ISO 9000 standards to their programs. Farthest along is the U.S. Food and Drug Administration's Center for Medical Devices and Radiological Health. The Center plans to replace its Good Manufacturing Practices Guidelines (GMPs) with a version of ISO 9001 by mid-1993. DOD has adopted the ANSI/ASQC Q90 Standard Series (technically equivalent to the ISO 9000 Standard Series), which means that the standards are listed in the DOD Index of Specifications and Standards (DODISS) and are available to DOD personnel through their publications distribution center. However, the use of the standards has not been included within the Federal Acquisition Regulation (FAR) or the DOD Federal Acquisition Regulation Supplement (DFARS). DOD is currently studying the use of the ANSI Q90 Standard Series and related issues. The Defense Electronics Supply Center (DESC) is considering obtaining ISO 9000 registrar status, depending on the outcome of the study. The Department of Energy (DOE) is also considering use of the ISO 9000 Series in the planned 1993 publication of its safety guide series which provides supplemental information for contractors on DOE's orders and rules. Other agencies, such as the Federal Aviation Administration (FAA), General Services Administration (GSA), the National Aeronautics and Space Administration (NASA), and the Nuclear Regulatory Commission (NRC) are looking into the usefulness of the ISO 9000 standards within the context of their regulatory and procurement programs. Return to CONTENTSARE MANY COMPANIES SEEKING REGISTRATION IN THE UNITED STATES?An increasing number of U.S. companies are seeking quality system registration to one of the ISO 9000 or ANSI/ASQC Q90 standards. In the Summer 1992 Registered Company Directory published by CEEM (See Appendix D), over 400 U.S. company sites were listed as being registered to an ISO 9000 standard. This represented an 80% increase from the total listed in the February 1992 issue of directory, and the number of registered U.S. companies continues to grow. CEEM's unofficial records indicate that 621 companies sites had obtained registration as of December 21, 1992. Some of the motivation for U.S. companies to seek quality system registration results from EC requirements. As noted previously, however, having an approved quality system will not be a blanket requirement for all products. Nevertheless, for suppliers of some products, having an approved quality system will be a key component of the EC's legal requirements. As already discussed, for most of these regulated products, ISO 9000 registration is but one alternative for proving compliance to the essential requirements contained in the so-called "new approach" directives, not an absolute requirement. However, much of the demand U.S firms are experiencing for ISO 9000 registration in Europe and elsewhere seems to be coming less from regulatory bodies than from the marketplace. As the importance of ISO 9000 registration becomes recognized and required by foreign and domestic buyers and as registration is seen and used by manufacturers as a competitive marketing tool, the demand for ISO 9000 compliance is expected to increase in non-regulated areas. The degree of interest and pressure felt by U.S. manufacturers to seek registration currently varies significantly by industry. In many of the "high tech" or "high safety and health risk" product areas where product reliability is crucial, the market pressure on U.S. manufacturers to seek registration is likely to be considerable. Return to CONTENTS
HOW DO YOU SELECT A QUALITY SYSTEM REGISTRAR?There are currently well over thirty U.S. based organizations offering quality system registration and that number is growing. The credentials of U.S. based registrars vary greatly. Some U.S. registrars have sought accreditation from one or more recognized accreditation bodies. Other U.S. registrars have established mutual recognition agreements with foreign based registrars. Some registrars have followed both courses, seeking mutual recognition agreements while also pursuing accreditation. A number of U.S. based registrars are subsidiaries of parent companies, which are accredited in their home country. In some cases, the registrar's parent company and the U.S. based company have both pursued accreditation by different organizations. A few U.S. based registrars have sought neither accreditation nor mutual recognition agreements with foreign counterparts. These various approaches and the resulting differences in credentials have caused considerable confusion among U.S. companies seeking to select a registrar. In selecting a registrar, companies must first determine if there are regulatory or marketplace requirements for registration. If there are regulatory requirements, which registrars are approved by the regulatory body to conduct the required registrations? If there are marketplace requirements, is the manufacturer's own declaration of the conformity of his quality system to ISO 9000 acceptable? If not, what registrars' certificates are recognized or accepted in markets where the company wishes to sell? It also is important for a company to not only ask if a registrar has been accredited, but also to inquire about the product or industry areas in which accreditation has been obtained -- the scope of the accreditation. Registrars are not necessarily accredited to perform work in all product or industry areas. Companies should determine if a registrar's scope of accreditation includes those product or service areas for which the company is seeking registration and if the registrar has conducted assessments of similar types of firms. Companies should ask the registrar for references. Other questions include: what sort of training, skills and experience do the auditors possess? Are the auditors certified or registered by a nationally recognized scheme? How does a registrar protect confidential information? What sort of appeals process or complaint resolution procedures does the registrar have? What are the registrar's policies and procedures regarding suspension or withdrawal of the registration? Does the registrar adequately respond to complaints or questions in a timely manner? Does the registrar have a good system for providing information to an applicant on deficiencies in the quality system? How soon can the registration be performed? Does the registrar have a backlog? Does the registrar publish and regularly update a list of registered companies, including the scope of registration? In general, how well does the registrar comply with the requirements of ISO/IEC Guide 48? Cost is, of course, an important consideration. However, a company should look at the total costs involved in obtaining and maintaining a registration. Such costs include: application fees; fees associated with document preparation; fees for quality manual review, as well as for the subsequent review of any needed revisions; cost of the initial visit, including travel and living costs; cost of any follow-up visits, if needed; cost of modifying the scope of registration, if desired; costs associated with surveillance visits and how often such visits will be conducted; and the cost of reassessment upon expiration of the original registration. Return to CONTENTSWHO EVALUATES THE COMPETENCE OF REGISTRARS?In 1989, the Registrar Accreditation Board (RAB) was established as an affiliate of ASQC to develop a program to evaluate the quality of services offered by registrars. RAB issued its first approval in March 1991, and additional firms have been approved since then. RAB and ANSI agreed to form a joint U.S. program in December 1991. Information on the RAB program is available from: RAB611 East Wisconsin Ave. P.O. Box 3005, Milwaukee, WI 53202 Phone: 414-272-8575; Fax: 414-765-8661 In February 1992, RAB announced the establishment of an ISO 9000 auditor certification program. RAB has also established requirements for the recognition of an auditor training course. For further information on the program, contact RAB at the above address. (20) The only European body which accredits registrars outside its geographical borders is the Dutch Council for Accreditation (RvC). It has also accredited registrars in the United States. RAB is currently working towards an agreement with RvC regarding mutual recognition of each other's accreditations. (21) The Standards Council of Canada (SCC) also has established an accreditation program for quality system registrars, which is open to U.S. registrars. (22) Programs similar to those of the RAB, RvC, and SCC have been established in a number of other European countries and elsewhere in the world, though they are currently not open to U.S. registrars. (23) However, some U.S. registrars with parent bodies in Europe have had their parent bodies accredited by other European accreditation bodies, such as the National Accreditation Council for Certification Bodies (NACCB) in the United Kingdom. Return to CONTENTS
WHAT IS THE RELATIONSHIP BETWEEN ISO/IEC GUIDE 25 AND ISO 9000?Both ISO/IEC Guide 25, General Requirements for the Competence of Calibration and Testing Laboratories, and the ISO 9000 Standard Series are official documents of the International Organization for Standardization. ISO/IEC Guide 25 has also been approved by the International Electrotechnical Commission (IEC). Developments in the field of quality systems were considered during ISO/IEC Guide 25 revision in 1990. For laboratories which serve as suppliers of calibration and test results to industry and others, ISO/IEC Guide 25 notes in its introduction: "Laboratories meeting the requirements of this Guide comply, for calibration and testing activities, with the relevant requirements of the ISO 9000 series of standards, including those of the model described in ISO 9002 when they are acting as suppliers producing calibration and test results." In addition, ISO/IEC Guide 25 includes technical requirements for the operation of a testing laboratory (i.e., participation in proficiency testing; adherence to specified test methodologies; and technical competence of laboratory personnel) which are not addressed in the ISO 9002. Return to CONTENTSWHAT CAN NIST'S MANUFACTURING TECHNOLOGY CENTERS DO TO HELP?NIST operates seven regional manufacturing technology centers that serve as resource facilities to help manufacturers improve their competitive position through the application of manufacturing technology. Several of these centers have sponsored workshops on ISO 9000. Manufacturers can contact these centers for specific information about the types of assistance they offer in the pre-assessment process for ISO qualification. A list of these centers is included in Appendix E. Return to CONTENTSWHAT CAN EDA's TRADE ADJUSTMENT ASSISTANCE PROGRAM DO TO HELP?The Department of Commerce's Economic Development Administration (EDA) funds a Trade Adjustment Assistance Program to help ailing companies. The program operates 12 regional centers. Companies that have experienced declines in sales and employment, due at least in part to increasing imports of competitive products, may apply to the program. The centers can provide financial assistance to companies, including assisting companies with costs associated with ISO 9000 registration. A list of these centers is included in Appendix F. Return to CONTENTSIS THERE ANY OTHER HELP AVAILABLE?Some state trade assistance/development authorities, alone or in conjunction with local colleges and universities, also have begun to provide training or offer other assistance. Interested parties should check with their appropriate state agencies. Return to CONTENTSWHERE CAN U.S. INDUSTRY GO TO GET ADDITIONAL INFORMATION?Additional information on U.S., foreign, and international voluntary standards; government regulations; and rules of certification for nonagricultural products is available from: National Center for Standards and CertificationInformation (NCSCI) National Institute of Standards and Technology (NIST) Bldg. 820, Room 164 Gaithersburg, MD 20899 Phone: (301) 975-4040 Fax: (301) 926-1559 For information on the EC 1992 Single Market program, copies of Single Market regulations, background information on the EC, or assistance regarding specific EC trade opportunities or potential problems, contact: The Office of EC AffairsInternational Trade Administration, Room 3036 14th and Constitution Ave., NW Washington, DC 20230 Phone: (202) 482-5823 Fax: (202) 482-2155 Both agencies are located in the Department of Commerce and can refer interested parties to other sources of information within and outside the federal government. Return to CONTENTSAPPENDIX AINFORMATION AND PUBLICATIONS AVAILABLE FROM Standards Services Division
APPENDIX B APPENDIX C
LIST OF SOME RELEVANT STANDARDSDOD Standards MIL-Q-9858A, Quality Program Requirements MIL-I-45208A, Inspection System Requirements ISO Standards/Guides ISO/IEC Guide 2, General Terms and their Definitions Concerning Standardization and Related Activities ISO/IEC Guide 7, Requirements for Standards Suitable for Product Certification ISO/IEC Guide 16, Code of Principles on Third-Party Certification and Related Standards ISO/IEC Guide 22, Information on Manufacturer's Declaration of Conformity with Standards or Other Technical Specifications ISO/IEC Guide 23 - Methods for Indicating Conformity with Standards for Third-Party Certification Systems ISO/IEC Guide 25, General Requirements for the Competence of Calibration and Testing Laboratories ISO/IEC Guide 27, Guidelines for Corrective Action to be Taken by a Certification Body in the Event of Misuse of its Mark of Conformity ISO/IEC Guide 28, General Rules for a Model Third-Party Certification System for Products ISO/IEC Guide 39, General Requirements for the Acceptance of Inspection Bodies ISO/IEC Guide 40, General Requirements for the Acceptance of Certification Bodies ISO/IEC Guide 43, Development and Operation of Laboratory Proficiency Testing ISO/IEC Guide 44, General Rules for ISO or IEC International Third-Party Certification Schemes for Products ISO/IEC Guide 45, Guidelines for the Presentation of Test Results ISO/IEC Guide 46, An Approach to the Review by a Certification Body of its Own Internal Quality System ISO/IEC Guide 48, Guidelines for Third-Party Assessment and Registration of a Supplier's Quality System ISO/IEC Guide 53, An Approach to the Utilization of a Supplier's Quality System in Third-Party Product Certification Draft ISO/IEC Guide 58, Calibration and Testing Laboratory Accreditation Systems - General Requirements for Operation and Recognition (Revision of ISO/IEC Guides 25, 54, and 55) ISO 8402, Quality - Terminology ISO 9000 (ANSI/ASQC Q90/EN 29000), Quality Management and Quality Assurance Standards - Guidelines for Selection and Use ISO 9000-3, Quality Management and Quality Assurance Standards Part 3: Guidelines for the Application of ISO 9001 to the Development, Supply and Maintenance of Software ISO 9001 (ANSI/ASQC Q 91/EN 29001), Quality Systems - Model for Quality Assurance in Design/Development, Production, Installation and Servicing ISO 9002 (ANSI/ASQC Q 92/EN 29002), Quality Systems - Model for Quality Assurance in Production and Installation ISO 9003 (ANSI/ASQC Q 93/EN 29003), Quality Systems - Model for Quality Assurance in Final Inspection and Test ISO 9004 (ANSI/ASQC Q 94/EN 29004), Quality Management and Quality System Elements - Guidelines ISO 9004-2, Quality Management and Quality System Elements - Part 2: Guidelines for Services ISO 10011 Part l, Guidelines for Auditing Quality Systems - Auditing ISO 10011 Part 2, Guidelines for Auditing Quality Systems - Qualification Criteria for Auditors ISO 10011 Part 3, Guidelines for Auditing Quality Systems - Management of Audit Programmes ISO 10012-1, Quality Assurance Requirements for Measuring Equipment - Part 1: Metrological Confirmation System for Measuring Equipment CEN/CENELEC - EN 45000 and 46000 Standards EN 45001 General Criteria for the Operation of Testing Laboratories EN 45002 General Criteria for the Assessment of Testing Laboratories EN 45003 General Criteria for Laboratory Accreditation Bodies EN 45011 General Criteria for Certification Bodies Operating Product Certification EN 45012 General Criteria for Certification Bodies Operating Quality System Certification EN 45012 General Criteria for Certification Bodies Operating Certification of personnel EN 45014 General Criteria for Supplier's Declaration of Conformity EN 45020 (ISO/IEC Guide 2), General Terms and their Definitions Concerning Standardization and Related Activities prEN 46001, Specific Requirements for the Application of EN 29001 for Medical Devices Return to CONTENTSAPPENDIX D
SOURCES FOR ADDITIONAL INFORMATION ON NIST-RELATED ACTIVITIES AND ORGANIZATIONS/DOCUMENTS REFERENCED IN THE TEXTo NIST's National Voluntary Laboratory Accreditation Program (NVLAP), contact: NVLAP/NIST o The Malcolm Baldrige National Quality Award Program, contact: Office of Quality Programs/NIST o NIST's Calibration Program, contact: Calibration Program/NIST o NIST's Standard Reference Materials Program, contact: Standard Reference Materials Program/NIST o NIST's Standard Reference Data Program, contact: Standard Reference Data Program/NIST o The American Society for Quality Control's (ASQC) standards, publications, activities and services; ISO TC 176's activities, contact: American Society for Quality Control (ASQC) o The Registrar Accreditation Board's (RAB) program, contact: Registrar Accreditation Board (RAB) o ANSI's activities or to purchase copies of ISO draft/final standards, other documents, magazines, and newsletters, and/or copies of European standards (ENs), contact: The American National Standards Institute (ANSI) o CEEM's Registered Company Directory, Quality Systems Update newsletter, and other publications, contact: CEEM o The Aerospace Industries Association's (AIA) activities, contact: Aerospace Industries Association o The Netherlands' RvC program, contact: Raad voor de Certificatie o The British Institute of Quality Assurance's (IQA) quality system assessor registration program, contact: The Secretary to the BoardNational Registration Scheme for Assessors of Quality Systems The Institute of Quality Assurance 10 Grosvenor Gardens London, U.K. SWIW ODQ Phone: 44-71-730-7154 o The Standards Council of Canada (SCC) Program, contact: Standards Council of Canada (SCC) o The European Organization for Testing and Certification, contact: The EOTC o The International Electrotechnical Commission's (IEC) Quality Assessment System for Electronic Components (the IECQ System), contact: Electronic Components Certification Board (ECCB) APPENDIX E (24)
MANUFACTURING TECHNOLOGY CENTERS (MTCs)NORTHEAST MTC SOUTHEAST MTC GREAT LAKES MTC CENTERS ESTABLISHED 7/21/92 Ms. Jane Pounds, Director MIDWEST MTC MID-AMERICA MTC APPENDIX F (25) TRADE ADJUSTMENT ASSISTANCE CENTERS (TAACs)NEW ENGLAND TAAC NEW JERSEY TAAC NEW YORK TAAC MID-ATLANTIC TAAC SOUTHEASTERN TAAC SOUTHWEST TAAC MID-AMERICA TAAC GREAT LAKES TAAC MIDWEST TAAC ROCKY MOUNTAIN TAAC NORTHWEST TAAC WESTERN TAAC APPENDIX GLIST OF ACRONYMSA
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E EEAC F & G
H, I & J
M & N
O, P & Q
R & S
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