ISO 9000
In brief Over the years, ISO 9000 + ISO 14000 News has published many case studies of ISO 9000 implementation in a wide variety of manufacturing and service organizations. Rarely, however, has the voice of the regulator been heard. That situation is rectified by the following major feature which examines ISO 9000 from a regulator’s perspective within the context of Europe’s Single Market. “The ISO 9000 family of standards plays an important role in the European Union’s industrial policy, both in relation to the promotion of the competitiveness of European industry, and with regard to the free movement of goods,” writes Andreas Julin, who has first-hand knowledge of the subject, having worked within the European Commission unit responsible for quality policy, certification and conformity marking (although the views expressed here are his own). The adoption of the ISO 9000 standards as European standards undoubtedly gave a formidable boost to international recognition of ISO 9000. At the same time, ISO 9000’s relationship with the European market has been dogged by some persistent misunderstandings, which Mr. Julin’s article will help to lay to rest. For those who still need convincing, he points out that: – the belief that ISO 9000 conformance is compulsory to do business in Europe is false; – the belief that ISO 9000 is the only quality assurance model acceptable in the European regulatory context is false; – the belief that if an ISO 9000 quality management system is certified, then it is automatically acceptable in the European regulatory context, is false.
by Andreas Julin
There is also a worry that in “raising the standard” of ISO 9001 requirements, the added cost for small and medium sized enterprises to implement the new version will cancel out the added value they may derive from it. The author draws on a recent EC survey to deliver some feedback on ISO 9000 from the market. Mr. Julin uses the survey results to make one of his main closing points – the blurred idea that ISO 9000 implementation must inevitably be followed by ISO 9000 certification. “Certification needs to be put back into perspective,” he writes. “Certification can give confidence to customers, but is in itself not a guarantee of product quality and customer satisfaction. It is essential to make a distinction between, on the one hand, the reasons for quality system implementation and its benefits, and, on the other hand, certification. Both have their own merits and, if applied together correctly, can provide an instrument for improving the competitiveness of a company.”
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Finally, Mr. Julin declares that too much effort is spent today in conforming to standards as an end in itself, instead of using the standards as a means to bring benefits to an organization and its customers. He writes: “In this respect, the objective of drafting a consistent pair of standards – ISO 9001 addressing quality management requiremens and ISO 9004 addressing quality management guidelines – and as stepping stones in relation to Total Quality Management (TQM) and business excellence, is in particular welcome.”
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and the European Union
Going on to the ISO 9000 revisions, Mr. Julin points out that due to the importance of the standards in EU regulations, then a major revision will have an impact on both general policy issues and specific requirements. The EC is therefore taking a close interest in the ongoing development of the revisions and Mr. Julin deals with the issues which are preoccupying the regulators, such as whether the revised ISO 9001 (which will replace the current ISO 9001, ISO 9002 and ISO 9003) will be compatible with the legislation built on the foundation of the current standards.
Introduction This article will describe the role of the ISO 9000 standards within the context of the European Union’s (EU) conformity assessment policy for industrial goods and will focus in particular on issues related to the revision of these standards. The views expressed in this article are those of the author and should not under any circumstances be regarded as an official position of the European Commission (EC). The ISO 9000 family of standards has, since publication in 1987, come to represent an international consensus on good management practice and has been adopted as national standards by more than 90 countries worldwide. In Europe, the ISO 9000 standards have been transposed as national standards by the national standards institutes which are members of the European standardization bodies, CEN and CENELEC. This means that the ISO 9000 standards have also been adopted as European standards, under the overall designation of EN ISO 9000.
lation to the promotion of the competitiveness of European industry, and with regard to the free movement of goods. The quality assurance standards, EN ISO 9001, EN ISO 9002 and EN ISO 9003, are referred to both in Council Decision 93/465/EEC and in some specific harmonization Directives in relation to conformity assessment modules based on quality systems.
ISO 9000 and EU legislation Before explaining the relationship between the ISO 9000 standards and EU legislation, it is necessary to describe the general legal framework in which they are situated. In order to create the “Single Market”, the EU put into place a new legal and technical framework within which to create har-
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1) “Harmonization” in this context refers to the need to replace the differing national legislations of EU Member States with a single body of legislation at EU level (e.g. in the form of “Directives ”) in order to ensure the free placing of goods on the market.
The actual detailed product specifications are laid down in harmonized European standards, drafted and adopted by the European standards organizations: CEN, CENELEC and ETSI. Misconceptions persist, so it is necessary to underline emphatically here that the use of such standards by a manufacturer remains voluntary. However, compliance with these standards gives a presumption of conformity with the said essential requirements. The New Approach, which was developed in 1985, was complemented in 1989 by the so-called “Global Approach”, a comprehensive policy and framework for conformity assessment. The Global Approach lays down the general principles and objectives that
The ISO 9000 family of standards plays an important role in the EU’s industrial policy
The ISO 9000 family of standards plays an important role in the EU’s industrial policy, both in re-
The use of the ISO 9000 standards is completely voluntary. The requirements in the quality assurance modules, in relation to the quality system, are generally formulated in order to allow options other than ISO 9000 to be adopted
These are the mandatory legal product requirements.
monized technical legislation for the free movement of industrial goods1). In the EU context, this is known as the “New Approach” to technical regulations and standards. Its basic idea is that when formulating technical regulations related to products, public authorities should limit themselves to setting out only the essential requirements – usually expressed as general health and safety objectives – to be met by the products.
govern conformity assessment for industrial products in the Single Market. A main objective is to create a homogeneous, transparent and credible technical environment in which to foster the necessary level of confidence among public authorities, economic operators and consumers alike. The Global Approach also lays down the conformity assessment methodology (in the form of modules, see figure 1 overleaf) to
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be used in technical harmonization Directives, as well as the principles governing the CE marking (Council Decision 93/ 465/EEC). With regard to the modules, they are based on the following characteristics:
management systems. These two activities are not identical from a technical point of view, but, what is important is that they achieve the same result, i.e. they ensure that products comply with essential requirements before being placed on the market.
• The modules entail either the manufacturer himself taking all actions necessary to ensure compliance of his product, or conformity assessment by an independent third party (“Notified Body” in EU parlance – see below).
• It is the European Council of Ministers and the European Parliament that decides, based on, among other things, the risks related to the product concerned, which modules should be used in specific Directives.
• The modules relate to the design and/or production phase of a product and, as a ground rule, a product is subject to the requirements of both of these phases before it can be placed on the market. The modules can be combined with each
To date, there are 14 New Approach Directives that make use of the quality assurance modules
other in a variety of ways in order to establish a comprehensive answer to conformity assessment requirements (see figure 2 ). • The modules are based on either product testing and product certification, or on quality
As should be evident, the aim of the Global Approach is to offer flexibility to economic operators by presenting them conformity assessment options that are adaptable to their situation and, at the same time, ensure a high level of health and safety. The principles and the rules of the New and Global Approaches are translated into individual technical harmonization “Directives” with a specific scope. There are, to date, 20 such Directives covering a wide range of economic activity.
CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY LEGISLATION A. (Internal control of production)
B. (type examination)
G. (unit verification)
H. (full quality assurance) EN 29001 (*)
Aa Intervention of notified body
Manufacturer submits to notified body - Technical documentation - Type
Notified body
- Ascertains conformity with essential requirements - Carries out tests, if necessary - Issues EC type-examination certificate
- Carries out surveillance of the QS - Verifies conformity of the design (1) - Issues EC design examination certificate (1)
D. (production quality assurance) EN 29002 (*)
P R O D U C T I O N
Aa Notified body - Tests on specific aspects of the product (1) - Product checks at random intervals (1)
E. (product quality assurance)
F. (product verification)
EN 29003 (*)
Manufacturer - Declares conformity with approved type - Affixes the CE mark
Manufacturer - Operates an approved quality system (QS) for production and testing - Declares conformity with approved type - Affixes the CE mark
Manufacturer - Operates an approved quality system (QS) for inspection and testing - Declares conformity with approved type, or to essential requirements - Affixes the CE mark
Manufacturer - Declares conformity with approved type, or with essential requirements - Affixes the CE mark
Manufacturer - Submits product - Declares conformity - Affixes the CE mark
Notified body - Tests on specific aspects of the product (1) - Product checks at random intervals (1)
Notified body
Notified body - Approves the QS - Carries out surveillance of the QS
Notified body - Verifies conformity - Issues certificate of conformity
Notified body - Verifies conformity with essential requirements - Issues certificate of conformity
- Approves the QS - Carries out surveillance of the QS
( 111) Supplementary requirements which may be used in specific directives (*) Renamed EN ISO 9001 (EN 29001), EN ISO 9002 (EN 29002) and EN ISO 9003 (EN 29003) in 1994 standards updating.
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Manufacturer - Operates an approved quality system (QS) for design
Notified body
C. (conformity to type)
A. Manufacturer - Declares conformity with essential requirements - Affixes the CE mark
Manufacturer - Submits technical documentation
Figure 1: The European Union’s conformity assessment modules.
Manufacturer - Operates an approved QS for production and testing - Declares conformity - Affixes the CE mark
Notified body - Carries out surveillance of the QS
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D E S I G N
Manufacturer Keeps technical documentation at the disposal of national authorities
Figure 2: the EU conformity assessment modules, with which products must comply before being placed on the European market with the CE mark,
DESIGN PHASE
PRODUCTION PHASE MODULE A MODULE C
MODULE B MODULE D TECHNICAL FILE
MODULE E
MANUFACTURER
MODULE F relate to both the design and production phases of products and can be combined in various ways.
ISO 9000 and the quality assurance modules (In the following, “ISO 9000 standards” is given to mean ISO 9001, ISO 9002 and ISO 9003). There are three modules based on quality management systems:
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Module D, which can be said to derive from ISO 9002, relates to quality assurance of production and final product testing, and inspection.
MODULE G MODULE H
lation to the quality system, are generally formulated in order to allow options other than ISO 9000 to be adopted. Figure 3
Modules
Directives
D
89/686/EEC – Personal protective equipment1) 90/384/EEC – Non-automatic weighing
machines1)
90/396/EEC – Active implantable medical devices
Module E, which can be said to derive from ISO 9003, relates to final product testing and inspection.
90/393/EEC – Gas appliances
Module H, which can be said to derive from ISO 9001, relates to quality assurance of design, production and final product testing, and inspection. There is also a variant of module H whereby the design phase is complemented by a design examination performed by a Notified Body (see below).
94/42/EEC – Hot water boilers
When the modules were conceived, the then existing ISO 9001, ISO 9002 and ISO 9003 were used as a basis and there was a clear intention to promote the use of these standards. Council Decision 93/465/EEC also indicates that conformance with these standards gives a presumption of conformity with the related requirements in the modules (Module D – ISO 9002, Module E – ISO 9003 and Module H – ISO 9001). However, the use of the ISO 9000 standards is completely voluntary. The requirements in the quality assurance modules, in re-
To date, there are 14 New Approach Directives that make use of the quality assurance modules (see figure 3).
9/13/EC – Telecommunications terminal equipment and satellite earth station equipment2)
93/15/EEC – Explosives for civil uses 93/42/EC – Medical devices 94/9/EC – Equipment and systems in potentially explosive atmospheres (ATEX) 94/25/EC – Recreational craft 95/6/EC – Lifts 96/98/EC – Marine equipment3) 97/23 – Pressure equipment 98/79/EC – In vitro diagnostic medical devices
E
H
t t t t t t t t t t t t
t t t t t
t t t t t t t t t t t t t
1) The quality assurance modules described in these directives do not completely correspond to those described in Council Decision 93/465/EEC. 2) This Directive will be replaced by Directive 99/5/EC on radio and telecommunications equipment. The conformity assessment procedures will mainly be based on module A, but module H will still be used. 3) This Directive is not considered as a “New Approach” Directive, although it follows the principles of the Global Approach.
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The quality assurance modules describe the elements a manufacturer must implement in his organization in order to demonstrate that the product fulfils the essential requirements of the applicable Directive. This means that a manufacturer is given the possibility of using a quality system for the purpose of demonstrating compliance with regulatory requirements, i.e. that the manufacturer has the capability to design (if applicable), manufacture and supply products that fulfil the applicable essential requirements. A quality management system implemented on the basis of the EN ISO 9001, EN ISO 9002 or EN ISO 9003 standard gives a presumption of conformity with the respective modules with regard to the provisions in the modules that may be met by these standards. This means that the manufacturer must specifically address regulatory needs when implementing and applying a quality management system for the purpose of the Directives, in particular:
• The identified standards or other technical solutions must be used as design input and verification that design output ensures that the essential requirements will be met. • The measures taken by the organization to control production must ensure that the products conform to the identified safety requirements. • The organization, in its measurement and control of production process and finished products, must identify and use methods which are either identified in standards, or other methods appropriate, to ensure that the essential requirements are met. • Quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, must be suitable to ensure the fulfillment of the applicable essential requirements.
notified (mandated) by the EU Member States after it has been determined that they are technically competent to carry out the tasks they are to be notified for. The Notified Bodies may offer their services to any economic operator in the EU, or in a third country. Likewise, a manufacturer is free to approach the Notified Body of his choice.
The manufacturer must specifically address regulatory needs when implementing and applying a quality management system for the purpose of the Directives
Basic misunderstandings In view of the above explanations, two basic misunderstandings in relation to the ISO 9000 standards and EU legislation can be clarified.
• The quality objectives, quality planning, quality manual and control of documents must fully take on board the objective of delivering products that conform to the essential requirements;
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• The manufacturer must identify and document the essential requirements that are relevant for the product and the harmonized (European) standards to be used or other technical solutions that will ensure fulfillment of the essential requirements.
The manufacturer has the responsibility to implement and continuously operate the quality management system in such a way that regulatory needs are respected. The Notified Body must ensure in its assessment, approval and continued surveillance that this is the case. As mentioned above, Notified Bodies are responsible for carrying out the conformity assessment activities requiring the intervention of a third party. As a consequence, Notified Bodies are always third parties. They are
Firstly, many New Approach Directives use module A (manufacturer’s “self certification”) as the conformity assessment procedure. In Directives that require the intervention of a Notified Body, the use of the quality assurance modules is only one of the alternative conformity assessment activities offered under the Directives. The Directives always offer other conformity assessment options based on product testing and product certification. Secondly, if a manufacturer chooses to use a conformity assessment option based on quality assurance, then he is not
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1) “Compliance to ISO 9000 is mandatory in order to do business in Europe”. From a legislative point of view and, in particular, the New Approach Directives, this is false.
obliged to use the ISO 9000 standards. He can very well base it on his own existing system, or on other quality management system models. However, he must convince the Notified Body that his quality management system complies with the requirements of the applicable Directive. In this context, a related misunderstanding is that the quality management system must be certified. This too is false. A Notified Body approves the quality management system in relation to the requirements of the Directive. This may be done on the basis of a certified quality system, but having a certified quality system is not a requirement. A quality system which is not certified is just as valid if it meets the requirements of the Directive, in the judgement of the Notified Body.
2) “My ISO 9000 certified quality system is good enough for the Directives.” By this is meant that a quality system which has been implemented and certified for “purely” commercial or contractual reasons is automatically assumed to fulfil the requirements of the Directive. This is false. If a quality system is to be implemented and “certified” for the purpose of the Directives as well, then this must be done, as decribed above, fully taking onboard all elements that will ensure that the products placed on the market comply with the essential health and safety requirements.
which will replace the existing ISO 9001, ISO 9002 and ISO 9003 – and ISO 9004. The examination by the Commission services has focused on a number of issues, among which the following should be highlighted: The suitability of the revised standards to support EU policy and legislation • In general terms, the objectives of the revision are welcome and the importance of having standards that refocus organizations on the key objectives for quality are underlined.
The manufacturer has the responsibility to implement and continuously operate the quality management system in such a way that regulatory needs are respected
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The Year 2000 revisions of ISO 9000 In view of the above, it will be easily understood that a major revision of the EN ISO 9000 standards will no doubt have an impact on both general policy issues and specific requirements in EU legislation. Because of this, the European Commission’s services have been actively examining the revision of the ISO 9000 standards, with particular attention to the implications for the modular conformity assessment methodology of the Global Approach. The Commission services have been granted an A-liaison status with Subcommittee 2 (SC 2) of ISO/TC 176, Quality management and quality assurance. SC 2 is responsible for revising ISO 9001 –
• With regard to addressing the needs related to regulatory requirements, there are some concerns. These concerns are related to both the standard ISO 9001 and to its future application in relation to the modules (for the latter point see below). The revised ISO 9001 can be considered to offer an overall methodology, but does not completely address specific needs for complying with product regulations related to protecting health and safety. The reason for this is that ISO 9001 is designed primarily to meet commercial and contractual needs and is aimed at customer satisfaction. Regulatory needs put a more pronounced emphasis on product conformity with regulatory requirements – something that can be
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• The Notified Bodies are well aware of the revision of the ISO 9000 standards and keep themselves informed through a number of channels.
considered to be not sufficiently addressed in the revised standard. Furthermore, the revised ISO 9001 can be considered to be “raising the standard” in a number of ways compared to the current 1994 version. It is questionable whether the potential costs related to additional and/or stricter requirements may be justifiable from a regulatory point of view.
• The responding Notified Bodies are in general positive to and welcome the revision of the ISO 9000 standards. Of the concerns raised, several pointed to the need of ensuring consistency between the revised ISO 9001 and the quality assurance modules.
If a manufacturer chooses to use a conformity assessment option based on quality assurance, then he is not obliged to use the ISO 9000 standards and have it certified. At the same time, it is SME’s that encounter the greatest difficulties in doing so. It is therefore essential that the revised standards properly address the situation of SME’s and that any “raising of the standard” that may lead to additional costs must be clearly justified as adding value through use of the revised standard. Ensuring continued consistency between the quality assurance modules and the revised ISO 9001
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• As mentioned above, the European Commission had in mind, when designing its conformity assessment approach based on modules, an aim of promoting the use of the ISO 9000 standards. The intention is that this should continue. In order to do so, one of the issues to deal with is how to ensure a consistent use of one quality system standard in relation to the three EU quality assurance modules. This is particularly relevant for the application of the concept of “reduced
scope”, which allows organizations to omit ISO 9001 requirements not relevant to them, such as, for example, the design requirements. Here, the discussions are still going on towards producing guidance for applying the revised ISO 9001 in relation to the modules.
What the Notified Bodies think of ISO 9000 The Notified Bodies are responsible for carrying out the conformity assessment activities of the Directives. These bodies can therefore be considered as a prime source of information on the use of the quality assurance modules. A questionnaire was consequently addressed by the EC to those bodies which are notified to carry out conformity assessment against the quality assurance modules of the New Approach Directives. The objective was to get a general impression of the use of the quality assurance modules, difficulties encountered by the Notified Bodies and their views in general on the revision of the ISO 9000 standards. The questionnaire was sent to 210 Notified Bodies with an overall response rate of 43 %. The results of the questionnaire can be summarized as follows:
A quality system which is not certified is just as valid if meets the requirements of the Directive, in the judgement of the Notified Body • Several Notified Bodies raised actual and potential difficulties for SME’s in applying the ISO 9000 standards and the corresponding modules, e.g. high costs, lack of information and lack of resources. • Almost half the Notified Bodies that responded to the questionnaire had not experienced, in general terms, any difficulties in applying the quality assurance modules. The main difficulty encountered could be characterized as concerning the difference in approach to the use of quality management systems related to the Directives (compliance with regulatory product requirements) and ISO 9000 (voluntary, customer satisfaction-oriented) respectively. • Many suggestions for improving the current ISO 9001, ISO 99002 and ISO 9003 were put forward. Most of these (e.g. more emphasis on customer satisfaction, continuous improvement, business process approach) are, in fact, actually being addressed in the revision process. Thirteen per cent of the Notified Bodies considered that no improvements were necessary.
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• Very often, it is small and medium sized enteprises (SME’s) that are faced, for different reasons, with an obligation to implement a quality system
• Almost half of the responding Notified Bodies did not foresee any problems with the revised ISO 9000 standards. The possible difficulties identified included the need to ensure compatibility between the revised ISO 9001 and the modules, ensuring a smooth transition from the current to the revised ISO 9000 standards, and the need for adapting the EN 46000 standards (related to medical devices, ISO 13845 and ISO 13488) to the revised ISO 9001. • The large majority of approved quality systems in the EU relates to the Directive on medical devices. Most of the quality management systems were approved according to Module D (equivalent to ISO 9002). The ISO 9001, ISO 9002 and ISO 9003 standards had been used as a basis in most cases. Most of the approved quality systems were for manufacturers in the European Economic Area countries.
This has led to the increased participation of the economic operators in the legislative process and better reallocation of responsibilities between the public and private sectors. It is clear from the above that conformity to EU regulatory requirements through the use of different quality instruments is a necessary condition for marketing products on the Single Market, but is not necessarily sufficient to ensure the proper level of competitiveness of European industry. This led the Commission services in 1996 to produce a “European Quality Promotion Policy for Improving European Competitiveness” (see, “European Commission’s verdict on ISO 9000”, ISO 9000 News, September/October 1997). The European Quality Promotion Policy was designed to develop a favourable environment in which companies and public administrations in Europe can
than on an overall economic perspective. This, in turn, had led to the development of a somewhat artificial market for certificates, i.e. added costs for companies, which has not necessarily led to added value considering the conditions in which some of the certification is carried out.
It is questionable whether the potential costs related to additional and/or stricter requirements may be justifiable from a regulatory point of view
As can be seen from these survey results, many of the concerns of the Commission services were confirmed by the practical experience of those using the quality assurance system modules and the ISO 9000 standards.
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A major revision of the EN ISO 9000 standards will no doubt have an impact on both general policy issues and specific requirements in EU legislation ISO 9000 and the competitiveness of industry EU policy for the free movement of industrial goods has evolved from an approach based purely on legislation and public intervention towards a more voluntary approach based on a homogeneous system combining regulatory and voluntary conformity assessment with standard and/or customer specifications.
aim to achieve excellence in terms of their output and internal organization for the benefit of society as a whole. The policy has a primary ambition of constituting an awareness policy – to give political visibility and support to a pan-European range of quality instruments and actions. In relation to the ISO 9000 standards, the European Quality Promotion Policy has an objective of placing these standards into perspective, particularly in relation to certification. The policy identified the need to tackle the excessive importance given to quality system certification due to, at least in part, the concentration of Community policy on conformity issues, rather
This situation is not only due to a minority of unscrupulous consultants or certifiers, but also to the unnecessary requirements of users, customers, big companies and even public authorities, who have a tendency to bank on these mechanisms to obtain guarantees that can best be obtained by other, less burdensome means. Such concentration on certification has given the impression to some parts of the market-place that a certified quality system is the answer to economic survival. Although quality systems are an important quality tool, as is certification, even when taken together they cannot be the answer to the whole problem, as can be seen when comparing the criteria
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About the author
In a survey commissioned by the Commission on the added value and credibility of third party certification of quality systems, some of the results indicated that one could question whether the quality systems implemented by the companies involved in the study fulfilled the key objectives and responsibilities for quality (as defined in ISO 9000-1). One of the main conclusions of the study was that certification needs to be put back into perspective. Certification can give confidence to customers, but is in itself not a guarantee of product quality and customer satisfaction. It is essential to make a distinction be-
It is essential to make a distinction between, on the one hand, the reasons for quality system implementation and its benefits, and, on the other hand, certification tween, on the one hand, the reasons for quality system implementation and its benefits, and, on the other hand, certification. Both have their own merits and, if applied together correctly, can provide an instrument for improving the competitiveness of a company.
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ISO 9004-1 has the primary aim of communicating the ideas behind quality management. Unfortunately, this standard is little known or used. It can be said that a lot of the quality efforts made today are geared towards complying to standards as an end in itself instead of a means of bringing benefits to an organization and its customers. In this respect, the objective of drafting a consistent pair of standards – ISO 9001 addressing quality management requirements and ISO 9004 addressing quality management guidelines – and as stepping stones in relation to Total Quality
Andreas Julin, a Swede, presently works for the European Commission’s DG I External Relations, where he is mainly responsible for trade policy issues in standards, certification and technical regulations in liaison with the USA. He previously worked for DG III Industry, in a unit responsible for quality policy, certification and conformity marking. There, he specifically dealt with matters related to testing, certification, inspection and accreditation, as well as associated standards, e.g. the EN 45000 and EN ISO 9000 series. After graduating from the Stockholm School of Economics with a Masters degree in economics, he has worked on competition and trade policy issues since 1989, in particular on technical barriers to trade. Before joining the European Commission, he has held posts with the Swedish Board for Competition, the Swedish National Board of Trade, the European Free Trade Association (EFTA), and the Swedish Board for Accreditation and Conformity Assessment (SWEDAC).
Andreas Julin, European Commission, DG I.M.2, CHAR 13/94, 200, rue de la Loi, B-1049 Brussels, Belgium. Tel. + 32 2 296 7586. Fax + 32 2 299 1651. E-mail
[email protected]
Management (TQM) and business excellence, is in particular welcome. This does not mean standardizing TQM but facilitating the further step towards TQM if a company so wishes to take it. However, it must be made very clear that the revised ISO 9004 must not become an implementation guide for ISO 9001 certification. Here we should reflect back to when the ISO 9000 standards were first adopted in 1987. Then, not many would have imagined the quality system certification market we have today. Q
Basic reference documents for this article – Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards. – Communication from the Commission to the Council and the European Parliament of 5 July 1989 on a global approach to testing and certification – “Quality measures for industrial products”. – Council Resolution of 21 December 1989 on a global approach to testing and certification for industrial products. – Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment activities and the rules for the affixing and use of the CE conformity marking. – Working document of the Commission, “A European Quality Promotion Policy for Improving European Competitiveness”.
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for the European Quality Award and the quality system requirements as set out in ISO 9001:1994.