Incidentes, Accidentes, Averías, Fugas y Fallos de Funcionamiento

With the growing use of accreditation to increase trust and quality by private actors, it also was increasingly implemented by the state. The prime focus in this case is the elimination of dangers to humans, the environment or society which may come up through for example fake products too low quality. To ensure a high quality and safety level, the state uses a combina-tion of market access control and market monitoring.

With the creation of the European single market, the EU has developed to be the central au-thority for laws touching upon conformity and accreditation. In 1985 the “New Approach”

was established with the goals to tackle technical barriers and to ensure a common (high) lev-el of safety for products. This is an important framework for the current regulatory instru-ments in the EU. On the basis of a Council Decision of May 1985, it creates a clear division of responsibilities of European lawmakers and standards bodies to facilitate a free movement of goods. EU directives thereby define the essential requirements to be fulfilled by goods and the European standards bodies have the task of creating the relevant technical specifications by adapting the essential requirements of the directives.⁶⁰ Chapter 3.2 describes the New Ap-proach in more detail.

The New Approach was expanded in 2008 with the “New Legislative Framework” (NLF),⁶¹ which applied the New Approach principles to further fields and sectors of the European sin-gle market. It includes specific measures aiming at removing the remaining obstacles to the free circulation of products and providing a major boost for trade among the EU Member States. To increase confidence in conformity assessment and certification facilities, the in-strument of accreditation was developed. Specific accreditation organizations were founded to certify the auditing competence of such entities.⁶²

The Regulation (EC) No 765/2008 states that the use of accreditation should be the preferred method to give proof of the competency of such notified bodies. With the changes made to the accreditation laws in 2010, this has also been widely put into practice (with exception of the medical sector⁶³). A further decision of the Regulation (EC) No 768/2008 deals with the

60 See Blind, Knut, “Deutschlands Standardisierungsstrategien hin zum Leitmarkt "Sicherheit": Potenziale und Herausforde-rungen”, in: Rolf Stober (ed.), Jahrbuch des Sicherheitsgewerberechts, Hamburg, Verlag Dr. Kovac (Schriften aus der For-schungsstelle Sicherheitsgewerbe 5), 2008, pp. 183-212.

61 The relevant regulation is “Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93”

62 See Blind, Knut and Axel Mangelsdorf, The Trade Impact of ISO 9000 Certifications and International Cooperation in Accreditation, 2012, Proceedings of the 17th EURAS Annual Standardisation Conference - Standards and Innovation-, pp.

21-34.

63See Teichler et al., op. cit., 2013, p. 37.

“presumption of conformity.” It declares that if the notified bodies are accredited for ful-filling the European standards then it can be assumed that they are also fulful-filling the require-ments of the regulations and directives. Of course, in case of deviation of the requirerequire-ments set by the standards and the regulations or directives, further examinations are necessary. Such deviations are expected in certain sectors, especially in the medical sector. In those cases the laws have priorities and those requirements have to be upheld. Further, specific requirements for the accreditation are to be tested separately.

It is declared by Regulation (EC) No 765/2008 that the CE marking is the only making which declares conformity with harmonized Community regulations. According to the regulation, Member States shall ensure the correct implementation of the regime governing the CE mark-ing and take appropriate action in the event of improper use of the markmark-ing. Other markmark-ing (which is has specific relevance in CRISP’s context) may be applied onto products if they provide additional information, value or cover a domain outside the Community regulations.

The NLF creates trust across the borders of the Member States of the EU and in their con-formity assessment bodies. Since the requirements are coming from harmonized European standards, they are shared by all members and allow products and services to be imported without an addition national test being necessary at the border. At the same time, the require-ments for the accreditation of the conformity assessment bodies are also set by the European standards and increase the trust in the results of the conformity assessment bodies of the other Member States.⁶⁴ With regards to the accreditation system in the law regulated section we can summarize as following:

 The basis of the competency validations are in the section of the European laws and standards. Accreditation may be, but is not mandatory, used to prove this competency;

 The accreditation can be found, when used, in the law regulated section, targeted to official institutions and governments of the Member States of the EU;

 The key function of the accreditation is to prove the competency of the conformity assessment bodies to the Member States of the EU; and

 The expectations towards the accreditation are, taking into account its key function, to preserve and test a level of competency dictated not only by the European standards but also by the laws and regulations.

In law regulated section, the state is especially a regulator. The characteristic feature of this section is that the state creates the conformity assessment system by legislation. This can be done at all three levels of influence:

 Defining the requirements for products and services, e.g. by harmonized standard;

 Defining the conformity assessment by law, e.g. by a legal duty to carry out a conformity assessment and/or by statutory provisions of the nature and method of conformity assessment; and

 Confirming competence of the conformity assessment bodies.⁶⁵

64See Röhl, Hans Christian and Yvonne Schreiber, Konformitätsbewertung in Deutschland. Konstanz: Universität Konstanz Fachbereich Rechtwissenschaft, 2006. http://nbn-resolving.de/urn:nbn:de:bsz:352-opus-19333

65See Teichler et al., op. cit., 2013, p. 29.

According to the European Parliament and the Council (2008)⁶⁶ and based on the specifc so-lutions of the companies concerned, conformity assessment procedures in the law regulated sector include 16 modules which are shown in Figure 9.

Source: Own figure

Figure 9: Modules of conformity assessment according to European Commission (2008)⁶⁷

Although the modules address production and products, CRISP’s emphasis is put on product-related assessments. According to the document, EC-type examination, for example, is the part of a conformity assessment procedure in which a notified body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of the legislative instruments that apply to it. Based on this module, the manu-facturer submits the following to the relevant notified body:

 Technical documentation;

 Supporting evidence for the adequacy of the technical design solution; and

 Specimen(s), representative of the production envisaged, as required.

Whereas the notified body:

66 See European Commission, Decision European Commission No 768/2008/European Commission of the European Par-liament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC, Brussels, 13.08.2008.

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008D0768&from=EN 67See European Commission, op. cit., 2008.

 Ascertains conformity with essential requirements;

 Examines technical documentation and supporting evidence to assess adequacy of the technical design for specimen(s): carries out tests, if necessary; and

 Issues EC-type examination certificate.

Technical requirements on Notified Bodies are outlined by European Commission (1997).⁶⁸ According to the document, notified bodies that can prove their conformity with the harmo-nised EN 45000 standards series by submitting an accreditation certificate or other documen-tary evidence are presumed to conform to the requirements of the directives. The EN 45000 series includes, for example, the following five standards describing requirements on the con-formity assessment bodies (Figure 10). Figure 11 shows the relevance of these standards for the conformity assessment modules described in Figure 9.

EN 45001 General criteria for the operation of testing laboratories

EN 45004 General criteria for the operation of various types of bodies performing inspec-tion

EN 45011 General requirements for bodies operating product certification systems EN 45012 General requirements for bodies operating assessment and certifica-tion/registration of quality system

EN 45013 General requirements for bodies operating certification of personnel Source: Own figure based on European Commission (1997)

Figure 10: EN 45000 standards with requirements on conformity assessment bodies

Aa B

HS not applied: EN 45004

HS applied: EN 45011 (observe relevant requirements in EN 45001 and/or EN 45004 for testing, examinations required) or EN 45004

Figure 11: Relevance of the EN 45000 series in European conformity assessment

68 See European Commission, The EN 45000 Series of Standards and the Conformity Assessment. Procedures of the Global Approach, Working Document, CERTIF 97/5 EN, Brussels, 15 September 1997.

http://ec.europa.eu/enterprise/policies/single-market-goods/files/mra/certif_97_5_en.pdf