sou · GUB3113 · 2007-01-01 00:00:00 — slår utredningen att regeringen uppdrar åt respektive föreskrivande myndighet att i sina föreskrifter införa explicita klausuler om öm- sesidigt erkännande, i de fall sådana klausuler saknas. Sådana klausuler har flera fördelar enligt utredningens mening. Dels visar myndigheten därmed att den faktiskt är medveten om att ömse- sidigt erkännande gäller. Dels får berörda kunder till kontrollorga- nen bättre information om att ömsesidigt erkännande gäller, vilket torde öka deras valmöjligheter. I det regelverk som styr ackrediteringsverksamheten, dvs. i första hand lagen och förordningen om teknisk kontroll samt SWEDAC:s föreskrifter, saknas effektiva möjligheter till sanktioner mot någon som olovligen åberopar ackreditering eller ställning av anmält organ. Utredningen föreslår därför att det i lagen om teknisk kontroll införs en sanktionsavgift i syfte att hantera sådana problem. Avgiften bör tillämpas mot överträdelser inom såväl det obligatoriska som det frivilliga området. Utredningen föreslår att vissa överklagandemöjligheter införs i lagen om teknisk kontroll. Således anser utredningen att det bör införas en explicit regel om att beslut rörande utnämnande av an- mälda organ får överklagas till allmän förvaltningsdomstol. Vidare anser utredningen att SWEDAC bör ges ansvar för att vid behov återkalla anmälningar till EU av anmälda organ, och att det sam- tidigt bör införas en möjlighet att överklaga sådana beslut till all- män förvaltningsdomstol. Användning av öppna system inom ytterligare områden Kontrollordningar som bygger på öppna system innebär att obe- roende och självständiga organ utför bedömning av överensstäm- melse i konkurrens. Enligt utredningen behöver teoretiskt sett en- dast ett kriterium vara uppfyllt för att ett öppet system skall kunna tillämpas för kontrollordningen inom ett visst område, nämligen att det går att definiera en norm mot vilken den som utför kon- trollen skall genomföra bedömningen av överensstämmelse. Denna norm måste vara så precist formulerad att av varandra oberoende bedömare kan använda den och komma till samma resultat. För att en sådan norm skall kunna tas fram måste de krav som ställs verbaliseras, tydliggöras och dokumenteras. Detta sker enklast genom hänvisning till standard, men kan också ske på andra sätt. Som framgått anser utredningen att öppna system är en rationell metod för att organisera kontrollverksamhet, och att det befintliga öppna systemet i stort sett fungerar väl. Utredningen kan heller inte se några betydande nackdelar med att använda öppna system. Mot denna bakgrund anser utredningen att öppna system som huvudregel bör användas i all kontrollverksamhet där så är möjligt. Enligt utredningen torde det teoretiskt sett vara möjligt att defi- niera den norm som krävs – och därmed använda öppna system – i alla situationer där kontroller sker mot en definierad kravmassa, dvs. i princip som en del i alla typer av tillsyn, oavsett sakområde. Om öppna system skall användas som ett redskap i offentlig till- syn är det dock väsentligt att påpeka att en sådan ordning i normal- fallet bör bygga på att de oberoende tredjepartsorganen endast utför själva kontrollerna, medan myndighetsutövningen – t.ex. att fatta beslut om sanktioner som en följd av att brister uppdagats vid en kontroll – alltjämt bör vara en myndighetsuppgift. Att slå fast en regel om att öppna system alltid skall användas vore dock inte lämpligt enligt utredningens mening. I ett enskilt fall kan det nämligen förekomma olika typer av omständigheter som vid en sammanvägd bedömning leder till slutsatsen att öppna system inte bör användas. En omständighet som kan tala emot att använda öppna system är att det inom det berörda området inte bedöms sannolikt att en rimligt välfungerande marknad av obe- roende tredjepartsorgan kan etableras. Andra omständigheter som kan tala emot att använda öppna system kan t.ex. vara att det inom det berörda området råder stränga sekretesskrav och dessa bedöms vara svåra att värna i ett öppet system. Vidare måste beaktas att det inom vissa områden gjorts ett aktivt ställningstagande från stats- makterna och/eller inom EU att inte använda öppna system, t.ex. är kontrollordningarna inom vissa produktområden, som inom EU harmoniserats med den gamla metoden, inte avsedda för öppna system. Detta innebär dock inte att öppna system per definition skulle vara omöjliga att använda inom dessa produktområden, men däremot att de med dagens ordning inte är avsedda för öppna system. För att bedöma om det i ett enskilt fall är lämpligt att använda ett öppet system krävs därför en djupgående situationsanpassad analys. Med det övergripande perspektiv som gällt för uppdraget, har utredningen dock inte haft möjlighet att göra sådana djup- gående situationsanpassade analyser av förutsättningarna för att införa öppna system inom enskilda sektorer. ens utvärdering av det befintliga, svenska öppna systemets genom- förande och funktion i första hand utgått från systemnivå, och inte enskilda områden. Mot bakgrund av ovanstående anser utredningen att den huvud- regel om öppna system som slogs fast av inför EES- avtalet bör befästas och förtydligas. Utgångspunkten för detta bör vara att öppna system som huvudregel bör användas som metod för att organisera kontrollen i all tillsyn som inkluderar kontroller mot en definierad kravmassa. Enligt utredningens mening bör som en konsekvens av detta ett allmänt krav ställas på såväl statliga myndigheter som offentliga utredningar om att de skall överväga öppna system som metod för tillsynsverksamhet. Utredningen anser att en presumtion därvid bör finnas om att öppna system skall användas, dvs. i de fall då en myndighet eller offentlig utredning anser att öppna system inte kan eller bör användas, bör det i princip ankomma på myndig- heten/utredningen att visa varför så inte bör ske. Utredningen anser att ett förtydligande av dagens huvudregel – med ovanstående inriktning – lämpligen bör ske genom ett princip- uttalande från sida. I syfte att förtydliga omfånget av den huvudregel som utred- ningen anser bör gälla föreslår utredningen också att lagen om teknisk kontroll bör byta namn till Lag (1992:1119) om bedöm- ning av överensstämmelse och annan teknisk kontroll. was assigned to evaluate the Swedish open system of testing and conformity assessment. Overall, this assignment is twofold. It involves, first, monitoring and evaluating the workings of the existing open system and, second, analysing how use of open systems can be developed further. Structure of the open system Inspection based on open systems means that independent, autonomous bodies perform conformity assessment in competition. Conformity assessment of a product or suchlike means the procedure for checking that the product meets existing requirements. Testing and assessment often take place on a voluntary basis. In as in many other countries there are also, however, mandatory rules of public law governing product design and inspection. These mandatory rules exist within the sectors of 20-odd central government regulatory agencies. From the mid-1970s, applied a system of national testing sites for compulsory testing and conformity assessment. These sites had a monopoly of all testing prescribed by various public agencies within the sites respective catchment areas. During the 1990s, major changes took place. In preparation for accession to the EEA, the Swedish Parliament (Riksdag) decided to discontinue the national testing-site system. Instead, mandatory conformity assessment was to be based on the new principles that had begun to be introduced in Community a few years before. Free movement of goods is one basic principle of EU cooperation. To facilitate this, Member States requirements concerning product design have, in many cases, been harmonised by means of various product directives. Where the EU has not yet drawn up uniform regulations, the principle of mutual recognition is applied. The premise for this principle is that a must approve a product from another if the product concerned meets product requirements in the home country. Product directives have been drawn up according to two different legislative methods. Directives drawn up according to the normally specify complete specifications that the products must fulfil. These directives of which just over 700 are still in force are thus highly detailed in technical terms. From the mid-1980s, the New Approach to technical harmonisation was applied. Directives drawn up according to the New Approach some 25 to date specify only basic safety requirements. Detailed specifications are, instead, found in technical standards drawn up according to the current routines for standardisation work and altered in line with technological development. However, these standards are not mandatory: the detailed technical requirements can be met in other ways as well. For the , there is no uniform procedure for testing and assessment. Instead, each directive specifies sometimes for groups of directives which procedures are to be observed before products are released on the market. Requirements concerning mandatory type inspection by a type-approval agency are some- times imposed. Parallel to the introduction of the New Approach, however, system of conformity assessment has also been reformed. This has been done through introduction of the Global Approach, which is now the norm for product areas harmonised by means of the New Approach. Compulsory advance approvals by public agencies have been abolished within the product areas concerned. Instead, the main rule in the Global Approach is that manufacturers themselves can certify that their products fulfil the requirements imposed in the directives concerned. In some cases, however, the manufacturer is required to have a certified quality system or assign to an independent inspection body (a notified body) the task of assessing, before a product is released on the market, whether it meets essential requirements. Notified bodies are those that a has deemed competent to perform testing, assessment or certification under a particular product directive, and that has been notified to the EU by the Member State for such tasks. Under the New Approach Directives, there are approximately 2,000 notified bodies, some 50 of which are Swedish. In the Global Approach, these notified bodies compete with one another in an open system. Official supervision of product conformity to the prescribed requirements takes place in the Global Approach, primarily through market surveillance. Before accession to the EEA, Parliament decided that an open system should be applied as the principal rule for testing and conformity assessment in , both in the areas harmonised through various EC directives (the harmonised sector) and in the areas where can decide independently how to organise assessment (the non-harmonised sector). The areas in which can decide, for the most part independently, concern requirements of assessment before products are launched on the market, when it comes to new products not covered by EC directives, and recurrent inspections. A recurrent inspection means, broadly, an inspection of various types of installation, such as lifts, that takes place annually or at other intervals. An open system has not, however, been introduced for all testing and conformity assessment regulated in public law. Certain product areas harmonised by means of the , such as compulsory advance testing of motor vehicles, are based on the premise that, for each directive, Member States should designate special assessment bodies. Thus, open systems are not intended for these product areas. Some sectors have also been exempted by the Government from the main rule on open systems. The most prominent example is periodic vehicle testing, where Parliament has decided that AB should have a monopoly. In each sector, the sector authority in charge is responsible for implementing and following up EC product directives and monitoring safety issues. These agencies are generally entitled to issue their own regulations imposing compulsory requirements, regulated in public law, governing product design and inspection. In the harmonised sector such agency regulations serve mainly to assist Swedish implementation of EC regulations. Before agencies issue regulations on testing and conformity assessment, they must consult (). Bodies wishing to compete for testing or assessment assign- ments in the open system must, in general, meet certain prescribed competence requirements. In the harmonised sector, they must be designated as notified bodies. In the non-harmonised sector, the regulatory agencies usually state that the bodies concerned must be accredited for the function under the Act (1992:1119) on technical conformity assessment. However, such requirements are often, but not always, supplemented by rules that bodies accredited under corresponding provisions in other EEA member countries may also be considered. Other models, too, may qualify: there are, for example, areas in which the provider of the service concerned must be certified for the task by an accredited certification body. The competence requirements for designation as a notified or accredited body are based mainly on applicable standards. How- ever, a regulatory agency is entitled to issue regulations imposing any special competence requirements that it deems necessary within its own sphere of activities. SWEDAC, which is national accreditation body, is responsible for competence assessment, designation and continuous supervision of Swedish notified and accredited bodies alike. Before notified bodies are designated, SWEDAC must consult the public agencies concerned. Accreditation is formal recognition that a body is competent to perform certain specified services, such as testing. At year-end 2005 there were more than 2,600 bodies with valid accreditation in . In the EU, an overview has been under way for several years to improve implementation of the New Approach and the principle of mutual recognition. This overview is expected to result in draft regulations to be adopted by Commission just before year-end 2006 and submitted to the Council and European Parliament in early 2007. The definitive regulations should therefore be issued around mid-2008. Based on its findings to date, the Committee considers that the proposals should be well in line with the main features of the Swedish open system of testing and conformity assessment. Accordingly, only relatively small compulsory adjustments of the Swedish system are likely to be needed as a result of the overview. The Committees assessment does not include market surveillance, which it has deemed to be beyond the scope of its assignment. Evaluation of the existing Swedish open system Within the harmonised sector, cannot opt for any solutions regarding testing and conformity assessment other than those that are compatible with Community law. Therefore, the only substantial scope for reassessing present-day Swedish solutions regarding testing and conformity assessment is likely to be within the nationally regulated sector. How far such a reassessment is called for may, in turn, be assessed only in the light of the workings of the current system. Given this background, the Committee has not found it worthwhile to attempt an entirely open-ended evaluation of the Swedish system of testing and conformity assessment, i.e. one based on the assumption that the whole of this system needs reassessing. Instead, the Committee has focused on seeking to assess how the existing Swedish open system of testing and conformity assessment works, and which problems exist in its implementation. In carrying out its evaluation, the Committee has considered sectors where an open system has been introduced, de facto, mainly in testing and conformity assessment but also in certain associated areas for assessment of conformity. It is difficult to determine with certainty what the effects of introducing the open system have been. This is partly because development in the product areas concerned has, of course, been influenced by other factors as well during the ten years or so in which open systems have existed in . These factors include, for example, increasing globalisation and general technological and product development. However, the overall assessment of the Committee is that the open system works well on the whole. There are also several reasons for believing that open systems are a rational method of organising assessment activities. Since open systems are based on competition between independent assessment bodies they can, for example, be assumed to promote efficiency. An ability to procure testing and assessment services in competition also presupposes that requirements concerning the services are verbalised, clarified and documented. Accordingly, in general, open systems are more transparent than non-open ones. This makes it easier for stakeholders concerned to grasp which requirements actually exist. can the Committee discern any substantial disadvantages in using open systems. Experience from the sectors in which open systems have been introduced shows, for example, that safety has not generally suffered as a result. In some product areas, the safety level seems rather to have improved in recent years. How far this can be ascribed to the introduction of open systems or is due to other causes is, however, uncertain. Moreover, the quality level of the testing and control conducted in the product areas concerned has, on the whole, remained unchanged following the introduction of open systems. Regarding the costs of testing and conformity assessment it is, admittedly, true that the costs incurred, especially by the agencies concerned, have not infrequently risen slightly as a result of open systems being introduced. Several agencies have explained this to the Committee with reference to increasing assessment activities and regulatory work performed by the agency in conjunction with the introduction of open systems. But the picture is unclear: there are also agencies that are of the opinion that costs have, rather, decreased after open systems have been introduced. In its evaluation, the Committee has identified certain problems in the implementation of the open system of testing and conformity assessment (see the next section). In the Committees estimation, however, these problems are not of such a dramatic nature as to prompt a return to the model applied before the open system was introduced, nor to question the very basis of the principal rule on open systems that, in the early 1990s, Parliament adopted in preparation for joining the EEA. Regarding several of the issues raised in the directives for the assignment, the Committee is also of the view that problems are, in practice lacking or that only limited problems exist. This applies to routines for consultation, information exchange and feedback in the open system, as well as to SWEDACs supervision of notified and accredited bodies. In addition, some of the problems observed by the Committee are expected to be soluble through measures that have been taken or are planned in other contexts. For example, the current EU overview of the New Approach is likely to deal with a criticism that has been put forward by various stakeholders: that the notified bodies of various Member States are of varying quality. In these cases, the Committee finds no need to propose any special measures. Proposed improvements in the current open system As explained above, the Committee considers that the problems observed in the implementation of the open system are not of such a kind as to prompt any dramatic changes in the present-day model. Within the framework of the existing basic structure, however, there is reason to make certain adjustments. In its report, the Committee cites several proposals with this focus. These may be summarised as follows. In the compulsory sector in which testing and assessment are prescribed by public agencies the Technical Conformity Assessment Act presumably gives SWEDAC a de facto sole right in terms of the kind of accreditation covered by the Act. proposes making it clear in the Act that this sole right also covers the voluntary sector. Such an amendment would enhance the clarity and credibility of the accreditation and the open system, and is also in line with the anticipated outcome of the current EU overview. Thus, a forthcoming statute is expected to enjoin Member States to organise accreditation as the means of ensuring the technical competence, capability and impartiality of conformity assessment bodies. This is to be done by the instituting and maintaining one national accreditation body to carry out accreditation regarding both compulsory and voluntary testing and assessment. In the Committees estimation, coordination of regulatory agencies testing and conformity assessment can probably be improved in certain cases, especially with respect to recurrent inspections of various kinds. This should, for example, apply to such matters as regulations on formulation of assessment results, frequency of inspections and competence requirements for carrying out the prescribed testing and conformity assessment. Typically, the competence requirements in the Committees chosen terminology are twofold: they cover both basic competence (e.g. being an accredited assessment body) and specialist competence (e.g. some documented experience of the area concerned). One factor that has probably contributed to the coordination problems is that clear, overarching principles are lacking for determining which method of competence assessment should be used in various situations. In other words, it is unclear whether competence assessment of the bodies to carry out a particular service should, for example, take place directly through accreditation or through certification performed by accredited certification bodies. One practicable method of facilitating greater coordination among various regulatory agencies requirements should be an attempt to harmonise the basic competence requirements for all assessments that are stipulated for a single object, such as a , that is subject to supervision. Based on this kind of platform, the bodies wishing to compete for these assessment assignments can then choose which, and how many, of the specialist skills they want to offer. has found that, for several years, SWEDAC has been making some efforts to develop a coordination method of this kind. According to the Committee, it is essential for this initiative to be reinforced. It is appropriate for SWEDAC to bear responsibility for pursuing this kind of development work, but the work must take place in close dialogue and collaboration with the regulatory agencies concerned. This is because assessing at a more concrete level whether, and if so how, the regulations of the agencies concerned can be further coordinated is a task that can primarily be performed by the agencies themselves. As a starting point for further development of the open system, there is also a need to develop overarching general principles to govern the choice of which methods of competence assessment should be used in various situations. One such choice is to decide whether the competence assessment of bodies that are to perform particular services should take place directly through accreditation or through certification carried out by accredited certification bodies. proposes that the Government should assign SWEDAC to draft general principles of this kind. This assignment should include surveying which methods of competence assessment are used at present in various sectors, which reasons have been cited for using these methods and which effects they may be assumed to have.