Johann Dietrich Zentralstelle der Länder für Sicherheitstechnik -ZLS-

1. Accreditation in Germany, Scope of Duties of the Central Authority of the German Federal States for Safety – ZLS regarding thePressure Equipment Directive Johann Dietrich Zentralstelle der Länder für Sicherheitstechnik -ZLS- Bayerisches Staatsministerium für Umwelt, Gesundheit und Verbraucherschutz Central Authority of the Federal States for Safety Bavarian State Ministry for Environment, Public Health and Consumer Protection Bucharest, February 2007

2. Accreditation Bodies- mandatory area - • Bundesamt für Sicherheit in der Informationstechnik – BSI(Federal Office for Security in the Information Technology) • Deutsche Akkreditierungsstelle für Umwelt – DAU(German Accreditation Body of Environmental Verifiers) • Deutsches Institut für Bautechnik – DIBt(German Institute for Building and Civil Engineering Technologies) • Kraftfahrt-Bundesamt – KBA (Federal Authority of Road Transport) • Regulierungsbehörde für Telekommunikation und Post – RegTP (Accreditation Body of the Regulatory Authority for Telecommunications and Posts) • Zentralstelle der Länder für Gesundheitsschutz – ZLG (Central Authority of the German Federal Statesf for Health Protection with regard to Medical Products and Medical Devices) • Zentralstelle der Länder für Sicherheitstechnik– ZLS (Central Authority of the GermanFederal States for Safety)

3. ZLS – Scope of duties ZLS fulfils tasks in the following fields • Maintaining and improving the state of the art of the safety of products, equipment as well as labour and consumer safety reached in the Federal Republic of Germany • Accreditation, recognition and designation according to the - Equipment and Product Safety Act , - Medical Devices Act (active medical devices), - Transport of Dangerous Goods Act, - Ship Safety Act • Accreditation of conformity assessment bodies (CABs) within the frame of Mutual Recognition Agreements (MRA)

4. ZLS – Scope of duties (continued) • Accreditation and recognition of Conformity Assessment Bodies within the frame of the GS- Mark • Supervision of all activities of notified bodies • Organising the sectoral and central exchange of experience activities • Participation in Notifying Authorities Forum at European level • Coordination of activities with the non-regulatory accreditation bodies

5. Notified Body Procedure - Designation/Notification Application ZLS Assessment by ZLS Assessment criteria Monitoring EN 45000/17000 series Standards Annex ofEC Directives Accreditation by ZLS Designation Notification to the EU-Commission and Member States Publication in the Official Journal

6. Duration of Accreditation / Notification • Accreditation procedures are subject to national and sometimes international agreements, duration is mostly 5 years • Surveillance audits (monitoring) at regular intervals (1 to 2 years) and for defined purposes(e. g. enlarging the scope, major changes in the organisation, problems occured, etc.) • Notification with no determined duration, can be repealed either if so wished by the body or if extensive irregularities are signalled

7. Requirements for Notified Bodies • No involvement in activities that may conflict with their independence, integrity, impartiality or secrecy • No design, construction, marketing or maintenance activities • No commercial or financial pressures or interests • Skilled, trained staff, facilities, equipment necessary for the tests, administrative possibilities • Adequate liability insurance, unless liability is assumed by the State • Defined by directives (Annexes IV/V 97/23/EC) Notified bodies involved in conformity assessment take over duties but not all responsibilities of manufacturers !

8. Documentation to be prepared by NBs • Application forms as required by authorities / accreditation bodies • Documentation demonstrating the ability of the organisation to meet the minimum criteria set out in the relevant annex (-es) of the directive(s) for which notification is sought (either by using standards or by other means) • Documentation related to possible subcontractors • Quality management documentation must reflect the actual situation in the organisation and needs to be focused on the future activity as a notified body • Commitment to following the rules of conduct, best practices and to cooperate with the accreditation body and other authorities • Ability to draw up technical reports must be flanked by ability to responsibly draw up certificates • Issues related to secrecy, certificates supervision and archiving

9. Criteria for notified bodies Additional documents • Guide to the implementation of directives based on New Approach and Global Approach („blue guide“) • 93/465/EEC - Council Decision of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives • DIN EN ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories • DIN EN 45011 - General requirements for bodies operating product certification systems • DIN EN 45012 – General requirements for bodies operating assessment and operation of quality systems • DIN EN 17020 – General criteria for the operation of various types of bodies performing inspection

10. ZLS within the Frame of Product and Equipment Safety • ZLS is part of a unit in the Bavarian Ministry for Environment, Public Health and Consumer Protection • Acts on behalf of authorities in all other German Federal States on the basis of a State Contract (no other competent authority in these fields of activity in other Federal States) • Is co-ordinated and advised by representatives of all Federal States and the Federal Government

11. ZLS within the Frame of the Product and Equipment Safety Act • ZLS provides in the administrative documents for co-operation of all notified bodies (and GS- Mark granting bodies) with the accreditation body with regard to tests and certification results of possibly defective products on the market • ZLS exchanges information with market surveillance authorities in Germany, of other Member States of the EU and authorities of third countries with a view to enhancing safety of products for professional, as well as for consumer use

12. Activities in the field of Directive 97/23/EC • Before accreditation in a field is started preliminary work is initiated • Sectoral committees with the participation of all stakeholders are convened (manufacturers, users, interest groups, authorities, standardizers, professional associations, testing and certification organisations, etc.) • Criteria set out by EU and national documents are concretized, final documents define more specific requirements

13. Activitiesin the field of Directive 97/23/EC • Documents are being made accessible to applicants • Sectoral committees remain active to allow for corrective actions and to provide guidance to the accreditation body • Necessary application forms available on the website • Determine which kinds of accreditation are most suitable (test laboratory, certification body for products, quality assurance systems, personnel) • Determine specific way of handling special cases (e.g. Recognized Third-Party Organization, User Inspectorates)

14. Accreditation process • Applicants submit all necessary evidence needed for recognition • Ability to assess results is considered not to be sufficient, always also proof of in-house testing possibilities (facilities, testing equipment and personnel) • Substantial evidence for quality management systems implemented, professional and in some cases vocational training of personnel, experience gained so far in the relevant field, participation in standardization work, ability to determine necessary tests and to carry out assessment of results against the requirements of the directive (not „only“ against standards), ability to assess also against requirements of other national or foreign codes and to perform scientific work in the absence of standards or codes

15. Assessment of documents and on-site • All documents are being assessed by trained personnel of ZLS • In case necessary specific knowledge is not available, determining independent specialists in the relevant technical field and involvement of them in the assessment • On-site review and check whether documents forwarded reflect the actual situation • If several offices or subsidiaries, on-site assessment of them • In case subcontractors are involved, evidence of their suitability, review of contracts, agreements and in the absence of accreditation in the relevant field, on-site assessment of them • In case activities abroad are likely, review of all the procedures applicable, of working contracts with staff working abroad and of the way responsible personnel of the notified body ensures quality of work, documentation and responsibilities

16. Accreditation and designation • If the applicant organization satisfies the accreditation requirements formal recognition is granted • At the same time the designation and subsequent notification process is started • Notification is somewhat more simple nowadays, as it is being done electronically by means of the NANDO database • Notification is only the goal to be reached, permanently satisfying the notification requirements is a constant challenge, in order to remain eligible and to get better • ZLS has also the task to provide evidence at all levels of the way criteria have been met by the bodies and to monitor all activities of them, be it in Germany, in other Member States or elsewhere

17. Monitoring notified bodies • The act of designation contains also information and conditions on subsidiaries and their involvement in the overall conformity assessment • Basically two ways to perform tests and certification: • Substantial parts of testing and inspection done on the site of the notified body, some tests (e.g. pressure test) on the premises of the manufacturer (in or outside the EU), certification in the office of the notified body (in Germany) • Substantial parts of required testing and inspection in the offices of the notified body (e.g. design, documentation provided by the manufacturer), on-site tests at the manufacturer site and certification by personnel of the notified body detached to the respective country N.B.: Subcontracting certification is not allowed!

18. Monitoring notified bodies • Documentation on who and where carried out tests and inspections needs to be forwarded to the certification body, i.e. notified body • Accreditation clauses require from the notified body to produce all evidence of the conformity assessment process to be inspected by the authority (ZLS) • The strategy adopted allows for quick information possibilities for the designating authority • Checks of subcontracted work are also possible under the terms of these provisions (as the notified body retains the whole responsibility) • If necessary, the designating authority can also check the premises of subsidiaries or subcontractors abroad • The work of certification, if done outside the country of origin of the notified body, is subject to special arrangements to be observed at all times and monitored by ZLS

19. Subsidiaries outside Germany of companies notified under the PED • If subsidiaries of German notified bodies are located in other EU Member States, they can act as subcontractors for their parent company (only for testing and inspection work). If they wish to become notified body themselves, they need to apply to the authorities in charge in the country they are registered and undergo the notification process according to the rules set by them • „Licensing“ of subsidiaries to perform certification work on behalf of the notified body in the country of origin is not possible for legal reasons • Nevertheless, even if working as subcontractors, these subsidiaries need to observe the laws of their „host“ countries and the rules and procedures imposed by the contracts with their parent company (who is responsible for the results delivered)

20. Certification staff abroad • Needs to know and follow the procedures of the notified body • Has the obligation to participate regularly in exchanges of experience organized by the notified body • Remains fully responsible to the head of the notified body (technically, administratively, disciplinary) • Can, under circumstance, be the citizen of the „host“country and even perform other types of work (not certification) if there are neither conflicts of interests nor activities impairing their ability to act as personnel of the notified body (part time activities) • No certification activities in the same field for two notified bodies! • Needs to be hired by the organization which is notified

21. Is the system efficient? • Yes! (So far...) • Additional work for the designating authority.... • Can become a burden, if huge companies develop „global player“ strategies, for the frequency of controls raises and travel time too... • The number of the notified bodies is still very high, the costs, however should be kept low... • Still, competition among the bodies plays a significant role • With the growing dimensions of notified bodies „fears“ to lose notification, with all the consequences also grow... • Potential for authorities to get hold of adverse information is higher, still cooperation with other national authorities is necessary!

22. Are there other strategies? For sure! • Making the notification preceding and monitoring activities more expensive? • Supervising abroad activities of notified bodies not in a somewhat „remote“ manner but by frequent visits of the foreign sites? This is not exactly meeting the needs of the manufacturing industry or of the „accompanying“ conformity assessment community! Nor is it helping small and medium sized enterprises to survive in the ever growing competition with the industry outside the EU! Cooperation with market surveillance and occupational health and safety authorities across the EU, better contacts with designating authorities and accreditation bodies may help get hold of possible problems

23. What is the future bringing? • Activities of the CAB forum to concentrate on the problems of notified bodies and to help assuring a „level playing field“ for them and thereby also for the manufacturing industry • Cooperation of designating and notifying authorities to allow for comparable results of assessments of bodies seeking notification • Constant monitoring of notified bodies, RTPOs and user inspectorates in their home country and abroad • Exchange of experience of the CAB community with all its members • Appropriate measures of the competent authorities in Member States against non-compliant products (market surveillance) and againstbodies not fulfilling (any more) the notification criteria • Strive of all stakeholders to ensure an appropriate level of safety on the European market for the benefit of its citizens

24. Thank you very much for your attention ! im Location:Address:Contact: Rosenkavalierplatz 2 ZLS im StMUGV phone: +49 (0) 89 9214 2321 D - 81925 München fax: +49 (0) 89 9214 3442 Postfach 810140 e-mail: zls@stmugv.bayern.de D - 81901 München BayerischenStaatsministeriumfür Umwelt, Gesundheit und Verbraucherschutz Bavarian State Ministry for Environment, Public Health and Consumer Protection