S.L. 427.45 ст. 5Accreditation Accreditation Board. As part of monitored by 1. Each Directorate a period in 2. The details of the 3. - A - A - - 4. At any in drawing up concerning procedures which THE Having in particular Having In Having Whereas modules for intended to *OJ No C 160, †OJ No C 125, published in the ‡

In Malta, accreditation certificates are issued by the National Body, which was set up pursuant to the Establishment of the Directorate Order, acting on the advise of the Accreditation Advisory SCHEDULE III MONITORING OF BODIES

the surveillance referred to in regulations 7.1 to 7.6, bodies shall be the Directorate, as follows:

year, at the end of each four-month period, the body sends to the list of all the inspections or certifications it has carried out during the question. body sends to the Directorate the quality and procedural handbook and inspections or certifications it carries out. Monitoring includes:

check of the documentation submitted pursuant to paragraph 2 above; sample check of manufacturers on whom inspections or certifications have been completed; Completion of at least one site inspection or certification; Evaluation of compliance with the obligations set out in paragraphs 1 and 2 of Schedule III. stage, the Directorate may involve the National Accreditation Body the monitoring programme and during its execution.

SCHEDULE IV Council Decision 93/465/EEC

COUNCIL DECISION of 22 July 1993 the modules for the various phases of the conformity assessment and the rules for the affixing and use of the CE conformity marking, are intended to be used in the technical harmonization directives (93/465/EEC) COUNCIL OF THE EUROPEAN COMMUNITIES, regard to the Treaty establishing the European Economic Community, and Article 100a thereof, * regard to the proposal from the Commission ( ), † cooperation with the European Parliament ( ), regard to the opinion of the Economic and Social Committee (‡),

Council Decision 90/683/EEC of 13 December 1990 concerning the the various phases of the conformity assessment procedures which are § be used in the technical harmonization directives ( ) needs to be

20.6.1991, p. 14; and OJ No C 28, 2.2.1993, p. 16. 18.5.1992, p.178; OJ No C 115, 26.4.1993, p.117; and Decision of 14 July 1993 (not yet Official Journal). 20.1.1992, p. 15; and OJ No C 129, 10.5.1993, p. 3. 31.12.1990, p. 13. substantially amended in various places; whereas it is necessary, in a and rationality, to consolidate its provisions by means of this Decision; Whereas the Council adopted a Resolution on 21 December 1989 * global approach to conformity assessments ( ); Whereas the introduction of harmonized methods for the assessment and the adoption of a common doctrine for their implementation facilitate the adoption of future technical harmonization directives placing on the market of industrial products and thus be conducive implementation of the internal market; Whereas such methods should ensure that products are in full conformity essential requirements laid down in the technical harmonization directives, to provide, in particular, for the health and safety of users and consumers;

Whereas such conformity should be assured without imposing onerous conditions on manufacturers, and by means of clear and comprehensible procedures; Whereas limited flexibility should be introduced as regards use modules, or variations in the modules, when the specific circumstances particular sector or directive so warrant, but not to such a degree as purpose of the current Decision and only when explicitly justified;

Whereas in the abovementioned Resolution of 21 December 1989 approved as a guiding principle the adoption of common rules on the marking; Whereas in its Decision 90/683/EEC the Council laid down that products covered by the technical harmonization directives can be market only after the manufacturer has affixed the CE marking to them; Whereas a single CE marking should be used in order to facilitate Community market by inspectors and to clarify the obligations operators in respect of marking under the various Community regulations;

Whereas the aim of the CE marking is to symbolize the conformity with the levels of protection of collective interests imposed harmonization directives and to indicate that the economic operator all the evaluation procedures laid down by Community law in respect HAS DECIDED AS FOLLOWS: Article 1