Law On The Accreditation Body

Original Language Title: Gesetz über die Akkreditierungsstelle

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Read the untranslated law here: http://www.gesetze-im-internet.de/akkstelleg/BJNR262500009.html

Law on the accreditation (accreditation bodies act - AkkStelleG) AkkStelleG Ausfertigung date: 31.07.2009 full quotation: "accreditation bodies act of July 31, 2009 (BGBl. I S. 2625), most recently by article 4 paragraph 82 of the Act of August 7, 2013 (BGBl. I p. 3154) is changed" stand: last amended by article 4 para 82 G v 7.8.2013 3154 for details on the stand number you find in the menu see remarks footnote (+++ text detection from) : 7.8.2009 +++) § 1 Accreditation (1) accreditation as a sovereign task of the Federal Government by the accreditation service performed. This is a national accreditation body within the meaning of Regulation (EC) no 765 / 2008 of the European Parliament and of the Council of 9 July 2008 on the requirements for accreditation and market surveillance in the marketing of products and repealing Regulation (EEC) No. 339/93 (OJ L 218 of the 13.8.2008, p. 30) and for accreditation pursuant to article 3 of Regulation (EC) no 765 / 2008 responsible.
(2) the jurisdiction of authorities to authorize places, as a conformity assessment body, covered by other legal provisions shall remain unaffected. This applies in particular to the areas of medical devices, Gendiagnostika, security technology as well as nutrition, agriculture and consumer protection including food safety.

§ 2 duties of accreditation body (1) leading accreditation body at the written request of a conformity assessment body accreditation procedure in accordance with article 5 of Regulation (EC) No. 765 / 2008 by. You apply made rules for the accreditation according to § 5, paragraph 3.
(2) the accreditation body keeps a register of accredited conformity assessment bodies with indication of the technical scope and keeps it up to date.
(3) the accreditation body should involve other authorities existing expertise in evaluation activities. The accreditation body will run areas by the authorities grant the power of endorsements for that in article 1, paragraph 2, sentence 2. The accreditation body can use when carrying out the monitoring of accredited conformity assessment bodies, the authorities grant the authority.

Powers of the accreditation body which can accreditation of the conformity assessment body and its personnel entrusted with the management and the implementation specialist tasks the information necessary for the identification and monitoring of professional competence and the suitability of a conformity assessment body and other support, in particular, the submission of documents require § 3 and make the necessary arrangements. The clerks and other officers of the accreditation body empowered to enter to the operating and business times premises, business and premises of the conformity assessment body, to visit and to consider, as far as this is necessary for the performance of their duties; the fundamental right of inviolability of the home (article 13 of the Basic Law) is limited in this respect. The conformity assessment body has to contribute to measures pursuant to sentence 1 to the extent necessary. The powers referred to in sentence 1 to 3 apply to the competent authorities which carry out activities within the scope of article 2, paragraph 3.

§ 4 cooperation with other authorities (1) as such to act the authorities granting the authority on the basis of a legal provision of conformity assessment bodies, the accreditation body immediately send the necessary information about accreditation activities or measures taken by the accreditation body. Be known business secrets of the accreditation body, it protects their confidentiality towards third parties.
(2) the accreditation body has to inform the authorities referred to in paragraph 1 shall at their request and to initiate a review procedure at its request if it is informed of defects with regard to the competence of a conformity assessment body.
(3) in the case of accreditation for the areas referred to in article 1, paragraph 2, sentence 2, the accreditation body makes the accreditation decision in agreement with the authorities which conduct the assessment according to § 2 paragraph 3.

An accreditation Advisory Board is set up § 5 accreditation Advisory Board (1) at the Federal Ministry of Economics and technology. He advises and supports the Federal Government and the accreditation body in questions of accreditation.
(2) the Accreditation Board has the duties, General or sectoral rules to determine 1 which clarify the requirements, in particular legislation on conformity assessment bodies or complement to determine 2 which define the requirements, in particular legislation, accreditation activities or supplement, 3. the use of accreditation as a confidence element of conformity assessment to promote the German representation and attitude for the sessions of the European cooperation for accreditation to coordinate 4. General or sectoral rules.
(3) the Federal Ministry of Economics and technology discloses the rules determined by the accreditation Advisory Board in consultation with the federal ministries professionally concerned referred to in paragraph 2 number 1 and 2 in the Federal Gazette.
(4) the accreditation Advisory Board expert people belong to, especially from the District 1 of the countries, 2. the bodies that authorize on the basis of a legal provision of conformity assessment bodies, as such, 3. the conformity assessment bodies, 4. the economy and 5 of consumers and consumers.
The membership is voluntary. In terms of knowledgeable persons pursuant to paragraph 4 number 1 and 2, if it is to make the countries, is to the right countries.
(5) the Federal Ministry for Economics and Technology appoints in agreement with article 8 paragraph 1 Nos. 1 and 3 to 7 above federal ministries for a period of three years the members of the accreditation Advisory Board and for each Member of a representative or a representative. The number of members should not exceed 15. The accreditation Advisory Council elects the Chairman or the Chairman from among its members. The election of the Chairman or the Chairman needs the approval of the Federal Ministry of Economics and technology.
(6) the top federal and land authorities or that certain of these bodies, as well as the accreditation body have the right to participate in meetings of the accreditation Advisory Committee and belongs to be, as well as to sign up agenda items and to submit consultation documents.
(7) the accreditation Advisory Board is a rules of procedure, requiring the approval of the Federal Ministry of Economics and technology and the number 1 and 3 to 7 above federal ministries in article 8 paragraph 1.
(8) the Accreditation Board establishes sectoral advisory boards. They have in particular the task to support the accreditation Advisory Board number 1 and 2 in determining the rules relevant in the respective sectors referred to in paragraph 2. You can also participate in the preparation of accreditation decisions. Details, including the occupation of the advisory boards, the bylaws govern the operations of the accreditation Advisory Board referred to in paragraph 7 (9) leads the Federal Institute for material research and testing.

§ 6 a conformity-assessment body on request allow accreditation symbol (1) which can accreditation body to use a symbol that points out on their accreditation (accreditation symbol).
(2) the Federal Ministry of Economics and technology is authorized by a regulation that requires not the consent of the Federal Council to regulate the following: 1. the design and protection of the accreditation symbol, 2. details of the use of the accreditation symbol and 3. rights of use for the accreditation symbol.

§ 7 fees and expenses (1) for individually attributable public services the accreditation body on the basis of this Act and Regulation (EC) no 765 / 2008 are to cover administrative overhead charges and expenses collected. As far as the services are subject to VAT, the fees and expenses to the VAT increase.
(2) the Federal Ministry of Economics and technology is empowered to envisage in agreement with the Federal Ministry of finance decree that not require the consent of the Federal Council, closer to determine the chargeable offences, the rates and the reimbursement of expenses and thereby fixed rates or frame rates. The tariffs are to be such that which is covered with the individually attributable public services linked all personnel and administrative expenses.

§ 8 the Federal Ministry of Economics and technology can loan or establishment (1) in consultation with the 1st Federal Ministry of the Interior, 2. Federal Ministry of finance, 3. Federal Ministry of labour and Social Affairs, 4. Federal Ministry of food, agriculture and consumer protection, 5. Federal Ministry of health, 6 Federal Ministry for traffic, construction and urban development, 7 Federal Ministry for environment, nature conservation and nuclear safety by decree with the consent of the Bundesrat encumber a legal person of private law with duties and powers of an accreditation body , if the requirements are met according to § 10. Pursuant to sentence 1 may in the Decree also detailed provisions competence the listed federal ministries for supervision and 2. are the organisation of supervision over 1.
(2) in the event that a legal entity of private law is not created pursuant to paragraph 1 or the loan is terminated according to § 10 paragraph 3, the Federal Ministry of Economics and technology in consultation with the ministries referred to in paragraph 1 may establish a Federal Agency for accreditation.

§ 9 supervision (1) the accreditation body is subject to the adopted on the basis of § 8 paragraph 1 sentence 2 No. 1 regulations of supervision by the competent Federal Ministry. The federal ministries exert the supervision so that the independence and impartiality of the accreditation body for accreditation decisions is maintained. The federal ministries can to carry out its supervisory activities in particular are at any time over the Affairs of the accreditation body, in particular by obtaining information, reports and submission of records of all kinds, teach, complain about unlawful actions and require appropriate remedy. The accreditation body is obliged to comply with the instructions of the federal ministries. They easily let if the accreditation body not or not timely comply with their instructions, perform the necessary measures in place, and at the expense of the accreditation body itself or carried out by someone else.
(2) the officials and other representatives of the federal ministries are authorized to enter at the operating and business times premises, business and operating rooms of the Nr.1B,c, to visit and to consider, as far as this is necessary for the performance of their duties; the fundamental right of inviolability of the home (article 13 of the Basic Law) is limited in this respect. Goods or business documents can be viewed on the scale required and taken into custody.
(3) the federal ministries can transfer the supervision to a subordinate authority or the Federal Ministry of Economics and technology.

§ 10 prerequisites and implementation of mortgage lending (1) the loan is permitted only if 1 the guarantee for the proper performance of the tasks of the accreditation body provides the mortgaged legal entity of private law, in particular the requirements laid down in article 8 of Regulation (EC) no 765 / 2008 meets, 2. the Bund to beleihenden legal person of private law two-thirds is involved or the Federal Government and the countries , as far as the latter wish to each one-third of the legal person of private law are involved and 3 the mortgaged legal person of private law has established an Accreditation Committee, which makes the accreditation decision in areas referred to in the internal relationship to in § 1, paragraph 2, sentence 2. Whose occupation is to make sure that two-thirds of the members of appropriate and qualified persons, who are members of the authorities grant the authority, shall be appointed. To discharge broadcasting rights corresponding to the departments referred to in article 8, paragraph 1 must be a, which exercise involving the Advisory responsible according to § 5 paragraph 8.
There is no entitlement to collateral.
(2) the legal person of private law to mortgaged must have appropriate insurance with a coverage of at least 10 million euros for the accreditation body.
(3) the loan may be terminated at the end of the fifth year for the first time after effective date of the loan with a term of two years. The loan with a period of two years at any time can be terminated after the end of the fifth year. Have not been the conditions for the loan or are they subsequently fall away, the loan may be terminated at any time.
(4) if the collateral set 3 is completed pursuant to paragraph 3, no claim to compensation.

§ 11 oversight of senior management persons entitled to the management of the Nr.1B,c must be reliable. The appointment to the Board of management is to display the Federal Ministry of Economics and technology through the Beliehene. But the Beliehene has to specify the facts that are material to the assessment of reliability and suitability.

§ 12 is penalty provisions (1) any person who wilfully or negligently contravenes an enforceable order pursuant to paragraph 3 sentence 1.
(2) the offence can be punished with a fine up to five thousand euros.

§ 13 transitional provisions (1) monitoring obligations for accreditations were issued before January 1, 2010, the date of effect of the collateral pursuant to § 8 paragraph 1 on the accreditation body under this Act go to.
(2) the accreditation body may employ officers to assigned to 31 December 2014 according to § 29 of the federal civil servants act or section 20 of the official State law and civil servants.

§ 14 entry into force this law enter into force on the day after the announcement.