Law on the Accreditation Body (Accreditation Body Act-AkkStelleG)

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AkkStelleG

Date of completion: 31.07.2009

Full quote:

" Accreditation place law of 31 July 2009 (BGBl. 2625), as last amended by Article 4 (82) of the Law of 7 August 2013 (BGBl). I p. 3154).

Status:

Last amended by Art. 4 Abs. 82 G v. 7.8.2013 I 3154

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 7.8.2009 + + +) 

  

Unofficial table of contents

§ 1 Accreditation

(1) The accreditation shall be carried out by the accreditation body as a sovereign task of the Federal Government. 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 on market surveillance. Repeal of Regulation (EEC) No 339/93 (OJ L 393, 31.12.1993, 30) and for accreditations pursuant to Article 3 of Regulation (EC) No 765/2008. (2) The competence of the authorities to issue powers under other legislation shall be the conformity assessment body shall remain unaffected. In particular, this applies to the areas of medical devices, genetic diagnostics, safety technology as well as food, agriculture and consumer protection, including food safety. Unofficial table of contents

§ 2 Tasks of the accreditation body

(1) The accreditation body shall conduct accreditation procedures in accordance with Article 5 of Regulation (EC) No 765/2008, at the written request of a conformity assessment body. The accreditation body shall apply a list of the accredited conformity assessment bodies with an indication of the technical scope and shall keep it up to date with the accreditation body. Stand. (3) The accreditation body shall use the expertise available from other authorities in the case of assessment activities. The Accreditation Body shall carry out assessments of the areas referred to in Article 1 (2), second sentence, by the authorities responsible for the power of authority. The accreditation body shall be able to operate the monitoring of the accredited conformity assessment bodies of the authorities responsible for the authority. Unofficial table of contents

§ 3 Powers of the Accreditation Body

The accreditation body may, from the conformity assessment body and its staff responsible for the management and conduct of technical tasks, to identify and monitor the professional competence and suitability of a conformity assessment body, require the necessary information and other support, in particular the submission of documents, as well as the necessary arrangements for this. The staff and other agents of the Accreditation Body shall have the power to enter, inspect and examine, to the extent that this is not the case, premises, business premises and premises of the conformity assessment body at the holding and business hours of the Office of Accreditation. is required for the performance of their duties; the fundamental right of inviolability of the dwelling (Article 13 of the Basic Law) is restricted to this extent. The conformity assessment body shall be required to participate in the measures referred to in the first sentence. The powers laid down in the first sentence of the first sentence shall also apply to the competent authorities carrying out the activities under Article 2 (3). Unofficial table of contents

Section 4 Cooperation with other authorities

(1) The authorities which, under a law, give conformity assessment bodies the power to act as such, the accreditation body shall, without delay, provide the necessary information on accreditation activities or Measures taken by the accreditation body. Where the accreditation body is aware of trade secrets, it shall protect their confidentiality with respect to third parties. (2) The accreditation body shall, at the request of the authorities referred to in paragraph 1, inform the authorities referred to in paragraph 1 and shall, at the request of the accreditation body, provide information on the request (3) In the case of accreditations for the areas referred to in Article 1 (2), second sentence, the accreditation body shall be notified of the application of the verification procedure. the accreditation decision in agreement with the authorities, which carry out the assessment in accordance with § 2 (3). Unofficial table of contents

§ 5 Accreditation Advisory Board

(1) An accreditation advisory board is established at the Federal Ministry of Economics and Technology. It advises and supports the Federal Government and the Accreditation Body in matters of accreditation. (2) The Accreditation Advisory Board has in particular the tasks,

1.

to identify general or sectoral rules specifying or supplementing the requirements, in particular from legislation, to conformity assessment bodies;

2.

to identify general or sectoral rules which specify or supplement the requirements, in particular from legislation, for accreditation activities;

3.

promote the use of accreditation as a confidence-building element of conformity assessment,

4.

to coordinate the German representation and posture for the meetings of the European Cooperation for Accreditation.

(3) The Federal Ministry of Economics and Technology, in agreement with the Federal Ministries concerned, is aware of the rules determined by the Accreditation Advisory Board in accordance with paragraphs 2 (1) and 2 (2) of the Federal Gazette. (4) The Federal Ministry of Economics and Technology (BMI) Accreditation advisory councils include experts, in particular from the circle

1.

of the countries,

2.

the bodies giving conformity assessment bodies the power to act as such on the basis of a law,

3.

the conformity assessment bodies,

4.

the economy and

5.

consumers and consumers.

Membership is honorary. In the case of the experts referred to in paragraph 4 (1) and (2), provided that they are bodies of the Länder, the right of proposal is available to the Länder. (5) The Federal Ministry of Economics and Technology convenes in agreement with the provisions of § 8 (1) (1) and (3) to (7), the members of the Accreditation Advisory Board for a period of three years and a representative or representative for each Member. The number of members shall not exceed 15. The Accreditation Advisory Board shall elect the Chairperson or the Chairperson from its midst. The election of the chairman or chairperson shall be subject to confirmation by the Federal Ministry of Economics and Technology. (6) The highest federal and state authorities, or the bodies designated by these authorities, as well as the accreditation body, have the following: Right to participate in meetings of the Accreditation Advisory Board and to be consulted and to register agenda items and provide advice. (7) The Accreditation Advisory Board shall adopt its Rules of Procedure, which shall be subject to the approval of the Federal Ministry of Economics and Technology and the Federal Ministry of Economics and Technology (§ 8) (1) and (3) (8) The Accreditation Advisory Board shall establish sectoral advisory councils. In particular, they have the task of supporting the Accreditation Advisory Board in determining the relevant rules referred to in paragraphs 2 (1) and 2 (2) of the relevant sectors. They may also participate in the preparation of accreditation decisions. The details, including the occupation of the Advisory Councils, are governed by the Rules of Procedure in accordance with paragraph 7. (9) The business of the Accreditation Advisory Board shall be carried out by the Federal Institute for Materials Research and Testing. Unofficial table of contents

§ 6 Accreditation symbol

(1) The accreditation body may, upon request, allow a conformity assessment body to use a symbol indicating its accreditation (accreditation symbol). (2) The Federal Ministry of Economics and Technology shall be authorized to: by means of a regulation which does not require the consent of the Federal Council to regulate:

1.

the design and protection of the accreditation symbol,

2.

Details of the use of the accreditation symbol and

3.

the rights of use for the accreditation symbol.

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§ 7 Fees and charges

(1) Charges and expenses are levied for the purpose of covering the administrative burden on individually attributable public services of the accreditation body under this Act and Regulation (EC) No 765/2008. As far as the services are subject to VAT, the fees and levies increase by the statutory turnover tax. (2) The Federal Ministry of Economics and Technology is authorized, in agreement with the Federal Ministry of Finance by means of a legal regulation which does not require the consent of the Federal Council to determine the chargeable facts, the fee rates and the delivery allowance in more detail, and to provide fixed rates or framework rates in this connection. The rates shall be calculated in such a way as to cover all personnel and material expenses associated with the public services which are individually attributable to the public. Unofficial table of contents

Section 8 Beleihung or erection

(1) The Federal Ministry of Economics and Technology may, in agreement with the

1.

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 of Transport, Building and Urban Development,

7.

Federal Ministry for the Environment, Nature Conservation and Nuclear Safety

By means of a legal regulation with the consent of the Bundesrat, a legal person of private law with tasks and powers of an accreditation body, if the conditions pursuant to § 10 are available. Further provisions may also be laid down in the legal regulation referred to in the first sentence of paragraph 1.

1.

the responsibility of the Federal Ministries for the supervision and supervision of the

2.

the design of supervision.

(2) In the event that a legal person of private law is not to be borrowed in accordance with paragraph 1 or the insult is terminated in accordance with Section 10 (3), the Federal Ministry of Economics and Technology may, in agreement with the Ministries are set up to establish a Federal Office for Accreditation. Unofficial table of contents

§ 9 Supervision

(1) The accreditation body shall be subject to the supervision of the competent Federal Ministry, subject to the provisions of Section 8 (1), second sentence, point 1 of the first sentence of the second paragraph. The Federal Ministries are exercising supervision in such a way that the independence and impartiality of the accreditation body is preserved in the case of accreditation decisions. In order to carry out their supervisory activities, the Federal Ministries may, in particular, at any time on the matters of the accreditation body, in particular by obtaining information, reports and the submission of records of all kinds, Inform the Commission of any illegal measures and require appropriate remedial action. The Accreditation Body is obliged to comply with the instructions of the Federal Ministries. If the accreditation body does not comply with its instructions or does not comply with its instructions on time, they can carry out the necessary measures in place and at the expense of the accreditation body itself or have it carried out by another. (2) The Staff and other agents of the Federal Ministries shall have the power to enter, visit and examine the premises, commercial and operating rooms of the Belieheners at the operating and business hours, in so far as this is necessary for the performance of their duties is necessary; the fundamental right of inviolability of the home (Article 13 of the Basic Law) is restricted to this extent. Objects or business documents can be viewed and taken into custody to the required extent. (3) The Federal Ministries may supervise a subordinate authority or the Federal Ministry of Economics and Technology. transfer. Unofficial table of contents

§ 10 Conditions and implementation of the insult

(1) The insult shall be admissible only if:

1.

the legal person under private law to be levied provides the guarantee for the proper performance of the tasks of the accreditation body, and in particular meets the requirements laid down in Article 8 of Regulation (EC) No 765/2008,

2.

the federal government is involved in two-thirds of the legal person under private law to be assigned to it, or the federal government and the Länder, to the extent that they wish to do so, are each involved in one third of the legal person in private law, and

3.

the legal person under private law to be charged has set up an accreditation committee meeting the accreditation decision in relation to the internal relationship in the areas referred to in the second sentence of paragraph 1 (2). Its occupancy shall ensure that two-thirds of the members are appointed by persons who are competent and competent and who are members of the authorities responsible for the power of authority. For this purpose, the Federal Ministries referred to in Article 8 (1) shall be granted the relevant rights of removal, which they exercise with the involvement of the relevant advisory councils in accordance with § 5 paragraph 8.

There is no right to an insult. (2) The legal person under private law to be charged must have adequate liability insurance for the accreditation body with a cover sum of at least EUR 10 million. (3) The For the first time at the end of the fifth year following the date of the expiry of the order, the envy may be terminated with a period of two years. After the end of the fifth year, the insult may be terminated at any time with a period of two years. If the conditions for the pardon have not been fulfilled or if they are subsequently omitted, the insult may be terminated at any time. (4) If the order is terminated in accordance with the third sentence of paragraph 3, there is no entitlement to compensation. Unofficial table of contents

Section 11 Supervision of the Executive Board

The persons who are entitled to the management of the service must be reliable. The order for management is to be reported to the Federal Ministry of Economics and Technology by the Beliehene. In doing so, the Beliehene shall state the facts which are essential for the assessment of the reliability and suitability of the product. Unofficial table of contents

§ 12 Penal rules

(2) The administrative offence may be punishable by a fine of up to five thousand euros. Unofficial table of contents

Section 13 Transitional provisions

(1) Accreditation requirements for accreditations granted before 1 January 2010 shall be applied to the accreditation body under this Act at the date of the application of the information provided for in Article 8 (1) of this Act. (2) The accreditation body shall be allowed to: on December 31, 2014 according to § 29 of the Federal Civil Service Act (Bundesbeamtengesetz) or § 20 of the Staff Status Act, officials and civil servants are employed. Unofficial table of contents

Section 14 Entry into force

This Act shall enter into force on the day following the date of delivery.