Regulation (2011:811) On Accreditation And Technical Control

Original Language Title: Förordning (2011:811) om ackreditering och teknisk kontroll

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2011:811

Definitions



paragraph 1 of the words and expressions used in this regulation were

the same meaning as in the Act (2011:791) on accreditation and

technical control.



Regulatory authorities and the obligation to hear the Board

for accreditation and technical control



section 2 of the Government agencies that may provide for certain

characteristics of products, facilities or equivalent

(regulatory authorities) to hear the Board of

accreditation and verification before they announce

regulations on conformity assessment.



The right to provide for accreditation



section 3 of the Swedish Board for accreditation and technical control,

provide for accreditation under the law (2011:791)

on accreditation and technical control.



A regulatory authority for the assessment of

compliance or other technical control shall notify

regulations on the accreditation requirements for certain activities may,

After consulting the Board, notify the specific regulations

If accreditation is needed for the business.



Bodies to be notified



Application



section 4 of The application for designation of bodies to be notified under

section 9 of the Act (2011:791) on accreditation and technical control,

be submitted to the Board for accreditation and technical control.



The provisioning requirements



paragraph 5 of the Bodies notified in accordance with section 9 of the Act (2011:791) if

accreditation and technical inspection shall be established in

Sweden.



Appropriations



section 6 of the Swedish Board for accreditation and technical control,

announce further provisions concerning bodies to

notified in accordance with section 9 of the Act (2011:791) on accreditation and

technical control.



A regulatory authority may, after consulting the Management Board,

the regulations on the bodies to be notified under section 9

the law on accreditation and technical control that is needed within the

the Agency's area of activity.



Notification



paragraph 7 of the Notice referred to in section 9 of the Act (2011:791) on accreditation

and technical control shall be carried out using the electronic

Notification tool developed and managed by the European

the Commission.



The notification shall include



1. details of the conformity assessment

that have been made,



2. detailed information on the modules for the assessment of

conformity which have been applied to the relevant

products, as well as



3. the relevant attestation of competence.



Requirements of the Government's authorized upon application for accreditation

or about to be appointed and notified body



Condition for application for accreditation



section 8, a regulatory authority or other governmental

authorities responsible for market surveillance or other

supervision shall not without the permission of the Government to apply for

accreditation for an activity that the Agency intends to

operate on a contract basis. Application for such permission shall

include information on



1. What are the specific reasons for conducting business

under government authority, and



2. how the authority has considered and resolved the issues of

conflicts of interest and distortion of competition which may arise

as a result of the Agency's other activities.



Permission for the application to be designated and notified body



§ 9 A governmental agency shall not without the permission of the Government

apply to be appointed to the bodies to be notified under section 9

Act (2011:791) on accreditation and technical control for a

task, as even bodies other than the authorities may be notified.

Application for such permission shall include information on



1. What are the specific reasons for conducting business

under government authority, and



2. how the authority has considered and resolved the issues of

conflicts of interest and distortion of competition which may arise

as a result of the Agency's other activities.



National standards laboratories



section 10 A national laboratory shall maintain a high standard with standards of

sufficient scope and relevance. Traceability of

measurement standards must be ensured and developed by

international comparisons and research and

development interventions. Of the Regulation (1989:527) if

national standards laboratories indicated which bodies are national standards laboratories.



Obligation for the Swedish Board for accreditation and conformity

control to notify and consult other agencies



11 § the Swedish Board for accreditation and verification,

inform the relevant ministries and Government agencies about decisions

related bodies to be notified in accordance with section 9 of the Act (2011:791) if

accreditation and technical control.



The Board shall hear relevant sectoral authorities before a notification

withdrawn according to section 10 of the law on accreditation and

control.



section 12 of the Swedish Board for accreditation and technical control,

inform the European Commission of their procedures for

the assessment and notification of bodies referred to in paragraphs 7-9 teams

(2011:791) on accreditation and technical control and on

any changes.



The Board shall, on request, provide the European Commission with all

information relating to the basis for notification or the notified

the Agency's continued excellence.



Supervision



paragraph 13 of The Oversight Board for accreditation and conformity

control exercise according to section 18 of the Act (2011:791) on accreditation

and technical control shall be carried out in compliance with the requirements

apply to such supervision in accordance with the provisions of the European

Union and international requirements.



section 14 of The supervision of national standards laboratories such as the Board of

accreditation and control exercise under section 18 of the Act

(2011:791) on accreditation and technical control shall have such

focus and scope that the Board may certify that a

National Laboratory meets international guidelines on

measurement sites.



Fees



section 15 A national laboratory which is the authority may charge a fee for

measurements. Such a national laboratory shall, after

heard the national financial management authority, provide for

the fees.



16 § the Swedish Board for accreditation and verification may,

After consulting the national financial management authority, provide

If the fees for accreditation, assessment and oversight

referred to in section 21 of the Act (2011:791) on accreditation and technical

control.



Penalty



According to section 17 of the penalty section 23 of the Act (2011:791) if

accreditation and technical control shall be fixed at not less than

5 000 kroons and not more than 1 000 000 kroons.