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.