Law (2011:791) On Accreditation And Technical Control

Original Language Title: Lag (2011:791) om ackreditering och teknisk kontroll

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2011:791

Scope of application and definitions



section 1 of this Act is complementary to the European Parliament and of the Council

Regulation (EC) no 765/2008 of 9 July 2008 setting out the requirements for

accreditation and market surveillance relating to the marketing of

products and repealing Regulation (EEC) No 339/93, when

terms of accreditation and CE marking.



This law shall also apply in respect of



1. bodies which are notified to the European Commission and the other

Member States for information in connection with the assessment of the

conformity according to harmonised EU legislation,



2. bodies which are notified to the European Commission for information

in relation to conformity assessment according to agreement

The European Union concluded with third countries,



3. national standards laboratories and laboratories for the measurement, and



4. additional accreditation by the Swedish Board for accreditation and

technical control.



section 2 for the purposes of this Act applies to the definitions

see Regulation (EC) no 765/2008.



paragraph 3 of the assessment of conformity and other technical control

performed under this Act by or with the involvement of

accredited agencies or bodies referred to in paragraph 1, second subparagraph

1 and 2 If the control



1. is prescribed in law or regulation,



2. have been imposed on anyone by decision of a public authority, or



3. after completion, specific legal effect under the law

or other statutes.



Accreditation



Accreditation bodies, etc.



section 4 of the Swedish Board for accreditation and verification

designated to be national accreditation body, is responsible for

accreditation in accordance with Regulation (EC) no 765/2008.



The Board is also responsible for accreditation in other organs

for conformity assessment.



When such accreditation referred to in the second paragraph, article

5.1 and 5.3 – (4) of Regulation (EC) no 765/2008 shall apply.



Decision on accreditation



5 § the Swedish Board for accreditation and technical control decides

in the case of accreditation in accordance with article 5(1) of Regulation (EC)

No 765/2008. Accreditation is granted by the issue of

accreditation certificate.



Accreditation certificate is valid for a fixed period or until further notice and

shall contain the conditions that apply for accreditation.



When the accreditation certificate may be limited or withdrawn



section 6 of the Swedish Board for accreditation and conformity control decides

If the limitation or revocation of a certificate of accreditation

According to article 5(4) of Regulation (EC) no 765/2008.



The Board of Directors may determine that a decision on the limitation or

withdrawal of accreditation certificate will apply with immediate

effect.



Bodies to be notified to the European Commission and the

other Member States



How conformity assessment body shall be appointed and notified



section 7 If a conformity assessment body requests

be appointed and notified for information in connection with the assessment

of conformity, the Swedish Board for accreditation and

technical control in consultation with the relevant authorities to determine whether

body meets the requirements for the indication in question

According to



1. harmonised EU legislation, or



2. agreements which the European Union concluded with third countries.



In such cases covered by the first subparagraph of paragraph 1, the Board of Directors

assessment done by accreditation, unless otherwise

before written.



Such bodies referred to in the first subparagraph of paragraph 2 shall be deemed to meet the

the requirements correspondingly for the task in question if the

they appear meet the requirements of the applicable standards by

accreditation or equivalent procedure.



8 § the Swedish Board for accreditation and technical control makes

decision to designate bodies for registration that meets the

the prerequisites under section 7.



§ 9 When a body has been designated under section 8 for information under the

7 paragraph 1, should the Swedish Board for accreditation and

technical monitoring report the body to the European Commission

and the other Member States, and shall inform the European

the Commission and the other Member States of any changes in

notification.



When a body has been designated under section 8 for information under section 7

item 2 of the first paragraph, the Board of Directors shall notify the body to the European

the Commission and inform it of any changes to the notification.



When the notification of conformity assessment bodies,

be limited or withdrawn



section 10 of the Swedish Board for accreditation and technical control,

decide to restrict or withdraw, temporarily or completely

a notification under section 9 If the notified body no longer

meets the requirements for carrying out the tasks

been notified, or has seriously failed to meet their

obligations.



The Board of Directors may determine that a decision on the limitation or

withdrawal of notification of a body shall apply with

immediate effect.



National standards laboratories and laboratories for the measurement



section 11 with the national laboratory referred to a body which has been designated to

a certain greatness officially responding for such measurement as in

relation to national measurement standards or scientific

defined units of measurement to ensure accuracy of measurements

carried out within the country and ensure that these measurement standards and

units of measure are affiliated with internationally accepted units.



section 12 of A national laboratory appointed by the Government for one or more

greats.



section 13 Laboratories that carry out metrological activities,

accredited to perform metering that should not occur in a

National Laboratory.



CE marking



The conditions for the CE marking



section 14 of the provisions concerning the CE marking provided for in article 30(1) to in

Regulation (EC) no 765/2008 and acts that have been designed

for some products, in accordance with the Council resolution of 7

May 1985 on a new approach to technical harmonisation and

standards.



section 15 CE marking of a product may only be made



1. If the labelling is in compliance with the specified in paragraph 14 of the

acts, and



2. If, when the Act consists of directives, regulations on

identification is in the law that implements the

the directive.



Obligation to take corrective action



section 16 If a product is CE-labelled, although it does not

in conformity with the requirements of the CE marking, the

responsible for CE-marking immediately take corrective action so

the infringement ceases.



Responsibility



section 17 of The who wilfully or negligently contravenes section 15

shall be liable to a fine if the Act is not subject to punishment according to the

other statutes.



The person who has infringed a imposition of fines handed down with

support of other statutes, shall not be liable under the

the first paragraph of an offence covered by the injunction.



Supervision



section 18 of the Swedish Board for accreditation and control exercise

overseeing the bodies referred to in this Act or in the

regulations issued under the law.



section 19 of the Swedish Board for accreditation and technical control has the right

that of bodies covered by the supervision on request

access to premises, as well as access to information and

documents to the extent necessary for the purposes of supervision.



Fees



section 20 of the national standards laboratories may levy a fee to cover the costs

for measurements according to what the Government or the

authority the Government closer.



paragraph 21 of the Accredited body or bodies that are assessed under section 7 shall

pay the fee to the Board for accreditation and conformity

check to cover the costs of accreditation, supervision

and assessment.



Privacy



section 22 of The dealing with a matter under this Act,

not improperly disclose or make use of what he or she thereby

been told if anyone's business or operating conditions.



In the public activities apply instead the provisions

in publicity and secrecy (2009:400).



Penalty



Conditions for the decision on penalty



section 23 of the Swedish Board for accreditation and technical control,

decide to charge a penalty of the unduly has

stated to be accredited or registered by the Board of

information in relation to conformity assessment.



The fine may be imposed even if the violation is not

committed with intent, recklessly or negligently.



section 24 of the Swedish Board for accreditation and technical control,

decide to take out the penalty by someone only if he has

been served a notice that the Board is considering taking

such a decision within five years of the infringement

occurred.



section 25 of the penalty may not be imposed for an infringement

subject to a penalty payment mechanism or a sanction under

other statutes.



Penalty may not be imposed for a violation of

the penalty has been imposed under other statutes.



Amount



section 26 of the penalty may be imposed in an amount determined by

account of the nature and scope of what is known

If the offender's economic conditions and fees

the facts are otherwise.



The Government may provide for how the fine

to be determined.



Exemption from penalty



section 27 If a violation is excusable or that of someone else

reason would be unfair to charge a fee,

It referred to in section 23 is wholly or partly released from

penalty.



The first paragraph also applies if it hasn't produced anything

claim for exemption from penalty.



Decision on the penalty



section 28 of the Swedish Board for accreditation and verification,

immediately inform regulators about the decision taken to

take out the penalty.



The Board shall also inform others that also have the opportunity to

take sanctions against infringement.



section 29 decision to fine to be levied from a physical

person shall be made to the County Administrative Board in the county where this has

their place of residence.




Decision to fine to be levied from a legal person

should be sent to the County Board in the county where this has its

seat.



section 30 of the penalty to be paid to the County Board where the

charging the culprit has his habitual residence, domicile or registered office. Payment must

be made within two months of the decision on the penalty

became final. An indication of this should be mentioned in the decision.



If the fine is not paid within the time specified in the

first subparagraph, shall also include a late-payment fee under

Act (1997:484) If late payment fee.



If the fine is not paid within the time specified in the

the first subparagraph, the County Administrative Board to which payment would

have occurred to request recovery of the fine and the

late payment fee to be charged in accordance with the second subparagraph.

Provisions of the Recovery Act (1993:891) if

recovery of State assets, etc. and in

enforcement regulation (1993:1229). During recovery,

enforcement under the enforcement code occur.



section 31 of the fine to the State.



32 § penalty falls away to the extent

enforcement has not been made within five years from the

the decision became final.



Appropriations



33 § Government or authority the Government determines

may provide for accreditation.



The Government or the authority that the Government may

provide, in the case of bodies to be notified under

§ 9.



Appeal



34 § decision under 5, 6 and 8 of the first paragraph, section 10, 19, 21

and 23 sections may be appealed to the administrative court.



Leave to appeal is required for an appeal to the administrative court.



Transitional provisions



2011:791



1. this law shall enter into force on 1 August 2011. By the law

repeals the Act (1992:1119) if technical control and the law

(1992:1534) about CE marking



2. A body notified under the Act (1992:1119) if

technical control of data in the context of the assessment of

conformity shall continue to be authorized to

carry out the tasks which it has been notified, provided

to meet the demands made at the time of notification.

This applies until 31 december 2014,

or the time before that when the Board for accreditation

and technical control makes a reassessment of the body.



3. for the purposes of section 6 of the equivalent accreditation certificate

decision on accreditation granted under the Act (1992:1119)

If technical control.



4. the provisions on sanctioning fee shall apply only to

violations that have taken place after this Act came into

force.



5. In other respects, shall apply the provisions of this law concerning

national standards laboratories, as well as accredited and notified bodies, even on

bodies at the time of entry into force is the national standards laboratories, or

accredited and notified, in accordance with the Act (1992:1119) if

technical control.