Regulations, 2007

L.N. 306 of 2007

MALTA STANDARDS AUTHORITY ACT

(CAP. 419)

National Accreditation Board (Malta) (Establishment)

Regulations, 2007

IN exercise of the powers conferred by article 21 of the Malta

Standards Authority Act, the Minister for Competitiveness and

Communications has made the following regulations>–

The title of these regulations is the National Accreditation

Board (Malta) (Establishment) Regulations, 2007.

(1)

In these regulations, unless the context otherwise

requires>

“accreditation” means third-party attestation by a public

authority, related to a conformity assessment body, conveying

formal demonstration of its competence to carry out specific

conformity assessment tasks<

“accreditation body” is the authoritative body that performs

accreditation and that operates under the responsibility of, and with

authority derived from, government<

“accredited body” means a body to which accreditation has

been granted<

“accreditation certificate” means a formal document or a set

of documents, stating that accreditation has been granted for a

defined scope<

“the Act” means the Malta Standards Authority Act<

“adverse decisions” includes refusal to accept an application,

refusal to proceed with an assessment, corrective action requests,

changes in accreditation scope, decisions to deny, suspend or

withdraw accreditation, and any other action that impedes the

attainment of accreditation<

“appeal” means a request by an applicant or accredited body

for reconsideration of any adverse decision made by the

accreditation body related to its desired accreditation status<

“applicant” means any body which has applied for

accreditation<

“assessment” means the process undertaken by an

accreditation body to assess the competence of a Conformity

Assessment Body based on any particular standard or other

normative documents and for a defined scope of accreditation.

Assessing the competence of a Conformity Assessment Body

involves assessing the competence of the entire operations of such

body, including the competence of the personnel, the validity of

the conformity assessment methodology and the validity of the

conformity assessment results<

“assessor” means a person assigned by an accreditation body

to perform, alone or as part of an assessment team, an assessment

of a Conformity Assessment Body<

“the Board” means the National Accreditation Board (Malta)

established in terms of regulation 3 of these regulations<

“body” means any person or association of persons, whether

corporate or incorporate, private or public<

“calibration” refers to all the operations for the purpose of

determining the values of errors of a measuring instrument<

“certification” means third-party attestation related to

products, processes, systems or persons<

“certification body” is a body that conducts certification<

“conformity” means the fulfilment by a product, process or

service of specified requirements<

“conformity assessment” means the demonstration that

specified requirements relating to a product, process, system, person

or body are fulfilled. It covers such activities such as testing,

calibration, inspection and certification<

“conformity assessment body ” means a body that performs

conformity assessment services<

“conformity assessment procedure” means the procedure by

which conformity assessment is attained<

“expert” means a person assigned by an accreditation body

to provide specific knowledge or expertise with respect to the scope

of accreditation to be assessed<

“extending accreditation” means the process of enlarging the

scope of accreditation<

“the Head of Directorate” means the person appointed to that

post according to the provisions of article 3(17) of the Act<

“inspection” means the examination of a product design,

product, service, process or plant, and the determination of their

conformity with specific requirements or, on the basis of

professional judgement, general requirements<

“inspection body” is a body that performs inspection<

“the Minister” means the Minister responsible for the Malta

Standards Authority<

“normative document” is a document that provides rules,

characteristics for activities or their results. The term “normative

document” is a generic term that covers such documents as

standards, technical specifications, codes of practice and

regulations<

“reducing accreditation” means the process of cancelling

accreditation for part of the scope of accreditation<

“scope of accreditation” means specific conformity

assessment services for which accreditation is sought or has been

granted< the specific tests, measurements or calibration for which

a body is formally accredited by the Board, including any

qualifications such as range of measurement, test procedures and

assigned measurement uncertainties<

“surveillance” means the set of activities, except reassessment,

to monitor the continued fulfilment by accredited Conformity

Assessment Bodies of requirements for accreditation.The term

includes both surveillance on-site assessments and other

surveillance activities, such as the following>

a) enquiries from the accreditation body to the

Conformity Assessment Body on aspects concerning the

accreditation<

b) reviewing the declarations of the Conformity

Assessment Body with respect to what is covered by the

accreditation<

c) requests to the Conformity Assessment Body to

provide documents and records (e.g. audit reports, results of

internal quality control forverifying the validity of Conformity

Assessment Body services, complaints records, management

review records)<

d) monitoring the performance of the Conformity

Assessment Body (such as results of participating in

proficiency testing)<

“suspending accreditation” means the process of temporarily

making accreditation invalid, in full or for part of the scope of

accreditation<

“test” means the technical operation that consists of the

determination of one or more characteristics of a given product,

process or service according to a specified procedure<

“third party” means any person or body that is recognised as

being independent of the parties involved as concerns the issue in

question<

“witnessing” means the observation of the Conformity

Assessment Body carrying out conformity assessment services

within its scope of accreditation<

“withdrawal of the accreditation” means the process of

cancelling accreditation in full.

(1) There shall be a Board to be known as the National Establishment of the

National

Accreditation Board (Malta) which shall carry out functions related to Accreditation Board

accreditation in terms of these regulations.

(Malta).

(2) The Board shall be composed of a chairman appointed

by the Minister and not more than twelve members appointed from

among persons of recognized standing and professional experience in

matters related to conformity assessment activities and accreditation,

provided that>

(a) the membership of the Board shall comprise a balanced

representation with no single party dominating and<

(b) without prejudice to point (a) of this sub-article, the

members shall be appointed by public, private, trade or industry

organisations.

(3) The Board shall establish its own procedure and shall

draw up its own rules including rules regarding the holding of meetings

and rules on quorum and voting at such meetings..

(4) The Board shall have the following functions>-

(a) to act as the National Accreditation Body in Malta

responsible for accreditation in accordance with the relevant

national, international and European standards and guides, and the

applicable national, international and European regulations<

(b) to act as the National Accreditation Body in Malta

responsible for adopting commitments and obligations relating to

accreditation arising out of any international agreement, whether

bilateral, regional or multilateral<

(c)

to accredit testing and calibration laboratories<

(d) to accredit certification bodies providing certification

of products, services, management systems and personnel<

(e)

to accredit inspection bodies<

(f) to take decisions on the granting, extending, reducing or

withdrawing of accreditation<

(g) to determine the general policy and objectives of the

Accreditation Directorate<

(h) to act as a liason point for all the sectors it represents,

and other persons having an interest therein<

(i) to review the annual business plan< and

(j) to approve, on recommendation of the Accreditation

Directorate, the establishment and disbanding of technical

committees as and when required.

(5) In the performance of its functions, the Board shall keep

the Minister periodically informed of its activities and shall provide

him with such information as may be necessary for this purpose.

(6) In exercising its functions, the Board shall operate in

line with the international standards which define the requirements for

accreditation bodies. In addition in exercising its functions under these

regulations, the Board shall be functionally independent as regards

operational matters and technical matters within its area of competence.

(1) The Accreditation Directorate, appointed in terms of the Accreditation

Directorate.

Malta Standards Authority (Establishment of the Accreditation

Directorate) Order, 2001, shall be responsible for the administrative L.N. 313 of 2001.

and executive functions of the Board.

(2) The Head of Directorate shall act as the Secretary of the

Board.

(1) The Directorate may, with the agreement of the Board, Technical

establish technical committees in order to provide scientific and technical committees.

advice in their respective defined areas of competence.

(2) The Directorate shall appoint a competent person to chair

and co-ordinate each technical committee.

(3) The Directorate may, with the agreement of the Board,

disband a technical committee and remove, replace or suspend any

member of such committee if such action is considered to be necessary

in order to maintain its impartiality, transparency, independence and

competence.

(1) Assessments for the accreditation of any body shall be Accreditation

procedure.

conducted in accordance with the applicable normative documents.

(2) The Board shall conclude a contract with any body

wishing to obtain accreditation, stipulating the rights and obligations of

the parties to the contract.

(3) The Board shall conclude a contract with assessors as

necessary and as required by the accreditation process.

(4) The Board shall grant a certificate of accreditation to

any Body which fulfils the requirements of the applicable normative

documents.

(5) The accredited body shall have to continue to conform

to the requirements for accreditation specified in sub-regulation (1) of

this regulation on a permanent basis. Failure to meet the said

requirements during the period of accreditation shall result in the

suspension, reduction in scope or withdrawal of the accreditation.

(6) All costs associated with assessment of competence,

accreditation and surveillance shall be borne by the conformity

assessment body.

(1) Any body which feels aggrieved by a decision of the

Board may appeal such a decision to the Directorate within thirty days

from the date when the decision was notified to the body or was made

public, whichever is the latest.

(2) The Directorate shall appoint, ad hoc, a suitably

competent, impartial and independent person, or group of persons

depending on the nature of the appeal to report on the merits of the

appeal and to make the appropriate recommendations to the Board.

The National Accreditation Board (Malta) (Establishment)

Repeals L.N. 252 of

2006. Regulations, 2006, is hereby being repealed.

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