Regulations, 2006

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,986, 24 ta’ Ottubru, 2006

L.N. 252 of 2006

MALTA STANDARDS AUTHORITY ACT, 2000

(ACT NO. XIX OF 2000)

National Accreditation Board (Malta) (Establishment)

Regulations, 2006

IN exercise of the powers conferred by article 21 (i) of the Malta

Standards Authority Act 2000, the Minister for Competitiveness and

Communications has made the following Order>–

(1) The title of these regulations is the ‘National Citation

commencement.

Accreditation Board (Malta) (Establishment) Regulations’.

(2) These regulations shall be deemed to have come into

force on 1 st October 2006.

(1)

In these regulations, unless the context otherwise Definitions.

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<

“National Accreditation Board (Malta)” means that board

established in terms of regulation of these regulations and which

hereinafter in these regulations is also referred to as the

“Accreditation Board” or the “Board”<

“accreditation body” is the authoritative body that performs

accreditation and that is either part of government or operates under

the responsibility of, and with authority derived from, government.<

“accreditation certificate” means a formal document or a set

of documents, stating that accreditation has been granted for a

defined scope<

“accredited body” means a body to which accreditation has

been granted<

“Act” means the Malta Standards Authority Act, 2000<

“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 particular standard(s) and#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<

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

corporate or incorporate, private or public<

“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<

“Chairman of the NAB-Malta” means the person appointed

in terms of Regulation 4 and shall be hereinafter in these regulations

referred to as “the Chairman”.

“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<

“Minister” means the Minister responsible for accreditation<

“Ministry” shall be construed accordingly.

“normative document” is a document that provides rules,

guidelines or 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 National Accreditation Board

(Malta) , 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.

“withdrawing accreditation” means the process of cancelling

accreditation in full.

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

Accreditation Board (Malta) to act on behalf of the Minister in all matters

related to accreditation.

(2) The Board shall assume the functions of the Directorate

for Accreditation established by means of L.N. 313 of 2001 listed in

regulation 3 of same and, the said Directorate for Accreditation shall

cease to exercise the said functions with immediate effect.

(3) In additions to the functions mentioned in the last

preceding subregulation, the functions of the Board shall also include

the following>

(a)

to accredit medical laboratories<

(b) to accredit EMAS Verifiers<

(c) to perform other assessments and approvals of

competence of bodies carrying out conformity assessment

activities<

(d) to collaborate with organisations of accreditation bodies,

and to represent in them the Maltese interests as and when

requested<

(e) to perform other assessments and approvals of

competence for carrying out conformity assessment activities,

including fulfilment of the requirements for conformity assessment

bodies pursuant to particular regulations for conformity assessment<

(f)

to publish accreditation guidelines.

(1) The Board shall be composed of such number of

Members, being not less than two and not more than seven as the Minister

may deem fit and it shall be chaired by the Chairman.

(2) The Minister shall appoint the Chairman and the

members of the Board.

(3) In the performance of its functions the National

Accreditation Board (Malta) shall be accountable to the Minister and

the Chairman shall be accountable operationally and shall report directly

to the Minister.

(1) Without prejudice to the functions listed in regulation 3,

the functions of the Chairman shall include>

(a) to provide for assessment visits of applicant bodies, as

required by the applicable relevant national, international and

European regulations, standards and guides according to the scope

of accreditation<

(b) to provide for periodic surveillance visits for the

assessment of the technical and organisational requisites of the

accredited bodies, as required by the applicable national,

international and European regulations, standards and guides

according to the scope of accreditation<

(c) to make publicly available information about the current

status of the accreditations that it has granted to Conformity

Assessment Bodies. The information shall include the name and

address of each accredited Conformity Assessment Body and the

scopes of accreditation, condensed and/or in full<

(d) to prepare an annual business plan and to monitor and

manage its implementation<

(e) to consult with the National Accreditation Board (Malta)

on the development of the policies related to accreditation, as

necessary, and to implement such policies<

(f) to take part in the work of international bodies operating

in the field of accreditation<

(g) to collaborate with the Standardization Body in order to

develop and promote appropriate drafting or updating of technical

standards<

(h) to collaborate with the relevant national and international

entities in order to develop and promote appropriate conformity

assessment procedures<

(i) to promote studies, meetings and actions in its area of

competence in co-operation with national and international

associations<

(j) to represent Malta in relevant national and international

activities< and

(k) to carry out such other functions, not conflicting in any

way with the provisions of this Order, as the Minister may, from

time to time, direct.

(2) In exercising its functions the National Accreditation

Board (Malta) 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 National Accreditation Board

(Malta) shall be functionally independent as regards operational matters

and, technical matters within its area of competence.

(1) There shall be established an Accreditation Committee,

the functions of which are>

(a) to provide advice of a technical nature to the Chairman

and to provide assistance on general matters of policy and

organisation relating to the functions and activities of the National

Accreditation Board (Malta)<

(b) to examine proposals for new accreditation projects and

to make recommendations on how to proceed in pursuance of these

proposals<

(c) to make recommendations on the granting and

withdrawal of accreditations.

(2) The Accreditation Committee shall be composed of a

balanced representation of interested parties as identified by the

Chairman with no single party predominating.

(3) The manner of procedure of the appointment of the

members and their terms of office shall be determined by the Minister

after consulting the Chairman, according to the relevant national

regulations and international and European standards and guides of the

European and international organisation of accreditation bodies.

(4) The Accreditation Committee shall draw up its own rules

of procedure, based on the relevant national, international and European

standards and documents of the European and international organisations

of accreditation bodies.

(5) Administrative matters relating to the Accreditation

Committee shall be conducted by the Chairman. The Chairman, or his

designate, shall act as the Secretary of the Board.

(1) Any person who feels aggrieved by a decision of the Appeals.

Accreditation Committee may appeal such a decision to the national

Accreditation Board (Malta) within thirty days from the date when the

decision was notified to him or was made public.

(2) The National Accreditation Board (Malta) shall assess

the validity of each appeal made from a decision of the Accreditation

Committee.

(3) The National Accreditation Board (Malta) shall appoint,

as and when necessary, 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 National Accreditation Board (Malta)

The National Accreditation Board (Malta) shall in the Staff.

performance of its functions use the services of such staff, contract

employees or contractors as may be assigned to it by or with the

concurrence of the Minister.

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

the Board, establish technical committees in order to provide scientific Committees.

and technical advice in their respective areas of competence.

(2) In agreement with the Board, the Chairman shall appoint

a competent person to chair and co-ordinate each technical committee.

(3) The Chairman may, with the agreement of the

Accreditation 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

conducted in accordance with the applicable national, international and

European regulations, standards and guides.

(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 national,

international and European normative documents.

(5) The accredited body shall continue to conform with 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) Rules regarding conformity assessment may specify

the participation of the National Accreditation Board (Malta) in

designating the bodies carrying out assessment of conformity in line

with the requirements of these regulations.

(2) Such rules may also specify that the competence of the bodies

responsible for assessing conformity in line with the requirements of

these regulations can be presumed on the basis of accreditation

certificates.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press