Directorate) (Amendment) Order, 2007

L.N. 307 of 2007

MALTA STANDARDS AUTHORITY ACT

(CAP. 419)

Malta Standards Authority (Establishment of the Accreditation

Directorate) (Amendment) Order, 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 order>–

The title of this Order is the Malta Standards Authority Citation.

(Establishment of the Accreditation Directorate) (Amendment) Order,

2007 and the Order shall be read and construed as one with the Malta

Standards Authority (Establishment of the Accreditation Directorate)

L.N. 313 of 2001.

Order, 2001, hereinafter referred to as “the principal order”.

For article 2 of the principal order there shall be substituted Substitutes article 2

of the principal

the following>

order.

“2. In this Order, the following definitions shall apply, 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<

“the Act” means the Malta Standards Authority Act<

“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<

“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<

“the Authority” means the Malta Standards Authority<

“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<

“EMAS’’ means Eco Management and Audit Scheme<

“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<

“medical and clinical laboratories” are laboratories for

the biological, microbiological, immunological, chemical,

immunohaematological, haematological, biophysical,

cytological, pathological or other examination of materials

derived from the human body for the purpose of providing

information for the diagnosis, prevention and treatment of

disease in, or assessment of the health of, human beings, and

which may provide a consultant advisory service covering

all aspects of laboratory investigation including the

interpretation of results and advice on further appropriate

investigation<

“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<

“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 for verifying 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.”

For article 3 of the principal order there shall be substituted

the following>

“3. There shall be established, within the Authority and as

provided for in section 3(14) of the Act, an Accreditation

Directorate, with the following principal functions and

responsibilities>

(a) to provide for assessment visits of testing and

calibration laboratories, as required by the applicable

accreditation normative documents<

(b) to provide for assessment visits of medical and

clinical laboratories, as required by the applicable

accreditation normative documents<

(c) to provide for assessment visits of inspection bodies

as required by the applicable accreditation normative

documents<

(d) to provide for assessment visits of certification

bodies providing certification of products, services,

management systems and personnel as required by the

applicable accreditation normative documents<

(e) to provide for assessment and supervision visits of

EMAS Verifiers as required by the applicable accreditation

normative documents<

(f) to perform other assessments and approvals of

competence of Conformity Assessment Bodies carrying out

conformity assessment activities, including fulfilment of the

requirements for conformity assessment bodies pursuant to

particular regulations for conformity assessment<

(g) to provide for periodic surveillance visits for the

assessment and reassessment of the technical and

organisational requisites of the accredited bodies, as required

by the applicable normative documents<

(h) to suspend accreditation and to inform the Board

of any such suspension<

(i) to receive and administer appeals to decisions of

the Board<

(j) to make publicly available information about the

current status of the accreditations that has been granted by

the Board to Conformity Assessment Bodies. The information

shall include the name and address of each accredited

Conformity Assessment Body and the scopes of accreditation,

either condensed or in full<

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

and manage its implementation<

(l) to consult with the Board on the development of

the policies related to accreditation, as necessary, and to

implement such policies<

(m) to establish and disband as and when required

technical committees in agreement with the Board<

(n) to participate in the work of international bodies

operating in the field of accreditation<

(o) to collaborate with the relevant national and

international entities in order to develop and promote

appropriate conformity assessment procedures<

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

of competence in co-operation with national and international

associations<

(q) to provide advice to the Government and other

public entities in matters concerning accreditation and other

assessments and in the approval or otherwise as to the

competence of bodies carrying out conformity assessment

activities<

(r) to represent Malta in relevant national and

international activities<

(s) to collaborate with organisations of accreditation

bodies, and to represent in them the Maltese interests as and

when requested<

(t) to publish accreditation guidelines<

(u) to publish accreditation regulations, policies and

other normative documents as necessary<

(v)

to keep a register of accredited bodies< and

w) to carry out such other functions as are ancillary or

complimentary to the above functions.”.

3. Sub-article (2) of article 4 of the principal order shall be deleted

and sub-articles (3) and (4) thereof shall be renumbered as sub-articles

(2) and (3) respectively, and in sub-article (2) as renumbered the words

“and in sub-article (2) of this article” shall be deleted.

Article 7 of the principal order shall be deleted.

Article 8 of the principal order shall be deleted.

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