ESTABLISHMENT OF ACCREDITATION DIRECTORATE OF THE MALTA STANDARDS AUTHORITY ORDER

SUBSIDIARY LEGISLATION 419.05

ESTABLISHMENT OF ACCREDITATION

DIRECTORATE OF THE MALTA STANDARDS

AUTHORITY ORDER

1st January, 2002

LEGAL NOTICE 313 of 2001, as amended by Legal Notices 253 of 2006

and 307 of 2007.

(1) The title of this Order is the Establishment of

Accreditation Directorate of the Malta Standards Authority Order.

(2) This Order lays down the establishment, organisation and

operation of the Accreditation Directorate within the Malta

Standards Authority. This Order specifies the fields in which

accreditation shall be performed and the application of

accreditation in all regulations specifying conformity assessment.

In this Order, the following definitions shall apply, unless

the context otherwise requires

"accred itati on" m ean s third-p arty at test ation by a publi c

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;

"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

w ith specific requ irem ent s or, on th e basis of professio nal

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;

" t e s t " m ea ns t h e t e c h n i c a l op e ra t i o n t h a t c on s i s t s o f t h e

determination of one or more characteristics of a given product,

process or service according to a specified procedure.

There shall be established, within the Authority and as

p r o v i d ed f o r i n s e c t i o n 3 ( 1 4 ) o f t h e A c t , a n A c c r e d i t a t i o n

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

ESTABLISHMENT OF ACCREDITATION DIRECTORATE

OF THE MALTA STANDARDS AUTHORITY

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.

(1) The Head of the Accreditation Directorate shall be

appointed according to the provisions of article 3(17) of the Act.

(2) In exercising its functions under this Order, the

Accreditation Directorate shall be functionally independent from

the Authority as regards operational matters and, more specifically,

as regards technical matters within its area of competence. In

particular, the Accreditation Directorate shall be independent of

any other structure or official within the Authority as regards the

implementation of the functions listed in article 3.

(3) Without prejudice to the immediately subarticle (3), the

Accreditation Directorate shall operate subject to the

administrative and financial control of the Authority as provided

for in the Act as well as subject to the general policy of the

Authority.

(Deleted by Legal Notice 253 of 2006).

(Deleted by Legal Notice 253 of 2006).

(Deleted by Legal Notice 307 of 2007).

(Deleted by Legal Notice 307 of 2007).

(1) The regulations laying down conformity assessment

may specify the participation of the Accreditation Directorate in

designating the bodies carrying out assessment of conformity in

line with the requirements of these regulations.

(2) The regulations laying down conformity assessment may

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.