L.S. 419.05 Ordni dwar it-Twaqqif tad-Direttorat ta' l-Akkreditament fl-Awtorità Maltija dwar l-Istandards

(1)The title of this Order is the Establishment of Accreditation Directorate of the Malta Standards Authority Order. Citation. Amended by: L.N. 253 of 2006.

(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.

1. In this Order, the following definitions shall apply, unless the context otherwise requires: Definitions. Amended by: L.N. 307 of
2. "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; Cap.
3. 2 [ S.L.419.05 ESTABLISHMENT OF ACCREDITATION DIRECTORATE OF THE MALTA STANDARDS AUTHORITY "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: (

1. a)enquiries from the accreditation body to the Conformity Assessment Body on aspects concerning the accreditation; (
2. b)reviewing the declarations of the Conformity Assessment Body with respect to what is covered by the accreditation; (
3. 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, ESTABLISHMENT OF ACCREDITATION DIRECTORATE OF THE MALTA STANDARDS AUTHORITY [ S.L.419.05 3 complaints records, management review records); (
4. 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. 3. 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: (
5. a)to provide for assessment visits of testing and calibration laboratories, as required by the applicable accreditation normative documents; (
6. b)to provide for assessment visits of medical and clinical laboratories, as required by the applicable accreditation normative documents; (
7. c)to provide for assessment visits of inspection bodies as required by the applicable accreditation normative documents; (
8. 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; (
9. e)to provide for assessment and supervision visits of EMAS Verifiers as required by the applicable accreditation normative documents; (
10. 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; (
11. 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; (
12. h)to suspend accreditation and to inform the Board of any such suspension; (
13. i)to receive and administer appeals to decisions of the Board; (
14. 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 the Accreditation Directorate. Substituted by: L.N. 307 of 2007. 4 [ S.L.419.05 ESTABLISHMENT OF ACCREDITATION DIRECTORATE OF THE MALTA STANDARDS AUTHORITY Body and the scopes of accreditation, either condensed or in full; (
15. k)to prepare an annual business plan and to monitor and manage its implementation; (
16. l)to consult with the Board on the development of the policies related to accreditation, as necessary, and to implement such policies; (
17. m)to establish and disband as and when required technical committees in agreement with the Board; (
18. n)to participate in the work of international bodies operating in the field of accreditation; (
19. o)to collaborate with the relevant national and international entities in order to develop and promote appropriate conformity assessment procedures; (
20. p)to promote studies, meetings and actions in its area of competence in co-operation with national and international associations; (
21. 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; (
22. r)to represent Malta in international activities; relevant national and (
23. s)to collaborate with organisations of accreditation bodies, and to represent in them the Maltese interests as and when requested; (
24. t)to publish accreditation guidelines; (
25. u)to publish accreditation regulations, policies and other normative documents as necessary; (
26. v)to keep a register of accredited bodies; and (
27. w)to carry out such other functions as are ancillary or complimentary to the above functions. The Head of the Accreditation Directorate. Amended by: L.N. 307 of 2007. 4.

(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. ESTABLISHMENT OF ACCREDITATION DIRECTORATE OF THE MALTA STANDARDS AUTHORITY [ S.L.419.05

1. (Deleted by Legal Notice 253 of 2006). Establishment of the Accreditation Advisory Board.
2. (Deleted by Legal Notice 253 of 2006). Establishment of the Accreditation Appeals Board.
3. (Deleted by Legal Notice 307 of 2007). Technical committees.
4. (Deleted by Legal Notice 307 of 2007). Accreditation procedure. 9.

(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. Regulations specifying conformity assessment. 5