NATIONAL ACCREDITATION BOARD (MALTA) (ESTABLISHMENT) [ S.L.419.07 SUBSIDIARY LEGISLATION 419.07 NATIONAL ACCREDITATION BOARD (MALTA) (ESTABLISHMENT) REGULATIONS 19th October, 2007 LEGAL NOTICE 306 of
- The title of these regulations is the National Accreditation Board (Malta) (Establishment) Regulations.
- In these regulations, unless the context otherwise requires: Citation. Definitions. "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; "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; Cap.
- 1 2 [ S.L.419.07 NATIONAL ACCREDITATION BOARD (MALTA) (ESTABLISHMENT) "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 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; "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 NATIONAL ACCREDITATION BOARD (MALTA) (ESTABLISHMENT) [ S.L.419.07 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; " 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; "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. 3.
(1)There shall be a Board to be known as the National Accreditation Board (Malta) which shall carry out functions related to accreditation in terms of these regulations.
(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 paragraph (a), 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. Establishment of the National Accreditation Board (Malta). 3 4 NATIONAL ACCREDITATION BOARD (MALTA) (ESTABLISHMENT) [ S.L.419.07
(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. Accreditation Directorate. S.L. 419.05 4.
(1)The Accreditation Directorate, appointed in terms of the Malta Standards Authority (Establishment of the Accreditation Directorate) Order shall be responsible for the administrative and executive functions of the Board.
(2)The Head of Directorate shall act as the Secretary of the Board. Technical committees. 5.
(1)The Directorate may, with the agreement of the Board, establish technical committees in order to provide scientific and technical advice in their respective defined areas of competence.
(2)The Directorate shall appoint a competent person to chair and co-ordinate each technical committee. NATIONAL ACCREDITATION BOARD (MALTA) (ESTABLISHMENT) [ S.L.419.07
(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. 6.
(1)Assessments for the accreditation of any body shall be 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 subregulation
(1)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. 7.
(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. Accreditation procedure. 5