S.L. 419.5 ст. 2Definitions.

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; "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.