2. In this Act, unless the context otherwise requires — Act No. 12 of 2011 Act No. of 2017 Act No. 2017 of Act No. 2017 of “ accreditation ” means third party attestation for a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks; “ adverse ” has the meaning assigned to it in the Environmental Management Act, 2011; “ Bureau ” means the Zambia Bureau of Standards established under the Standards Act, 2017; “ certification ” means the formal substantiation that a product, process, service, organisation or individual meets the requirements of a standard; “ commodity ” has the meaning assigned to it in the Standards Act, 2017; “ compulsory standard ” means a compulsory standard declared under the Compulsory Standards Act, 2017; “ conformity assessment ” means the demonstration that a product, process, system, person or body meets the specified requirement; “ conformity assessment procedure ” means a procedure used, directly or indirectly, to determine that relevant requirements of a technical regulation or standard are met, and includes inspection, a procedure for sampling, evaluation,verification, assurance of conformity, registration, accreditation and approval or a combination of these procedures; testing, “ conformity assessment scheme ” means the rules, procedures and management for carrying out a conformity assessment; “ Department ” means the Department of Technical Regulation established under section 5; “ designate ” in relation to conformity assessment service providers, means the governmental authorisation of a conformity assessment body to perform specified conformity assessment activities with a public domain responsibility; National Technical Regulation [No. 5 of 2017 123 “ Director ” means the Director of Technical Regulation appointed under section 7; “ environment ” has the meaning assigned to it in the Environmental Management Act, 2011; “ inspection ” means the examination of a product,process or installation and determination of its conformity with specific requirements or, on the basis of professional judgement, with general requirements; “ ISO ” means the International Organisation for Standardisation; “ legal metrology ” has the meaning assigned to it in the Metrology Act, 2017; “ market ” in relation to any goods or services, includes a market for those goods or services and other goods or services that are substitutable for, or otherwise competitive with, the goods or services; “ market surveillance ” means random checks and audits of, or taking samples and gathering of information with regard to, products and services available on the market and in warehouses; “ metrology ” has the meaning assigned to it in the Metrology Act, 2017; “ national quality infrastructure ” means the totality of the institutional framework, whether public or private, the output of which includes metrology, standards, inspection, testing, certification and accreditation; “ pre-market approval ” means the scientific and regulatory review of a commodity, by the regulatory agency responsible for enforcing standards to which that commodity is subject, in order to establish that commodity’s safety and effectiveness before its approval for the market; “ process ” means a method of operation, manufacturing, production, storage, transportation, disposal or combination of these processes; “ product ” has the meaning assigned to it in the Standards Act, 2017; “ production method ” means the mechanical or chemical steps used to create an object, usually repeated to create multiple units of the same item and generally involves the use of raw materials, machinery and human resource to create a product; “ regulatory agency ” means a Ministry, department or agency with authority and power to develop or oversee the implementation of a technical regulation; Act No. 12 of 2011 Act No. of 2017 Act No. of 2017 Act No. of 2017 124 No. 5 of 2017] National Technical Regulation “ relevant Minister ” means the Minister under whose portfolio a regulatory agency falls; “ service ” means any work or doing work for remuneration and at the request of a recipient of the service, and includes the process used for delivering the service; “ service provider ” means a person who supplies a service to which a technical regulation applies; “ standard ” means a document, approved by a recognised body, which provides for common and repeated use of the rules, guidelines or characteristics for products and their related processes or production methods, with which compliance is not mandatory, and includes terminology, symbols, packaging, marking or labelling requirements as they apply to a product or process; “ supplier ” means the manufacturer, merchant, distributor, importer or agent who places a product, process or service onto the market; “ SADC ” means the Southern African Development Community; “ technical regulation ” means a document which lays down commodity or service characteristics or their related processes and production methods, including administrative provisions, with which compliance is mandatory, and includes terminology, symbols, packaging, marking or labelling requirements as they apply to a commodity or service or their related processes; “ technical regulation framework ” means the manner in which technical requirements, the conformity assessment system, regulatory authority mandates and sanctions are applied in the development and implementation of technical regulation; “ trade ” means the buying, selling or exchange of goods and services; “ WTO TBT Agreement ” means the World Trade Organisation Agreement on Technical Barriers to Trade; and “ Zambian National Standard ” means a standard approved by the Bureau under the Standards Act, 2017 . Act No. of 2017 National Technical Regulation [No. 5 of 2017 125
