Accreditation of medical laboratoriesCurrent events
On Tuesday, 27th January, Dejan Krnjaić, PhD, ATS Director, gave a lecture on the subject of accreditation of medical laboratories at a meeting of the Microbiology Department within the Serbian Medical Society.
Mr Krnjaić presented to the present members of the Serbian Medical Society the issues relating to accreditation, legal framework governing accreditation in our country and in the European Union, main objectives of accreditation, activities of the ATS, and described accreditation process briefly.
Accreditation is a procedure performed by a national accreditation body and is a basis for determining and confirming whether a certain body meets the requirements to perform relevant conformity assessment activities as laid down in relevant international standards, and whether that body is competent to perform those activities.
Competence – is a demonstrated ability to apply skills and knowledge
The Accreditation Board of Serbia (ATS) performs accreditation in Serbia. The ATS was established by the Republic of Serbia as an independent and non-profit body implementing the Law on Accreditation.
When performing conformity assessment it is necessary to carry out different activities to confirm the fulfilment of specific requirements pertaining to products, processes, systems, persons or bodies, explained Mr Krnjaić and added that conformity assessment bodies are bodies that can provide conformity assessment services by performing different testing, certification or inspection activities. Conformity assessment process may be performed by manufacturers or by a body completely independent from both manufacturers and clients.
Nowadays on global market consumers / state institutions require or lay down that it is necessary to fulfil a large number of requirements of standards, i.e. technical regulations that must be met prior to the placement of products on the market. Manufacturers, i.e. suppliers are obliged to take all necessary actions to ensure high level protection of elements of public interest such as safety, human health, animal and plant health, and environmental protection which can be attained by performing conformity assessment.
Mr Krnjaić explained that accreditation, as a harmonised process performed in accordance with ISO/IEC 17011, is an efficient way of confirming and monitoring competence of conformity assessment bodies and is performed by an independent and impartial institution represented by a national accreditation body. On the other hand, only conformity assessment bodies the competence of which was confirmed by the ATS in accordance with harmonised criteria of international standards and guides of international and regional organisations for accreditation may ensure quality and reliability of conformity assessment results (testing, certification,...).
Implementation of harmonised activities performed by national accreditation bodies shall ensure similar competence levels of conformity assessment bodies and obtaining of comparable results whereby contributing, within different international (ILAC MRA, IAF MLA, CIPM MRA) and regional agreements (EA MLA), to mutual recognition of reports and certificates. Furthermore, this will contribute to worldwide networking of accreditation bodies and attainment of high level of trust of all participants on the global market.
While talking about the quality of services provided by medical laboratories Mr Krnjaić emphasised that their services are of enormous importance for patient healthcare, and, therefore, a laboratory should meet the requirements of both patients and clinical staff. Therefore, according to him laboratory services must be: safe, effective, timely, i.e. fast and patient oriented.
Depending on the level of risk arising from product nonconformities, risk posed to injury of health and safety, and with the aim of reducing the risk to an acceptable level, a country may set forth regulations requiring mandatory conformity assessment. In the Republic of Serbia technical regulations govern conformity assessment in the areas of environmental protection, agriculture and food safety. In this respect state bodies have been introduced as the third and top level of the hierarchy in the whole system in addition to testing laboratories and the national accreditation body confirming their competence.
According to Mr Krnjaić the ATS accredits medical laboratories on a voluntary basis as per SRPS ISO/IEC 17025:2006 – General Requirements for Competence of Testing Laboratories and Calibration Laboratories or as per SRPS ISO 15189 – Medical Laboratories – Special Requirements for Quality and Competence, whereas a laboratory may choose a standard.
“By signing EA MLA the accreditation system in the Republic of Serbia will be recognised worldwide, whereby this will enable our country to remove barriers to trade and attain better competitiveness on the global market, was one of the conclusions put forward by the ATS Director in his lecture. Furthermore, he added that better quality of general safety and health, and environmental protection would be ensured by taking on international standards and harmonising our laws with those of the EU.
Dejan Krnjaić, PhD, ATS Director, giving lecture at the Serbian Medical Society (SMS)
Dejan Krnjaić, PhD, and prof.dr Branislava Kocić, President of the Microbiology Department within the SMS