Upgrading the Iranian national laboratory standard to conform to ISO 15189:2012

Accreditation and Quality Assurance - The Reference Health Laboratory (RHL) of Iran is the national authority responsible for making policies and plans for providing quality laboratory services...     

Assessors’ attitudes toward and experiences of national quality standards: a qualitative study in Iran

To establish a national accreditation system for medical laboratories, Iran has set national standards based on the international standard ISO 15189. Central to the accreditation process are the technical assessors. Their attitude in this regard and their experiences should be identified. This study aims to explore assessors’ attitudes toward national laboratory accreditation and their experiences of assessment process in order to identify current gaps and suggest required interventions to solve them. A qualitative study using an open-ended questionnaire was employed. A total of 150 assessors working in the General Directorate of Laboratory Affairs participated in the study. While almost all Iranian laboratory accreditation assessors were generally supportive about the necessity of laboratory accreditation and cited benefits of this process, they pointed to improvement areas including developing assessor selection and appraisal criteria, continuous training, taking into consideration the heterogeneity of laboratories throughout the country, participation of professional associations and adopting measures to increase laboratories’ involvement.     

Establishing an Iranian medical laboratory standard based on ISO 15189

To strengthen clinical laboratories’ capabilities, the Reference Health Laboratory (RHL) of the Ministry of Health decided to compile a national professional laboratory standard to be followed by all medical laboratories in the country. Providing a national laboratory standard, as approved criteria for competency assessment, is also essential for establishment of a national accreditation system for medical laboratories. ISO 15189 addresses different processes and activities in a medical laboratory, but considering the local situation and limitations in the country it was not feasible to implement all the requirements of ISO 15189 at once in laboratories in different sectors and in different provinces of the country. For this reason, the RHL decided to define and publish the national standard, as minimum quality requirements that could be mandatory for all clinical laboratories throughout the country. After conducting a countrywide situation analysis, a national standard was composed by RHL expert committees and officially announced in September 2007. The main reference of this standard was ISO 15189:2007, although some important technical details were added to it from other credible references, such as WHO documents and CLSI guidelines. In this study, the Iranian national standard is compared to ISO 15189:2007 in terms of format and content in order to show how an international standard was localized for compiling a national standard.