Nepali pathology laboratory has been accredited with ISO certificate for the first time.
Samyak Diagnostic Pvt Ltd was recently given ISO 15189:2012 by AERSSC, the affiliate member of International Laboratory Accreditation Cooperation (ILAC), Geneva Switzerland.
ILAC is the accreditation body which has the authority to grant certification to laboratories after thorough investigation process. ILAC affiliate, AERSSC, handed over the certificate MLS-001 to Samyak Diagnostic in Kathmandu on Tuesday.
“ISO 15189:2012 signifies our commitment toward quality reports for proper patient care. We are proud to get Samyak Diagnostic at a global stage, as far as quality of service is concerned,” said Dr Keyoor Gautam, Chairman, Samyak Diagnostic Pvt. Ltd., after receiving the certification.
Samyak initiated the quest for quality in pathology laboratories in Nepal, according to Dr Gautam.
“We shall now try to encourage other laboratories in the country to be accredited, helping them raise their standard in terms of quality and process. We hope, this will ultimately lead to the overall improvement in the health care system in our country,” he said.
What is ISO 15189:2012?
ISO stands for International Organization of Standardization. ISO 15189 was created for Medical Laboratories- Particular Requirement for Quality and Competence in the year 2003, which was revised and republished in 2007 and 2012.
ISO 15189:2012 consists of both management and technical requirements for a medical laboratory.
In 2004, 23 countries adopted the standard within a year of publication. In 2013, over 60 countries had adopted this international quality standards. ISO 15189 is very comprehensive and involves laboratory quality, management, staff, customer, physical lab, technical quality together with error recognition and improvement. The focus on quality control is dependent upon personnel competency, procedure process, procedure documentation, reagents and materials, environmental condition and equipment.