Accredited Medical Laboratory

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What is accredited medical laboratory? Intro: History A medical laboratory is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient, as main objectives are diagnosis and treatment. In 1980, a automated instruments were introduced to run clinical tests in medical laboratory. Quality was become one of the main concern in producing reliable result. During that time, quality control was present but non-standardized and many country had its own accreditation process. After this, most of the medical laboratory were selected ISO/IEC 17025 as a standard for accreditation, as this is the only standard for competence and calibration laboratories. However, this standard is not suitable as medical …show more content…

Accredited means officially recognized or authorized of the performance quality by Organization for Standardization. An accredited laboratory is a laboratory meets both the technical competence and the management system requirements that are necessary for it to consistently deliver technically valid results. On the other word, the accredited laboratory is competent and has quality in the work performed. All works are performed by qualified and trained person according to approval protocol/procedure. Test result is highly reliable and significant in diagnosis and treatment. Who are the accreditation body in Malaysia? In Malaysia, Department of Standard Malaysia under Ministry of Science, Technology and Innovation (MOSTI) is one of the main accreditation body. It is established on 28 August 1996 and has an important role in standardisation and accreditation. All duties and functions is governed by Standards of Malaysia Act 1996 (Act 549) under National Laboratory Accreditation Scheme of Malaysia (SAMM). The Accreditation process Accreditation process can be divided into 6 major steps as elaborated detailed in below. 1. Preparation and …show more content…

Customer would never need to worry about result as accredited medical laboratory has been recognized worldwide to provide a reliable and accurate of test result. False positives and negatives, which can directly affect compliance with regulations, are minimized. To government or regulators, accredited medical laboratory could increasing confidence in data that is used to establish baselines for key analyses and decisions. This could reduce uncertainties associated with decisions that affect the protection of human health and the environment. At the same time, it could increase public confidence and eliminate redundant reviews and improving the efficiency of the assessment process which may reduce costs. This also could avoid the need to set up equivalent attestation infrastructures which causing in waste of money. To staff, they will has more awareness and confidence in their working area as competency and proficiency assessment is mandatory. All staff that work under accredited laboratory is qualified and trained worker. It is a requirement for a comprehensive orientation and induction program to introduction of new members of staff. Besides that, staff will has a conducive working area to ensure personal safety, comfort and hygiene which is required in

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