What is an ISO 15189 certification?
ISO 15189 accreditation involves an independent assessment of the medical laboratory that includes an examination of personnel qualifications and competence, equipment, reagents and supplies, quality assurance, and analytical, pre-analytical, and post-analytical factors.
Is CLIA the same as ISO 15189?
CLIA regulations serve as the sieve for laboratory quality, while the ISO 15189 standard catches quality issues that fall through that sieve—issues that are often responsible for a significant number of clinical laboratory errors.
What are laboratory accreditations?
Laboratory accreditation is a 3rd party assessment of a Calibration or Testing laboratory by the Laboratory Accreditation Body, to evaluate the laboratory’s compliance to the requirements of ISO/IEC 17025 and any addition applicable accreditation policies.
What is Hoklas?
HOKLAS is an accreditation scheme operated by Hong Kong Accreditation Service (HKAS). The scheme is open to voluntary participation from any Hong Kong laboratory that performs objective testing and calibration falling within the scope of the Scheme and meets the HOKLAS criteria of competence.
What is the difference between ISO 17025 and ISO 15189?
The difference is that ISO/IEC 17025 is directed to laboratories performing tests and/or calibrations while ISO 15189 is directed to medical laboratories. 2. Normative references ISO/IEC 17025 is cited as a normative reference in ISO 15189. Therefore, ISO/IEC 17025 is considered ‘indispensable’ for applying ISO 15189.
What is the difference between ISO 15189 and ISO 9001?
ISO 9001 is a certification/registration of a quality management system and is intentionally very generic. ISO 15189 incorporates the essential elements of ISO 9001 and adds technical competency factors relevant to medical laboratories.
Is ISO 15189 accreditation mandatory?
Is ISO 15189 mandatory? ISO 15189 accreditation is not mandatory in every jurisdiction, but it’s worth checking your local regulations. Nevertheless, the importance of laboratory accreditation should never be overlooked, especially when you are dealing with public health.
What is ISO and what is the role it plays in lab accreditation?
ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world.
What is an Hoklas endorsed test report?
An HOKLAS endorsed test report or certificate is a test report or certificate issued by an HKAS accredited laboratory for reporting the result of an activity accredited under HOKLAS. An HOKLAS endorsed report or certificate bears the HOKLAS accreditation symbol on the right hand top corner of its front page.
What is ISO standard for laboratory?
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.
What does ISO 15189 2012 tell you?
ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence.