What is the ISO 15189 standard used for?
Provides requirements for competence and quality that are particular to medical laboratories.
What does ISO 15189 2012 tell you?
ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
What is the difference between ISO 15189 and ISO 9001?
A. 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.
What is the latest ISO 15189?
ISO 15189:2012 is a regulatory standard for medical labs. Its criteria help labs develop quality management systems and assess their own competence. The standard is also used by regulators, accreditation bodies and customers to confirm or recognize a lab’s competence.
Which is the standard for medical laboratories?
A majority of laboratories rely on International Quality Standards known as ISO/IEC/17025 for all types of testing and calibrating laboratories and more specifically ISO 15189 for medical laboratories. These standards are quite comprehensive and often very resource-intensive.
What UKAS 15189?
ISO/IEC 15189:2012 is a globally recognised standard that specifies requirements for quality and competence particular to medical laboratories. It is for use by medical laboratories in developing their quality management systems and assessing their competence.
Is CLIA equivalent to ISO 15189?
Relationship of CLIA and ISO 15189 accreditation Accreditation to the ISO 15189 standard does not meet US CLIA requirements and cannot replace a CLIA-based accreditation. ISO 15189 could be chosen as the QMS of a CLIA laboratory, but it needs to be supplemented with the specific CLIA requirements.
What is ISO for lab?
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 is accreditation in medical laboratory?
Accreditation is an official recognition that a facility or laboratory is competent to perform specific tasks and has a documented manual on a Quality Management System (QMS) in place. This has motivated more and more laboratories to be accredited.