What are the ISO 15189 standards?

What is ISO 15189? ISO 15189:2012 is an international standard for medical laboratories. Laboratory accreditation helps labs develop quality management systems, assesses their competence and ensures they are functioning in line with industry and legal standards.

What does ISO 15189 2012 tell you?

International Standards Observer provides accreditation to the internationally recognised standard ISO 15189:2012 Medical Laboratories requirements for quality and competence.

What is ISO 15189 quality management system?

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.

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.

How do you cite ISO 15189?

Your Bibliography: 15189:2012, I., 2017. ISO 15189:2012 – Medical laboratories — Requirements for quality and competence. [online] Iso.org. Available at: [Accessed 8 April 2017].

Why is Neqas important?

The National External Quality Assessment Scheme (NEQAS) for Parasitology is one of the measures by the Department of Health (DOH) to assess the reliability of laboratory diagnosis and maintain quality assurance of licensed medical parasitology laboratories in the country.

Is ISO 17025 the same as ISO 15189?

The minor differences found in the wordings of the management requirements of ISO 15189 and ISO/IEC 17025 are in fact further elaboration on the actual application of the standards requirements and the expectation of quality service. The essence is the same in the two standards.

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.

Is CLIA the same as ISO 15189?

Accreditation to the ISO 15189 standard does not meet US Clinical Laboratory Improvement Amendments (CLIA) requirements and cannot replace a CLIA-based accreditation for laboratories in the United States.

What do Neqas do?

We provide information and leadership to harmonise the quality of diagnostic and/or clinical services across networks and international borders.

What is the ISO 15189 standard?

ISO 15189:2003 is an international standard developed particularly for the medical laboratories. Though it is based upon ISO/IEC 17025:1999 and ISO 9000:2000, it is a standalone standard for medical laboratories with a title particularly referred to “quality and competence”.

What is laboratory management according to ISO 15189?

BS EN ISO 15189:2012 ISO 15189:2012(E) 3.10 laboratory management person(s) who direct and manage the activities of a laboratory NOTE The term ‘laboratory management’ is synonymous with the term ‘top management’ in ISO 9000:2005. 3.11 medical laboratory clinical laboratory

What are the ISO 15194 and IEC 17011 standards?

[8] ISO 15194, In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation [9] ISO/IEC 17011, Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies

What are the ISO/IEC 17043 and ISO 19011?

[10] ISO/IEC 17043:2010, Conformity assessment — General requirements for proficiency testing [11] ISO 19011, Guidelines for auditing management systems [12] ISO/IEC 27001, Information technology — Security techniques — Information security management systems — Requirements