Q&A

What are ISO 15189 standards?

What are ISO 15189 standards?

ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization’s Technical Committee 212 (ISO/TC 212).

What is the difference between ISO 17025 and ISO 15189?

A. It is an international standard, based on ISO/IEC 17025 and ISO 9001, that specifies requirements for competency and quality that are particular to medical laboratories. ISO 15189 focuses on the continuum of care directly connected with improved patient safety, risk mitigation and operational efficiency.

What are the features of ISO 22870 standards?

ISO 22870:2016 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care.

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What does ISO stand for laboratory?

International Organization for Standardization
ISO/IEC 17025 is a company level accreditation based on a standard published by the International Organization for Standardization (ISO) titled “General requirements for the competence of testing and calibration laboratories”.

Why is UKAS accreditation important?

UKAS ensure that certification bodies meet the ISO 17021 standard for conformity assessment. Companies that achieve UKAS accreditation should be shouting about it. The internationally-recognised accreditation gives your business a competitive advantage, opening access to new markets within the EU and beyond.

Is CityMD CAP accredited?

UCAOA Accreditation distinguishes CityMD as an organization that has chosen to excel and raise the bar.” With its accreditation, CityMD and the Urgent Care Association of America demonstrate their commitment toward providing patients with convenient access to quality care of the highest level.

How does point of care testing work?

In general, point-of-care testing encompasses any tests that are performed at or near a patient and at the site where care or treatment is provided. Results are typically available relatively quickly so that they can be acted upon without delay.

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Does ISO mean equal?

Iso-: A prefix meaning “equal,” used in meteorology in conjunction with another word to denote lines on a weather map along which values of a given element, such as temperature (isotherm), are constant.

What is ISO and why is it important?

ISO or the International Standards Organization is an independent body which provides standards of the organization. The ISO certificate helps to improve your business credibility and authority as well as the overall efficiency of the business.

What is ISO 22870 and why is it important?

ISO 22870:2016 gives specific requirements to Point of Care Testing when carried out in hospitals, clinics and by healthcare organisations offering ambulatory care. Providing independent assurance of quality and safety that supports objectives to deliver better care and value for patients

What does ISO 22870 mean for POCT providers?

ISO 22870:2016 is always used in conjunction with ISO 15189:2012 and therefore the assessment and accreditation of POCT providers shall include the requirements of both international standards.

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What is popoct awareness course – ISO 22870?

PoCT Awareness Course – ISO 22870:2016 – Take a look at this practical and interactive 1-day course, designed to provide delegates with existing ISO 15189 experience; with the skills and knowledge to develop their organisational processes in line with the requirements of ISO 22870:2016. Find out more and book here. Who’s accredited?

Is isoiso responsible for identifying any or all patent rights?

ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents ).