ISO 15189 and ISO 22870 Integrated Requirements for Covid-19 Testing Laboratorie

Posted by John Mills on February 13th, 2021

In the present pandemic, globally many COVID testing laboratories are requiring integrated ISO 15189 and ISO 22870 documentation requirements for quality and competence. Few of many organizations are providing such accurate documents that fulfil all the requirements of such certification for Covid-19 testing laboratories and Global Manager Group is named in one of such few, world’s leading ISO consultants. With highly experienced team's efforts Global Manager Group has introduced Ready-to-use ISO 15189 and ISO 22870 Integrated documentation kit for COVID testing laboratories to provide quality test work to society with such an integrated documentation package.

ISO standard related to POCT is ISO 22870: 2016 Point Care for Care Testing - Requirements for Quality and Eligibility. These standards give specific requirements that apply to POCT testing and apply when POCT is conducted in a healthcare institution providing hospital, clinic or ambulance care. However, it is important to note and remember that ISO 22870 does not need to be viewed as a separate, standalone document, in fact, it is to be used in conjunction with ISO 15189:2012 Medical Laboratories - Special Requirements for Quality and Eligibility.

There is now an international standard for ISO 22870, specifically for POCT testing. This standard is to be used by medical laboratories in accordance with the standard of ISO 15189. This means that aspects related to point-of-care testing such as training, aptitude and quality of documentation should be carefully planned, implemented and handled by the management system and QC and EQA need to be done where available.

All POCT services must be managed through a robust quality management system (QMS). QMS Hosting Medical Laboratory must be configured with QMS. Only competent quality management staff can design and operate QMS, which must be accredited by the international standards ISO 15189 and ISO 22870.

Advances in testing and information technologies have increased the availability of point-of-care testing (POCT) devices not only in healthcare, but also in non-health settings. POCT laboratory accreditation under ISO 22870 has been implemented in conjunction with ISO 15189 in European countries. A markedly increasing number of facilities are performing POCT in non-healthcare settings in the United States with a certificate of waiver and in European countries; Concerns are being raised about the lack of supervision and requirements for staff qualifications and training. Canters for Disease Control and Prevention are making efforts to develop educational tools.

ISO 22870 provides specific requirements that apply to POCTs conducted by a healthcare organization providing hospital, clinic or ambulance care. It covers aspects such as organization and management, identification and control of non-profiles, and quality assurance of examination processes.

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John Mills

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John Mills
Joined: November 15th, 2019
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