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ISO 15189 AND ISO 22870 DOCUMENTATION KIT Editable MANUAL, PROCEDURES, TEMPLATES, Forms, Audit Checklist and more.. D-176 www.Globalmanagergroup.com Sales@Globalmanagergroup.com
Introduction The ISO 15189 is the international standard that specifies the quality management system requirements for medical laboratories; While ISO 22870 gives specific requirements applicable to point-of-care testing (POCT) and is used by medical laboratories in accordance with the ISO 15189 standard. The requirements of ISO 22870 apply when a POCT is performed in a hospital, clinic, and by a healthcare organization providing ambulance care. 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.
Contents Exhibits Procedures Standard operation procedures Manual Sample Risk Assessment Sheet Audit Checklist Job description Readymade Formats
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