ISO 15189 and ISO 22870 Documents Requirements

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ISO 15189 AND ISO 22870 DOCUMENTATION KIT EDITABLE MANUAL, PROCEDURES, TEMPLATES, FORMS, AUDIT CHECKLIST AND MORE..

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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

Manual

Readymade Formats

Procedures

Job description

Standard operation procedures

Audit Checklist

Exhibits

Sample Risk Assessment Sheet

Features

• Total ISO 15189 and ISO 22870 documents are in plain English and easy to understand the documentation process.

• A soft-copy of an editable ISO 15189 and ISO 22870 documentation kit is provided that saves much time.

• It is easy to learn and user-friendly and comply with all ISO 15189:2012 and ISO 22870:2016 requirements.

• Good learning materials for establishing good environmental and quality management systems.

• It is been verified and evaluated at various levels during system implementation by our team and more than 1000 hours are spent in preparation of such a readymade documentation kit.

• Our products are highly sold globally and used by many multinational companies, which got total customer satisfaction as well as value for money.

How Useful ?

• The user can very easily modify the templates according to their products and create the documents for their organization within 3 days.

• The kit takes care of all the sections and sub-sections of ISO 15189 and ISO 22870 standards and helps you to establish a better system.

• Save much time and cost in document preparation.

• Our products are highly sold across the globe and are used by many multinational companies. They have got total satisfaction as well as experienced value for money.

• In the preparation of the documentation kit, our team has verified and evaluated the entire content at various levels. More than 1000 hours have been spent in the preparation of this documentation kit.

Method Of Delivery

After the purchase of our ISO 15189:2012 and ISO 22870:2016 documentation package - we are sending an email with username and password within 12 to 24 hours for the online delivery of our products to download from our FTP server.

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