Management
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ISO 15189:2022 - Medical Laboratories' Quality Assurance & Competence

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Course Features

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Duration

5 hours

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Delivery Method

Online

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Available on

Limited Access

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Accessibility

Mobile, Desktop, Laptop

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Language

English

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Subtitles

English

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Level

Beginner

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Teaching Type

Self Paced

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Video Content

5 hours

Course Description

The concept and practices of quality regulations are extremely crucial for medical laboratories. They must analyze thousands of samples daily, and this mandates integrity, robustness, and impartiality within their quality regulations framework. ISO 15189 is an international standard developed by ISO, and it provides several requirements that medical laboratories can fulfill to enact a foolproof Quality Management System. Exoexcellence Consultants developed this course on Alison that explains the premise and requirements of this standard. The course is divided into three modules. The first module contains five topics, out of which the initial two explore the fundamental aspects of ISO 15189. These topics will discuss the importance of ISO 15189 for quality regulations in medical laboratories and also navigate the differences between the latest version and the previous versions of the standard. From the third topic onwards, the course explains each clause of ISO 15189. All the course topics have explained ISO 15189 requirements in easy language and contain vibrant graphics. This said, this course’ certification will equip you with all the necessary information concerning quality regulations in medical laboratories. By taking this course, you can easily establish yourself as a professional who can help medical laboratories become compliant with this standard. Not only that, but you can also upscale your skills as a quality management professional.

Course Overview

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Skills You Will Gain

What You Will Learn

Analyze why quality regulations are important for medical laboratories

Assess the changes made in ISO 15819:2022 and its previous version

Evaluate general requirements regarding laboratory consumables and reagents

Analyze the roles of referral laboratories and consultants, as defined by ISO 15189

Indicate how the laboratory will provide information to its users and patients

Define the criteria for medical laboratories and certification requirements

Describe various terms regarding quality regulations

Recall the requirements regarding the examination process

Assess what additional information must be added to the laboratory reports

Recognize ISO 15189's requirements regarding the management system

List the requirements to intend the records

Paraphrase ISO 15189's requirements regarding management review

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