Quality Management System and Internal Audit In Medical Labs as per ISO 15189:2012

Quality Management System & Internal Audit in Clinical labs as per ISO 15189

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Language: English

Instructors: Dr. Mrs. Jatinder Bhatia

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Why this course?


This is a four day training course, a prerequisite of Quality Implementation in a Clinical  Laboratory. This is important for all the employees working in a clinical lab and is mandatory for the Quality Manager. This teaches you in detail about the ISO Standard 15189. It helps you to understand the Quality Implementation Protocols along with the method of writing Quality System Procedures, Technical  SOPs, Quality manual and Conducting Audit.

In these four days, it gives you theory and presentations in the first 2 days.

Exercises , Mock audit and procedures on the third day

Interaction with Faculty and Q&A on 4th day 

Course Curriculum

1st day


Global Perspective of ISO 15189

Clause 4 : Management Clauses

Exercise I 


2nd day

Clause 5 : Technical clauses

Exercise II

These are in the form of scenarios. You have to write the Main Clause and Sub-clause for these scenarios after consulting the Standard. 


3rd day

Presentation on Internal Audit

Principles of Audit
· Types of Audit
· Audit Conduct


Writing of Quality System Procedure 

Mock Audit

Finding inadequacies in the Quality Manual

Route to Accreditation


4th day 

 Live Q/A session by the faculty.

The writing of NCs and the closure would be discussed.

QSP and QM will be discussed.

Discussion on Ex.I & II



In the end, you will have an online test of 1 hr .  60% scoring is required to qualify for certification.


Advantages of Online classes

You can manage your time 

You have time to go through the material repeatedly and ask questions on 4th day.


Certificate will be delivered after the completion and qualification of the exam.

Course Curriculum

Management Clauses: 4.1 By Dr JBhatia 360HELP
Management Cl No 4.2 to 4.4 By JBhatia 360HELP (33:00)
Cl No 4 5 Examnation by referal labs By Dr JBhatia 360HELP (13:00)
management Cl No 4.6 to 4.10 By Dr J Bhatia 360HELP (26:00)
Management Cl No 4.10 to 4.15 By Dr J Bhatia 360HELP (46:00)
Technical Clause No 5.1 Personnel to 5.2 by Dr JBhatia 360HELP (43:00)
Technical Cl No 5.3 to by Dr JBhatia 360HELP (38:00)
Technical Cl No 5.4 to 5.5 By Dr JBhatia 360HELP (63:00)
Cl No 5.6 to 5.6.4 By Dr JBhatia 360HELP (29:00)
Technical Cl No 5.7 to 5.9 By Dr JBhatia 360HELP (39:00)
Technical Cl No 5.10 Lab Information System By Dr JBhatia 360HELP (42:00)
Internal Audit in Clinical lab - Dr Jatinder Bhatia (34:00)
QMS & IA ISO 15189:2012 Standard (55 pages)
NABL-112 effective from 01.06.2019 (102 pages)
QUALITY MANUAL 15189 (41 pages)
Assignment & Exercise QMS&IA training
Find the inadequacies in the Mock Quality Manual given to you
Write Quality System Procedure
Write one NC each in Pre Examination, Examination and Post Examination Process
QMS & IA Exercise 1
QMS & IA Exercise 2
Feedback Form
Exam 1
Exam 2
QMS & IA 10th Dec 22

How to Use

To purchase this course. Make payment on below account or Pay using Google Pay UPI Id: 9811159996@okbizaxis 

Soon our team will get back to you.

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