Cognicert ISO 15189:2012 Medical Laboratory Conformity Assessment Lead Assessor Course

Cognicert Limited

The “ISO 15189:2012   Lead Assessor” course provides comprehensive training for participants to be able to:

  • Understand to audit each and every ISO 15189:2012  requirements
  • Learn basic auditing skills;
  • Implement methods to comply with the ISO 15189:2012
  • Audit process and techniques
  • Improve assessor’s skills and techniques
  • Examine the requirements of ISO 15189 from an Internal Assessor Perspective
  • Write Audit reports process and follow up corrective actions
  • Plan and conduct an ISO 15189 audit, and how to report audit results;
  • Effectively use root cause analysis as part of the ISO 15189 Management procedure on corrective action


  • Persons responsible for conducting internal assessment according to ISO 15189:2012     requirements
  • Persons involved in the accreditation of Management systems ISO 15189:2012


Background and Development of ISO 15189:2012    

Definition of ISO 15189:2012

Benefits of ISO 15189:2012

Types of Assessments

Why medical laboratory accreditation Assessments are needed

Introduction to the Requirements of the ISO 15189:2012 Standard

Interpretations of Key Terms

Elements of a Management System

The ISO 15189:2012     Standard

Continual Improvement Cycle

Management Process Model

Management System Requirements

The Documentation Requirements of ISO 15189:2012

Management Responsibility

Resource Management

Measurement, Analysis and Improvement

The Process Management Approach

Process Management Approach

The Planning Phase

Establish Process Measurements

Analyze the Process

Design or Redesign the Process

Process Mapping

Introduction to Document Control

Elements of Documents

Process Approach to Documentation

Identifying Documents and their Owners

Types of Documents

Master Document List

Document Control

Revisions and Maintenance

Tips for Document Writers

Introduction to Management Review

Making Management Review relevant to Management

What will be reviewed?

Establishing the Objectives

Planning the Management Review

Output of Management Review

ISO 19011:2018, ISO 17011:2017 and ISO 15189:2012

Fundamentals of Internal Auditing

Decide how to Audit

Principles of Auditing

Managing an Audit Programme

Preparation & Planning Of Assessments
Preparation Of checklist

ISO 19011:2018, ISO 17011:2017 and ISO 17021:2015

Audit Activities

ISO 17021:2015  Assessment Process

External assessment processes and criteria

Identification of Non-Conformities [N/C’s].

Documenting the Audit (Audit Report)

Conducting Audit Follow-Up

Practical Auditing Exercise

Competence and Evaluation of Assessors.

Creating a Corrective Action Plan

What is Root Cause Analysis?

When (and when not) to use Root Cause Analysis

The Root Cause Analysis Process

How to construct a Root Cause Analysis Checklist

Examples of how a well-run Root Cause Analysis Process works

Corrective and Preventive Actions


Duration: 5 days

Training Methodologies

  • Case Study
  • Individual Exercises
  • Role Play
  • Group Exercises
  • Group Presentation
  • Examination

Assessment and Qualification
Learning is assessed through:

  • 4 hours open examination. Passing the exams qualifies the candidate for Cognicert ISO 15189 Lead Assessor (Provisional Auditor Certificate)
  • Practical experience of 20 days with activity log qualifies participants for our Cognicert ISO 15189 Lead Assessor (Auditor Category) I.D Card and Certificate
  • Practical experience of 40 days with activity log qualifies participants for our Cognicert ISO 15189 Lead Assessor (Lead Auditor Category) I.D Card and Certificate

Self-Study Material, Exam and Certification 

Online Training, Material, Exam and Certification 

Classroom Training, Material, Exam and Certification – Locations here

February 27 January 22, 2022
March 24 February 22, 2022
April 21 March 22, 2022
May 18 April 22, 2022
June 22 May 24, 2022
July 27 June 22, 2022
Aug 24 July 22, 2022
September 21 August 24, 2022
October 19 September 15, 2022
November  23 October 13, 2022
December 18 November 11, 2022

Cancellation: 3 weeks before examination attract 100% refund. 0% refund after.