Cognicert ISO 15189:2012 Medical Laboratory Conformity Assessment Lead Assessor Course
Cognicert Limited www.cognicert.com
COURSE OBJECTIVES
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
WHO NEEDS THIS COURSE?
- Persons responsible for conducting internal assessment according to ISO 15189:2012 requirements
- Persons involved in the accreditation of Management systems ISO 15189:2012
COURSE CONTENT
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
| EXAM | APPLICATION DEADLINE |
| 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.