Cognicert Limited www.cognicert.com
Lead Assessor Course
COURSE OBJECTIVES
The “ISO 17025:2005 Lead Assessor” course provides comprehensive training in
the ISO 17025:2018 standard and all its requirements from the Assessor’s point of view, as well as basic skills necessary to complete an internal audit. It’s a practical-oriented training that should be considered “a must” for every ISO 17025:2018 Assessor. This intensive course is specifically designed to train corporate staff to serve as internal ISO 17025 Assessors (as required by ISO 17025:2018 ). The interactive training program, complete with quizzes, will provide the necessary technical knowledge and understanding of all ISO 17025:2018 requirements to implement the requirement of the standard and complete internal ISO 17025 Assessment of your company. This ISO Assessor training should be taken by each employee appointed as internal ISO 17025 Assessor to:
- Learn how to audit each and every ISO 17025: 2018 and ISO 17021:2018 requirements
- Learn basic auditing skills;
- Implement methods to comply with the ISO 17025:2018 requirements.
- Auditing process and techniques
- Assessor’s skills and techniques
- To examine the requirements of ISO 17025 from an Internal Assessor Perspective
- Auditing reports process, corrective action and follow-up
- Learn how to plan and conduct an internal ISO 17025 audit, and how to report audit results;
- Learn how to effectively use root cause analysis as part of the ISO 17025 Laboratory procedure on corrective action
WHO NEEDS THIS COURSE?
• Persons responsible for conducting internal and external audits according to ISO 17025:2018 requirements
• Persons involved in the Laboratory management systems ISO 17025:2018
COURSE CONTENT
Lesson 1: Background and Development of ISO 17025:2005
Definition of ISO 17025:2018
History of Laboratory
Major Changes in ISO 17025:2018
The Laboratory Management Principles
Benefits of ISO 17025:2018
Types Of Audits
Why Management System Audits are needed
Lesson 2: Introduction to the Requirements of the ISO 17025:2018 Standard
Interpretations of Key Terms
Elements of a Laboratory System
The ISO 17025:2018 Standard
Eight Principles of Laboratory Management
Continual Improvement Cycle
Laboratory Management Process Model
Laboratory System Requirements
The Documentation Requirements of ISO 17025:2018
Management Responsibility
Resource Management
Product Realization
Measurement, Analysis and Improvement
Lesson 3: The Process Management Approach
Process Management Approach
The Planning Phase
Establish Process Measurements
Analyze the Process
Design or Redesign the Process
Process Mapping
Lesson 4: 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
Lesson 5: 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
Lesson 6: How to Deal with External Assessors – A Basic Guide for Internal Assessors
What is an External Laboratory Audit?
What should an Employee expect during an Audit?
How should Employees interact with Assessors?
Lesson 7: ISO 19011:2018 and ISO 17021:2018
Fundamentals of Internal Auditing
Decide how to Audit
Principles of Auditing
Managing an Audit Programme
Preparation & Planning Of Audits
Preparation Of checklist
Lesson 8: ISO 19011:2018 and ISO 17021:2018
Audit Activities
Identification of Non-Conformities [N/C’s].
Documenting the Audit (Audit Report)
Conducting Audit Follow-Up
Practical Auditing Exercise
Competence and Evaluation of Assessors.
Lesson 9: Creating a Corrective Action Plan
Who participates?
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
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