ISO 17025 Lead Assessor Course

COURSE OBJECTIVES
The “ISO 17025:2018 Lead Assessor” course provides comprehensive training in

Learn how to audit each and every ISO 17025: 2018 and ISO 17011 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 17025:2018

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 17011:2017

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 17011:2017

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

Duration: 5 days
Training Methodologies
- Case Study
- Individual Exercises
- Role Play
- Group Exercises
- Group Presentation
- Examination