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ISO 17025 Lead Auditor

Training Course
Contents
Contents 2

ISO 17025 Lead Auditor Training Course 6

Syllabus 7

Module 1: Introduction to ISO 17025 9

Module 2: Requirements of ISO 17025 9

Module 3: ISO 19011 Relationship to ISO 17025 10

Module 4: Scope 10

Module 5: Normative References 11

Module 6: Terms and Definitions 11

Module 7: General Requirements 12

Module 8: Structural Requirements 12


Contents
Module 9: Resource Requirements 13

Module 10: Process Requirements 14

Module 11: Management System Requirements 15

Module 12: Management System Documentation 16

Module 13: Control Management System Documents 16

Module 14: Control of Records 17

Module 15: Address Risks and Opportunities 17

Module 16: Improvement 18

Module 17: Corrective Actions 18

Module 18: Internal Audit and Management Reviews 19

Module 19: Terminology – ISO 9000, VIM etc. 19


Contents
Module 20: Fundamental Audit Concepts and Principles 20

Module 21: Auditing Requirements and Assessment: ISO 17011:2004, ISO 19011:2018 20

Module 22: Recognition and Oversight of ILAC, IAAC, APAC etc. 21

Module 23: Test Reports, AB symbols, Equipment Stickers, Certificates 22

Module 24: Clauses 4, 5, and 6 Review 23

Module 25: Clauses 7 and 8 Review 23

Module 26: Guidelines for Auditing: ISO 19011 24

Module 27: GUM (Uncertainty), PT/ILC, Traceability 24

Module 28: Opening and Closing Meeting Activities 25

Module 29: ISO 19011 Relationship to ISO 17025 26

Module 30: Auditing Technical Methods 26


Contents
Module 31: Reporting Audit Results 27

Module 32: Audit Checklists 27

Module 33: Review of Standards and Internal Auditing Issues 28

Module 34: Introduction to Lab Management System (LMS) 29

Module 35: Planning LMS Implementation 30

Module 36: Implementing LMS 31

Module 37: Monitoring, Measurement, and Continuous Improvement 32

Module 38: Planning ISO 17025 Audit 33

Module 39: Conducting the ISO 17025 Audit 33

Module 40: Concluding and Ensuring Follow-Up of ISO 17025 Audit 34

Our Delivery Method 35

Have Questions for Us? 36


ISO 17025 Lead
Auditor Training
Course
✓ This ISO 17025 Lead Auditor course aims to build on the knowledge
ascertained in the ISO 17025 Internal Auditor training course. It enables
you to develop the required expertise for auditing a Laboratory
Management System (LMS) and for managing a team of auditors.

✓ During this training, you will gain knowledge and skills to plan and
perform internal and external audits. In addition, you will learn how to
evaluate corrective action plans. After the completion of this intensive
training, you will develop the skills and competencies to conduct an
audit efficiently.

✓ This ISO 17025 Lead Auditor is the third of four courses that will enable you
to obtain the full ISO 17025 certification. Prior to this course, you can
complete the ISO 17025 Foundation course and the ISO Internal Auditor
training course. The final course within this series is the ISO 17025 Lead
Implementer training.
Syllabus
This course is split into 40 easy-to-understand modules.

Module 1: Introduction to ISO 17025 Module 11: Management System Requirements

Module 2: Requirements of ISO 17025 Module 12: Management System Documentation

Module 3: ISO 19011 Relationship to ISO 17025 Module 13: Control Management System Documents

Module 4: Scope Module 14: Control of Records

Module 5: Normative References Module 15: Address Risks and Opportunities

Module 6: Terms and Definitions Module 16: Improvement

Module 7: General Requirements Module 17: Corrective Actions

Module 8: Structural Requirements Module 18: Internal Audit and Management Reviews

Module 9: Resource Requirements Module 19: Terminology – ISO 9000, VIM etc.

Module 10: Process Requirements Module 20: Fundamental Audit Concepts and Principles
Syllabus
Module 21: Auditing Requirements and Assessment: Module 31: Reporting Audit Results
ISO 17011:2017, ISO 19011:2018
Module 32: Audit Checklists
Module 22: Recognition and Oversight of ILAC, IAAC, APAC etc.
Module 33: Review of Standards and Internal Auditing Issues
Module 23: Test Reports, AB Symbols, Equipment Stickers,
and Certificates
Module 34: Introduction to Lab Management System (LMS)

Module 24: Clauses 4, 5, and 6 Review


Module 35: Planning LMS Implementation
Module 25: Clauses 7 and 8 Review
Module 36: Implementing LMS
Module 26: Guidelines for Auditing: ISO 19011
Module 37: Monitoring, Measurement, and Continuous
Improvement
Module 27: GUM (Uncertainty), PT/ILC, and Traceability

Module 28: Opening and Closing Meeting Activities Module 38: Planning ISO 17025 Audit

Module 29: ISO 19011 Relationship to ISO 17025 Module 39: Conducting the ISO 17025 Audit

Module 30: Auditing Technical Methods Module 40: Concluding and Ensuring Follow-Up of ISO 17025 Audit
Module 1

Introduction to ISO 17025


ISO 17025

Module 2

Requirements of ISO 17025


Overview
Module 3

ISO 19011 Relationship to ISO 17025


ISO 19011

ISO 17025

Module 4

Scope
Overview
Module 5

Normative References
Introduction to Normative References

Module 6

Terms and Definitions


Overview
Module 7

General Requirements
Overview

Impartiality

Confidentiality

Module 8

Structural Requirements
Overview of Structural Requirements
Module 9

Resource Requirements
General

Personnel

Facilities and Environmental Conditions

Equipment

Metrological Traceability

Externally Provided Products and Services


Module 10

Process Requirements
Review - Requests, Tenders, and Contracts

Selection, Verification, and Validation of Methods

Handling Test or Calibration Items

Technical Records

Evaluation of Measurement Uncertainty

Ensure Results Validity

Reporting of Results

Complaints

Nonconforming Work

Control of Data and Information Management


Module 11

Management System Requirements


Options

● Option A

● Option B

General
Module 12

Management System Documentation


Overview

Document Categories

Module 13

Control Management System Documents


Overview

Primary Document Control Requirements in the ISO 17025 Standard


Module 14

Control of Records
Overview

Module 15

Address Risks and Opportunities


Overview of Address Risks and Opportunities
Module 16

Improvement
Overview of Improvement

Module 17

Corrective Actions
Steps to Take Corrective Actions
Module 18

Internal Audit and Management Reviews


Internal Audit

Management Reviews

Module 19

Terminology – ISO 9000, VIM etc.


ISO 9000 Terminology in English

● What is ISO 9000?

● Common ISO Definitions


Module 20

Fundamental Audit Concepts and Principles


Overview

Module 21

Auditing Requirements and Assessment:


ISO 17011:2017, ISO 19011:2018
Auditing: ISO 17011:2017

Auditing: ISO 19011:2018


Module 22

Recognition and Oversight of ILAC, IAAC,


APAC etc.
Description of ILAC

ILAC’s Global Role

Abbreviations

ILAC Documents

ILAC P10 Traceability Policy


Module 23

Test Reports, AB Symbols, Equipment


Stickers, Certificates
AB Symbols

Certificates

● Certificate Naming Convention


Module 24

Clauses 4, 5, and 6 Review


Clause 4: General Requirements

Clause 5: Structural Requirements

Clause 6: Resource Requirements

Module 25

Clauses 7 and 8 Review


Clause 7: Process Requirements

Clause 8: Option
Module 26

Guidelines for Auditing: ISO 19011


ISO 19011 Auditing Guidelines

● What is ISO 19011?

● Standard Facts of ISO 19011

● Who ISO 19011:2018 should be Used?

● What does ISO 19011:2018 Accomplish?

Module 27

GUM (Uncertainty), PT/ILC, Traceability


GUM (Uncertainty)

PT/ILC

Traceability
Module 28

Opening and Closing Meeting Activities


Opening Meeting

● What Happens in an Opening Meeting?

Closing Meeting

● What Happens in a Closing Meeting?


Module 29

ISO 19011 Relationship to ISO 17025


ISO 19011

ISO 17025

Module 30

Auditing Technical Methods


Overview
Module 31

Reporting Audit Results


Internal Audit Report

Module 32

Audit Checklists
ISO 17025:2017 Audit Checklist for Laboratory Accreditation System Requirements

Content of ISO/IEC 17025:2017 Audit Checklists


Module 33

Review of Standards and Internal


Auditing Issues
Review of Standards

Internal Auditing Issues


Module 34

Introduction to Lab Management System (LMS)


Standard and Regulatory Framework

Laboratory Management System

Laboratories and Accreditation Principles

Testing and Calibration Concepts

Identifying the Objective and Scope

Understanding Organisation

Analysing Existing System


Module 35

Planning LMS Implementation


Leadership and LMS Project Approval

Laboratory Policies

Document Management Process


Module 36

Implementing LMS
Design of Controls

Drafting of Specific Policies and Procedures

Communication Planning

Training and Awareness Planning

Resource Management

Customer Management

Operations Management
Module 37

Monitoring, Measurement, and Continuous


Improvement
Monitoring, Analysis, and Evaluation

Treating Problems and Nonconformities

Continual Improvement

Accreditation Preparation

Implementers Evaluation
Module 38

Planning ISO 17025 Audit


Planning ISO 17025 Audit

Preparing the ISO 17025 Audit

Conducting an Opening Meeting

Module 38

Conducting the ISO 17025 Audit


Initiating Audit

Preparing Audit Activities

Conducting Audit Activities


Module 40

Concluding and Ensuring Follow-Up of ISO


17025 Audit
Audit Documentation

Quality Review

Closing Meeting

Evaluation of Corrective Action plans

ISO 17025 Surveillance Audits


Our Delivery Methods

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Online Instructor-led Online Self-paced In-house Classroom

Join a scheduled class with a live Learn at your own pace. Our Our courses can be adapted to Some of our courses are
instructor and other delegates. expert trainers are on hand to meet your individual project or available in our classrooms. All of
Ask questions, share documents, help you with anything. business requirements. In-house our trainers are highly qualified,
interact with whiteboards, ask All of our courses come with a training gives your team a great having 10+ years of experience.
live questions and communicate standard 90 days access which opportunity to come together, We use the highest quality
with your trainer and peers. can be upgraded if need be.. bond and discuss, which may be learning facilities to make sure
Access the best pool of trainers, Our e-learning platform is limited in a standard classroom your experience is as
wherever you are. available on all devices. setting. comfortable as possible.
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