MASTERING THE LABORATORY MANAGEMENT SYSTEM BASED ON ISO 17025, IN COMPLIANCE WITH THE REQUIREMENTS OF ISO 19011 AND ISO 17021

1. CERTIFIED ISO 17025
LEAD AUDITOR
MASTERING THE LABORATORY MANAGEMENT SYSTEM BASED ON ISO 17025,
IN COMPLIANCE WITH THE REQUIREMENTS OF ISO 19011 AND ISO 17021
SUMMARY
This five-day intensive course enables the participants to develop the necessary expertise to audit a Laboratory
Management System based on ISO/IEC 17025 and to manage a team of auditors by applying widely recognized audit
principles, procedures and techniques. During this training, the participants will acquire the necessary knowledge and
skills to proficiently plan and perform internal and external audits in compliance with ISO 19011 and certification audits
according to ISO 17021. Based on practical exercises, the participants will develop the skills (mastering audit techniques)
and competencies (managing audit team and audit program, etc.) necessary to efficiently conduct an audit.
COURSE AGENDA
DURATION: 5 DAYS
DAY 1
Introduction to Laboratory Management
System concepts and requirements as
specified in ISO 17025
DAY 2
Planning and initiating an ISO 17025 audit
▶▶ undamental principles of laboratories and
F
accreditation
▶▶ reparation of an ISO 17025 audit
P
▶▶ undamental audit concepts and principles
F
▶▶ udit approach based on evidence
A
▶▶ onducting an opening meeting
C
▶▶ aboratory Management System (LMS)
L
▶▶ etailed presentation of the clauses of ISO 17025
D
DAY 3
Conducting an ISO 17025 audit
▶▶ ommunication during the audit
C
▶▶ udit procedures: observation, document review,
A
interview, sampling techniques, technical verification,
corroboration and evaluation
▶▶ udit test plans
A
▶▶ ormulation of audit findings
F
▶▶ ocumenting nonconformities
D
DAY 5
DAY 4
Concluding and ensuring the follow-up of
an ISO 17025 audit
▶▶ udit documentation
A
▶▶ uality review
Q
▶▶ onducting a closing meeting and conclusion of an
C
ISO 17025 audit
▶▶ valuation of corrective action plans
E
▶▶ SO 17025 surveillance audits
I
▶▶ SO 17025 internal audit management program
I
Certification Exam
www.pecb.org

2. WHO SHOULD ATTEND?
▶▶ nternal auditors
I
▶▶ uditors wanting to perform audits to ISO 17025
A
▶▶ roject managers or consultants wanting to master the Laboratory Management System audit process of
P
laboratories
▶▶ aboratory managers
L
▶▶ uality managers
Q
▶▶ aboratories seeking ISO 17025 accreditation
L
▶▶ echnical experts wanting to prepare for a laboratory audit function
T
LEARNING OBJECTIVES
▶▶ o acquire expertise to perform an ISO 17025 internal audit following ISO 19011 guidelines
T
▶▶ o acquire the expertise necessary to manage an LMS audit team
T
▶▶ o understand the operation of an ISO 17025 conformant Laboratory Management System
T
▶▶ o understand the requirements of ISO 17025
T
▶▶ o improve the ability to analyze the internal and external environment of a laboratory, and audit decision-making in
T
the context of an LMS
PECB
www.pecb.org
Certified
ISO 17025
Lead Auditor

3. EXAMINATION
▶▶ he “Certified ISO 17025 Lead Auditor” exam fully meets the requirements of the PECB Examination and
T
Certification Program (ECP). The exam covers the following competence domains:
DOMAIN 1: FUNDAMENTAL PRINCIPLES AND CONCEPTS IN TESTING AND CALIBRATION LABORATORIES
1
Main Objective: To ensure that the ISO 17025 Lead Auditor candidate can understand, interpret and illustrate the main
process improvement concepts related to general requirements for the competence of testing and calibration laboratories
(TCLA)
DOMAIN 2: GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION
LABORATORIES (TCLA)
2
3
Main Objective: To ensure that the ISO 17025 Lead Auditor candidate can understand, interpret and illustrate the
main concepts and components of general requirements for the competence of testing and calibration laboratories
based on ISO 17025
DOMAIN 3: FUNDAMENTAL AUDIT CONCEPTS AND PRINCIPLES
Main Objective: To ensure that the ISO 17025 Lead Auditor candidate can understand, interpret and apply the
main concepts and principles related to a TCLA audit in the context of ISO 17025
DOMAIN 4: PREPARATION OF AN ISO 17025 AUDIT
4
5
6
Main Objective: To ensure that the ISO 17025 Lead Auditor candidate can prepare appropriately a TCLA audit in
the context of ISO 17025
DOMAIN 5: CONDUCT OF AN ISO 17025 AUDIT
Main Objective: To ensure that the ISO 17025 Lead Auditor candidate can conduct efficiently a TCLA audit in the
context of ISO 17025
DOMAIN 6: CONCLUSION AND FOLLOW-UP OF AN ISO 17025 AUDIT
Main Objective: To ensure that the ISO 17025 Lead Auditor candidate can conclude a TCLA audit and conduct
follow-up activities in the context of ISO 17025
DOMAIN 7: MANAGEMENT OF AN ISO 17025 AUDIT PROGRAM
7
Main Objective: To ensure that the ISO 17025 Lead Auditor understands how to establish and manage a TCLA
audit program
▶▶ The “Certified ISO 17025 Lead Auditor” exam is available in different languages, including English, French, Spanish and
Portuguese
▶▶ Duration: 3 hours
▶▶ For more information about the exam, please visit: www.pecb.org
www.pecb.org

4. CERTIFICATION
▶▶ fter successfully completing the exam, participants can apply for the credential of Certified ISO/IEC 17025
A
Provisional Implementer, Certified ISO/IEC 17025 Implementer or Certified ISO/IEC 17025 Lead Implementer,
depending on their level of experience
▶▶ certificate will be issued to participants who successfully pass the exam and comply with all the other
A
requirements related to the selected credential:
Credential
Exam
Professional
Experience
TCLA Audit
Experience
TCLA Project
Experience
Other
Requirements
ISO 17025
Provisional
Auditor
ISO 17025
Lead Auditor
Exam
None
None
None
Signing the
PECB
code of ethics
ISO 17025
Auditor
ISO 17025
Lead Auditor
Exam
Two years
One year of
Testing and Calibration Laboratories work
experience
Audit activities
totaling 200
hours
None
Signing the
PECB
code of ethics
ISO 17025
Lead
Auditor
ISO 17025
Lead Auditor
Exam
Five years
Two years of
Testing and Calibration Laboratories work
experience
Audit activities
totaling 300
hours
None
Signing the
PECB
code of ethics
GENERAL INFORMATION
▶▶
▶▶
▶▶
▶▶
Certification fees are included in the exam price
Participant manual contains over 450 pages of information and practical examples
A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued to participants
In case of failure of the exam, participants are allowed to retake it for free under certain conditions
For additional information,
please contact us at info@pecb.org
www.pecb.org
PECB
Certified
ISO 17025
Lead Auditor