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

DAY 1 DAY 2

DAY 3 DAY 4

DAY 5

DURATION: 5 DAYSCOURSE AGENDA

WHO SHOULD ATTEND?

SUMMARY

▶ Internal auditors

▶ Auditors wanting to perform audits to ISO 17025

▶ Project managers or consultants wanting to master the Laboratory Management System audit process of laboratories

▶ Laboratory managers

▶ Quality managers

▶ Laboratories seeking ISO 17025 accreditation

▶ Technical experts wanting to prepare for a laboratory audit function

Introduction to Laboratory Management System concepts and requirements as specified in ISO 17025

▶ Fundamental principles of laboratories and accreditation

▶ Laboratory Management System (LMS)

▶ Detailed presentation of the clauses of ISO 17025

Conducting an ISO 17025 audit ▶ Communication during the audit

▶ Audit procedures: observation, document review, interview, sampling techniques, technical verification, corroboration and evaluation

▶ Audit test plans

▶ Formulation of the audit findings

▶ Documenting nonconformities

Certification Exam ▶ PECB’s 3 Hour Certified ISO 17025 Lead Auditor Exam is available in different languages. The candidates who

do not pass the exam will be able to retake it for free within 12 months from the initial exam date.

Planning and initiating an ISO 17025 audit ▶ Fundamental audit concepts and principles

▶ Audit the approach based on evidence

▶ Preparation of an ISO 17025 audit

▶ Conducting an opening meeting

Concluding and ensuring the follow-up of an ISO 17025 audit

▶ Audit documentation ▶ Quality review ▶ Conducting a closing meeting and conclusion of an

ISO 17025 audit ▶ Evaluation of corrective action plans ▶ ISO 17025 surveillance audits ▶ ISO 17025 internal audit management program

www.pecb.org

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 participant 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 participant will develop the skills (mastering audit techniques) and competencies (managing audit team and audit program, etc.) necessary to efficiently conduct an audit.

CERTIFIED ISO 17025 LEAD AUDITOR

▶ 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

▶ The “Certified ISO 17025 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competence domains:

» Domain 1: Fundamental concepts and requirements of ISO 17025

» Domain 2: Laboratory Management System

» Domain 3: Fundamental Audit Concepts and Principles

» Domain 4: Preparation of an ISO 17025 audit

» Domain 5: Conducting of an ISO 17025 audit

» Domain 6: Closing an ISO 17025 audit

» Domain 7: Managing an ISO 17025 audit program

▶ For more information about the exam, please visit: www.pecb.org

▶ After successfully completing the exam, the participants can apply for the credential of Certified ISO 17025 Provisional Auditor, Certified ISO 17025 Auditor or Certified ISO 17025 Lead Auditor, depending on their level of experience. Those credentials are available for internal and external auditors

▶ A certificate will be issued to participants who successfully pass the exam and comply with all the other requirements related to the selected credential:

For additional information, please contact us at info@pecb.org

Credential Exam ProfessionalExperience

TCLA AuditExperience

TCLA ProjectExperience

OtherRequirements

ISO 17025 Provisional

Auditor

ISO 17025 Lead Auditor

ExamNone None None

Signing thePECB

code of ethics

ISO 17025 Auditor

ISO 17025 Lead Auditor

Exam

Two yearsOne year of

Testing and Calibration Laboratories work

experience

Audit activities totaling 200

hoursNone

Signing thePECB

code of ethics

ISO 17025Lead

Auditor

ISO 17025 Lead Auditor

Exam

Five yearsTwo years of

Testing and Calibration Laboratories work

experience

Audit activities totaling 300

hoursNone

Signing thePECB

code of ethics

EXAMINATION

CERTIFICATION

GENERAL INFORMATION

www.pecb.org

PECBCertified

ISO

Lead Auditor

17025