ISO/IEC 17025 - Certified Lead Implementer

Certification Overview
Exam Information
Course Outline
Target Audience
Registration Process for E-Course and Exam

Certification Overview

ISO/IEC 17025 - Certified Lead Implementer

Exam Code: ISO-17025-CLI

ISO/IEC 17025 – Certified Lead Implementer is a professional certification designed for individuals who aim to demonstrate expertise in implementing and managing a laboratory management system in accordance with the ISO/IEC 17025 standard. ISO/IEC 17025 specifies the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. This certification equips participants with the knowledge and skills necessary to establish a robust quality management system that ensures reliable and accurate laboratory results while complying with international standards.

The certification program covers the end-to-end implementation process, from initial planning and gap analysis to risk-based thinking, operational control, and continual improvement of laboratory processes. Participants learn how to align laboratory operations with organizational objectives, define roles and responsibilities, manage resources effectively, and establish proper documentation and reporting systems. Emphasis is placed on risk assessment, validation of methods, equipment calibration, and the integration of quality assurance practices to ensure consistent and trustworthy laboratory outcomes.

Achieving ISO/IEC 17025 Lead Implementer certification enables professionals to lead implementation projects within testing and calibration laboratories, ensuring compliance with regulatory requirements and international best practices. It also empowers them to conduct audits, identify non-conformities, and drive continual improvement initiatives. This certification is particularly valuable for laboratory managers, quality managers, technical supervisors, and consultants who wish to enhance operational efficiency, credibility, and confidence in laboratory results, thereby contributing to the organization’s overall quality and reputation.

Exam Information

The exam comprises of 40 Multiple Choice Questions out of which the candidate needs to score 70% (28 out of 40 correct) to pass the exam.

The total duration of the exam is 1 hour (60 Minutes).

The exam is delivered through ProctorU in a proctored mode. With a webcam and a reliable internet connection, exam can be taken anytime and anywhere.
Upon purchasing the Premium Package or an Exam Voucher Code, a voucher code with two attempts will be assigned to your login profile.

The Exam Voucher included in the Premium Package or purchased separately is valid for two (2) attempts.
If you are unable to pass the exam within these two attempts, you can purchase a new voucher code, which will grant you an additional two attempts.

The ISO/IEC 17025 - Certified Lead Implementer is valid for life.

Displaying your certificate

Remember, when labeling a product or system as certified to an ISO standard:
Don't say: "ISO certified" or "ISO certification"
DO say: "ISO 9001:2008 certified" or "ISO 9001:2008 certification" (for example).

N/A

The Certificaiton has no specific prerequisites.

Download Sample Exam

Course Outline

Module 1 - Introduction to ISO/IEC 17025

Overview of ISO/IEC 17025: Scope, objectives, and benefits
History and evolution of laboratory accreditation standards
Key principles of testing and calibration laboratories
Structure of ISO/IEC 17025 standard (Clause-wise overview)
Importance of competence, impartiality, and consistent operation
Integration with other management systems (ISO 9001, ISO 15189)

Module 2 - Requirements of ISO/IEC 17025

General requirements: impartiality, confidentiality, and organizational structure
Structural requirements: roles, responsibilities, and authorities
Resource requirements: personnel competence, facilities, equipment
Process requirements: methods, validation, calibration, and traceability
Management system requirements: document control, records, and continual improvement
Risk-based thinking in laboratory management

Module 3 - Laboratory Processes and Technical Competence

Sample handling, storage, and transportation procedures
Selection and validation of test and calibration methods
Equipment management: calibration, maintenance, and verification
Quality control procedures and inter-laboratory comparisons
Measurement uncertainty and traceability principles
Handling non-conforming work and corrective actions

Module 4 - Implementation of ISO/IEC 17025

Planning for ISO/IEC 17025 implementation
Gap analysis and maturity assessment of existing laboratory systems
Developing policies, procedures, and standard operating procedures (SOPs)
Resource allocation and competency development
Documenting processes and record management
Change management and leadership involvement

Module 5 - Auditing, Compliance, and Risk Management

Internal audit planning and execution
Preparing for third-party accreditation audits
Identifying, assessing, and mitigating laboratory risks
Root cause analysis and corrective/preventive actions
Key performance indicators (KPIs) and continual improvement
Maintaining compliance with regulatory and accreditation requirements

Module 6 - Strategic Alignment and Continual Improvement

Aligning laboratory operations with organizational strategy
Integration of ISO/IEC 17025 with other management systems
Developing a culture of quality and technical excellence
Leveraging data for decision-making and performance improvement
Sustainability and long-term operational efficiency
Certification process, assessment, and readiness review

Download Brochure

Target Audience

Laboratory Managers – Professionals responsible for managing testing and calibration laboratories and ensuring compliance with ISO/IEC 17025 standards.
Quality Managers – Individuals overseeing quality management systems in laboratories and seeking to strengthen operational effectiveness and compliance.
Technical Supervisors – Personnel supervising laboratory operations, equipment, and testing procedures who need to implement standardized practices.
Laboratory Consultants – Experts advising organizations on implementing, auditing, or improving laboratory management systems in line with ISO/IEC 17025.
Compliance Officers – Professionals ensuring that laboratory operations meet regulatory, accreditation, and international standard requirements.
Auditors (Internal & External) – Personnel conducting internal audits or preparing laboratories for third-party accreditation and certification assessments.
Project Managers – Individuals managing ISO/IEC 17025 implementation projects, ensuring alignment with organizational objectives and timelines.
Engineers & Technicians – Laboratory staff involved in testing, calibration, or validation processes who require a structured understanding of standard requirements.
Academicians & Researchers – Faculty or research leaders looking to establish or improve laboratory quality systems in educational or research institutions.
Senior Management – Executives and decision-makers responsible for approving, supporting, and overseeing laboratory management initiative

Registration Process for E-Course or E-Book and Exam

Premium Package
(E-Book Version)

E-Book Included
This package provides a voucher code granting eligibility for two (2) exam attempts.
Includes E-certificate and Digital Badge if you qualify in the exam.
E-Book Download Validity :
40 Days
( Once the E-Book is downloaded, it remains valid for life. )
Price: 210 USD

Exam
Voucher

Validity: 240 Days
Price: 190 USD
Please Read Carefully:

1) The Exam Voucher is valid for two (2) attempts.

2) You will receive your voucher code within 24 business hours.

3) You can schedule your exam through ProctorU.

Exam Registration

To Register for an Exam

Click Here

ISO/IEC 17025 - Certified Lead Implementer

Certification Overview