ISO/IEC 17025 Testing and Calibration Laboratories Lead Implementer
ISO/IEC 17025 is the international standard that specifies the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It ensures laboratories produce valid and reliable results, which are critical for quality assurance, regulatory compliance, and customer confidence.
A Lead Implementer of ISO/IEC 17025 is a qualified professional who leads the development and implementation of a laboratory management system in accordance with this standard. This role involves guiding laboratories through the process of meeting technical and management requirements to demonstrate their competence and improve operational efficiency.
Aim of ISO/IEC 17025 Testing and Calibration Laboratories Lead Implementer
The aim of the ISO/IEC 17025 Lead Implementer course is to equip professionals with the knowledge, skills, and tools necessary to effectively implement, manage, and maintain a laboratory management system that complies with the ISO/IEC 17025 standard. This enables testing and calibration laboratories to demonstrate technical competence, ensure reliable and accurate results, achieve accreditation, and continually improve their quality management processes.
Course Overview
ISO/IEC 17025 Testing and Calibration Laboratories Lead Implementer
Educational Background:
A minimum of a high school diploma or equivalent. A degree or diploma in science, engineering, laboratory technology, or related fields is preferred.
Work Experience:
At least 2 years of experience working in testing or calibration laboratories, quality management, or related roles. Experience with ISO/IEC 17025 or other ISO management system standards is an advantage.
Knowledge Requirements:
Basic understanding of laboratory operations, quality management principles, and ISO standards.
| Course Code | Curriculum Title | Credit | DLH |
|---|---|---|---|
| BUK1976-1 | Introduction to ISO/IEC 17025 and Laboratory Management Systems | 3 | 15 |
| BUK1976-2 | Understanding ISO/IEC 17025 Requirements | 3 | 15 |
| BUK1976-3 | Planning for ISO/IEC 17025 Implementation | 3 | 15 |
| BUK1976-4 | Developing and Implementing the Laboratory Management System | 3 | 15 |
| BUK1976-5 | Operational Control and Technical Competence | 3 | 15 |
| BUK1976-6 | Performance Evaluation and Monitoring | 3 | 15 |
Learning Objectives
Introduction to ISO/IEC 17025 and Laboratory Management Systems
- Overview of ISO/IEC 17025:2017
- Importance of accreditation for laboratories
- Structure and key concepts of the standard
Understanding ISO/IEC 17025 Requirements
- Management requirements (quality management system)
- Technical requirements (competence of testing and calibration)
- Annexes and normative references
Planning for ISO/IEC 17025 Implementation
- Gap analysis and risk assessment
- Defining scope and objectives
- Resource planning and team formation
Developing and Implementing the Laboratory Management System
- Document control and record management
- Procedure development for testing and calibration processes
- Competence, training, and personnel qualification
Operational Control and Technical Competence
- Equipment calibration and maintenance
- Method validation and measurement uncertainty
- Handling test and calibration items
Performance Evaluation and Monitoring
- Internal audits and management reviews
- Corrective and preventive actions
- Monitoring key performance indicators (KPIs)
Preparing for Accreditation and External Audits
- Accreditation process overview
- Roles of the Lead Implementer during audits
- Addressing nonconformities and continuous improvement
Practical Exercises and Case Studies
- Hands-on activities for documentation and audit preparation
- Real-world examples and group discussions
- Technical and Laboratory Personnel
- Quality Assurance and Compliance Professionals
- Consultants and Implementers
- Accreditation and Certification Bodies
- Students and Graduates (with relevant background)
- Anyone Seeking ISO/IEC 17025 Knowledge
- All Modules within this qualification are assessed internally by the approved training Centre and externally verified by BURRAQ UK. The program uses a criterion-referenced assessment approach to ensure that learners successfully meet all required learning outcomes.
- A Pass in any unit is granted only when the learner submits valid, reliable, and authentic evidence that demonstrates achievement of the assessment criteria. The Assessor is responsible for reviewing this evidence and confirming that the learner has attained the expected standard.