ISO/IEC 17025: LEAD IMPLEMENTER
The ISO/IEC 17025: Lead Implementer course is an advanced professional program designed to equip participants with the knowledge and practical skills required to plan, implement, manage, and continually improve a laboratory management system in accordance with ISO/IEC 17025. ISO/IEC 17025 is published by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It specifies the requirements for laboratory competence, impartiality, and consistent operation, enabling laboratories to produce technically valid and reliable test and calibration results. This course focuses on hands-on implementation, guiding participants through the establishment of governance structures, technical and management system requirements, documentation, risk-based thinking, and preparation for accreditation. It prepares professionals to lead ISO/IEC 17025 implementation projects, coordinate laboratory teams, and interact effectively with accreditation bodies. Course Objectives By the end of this course, participants will be able to: Interpret ISO/IEC 17025 requirements from an implementation perspective Plan and manage an ISO/IEC 17025 implementation project Establish and document a compliant laboratory management system Implement technical competence, impartiality, and risk controls Select and apply appropriate management system options (A or B) Prepare laboratories for accreditation assessments Maintain and continually improve the laboratory management system
Course Curriculum
1
- Purpose and scope of ISO/IEC 17025
- Implementation lifecycle and accreditation context
- Role and responsibilities of the Lead Implementer
- Relationship with laboratory operations and strategy
2
- Clause-by-clause review of ISO/IEC 17025
- General, structural, resource, process, and management system requirements
- Outcome-based and risk-focused approach
- Mandatory requirements vs flexibility
3
- Defining laboratory scope and activities
- Establishing governance and accountability
- Resource planning and competence requirements
- Implementation roadmap and milestones
4
- Identifying risks to impartiality
- Managing conflicts of interest
- Confidentiality controls
- Leadership responsibilities and oversight
5
- Personnel competence, authorization, and training
- Facilities and environmental conditions
- Equipment management and maintenance
- Metrological traceability
6
- Review of requests, tenders, and contracts
- Method selection, verification, and validation
- Sampling and handling of test and calibration items
- Ensuring validity of results
- Reporting of results
7
- Management system options (Option A and Option B)
- Documented information and record control
- Control of nonconforming work
- Corrective actions and improvement
8
- Identifying risks and opportunities
- Managing risks affecting validity of results
- Integrating risk into laboratory planning
- Monitoring risk treatment effectiveness
9
- Monitoring laboratory performance
- Internal audits (overview)
- Management review inputs and outputs
- Using performance data for improvement
10
- Preparing for accreditation assessments
- Pre-assessment and readiness reviews
- Managing assessor interactions
- Handling nonconformities and corrective actions
11
- Managing change in laboratory operations
- Improving technical and management processes
- Sustaining compliance and competence
- Preparing for reassessments
12
- Laboratory documentation development
- Method validation and risk scenarios
- Implementation planning exercises
- Peer review and feedback
13
- Review of ISO/IEC 17025 Lead Implementer syllabus
- Scenario-based questions and exam techniques
- Certification exam guidance
14
- Instructor-led classroom or virtual training
- Practical workshops and laboratory-focused exercises
- Case studies and facilitated discussions
15
- Laboratory managers and technical managers
- Quality managers and ISO/IEC 17025 coordinators
- Senior laboratory personnel and supervisors
- Consultants supporting laboratory accreditation
- Professionals preparing for ISO/IEC 17025 Lead Implementer certification
16
- ISO/IEC 17025 Foundation certificate or equivalent knowledge
- Practical experience in laboratory operations is strongly recommended
17
- Practical implementation and documentation exercises
- Scenario-based discussions
- ISO/IEC 17025 Lead Implementer certification examination
This course includes
- 17+ Activity Modules
- 40 hours + lessons
- Lifetime access
- Certificate of completion
- Available on desktop and mobile
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