Program Overview
This intensive program equips quality and technical professionals with the knowledge and tools to align ISO/IEC 17025 laboratory practices with broader quality management systems. Participants will gain a strong conceptual foundation in the standard’s management and technical requirements, along with practical insights into lab-QMS integration, audit preparedness, and risk mitigation. Delivered by a senior industry expert, this session emphasizes actionable strategies through real-world case studies, simulations, and interactive exercises, enabling professionals to enhance lab utilization, traceability, and product quality across the enterprise.
Features
- Understand ISO/IEC 17025 requirements and their integration with ISO 9001/IATF 16949
- Apply lab data for quality improvement, audit readiness, and traceability
- Manage internal and outsourced labs for compliance and efficiency
- Identify and address common gaps in lab-QMS interfaces through risk-based thinking
Target audiences
- Quality Managers
- Compliance Officers
- QMS Professionals
Curriculum
- 5 Sections
- 24 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- Foundation of ISO/IEC 170255
- 1.1Overview of ISO/IEC 17025: Purpose, Scope, Applicability
- 1.2Key definitions: Calibration, Traceability, Measurement Uncertainty, Proficiency Testing
- 1.3Differences between ISO/IEC 17025 and ISO 9001, IATF 16949
- 1.4Role of certified test labs in regulated environments
- 1.5Interactive Quiz: Terminology and scope
- Requirements of ISO/IEC 170255
- 2.1Management Requirements: Risk-based thinking, impartiality, confidentiality
- 2.2Technical Requirements: Personnel competence, method validation, test equipment control
- 2.3Documentation and recordkeeping expectations
- 2.4Key Concepts: Metrological traceability, LIMS, Interlaboratory comparisons
- 2.5Scenario-based discussion on major and minor compliance failures
- Integration into QMS – Real World Case Studies5
- 3.1How certified labs feed data into the QMS
- 3.2Examples from Automotive, Pharma, and Electronics industries
- 3.3Case: Using lab results in CAPA investigations
- 3.4Linking lab compliance with product and process validation
- 3.5Interactive: Case walkthrough – “Audit trail disconnects due to lab misalignment”
- Risk-Based Thinking and Continual Improvement4
- Audit Readiness and Supplier Lab Management5
Instructor
