Training on IEC 17025:2017 Laboratory Quality Management Systems

Module 1: Introduction to ISO/IEC 17025:2017

• Overview, structure, and purpose of ISO/IEC 17025:2017
• Importance of laboratory accreditation and compliance
• Key changes between ISO/IEC 17025:2005 and ISO/IEC 17025:2017
• Benefits of implementing internationally recognized laboratory standards
• Understanding accreditation processes and requirements
• Case Study: Laboratory accreditation journey and compliance challenges

Module 2: Management Requirements

• Organizational structure, impartiality, and confidentiality requirements
• Document control and records management systems
• Managing customer feedback, complaints, and nonconformities
• Corrective actions and quality management procedures
• Strengthening accountability and compliance within laboratory operations
• Practical: Draft quality management and laboratory documentation

Module 3: Technical Requirements

• Competence and qualification requirements for laboratory personnel
• Equipment calibration, maintenance, and traceability systems
• Validation of test methods and measurement uncertainty principles
• Ensuring accuracy, reliability, and consistency in laboratory testing
• Managing laboratory technical records and quality assurance systems
• Case Study: Managing equipment calibration and traceability records
• Practical: Review and assess laboratory technical compliance records

Module 4: Risk Based Thinking and Internal Audits

• Applying risk based thinking in laboratory management systems
• Risk assessment and decision making in laboratory processes
• Planning, conducting, and reporting internal audits
• Identifying nonconformities and implementing corrective actions
• Strengthening continuous compliance through audit systems
• Practical: Develop a laboratory risk register and internal audit checklist

Module 5: Continuous Improvement and Accreditation Readiness

• Conducting management reviews and performance monitoring
• Preparing for external assessments and accreditation audits
• Building a culture of continual improvement in laboratory operations
• Monitoring quality objectives and operational effectiveness
• Best practices for sustaining accreditation compliance
• Case Study: Successful implementation of ISO/IEC 17025 in a laboratory environment
• Practical: Develop an accreditation readiness and improvement action plan