Course Scope
This comprehensive training program provides laboratory professionals with the knowledge and practical skills required to develop, implement, and maintain a Quality Management System (QMS) in compliance with ISO/IEC 17025:2017, the international standard for the competence of testing and calibration laboratories.
The course emphasizes laboratory quality fundamentals, document control, technical procedures, method validation, measurement traceability, uncertainty estimation, internal auditing, and accreditation readiness throughout the laboratory quality lifecycle. The curriculum is aligned with ISO/IEC 17025:2017 requirements and the process approach to laboratory quality management.
Included within scope:
- Laboratory quality fundamentals and key definitions
- Accreditation vs certification distinctions
- Quality Management System (QMS) structure and elements
- Document hierarchy and control
- Quality manual development
- Policy and procedure writing
- Technical procedures and Standard Operating Procedures (SOPs)
- Method validation and verification
- Measurement traceability and calibration
- Estimation of measurement uncertainty
- Quality control and proficiency testing
- Internal auditing and management review
- Corrective and preventive actions
- Document and record control
- Personnel training and competency
- Equipment management
- Sample handling and chain of custody
- Reporting results
- Stepwise approach to accreditation (20 Milestones)
- Continuous quality improvement (PDCA model)
Excluded from scope:
- Medical laboratory requirements (ISO 15189) – covered in separate training
- Sector-specific laboratory requirements
- Detailed statistical methodology
- Specific analytical techniques
Course Objectives
Upon successful completion of this training program, participants will be able to:
Laboratory Quality Knowledge:
- Understand the structure and requirements of ISO/IEC 17025:2017
- Distinguish between accreditation and certification
- Interpret laboratory quality terms and definitions
- Apply the process approach to laboratory quality management
QMS Development:
- Develop a quality policy statement
- Structure and write a quality manual
- Create administrative and technical procedures
- Implement document control systems
- Establish record management processes
Technical Competence:
- Validate and verify test methods
- Ensure measurement traceability
- Estimate measurement uncertainty
- Implement quality control procedures
- Manage equipment and calibration
QMS Implementation:
- Implement the stepwise approach to accreditation (20 Milestones)
- Conduct internal audits
- Perform management reviews
- Address nonconformities and implement corrective actions
- Drive continuous quality improvement
Laboratory Operations:
- Manage personnel training and competency
- Control documents and records
- Handle samples properly
- Report results accurately
- Maintain confidentiality and impartiality
Target Audience
This training is intended for all individuals and organizations involved in the development, implementation, and maintenance of quality management systems in testing and calibration laboratories. The content is tailored to the specific responsibilities of each role.
Primary audiences include:
- Laboratory directors and managers
- Quality managers and quality assurance personnel
- Technical managers and supervisors
- Laboratory analysts and technicians
- Internal auditors
- Laboratory consultants
- Personnel involved in QMS implementation
- Personnel involved in accreditation preparation
- Quality system coordinators
- Document control personnel
- Training coordinators
- Any laboratory personnel involved in quality activities
Regulatory References
This training is built upon the following authoritative documents:
Primary Standard:
- ISO/IEC 17025:2017 – General requirements for the competence of testing and calibration laboratories
Supporting Documents:
- ILAC G2 – Traceability of Measurement
- ILAC G9 – Guidelines for the Selection and Use of Certified Reference Materials
- ILAC G13 – Guidelines for the requirements for the Competence of Providers of Proficiency Testing Schemes
- ISO/IEC 17043 – Conformity Assessment – General Requirements for Proficiency Testing
- ISO 9000 – Quality Management Systems – Fundamentals and vocabulary
- ISO 19011 – Guidelines for auditing management systems
- ISO/TR 10013 – Guidelines for Quality Management System documentation
- ISO 10002 – Quality Management – Customer Satisfaction – Guidelines for complaints handling
Certification Details
Upon successful completion of this training program, participants will receive a certificate of completion documenting their understanding of ISO/IEC 17025:2017 requirements.
Certification Requirements:
- Complete all 10 training modules
- Achieve a passing score of 80% or higher on each module assessment
- Complete all module knowledge checks (10 questions per module)
Training Records:
- Training records must be documented, monitored, and retained
- This program provides downloadable certificates and maintains records of completion for organizational audit and accreditation purposes
