ISO/IEC 17025:2017 Laboratory Competence Lead Implementer Training and Certification Program

Programme Summary

Lead the practical development of a laboratory system that supports valid results and controlled operations. Participants translate ISO/IEC 17025 into an implementation plan covering technical competence, measurement traceability, methods, data and management assurance. A progressive laboratory case develops linked procedures, evidence requirements and readiness reviews while preserving the distinction between system design and demonstrated technical performance.

Training Objectives

1 Structure a practical laboratory implementation programme; 2 Integrate technical controls with management responsibilities; 3 Plan evidence for reliable measurement processes; 4 Coordinate laboratory resources risks and change; 5 Establish sustainable monitoring and improvement arrangements.

Learning Outcomes

1 Define laboratory scope and implementation priorities; 2 Build a laboratory competence authorisation matrix; 3 Design linked technical control records; 4 Develop a risk based implementation roadmap; 5 Present a defensible laboratory readiness review.

Target Audience

Laboratory Managers; Technical Managers; Laboratory Quality Managers; Implementation Project Leads; Calibration Managers.

Target Industries

Independent Testing Laboratories; Calibration Laboratories; Food Testing Laboratories; Environmental Testing Laboratories; Materials Testing Laboratories; Industrial Quality Laboratories.

Course Contents

• Module 1 Implementation Governance: Laboratory objectives scope and deliverables; Sponsor ownership and project responsibilities; Implementation stages resources and milestones.
• Module 2 Gap Assessment and Priorities: Evidence based baseline assessment; Technical gaps affecting result validity; Risk ranked implementation action planning.
• Module 3 Impartiality and Confidentiality Controls: Commercial pressures and conflicting interests; Risk evaluation and documented safeguards; Information classification and disclosure controls.
• Module 4 Laboratory Structure and Authority: Legal accountability and organisational interfaces; Technical responsibilities and delegated authority; Escalation routes and communication design.
• Module 5 Personnel Competence System: Role specific competence acceptance criteria; Training supervised practice and observation; Authorisation monitoring and reauthorisation triggers.
• Module 6 Facilities and Working Conditions: Method specific environmental condition limits; Segregation contamination and access controls; Monitoring records and excursion responses.
• Module 7 Equipment Lifecycle Management: Equipment selection and acceptance evidence; Calibration maintenance and intermediate checks; Out of service and impact assessments.
• Module 8 Metrological Traceability Design: Measurement references and traceability routes; Calibration certificate suitability review; Reference material selection and control.
• Module 9 Supplier and External Service Controls: Technical purchasing specifications and evaluation; Externally provided laboratory activity controls; Supplier performance and acceptance records.
• Module 10 Customer Request Review: Method capability and resource review; Customer communication and deviation agreement; Contract change and subcontracting interfaces.
• Module 11 Method Selection and Verification: Standard method applicability and scope; Verification design and acceptance criteria; Controlled transfer into routine operation.
• Module 12 Method Validation Planning: Performance characteristics and intended use; Study design and technical review; Validation conclusions and change triggers.
• Module 13 Sampling and Item Handling: Sampling responsibilities and documented plans; Receipt identification and integrity controls; Storage retention transport and disposal.
• Module 14 Measurement Uncertainty Framework: Method specific uncertainty evaluation routes; Data sources and budget ownership; Review triggers and reporting decisions.
• Module 15 Assuring Validity of Results: Internal control plans and acceptance rules; Proficiency testing strategy and investigations; Trend reviews and action effectiveness.
• Module 16 Records and Information Systems: Technical record design and traceability; Data access backup and recovery; System validation and controlled changes.
• Module 17 Reports and Conformity Decisions: Report templates and authorised release; Agreed decision rules and uncertainty; Amendments opinions and customer communication.
• Module 18 Laboratory Response Processes: Complaints independence and communication; Nonconforming work control and impact; Root causes actions and effectiveness.
• Module 19 Management System Assurance: Document control and record retention; Internal audit and management review; Risks opportunities and improvement follow through.
• Module 20 Implementation Readiness Workshop: Integrated laboratory evidence portfolio; Milestones responsibilities and resource decisions; Readiness presentation and remaining gaps.

Assessment

• 100 single best answer questions, including applied scenarios; one mark per question.
• 150 minute invigilated digital examination with identity verification. Approved accessibility adjustments preserve the assessed competence.
• Supplied reference pack and calculator permitted; external internet and AI prohibited.
• Individual applied assessment (90 minutes): Produce an implementation roadmap, a competence matrix and a technical control evidence plan for a fictional laboratory; defend priorities in a readiness briefing.
• Assessment criteria: Coverage of technical implementation risks; Consistency of controls and evidence; Feasible ownership and implementation sequencing.
• Pass each component separately: 75/100 written marks (75%) and at least 70% on the applied task.
• Individual results and feedback are provided. One reassessment may follow coaching under the published enrolment terms.

Certification

• Successful learners receive a TQCSI Arabia digital Certificate of Successful Completion.
• The certificate records the learner name, exact programme title, teaching hours, completion date and unique verification reference.
• Verified identity, full attendance and separate written and applied passes are required; all mandatory critical criteria must be met.
• Proposed issue target: within 30 calendar days of approved results and settlement of applicable fees.
• Records laboratory system implementation learning; it does not establish accreditation eligibility, approve technical methods or authorise laboratory personnel.
• Attendance confirmation may record completed hours for unsuccessful learners; it does not certify successful completion.

Programme Profile

Number of daysNumber of daysNumber of days

555

Total teaching hoursTotal teaching hoursTotal teaching hours

35 hours; breaks, pre course work and formal final assessments excluded.35 hours; breaks, pre course work and formal final assessments excluded.35 hours; breaks, pre course work and formal final assessments excluded.

Delegates allowedDelegates allowedDelegates allowed

Maximum 16 delegates.Maximum 16 delegates.Maximum 16 delegates.

Training prerequisitesTraining prerequisitesTraining prerequisites

ISO/IEC 17025 knowledge and laboratory operational experience are required. Participants should understand at least one testing or calibration process and its principal technical risks.ISO/IEC 17025 knowledge and laboratory operational experience are required. Participants should understand at least one testing or calibration process and its principal technical risks.ISO/IEC 17025 knowledge and laboratory operational experience are required. Participants should understand at least one testing or calibration process and its principal technical risks.

Pre course assignment and assessmentPre course assignment and assessmentPre course assignment and assessment

Complete a 45-minute laboratory gap diagnostic using a fictional scope, equipment list and workflow.Complete a 45-minute laboratory gap diagnostic using a fictional scope, equipment list and workflow.Complete a 45-minute laboratory gap diagnostic using a fictional scope, equipment list and workflow.

End of course assessmentEnd of course assessmentEnd of course assessment

100 question written exam (150 minutes) and individual applied task (90 minutes).100 question written exam (150 minutes) and individual applied task (90 minutes).100 question written exam (150 minutes) and individual applied task (90 minutes).

Passing criteriaPassing criteriaPassing criteria

75% written and 70% applied, passed separately; full attendance.75% written and 70% applied, passed separately; full attendance.75% written and 70% applied, passed separately; full attendance.