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

Programme Summary

Prepare experienced laboratory professionals to lead rigorous audits across technical and management processes. Participants manage audit teams, evaluate complex evidence trails and form balanced conclusions about controls supporting valid results. Extended simulations cover planning, interviewing, technical records, disputed findings and reporting, with clear boundaries between laboratory audit competence and specialist accreditation assessment authority.

Training Objectives

1 Lead risk informed laboratory audit engagements; 2 Allocate audit work to competent team members; 3 Evaluate interconnected technical and management evidence; 4 Manage audit communication and difficult situations; 5 Form justified conclusions and follow up decisions.

Learning Outcomes

1 Design a complete laboratory audit programme; 2 Lead a simulated laboratory audit team; 3 Evaluate complex technical evidence for consistency; 4 Defend findings against stated audit criteria; 5 Present a concise laboratory audit conclusion.

Target Audience

Laboratory Lead Auditors; Laboratory Quality Managers; Technical Managers; Audit Programme Managers; Laboratory Assurance Leads.

Target Industries

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

Course Contents

• Module 1 Laboratory Audit Leadership: Audit purpose scope and intended users; Lead auditor responsibilities and ethics; Technical scope and competence boundaries.
• Module 2 Laboratory Requirement Interpretation: Competence impartiality and consistent operation; Management controls supporting technical results; Requirement interpretation and evidence expectations.
• Module 3 Audit Programme Strategy: Risk based coverage across laboratory activities; Multi location and external activity interfaces; Programme performance and resource planning.
• Module 4 Audit Team Competence: Discipline specific technical competence needs; Team selection and responsibility allocation; Using technical experts without delegation gaps.
• Module 5 Audit Initiation: Objectives criteria and feasible scope; Information requests and preliminary contact; Confidentiality access and safety arrangements.
• Module 6 Reviewing Laboratory Documentation: Scope methods and technical procedures; Prior findings performance and complaints; Readiness gaps and targeted audit trails.
• Module 7 Planning the Audit: Process risks and sampling strategy; Interview sequence and time management; Remote evidence opportunities and limitations.
• Module 8 Opening Meetings and Coordination: Confirming arrangements and communication routes; Team briefings and evidence consistency; Managing changes during audit delivery.
• Module 9 Personnel and Facility Evidence: Competence authorisations and witnessed practice; Environment controls and contamination prevention; Evidence of sustained technical suitability.
• Module 10 Equipment and Traceability Evidence: Calibration suitability and uncertainty relevance; Intermediate checks and equipment failures; Traceability chains and reference material control.
• Module 11 Method and Sampling Evidence: Verification validation and method changes; Sampling responsibility and representative collection; Handling deviations and technical consequences.
• Module 12 Result Validity and Uncertainty: Uncertainty models and available evidence; Control trends and proficiency performance; Investigating gaps affecting valid results.
• Module 13 Information and Reporting Evidence: Technical records and calculation traceability; Data access validation and audit trails; Decision rules report release and amendments.
• Module 14 System Assurance Evidence: Complaints and nonconforming work response; Corrective action and effectiveness checks; Internal audit and management review outputs.
• Module 15 Advanced Interviewing: Evidence focused questions and listening; Managing resistance and conflicting statements; Triangulation and professional scepticism.
• Module 16 Findings and Audit Conclusions: Evidence sufficiency and requirement linkage; Systemic patterns and consequence evaluation; Balanced conclusions within sampled scope.
• Module 17 Team Consensus and Closing Meetings: Reviewing findings across audit team; Handling factual disagreement professionally; Presenting clear limitations and conclusions.
• Module 18 Audit Reports and Records: Concise reports and supporting evidence; Confidential record retention and access; Timely communication and correction handling.
• Module 19 Corrective Action Evaluation: Cause adequacy and proposed action review; Implementation and effectiveness verification; Follow up priorities and closure decisions.
• Module 20 Lead Auditor Simulation: Leading an observed laboratory audit segment; Defending findings and evidence decisions; Presenting final report and follow up plan.

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 (150 minutes): Lead a simulated laboratory audit segment, evaluate a technical evidence pack, agree team findings and present an individual audit report with follow up decisions.
• Assessment criteria: Audit leadership and evidence control; Technically justified findings and conclusions; Clear reporting and follow up judgement.
• 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 assessed laboratory audit leadership skills; it does not appoint an accreditation assessor or demonstrate competence in every laboratory discipline.
• 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, laboratory experience and prior internal audit training or equivalent experience are required. Candidates must understand the technical scope they intend to audit.ISO/IEC 17025 knowledge, laboratory experience and prior internal audit training or equivalent experience are required. Candidates must understand the technical scope they intend to audit.ISO/IEC 17025 knowledge, laboratory experience and prior internal audit training or equivalent experience are required. Candidates must understand the technical scope they intend to audit.

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

Complete a 45-minute audit readiness diagnostic and analyse a fictional laboratory case pack.Complete a 45-minute audit readiness diagnostic and analyse a fictional laboratory case pack.Complete a 45-minute audit readiness diagnostic and analyse a fictional laboratory case pack.

End of course assessmentEnd of course assessmentEnd of course assessment

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