ISO 17025 Testing & Calibration Laboratories Lead Auditor

Module 1: Introduction to ISO/IEC 17025

• Purpose and scope
• Laboratory competence
• Testing laboratories
• Calibration laboratories
• Standard structure
• Key terminology

Module 2: ISO/IEC 17025 Framework

• General requirements
• Structural requirements
• Resource requirements
• Process requirements
• Management system requirements
• Requirement relationships

Module 3: Impartiality Requirements

• Impartiality principles
• Impartiality risks
• Conflict of interest
• Risk identification
• Risk mitigation
• Maintaining objectivity

Module 4: Confidentiality Requirements

• Confidential information
• Customer information
• Information protection
• Disclosure requirements
• Personnel responsibilities
• Confidentiality controls

Module 5: Structural Requirements

• Legal responsibility
• Organisational structure
• Management responsibilities
• Roles and authority
• Laboratory activities
• Organisational controls

Module 6: Personnel Competence

• Competence requirements
• Education and experience
• Training
• Competence evaluation
• Personnel authorisation
• Competence records

Module 7: Facilities & Environmental Conditions

• Facility requirements
• Environmental conditions
• Environmental monitoring
• Contamination prevention
• Access controls
• Facility records

Module 8: Equipment Management

• Equipment selection
• Calibration requirements
• Equipment verification
• Maintenance
• Intermediate checks
• Equipment records

Module 9: Metrological Traceability

• Traceability principles
• Calibration hierarchy
• Measurement standards
• Reference materials
• Traceability chains
• Traceability evidence

Module 10: Externally Provided Products & Services

• External providers
• Supplier evaluation
• Purchasing controls
• Service requirements
• Provider monitoring
• Outsourced laboratory activities

Module 11: Review of Requests, Tenders & Contracts

• Customer requirements
• Capability assessment
• Resource availability
• Method suitability
• Contract review
• Requirement changes

Module 12: Methods, Verification & Validation

• Method selection
• Standard methods
• Laboratory-developed methods
• Method verification
• Method validation
• Technical documentation

Module 13: Sampling & Handling of Items

• Sampling plans
• Sampling methods
• Sample identification
• Transportation
• Storage
• Handling controls

Module 14: Technical Records

• Technical documentation
• Original observations
• Data recording
• Amendments
• Traceability of records
• Record integrity

Module 15: Measurement Uncertainty

• Uncertainty concepts
• Sources of uncertainty
• Uncertainty components
• Evaluation approaches
• Reporting considerations
• Audit considerations

Module 16: Ensuring Validity of Results

• Quality control activities
• Reference materials
• Replicate testing
• Proficiency testing
• Interlaboratory comparisons
• Trend monitoring

Module 17: Reporting Laboratory Results

• Test reports
• Calibration information
• Reporting requirements
• Statements of conformity
• Report amendments
• Result authorisation

Module 18: Complaints & Nonconforming Work

• Complaint handling
• Complaint investigation
• Nonconforming work
• Impact evaluation
• Corrective actions
• Resumption of activities

Module 19: Management System Requirements

• Management system options
• Document control
• Record control
• Risks and opportunities
• Corrective actions
• Continual improvement

Module 20: Audit Principles & Lead Auditor Responsibilities

• Audit principles
• Auditor competence
• Professional behaviour
• Lead auditor responsibilities
• Independence
• Evidence-based auditing

Module 21: Managing an Audit Programme

• Programme objectives
• Audit priorities
• Audit frequency
• Resources
• Auditor selection
• Programme monitoring

Module 22: Audit Planning & Preparation

• Audit objectives
• Audit scope
• Audit criteria
• Audit plan
• Document review
• Audit checklist development

Module 23: Risk-Based Audit Planning

• Laboratory risks
• Technical risks
• Process criticality
• Previous findings
• Audit priorities
• Sampling strategies

Module 24: Conducting Opening Meetings

• Team introductions
• Confirming scope
• Confirming objectives
• Audit communication
• Audit arrangements
• Addressing concerns

Module 25: Gathering & Evaluating Audit Evidence

• Interviews
• Observations
• Document review
• Record sampling
• Objective evidence
• Evidence evaluation

Module 26: Auditing Technical Laboratory Activities

• Personnel competence
• Equipment controls
• Metrological traceability
• Method implementation
• Measurement uncertainty
• Result validity

Module 27: Audit Findings & Nonconformities

• Evaluating conformity
• Identifying nonconformities
• Objective evidence
• Writing findings
• Finding classification
• Communicating findings

Module 28: Audit Reporting & Closing Meeting

• Audit conclusions
• Audit report structure
• Findings summary
• Closing meeting
• Management communication
• Report distribution

Module 29: Corrective Actions & Follow-Up

• Root cause analysis concepts
• Corrective action plans
• Reviewing responses
• Verifying effectiveness
• Closing findings
• Follow-up audits

Module 30: Leading Audit Teams & Continual Improvement

• Audit team coordination
• Task allocation
• Managing conflicts
• Reviewing auditor work
• Audit programme improvement
• Lessons learned