ISO 17025 Testing & Calibration Laboratories Internal 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 Requirements Overview

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

Module 3: Impartiality & Confidentiality

• Impartiality principles
• Identifying impartiality risks
• Conflict management
• Confidential information
• Information protection
• Laboratory responsibilities

Module 4: Structural Requirements

• Legal responsibility
• Organisational structure
• Laboratory management
• Roles and responsibilities
• Authority
• Laboratory activities

Module 5: Personnel Competence

• Competence criteria
• Training requirements
• Skills evaluation
• Personnel authorisation
• Responsibilities
• Competence records

Module 6: Facilities & Environmental Conditions

• Facility suitability
• Environmental requirements
• Monitoring conditions
• Contamination controls
• Access controls
• Environmental records

Module 7: Equipment Requirements

• Equipment selection
• Equipment calibration
• Maintenance
• Equipment identification
• Equipment status
• Equipment records

Module 8: Metrological Traceability

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

Module 9: Laboratory Process Requirements

• Request review
• Method selection
• Verification
• Validation
• Sampling
• Handling laboratory items

Module 10: Measurement Uncertainty & Result Validity

• Measurement uncertainty
• Sources of uncertainty
• Evaluation concepts
• Quality control
• Proficiency testing
• Monitoring validity

Module 11: Reporting & Nonconforming Work

• Test reports
• Calibration information
• Reporting results
• Report amendments
• Complaints
• Nonconforming work

Module 12: Management System Requirements

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

Module 13: Internal Audit Fundamentals

• Purpose of internal audits
• Audit principles
• Audit objectives
• Audit scope
• Audit criteria
• Auditor responsibilities

Module 14: Internal Audit Programme

• Audit programme planning
• Audit frequency
• Audit priorities
• Resource allocation
• Auditor selection
• Programme monitoring

Module 15: Preparing for an Internal Audit

• Reviewing documentation
• Understanding laboratory processes
• Identifying requirements
• Audit planning
• Audit schedule
• Audit preparation

Module 16: Developing Audit Checklists

• Checklist purpose
• Requirement-based questions
• Process-based questions
• Technical process questions
• Sampling considerations
• Checklist flexibility

Module 17: Conducting the Opening Meeting

• Meeting objectives
• Introductions
• Confirming scope
• Confirming audit plan
• Communication arrangements
• Addressing questions

Module 18: Gathering Audit Evidence

• Document review
• Record review
• Observation
• Interviews
• Sampling
• Evidence verification

Module 19: Auditing Laboratory Technical Activities

• Personnel competence
• Equipment controls
• Calibration status
• Method implementation
• Sample handling
• Result validity

Module 20: Audit Findings & Nonconformities

• Evaluating evidence
• Conformity
• Nonconformity
• Objective evidence
• Writing clear findings
• Finding classification concepts

Module 21: Audit Reporting & Closing Meeting

• Audit report structure
• Findings summary
• Reporting evidence
• Closing meeting
• Communicating conclusions
• Auditor responsibilities

Module 22: Corrective Action & Audit Follow-Up

• Root cause concepts
• Corrective action
• Reviewing responses
• Verifying implementation
• Follow-up activities
• Continual improvement