ISO 17025 Lead Auditor Training Course Outline
Module 1: Introduction to ISO 17025
Module 2: Requirements of ISO 17025
Module 3: The Relationship between ISO 19011 and ISO 17025
Module 4: Scope
Module 5: Normative References
Module 6: Terms and Definitions
Module 7: General Requirements
- Impartiality
- Confidentiality
Module 8: Structural Requirements
Module 9: Resource Requirements
- General
- Personnel
- Facilities and environmental conditions
- Equipment
- Metrological traceability
- Externally provided products and services
Module 10: Process Requirements
- Review - requests, tenders, and contracts
- Selection, verification, and validation of methods
- Sampling
- Handling test or calibration items
- Technical records
- Evaluation of measurement uncertainty
- Ensuring result validity
- Reporting of results
- Complaints
- Nonconforming work
- Control of data and information management
Module 11: Management System Requirements
- Options
- General
- Option A
- Option B
Module 12: Management System Documentation
Module 13: Control Management System Documents
Module 14: Control of Records
Module 15: Address Risks and Opportunities
Module 16: Improvement
Module 17: Corrective Actions
Module 18: Management Reviews
Module 19: Terminology – ISO 9000, VIM etc.
Module 20: Fundamental Audit Concepts and Principles
Module 21: Auditing Requirements and Assessment: ISO 17011:2004, ISO 19011:2011
Module 22: Recognition and Oversight of ILAC, IAAC, APLAC
Module 23: Test Reports, AB Symbols, Equipment Stickers, Certificates
Module 24: Clauses 4, 5, and 6 Review
- Case studies on clauses 4, 5 and 6
Module 25: Clauses 7 and 8 Review
- Case studies on clauses 7 and 8
Module 26: Guidelines for Auditing: ISO 19011
Module 27: GUM (Uncertainty), PT/ILC, Traceability
Module 28: Opening and Closing Meeting Activities
Module 29: Auditing Technical Methods
Module 30: Reporting Audit Results
Module 31: Audit Checklists and Audit Reports
Module 32: Review of Standards and Internal Auditing Issues
Module 33: Introduction to Lab Management System (LMS)
- Standards and regulatory frameworks
- Laboratory management systems
- Laboratories and accreditation fundamental principles
- Testing and calibration concepts
- Implementation of LMS
- Understanding the organization
- Analyzing existing systems
Module 34: Planning LMS Implementation
- Leadership and LMS project approval
- Scope of LMS
- Laboratory policies
- Organizational structure
- Document management process
Module 35: Implementing an LMS
- Design of controls
- Drafting of specific policies and procedures
- Communication planning
- Training and awareness planning
- Resource management
- Customer management
- Operations management
Module 36: LMS Monitoring, Measurement, and Continuous Improvement
- Monitoring, analysis, and evaluation
- Treating problems and nonconformities
- Continual improvement
- Accreditation preparation
- Implementers evaluation
Module 37: Planning an ISO 17025 Audit
- Audit approach
- Preparing the ISO 17025 Audit
- Conducting an opening meeting
Module 38: Conducting the ISO 17025 Audit
- Communication during audit
- Audit procedures
- Observation
- Document review
- Interview
- Sampling techniques
- Technical verification
- Corroboration and evaluation
- Audit test plans
- Formulation of audit findings
- Documenting nonconformities
Module 39: Concluding and Follow-Up of ISO 17025 Audits
- Audit documentation
- Quality review
- Closing meeting
- Evaluation of corrective action plans
- ISO 17025 surveillance audits
- ISO 17025 internal audit management program
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