ISO 17025 Lead Auditor - United States

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