ISO 17025 Internal Auditor

• Educational Background: No prior auditing experience is required, though a basic understanding of laboratory practices or quality management systems is beneficial. 

• Language Proficiency: Learners should have a good command of English, as course materials and discussions are delivered in English. 

• Interest in Quality Assurance: Ideal for individuals involved in laboratory operations, quality management, or seeking to enhance their auditing skills. 

• Master ISO 17025 Requirements: Gain a comprehensive understanding of the principles and requirements of ISO 17025. 

• Develop Audit Skills: Learn to plan, conduct, and report internal audits effectively. 

• Identify and Address Non-Conformities: Build skills to assess laboratory systems and recommend improvements. 

• Enhance Risk-Based Thinking: Understand risk assessment techniques to improve compliance and quality management. 

The ISO 17025 Internal Auditor Course is tailored for professionals involved in laboratory quality management and auditing. It equips learners with the tools and techniques to conduct effective internal audits, ensuring compliance with ISO 17025 and improving laboratory performance. Below are the individuals who will benefit from this course: 

• Laboratory Managers 

• Quality Assurance Officers 

• Internal Auditors 

• Laboratory Technicians 

• Compliance Officers 

• Quality Managers 

• Consultants specialising in laboratory accreditation 

Module 1: Introduction to ISO 17025 

• ISO 17025
   

Module 2: Requirements of ISO 17025 

• Overview
   

Module 3: ISO 19011 Relationship to ISO 17025 

• ISO 19011 

• ISO 17025
   

Module 4: Scope 

• Overview
   

Module 5: Normative References 

• Introduction to Normative References
   

Module 6: Terms and Definitions 

• Overview
   

Module 7: General Requirements 

• Overview 

• Impartiality 

• Confidentiality
   

 Module 8: Structural Requirements 

• Overview of Structural Requirements
   

Module 9: Resource Requirements 

• Introduction 

• General 

• Personnel 

• Facilities and Environmental Conditions 

• Equipment 

• Metrological Traceability 

• Externally Provided Products and Services
   

Module 10: Process Requirements 

• Introduction to 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 

• Ensure Results Validity 

• Reporting of Results 

• Complaints 

• Nonconforming Work 

• Control of Data and Information Management
   

Module 11: Management System Requirements 

• Options 

• Option A 

• Option B 

• General 

Module 12: Management System Documentation 

• Overview 

• Document Categories 

Module 13: Control Management System Documents 

• Overview 

• Primary Document Control Requirements in the ISO 17025 Standard 

Module 14: Control of Records 

• Overview
   

Module 15: Address Risks and Opportunities 

• Overview of Address Risks and Opportunities
   

Module 16: Improvement 

• Overview of Improvement
   

Module 17: Corrective Actions 

•  Steps to Take Corrective Actions
   

Module 18: Internal Audit and Management Reviews 

• Internal Audit 

• Management Reviews
   

Module 19: Terminology – ISO 9000, VIM etc. 

• ISO 9000 Terminology in English 

• What is ISO 9000? 

• Common ISO Definitions 

Module 20: Fundamental Audit Concepts and Principles 

• Overview 

Module 21: Auditing Requirements and Assessment: ISO 17011:2017, ISO 19011:2018 

• Auditing: ISO 17011:2017 

• Auditing: ISO 19011:2018 

Module 22: Recognition and Oversight of ILAC, IAAC, APAC etc. 

• Description of ILAC 

• ILAC’s Global Role 

• Abbreviations 

• ILAC Documents 

• ILAC P10 Traceability Policy 

Module 23: Test Reports, AB Symbols, Equipment Stickers, and Certificates 

• AB Symbols 

• Certificates 

• Certificate Naming Convention 

Module 24: Clauses 4, 5, and 6 Review 

• Clause 4: General Requirements 

• Clause 5: Structural Requirements 

• Clause 6: Resource Requirements 

Module 25: Clauses 7 and 8 Review 

• Clause 7: Process Requirements 

• Clause 8: Option 

Module 26: Guidelines for Auditing: ISO 19011 

• ISO 19011 Auditing Guidelines 

• What is ISO 19011? 

• Standard Facts of ISO 19011 

• Who ISO 19011:2018 should be Used? 

• What does ISO 19011:2018 Accomplish? 

Module 27: GUM (Uncertainty), PT/ILC, and Traceability 

• GUM (Uncertainty) 

• PT/ILC 

• Traceability 

Module 28: Opening and Closing Meeting Activities 

• Opening Meeting 

• What Happens in an Opening Meeting? 

• Closing Meeting 

• What Happens in a Closing Meeting? 

Module 29: ISO 19011 Relationship to ISO 17025 

• ISO 19011 

• ISO 17025 

Module 30: Auditing Technical Methods 

• Overview 

Module 31: Reporting Audit Results 

• Internal Audit Report  

Module 32: Audit Checklists 

• ISO 17025:2017 Audit Checklist for Laboratory Accreditation System Requirements 

• Content of ISO/IEC 17025:2017 Audit Checklists
   

Module 33: Review of Standards and Internal Auditing Issues 

• Review of Standards 

• Internal Auditing Issues