ISO 17025 Lead Auditor

• Educational Background: A basic understanding of ISO standards and quality management systems is recommended. 

• Professional Experience: Prior experience in laboratory operations, quality control, or auditing will be beneficial for understanding course concepts. 

• Language Proficiency: A good command of English is required, as all course materials and assessments are in English. 

• Master ISO 17025 Standards: Gain a deep understanding of ISO 17025 requirements and their application in laboratory environments. 

• Develop Auditing Skills: Learn to plan, execute, and manage audits effectively to assess compliance with ISO 17025. 

• Identify and Address Non-Conformities: Build expertise in detecting and resolving non-conformities during audits. 

• Enhance Reporting Techniques: Gain proficiency in documenting and presenting audit findings to improve laboratory quality systems. 

The ISO 17025 Lead Auditor Training Course is tailored for professionals seeking to lead audits in laboratory environments. It equips learners with the knowledge and skills to ensure compliance with ISO 17025 standards and support accreditation efforts effectively. Below are the individuals who will benefit from this course:

• Lead Auditors
• Quality Managers
• Laboratory Managers
• Quality Assurance Officers
• Technical Experts
• Auditors
• Process Improvement Professionals
• Consultants

Module 1: Introduction to ISO 17025 

• ISO 

• ISO 17025 
   

Module 2: Requirements of ISO 17025 

• Overview 

• Requirements of ISO 17025 
   

Module 3: Relationship between ISO 19011 and ISO 17025 

• ISO 19011 

• Relationship between ISO 19011 and ISO 17025 
   

Module 4: Scope 

• Overview 

• Scope of ISO 17025 
   

Module 5: Normative References 

• Introduction to Normative References 
   

Module 6: Terms and Definitions 

• Overview 

• Terms and Definitions 
   

Module 7: General Requirements 

• Overview 

• Impartiality 

• Confidentiality 
   

Module 8: Structural Requirements 

• Overview of Structural Requirements 
   

Module 9: Resource Requirements 

• 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 

• Ensuring Result Validity 

• Reporting of Results 

• Complaints 

• Nonconforming Work 

• Control of Data and Information Management 
   

Module 11: Management System Requirements 

• Options 

• 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 
   

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, APLAC 

• Description of ILAC 

• ILAC’s Global Role 

• Abbreviations 

• ILAC Documents 

• ILAC P10 Traceability Policy 
   

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

• Case studies on clauses 7 and 8 
   

Module 26: Guidelines for Auditing: ISO 19011 

• ISO 19011 Auditing Guidelines 
   

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

• GUM (Uncertainty) 

• PT/ILC 

• Traceability 
   

Module 28: Opening and Closing Meeting Activities 

• Opening Meeting 

• Closing Meeting 
   

Module 29: Auditing Technical Methods 

• Overview 
   

Module 30: Reporting Audit Results 

• Internal Audit Report 
   

Module 31: Audit Checklists and Audit Reports 

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

• Content of ISO/IEC 17025:2017 Audit Checklists  
   

Module 32: Review of Standards and Internal Auditing Issues 

• Review of Standards 

• Internal Auditing Issues 
   

Module 33: Introduction to Lab Management System 

• Standards and Regulatory Frameworks 

• Laboratory Management Systems 

• Laboratories and Accreditation Fundamental Principles 

• Testing and Calibration Concepts 
   

Module 34: Planning LMS Implementation 

• Leadership and LMS Project Approval 

• Scope of LMS 

• Laboratory Policies 

• Organisational 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