ISO 17025 Lead Implementer

• Educational Background: A basic understanding of laboratory operations or quality management systems is recommended. 

• Professional Experience: Experience in laboratory management, quality control, or auditing is beneficial but not mandatory. 

• Language Proficiency: Learners should have a good command of English, as the course and certification exam are conducted in English. 

• Master ISO 17025 Standards: Gain a thorough understanding of ISO 17025 principles and requirements. 

• Implement Laboratory Quality Systems: Develop the skills to establish and manage compliant laboratory quality management systems. 

• Enhance Risk Management Expertise: Learn to identify, assess, and mitigate risks in laboratory operations. 

• Conduct Internal Audits: Build the ability to perform effective internal audits to ensure ongoing compliance. 

The ISO 17025 Lead Implementer course is ideal for professionals involved in laboratory operations, quality management, and compliance. Below are the individuals who will benefit from this course:

• Laboratory Managers
• Quality Assurance Officers
• Compliance Specialists
• Internal Auditors
• Technical Managers
• Calibration and Testing Professionals
• Quality Control Analysts 

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 
   

Module 34: Introduction to Lab Management System (LMS) 

• Standard and Regulatory Framework 

• Laboratory Management System 

• Laboratories and Accreditation Principles 

• Testing and Calibration Concepts 

• Identifying the Objective and Scope 

• Understanding Organisation 

• Analysing Existing System 
   

Module 35: Planning LMS Implementation 

• Leadership and LMS Project Approval 

• Laboratory Policies 

• Document Management Process 
   

Module 36: Implementing LMS 

• Design of Controls 

• Drafting of Specific Policies and Procedures 

• Communication Planning 

• Training and Awareness Planning 

• Resource Management 

• Customer Management 

• Operations Management 
   

Module 37: Monitoring, Measurement, and Continuous Improvement 

• Monitoring, Analysis, and Evaluation 

• Treating Problems and Nonconformities 

• Continual Improvement 

• Accreditation Preparation 

• Implementers Evaluation