What is ISO 17025 Lead Auditor?

ISO 17025 is the globally recognised standard for testing and calibration laboratories, focusing on quality and technical competence. This course equips delegates with the skills to conduct thorough audits of laboratory management systems, ensuring compliance with ISO 17025 requirements. It provides a robust framework for improving laboratory performance and building trust in test and calibration results.

Proficiency in ISO 17025 auditing is essential for professionals involved in quality management, laboratory operations, or compliance roles. This course is ideal for Laboratory Managers, Quality Assurance Officers, Auditors, and Professionals seeking to enhance their expertise in auditing laboratory management systems. Mastery of ISO 17025 ensures organisations deliver accurate and reliable results, meeting industry and regulatory demands.

This 5-day course offered by Oakwood International provides comprehensive training in ISO 17025 auditing practices. Delegates will gain practical knowledge of audit planning, execution, and reporting. Interactive sessions, case studies, and expert guidance ensure delegates are fully equipped to lead audits that drive continual improvement and maintain compliance.
 

Course Objectives:
 

  • To understand the principles and requirements of ISO 17025
  • To develop the skills required to plan, conduct, and report audits
  • To identify and address non-conformities in laboratory management systems
  • To evaluate laboratory practices against ISO 17025 standards
  • To ensure consistent and reliable test and calibration results
  • To foster a culture of quality and continual improvement
  • To gain confidence in leading audit teams effectively

Upon successful completion, delegates will receive an ISO 17025 Lead Auditor certification from Oakwood International, demonstrating their expertise in auditing laboratory management systems and enhancing their professional credentials.

Course Outline

ISO 17025 Lead Auditor

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

Included

Included

  • No course includes are available.

Offered In This Course:

  • vedio Video Content
  • elearning eLearning Materials
  • exam Study Resources
  • certificate Completion Certificate
  • study Tutor Support
  • workbook Interactive Quizzes
Individual Training

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Learning Options

Discover a range of flexible learning options designed to meet your needs. Select the format that best supports your personal growth and goals.

Online Instructor-Led Training

  • Live virtual classes led by experienced trainers, offering real-time interaction and guidance for optimal learning outcomes.

Online Self-Paced Training

  • Flexible learning at your own pace, with access to comprehensive course materials and resources available anytime, anywhere.

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Frequently Asked Questions

Q. What is ISO 17025 Lead Auditor Training?

ISO 17025 Lead Auditor Training provides the knowledge and skills needed to plan, conduct, and report audits for testing and calibration laboratories.

Q. Who should attend this training?

This training is ideal for lead auditors, quality managers, laboratory managers, quality assurance officers, technical specialists, and consultants involved in lab audits.

Q. What will I learn from this training?

Delegates will learn auditing techniques, ISO 17025 requirements, how to evaluate lab systems, and methods to ensure compliance and quality improvement.

Q. How does this training benefit my career?

ISO 17025 Lead Auditor certification enhances your credentials, opens up auditing opportunities, and demonstrates expertise in laboratory quality assurance.

Q. Do I need prior auditing experience?

Prior auditing experience is helpful but not required, as the course covers all essential auditing principles and techniques.

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