ISO 17025 Lead Auditor Overview

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 organisation
  • Analysing existing systems

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

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Who should attend this ISO 17025 Lead Auditor Course?

The ISO 17025 Lead Auditor Course is a course designed to provide professionals with the knowledge to lead and conduct audits of testing and calibration laboratories in accordance with the ISO 17025 standards. This course can be beneficial to a wide range of professionals, including:

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

Prerequisites of the ISO 17025 Lead Auditor Training Course

There are no formal prerequisites for this ISO 17025 Lead Auditor Course.

ISO 17025 Lead Auditor Training Course Overview

ISO 17025 Lead Auditor Training holds significant relevance in the context of international standards for testing and calibration laboratories. The ISO 17025 standard ensures that these laboratories maintain a high level of quality, competence, and consistency in their operations. With the increasing demand for reliable and accurate results across diverse industries such as healthcare, environmental monitoring, and manufacturing, adherence to ISO 17025 has become paramount. 

For professionals aiming to master ISO 17025, the importance lies in their ability to enhance and ensure the quality of laboratory processes. Individuals in roles such as Quality Managers, Laboratory Supervisors, and Auditors play a crucial role in upholding standards and compliance. This ISO 17025 Training enables them to conduct effective audits that identify areas of improvement, nonconformities, and potential risks.

The 5-day ISO 17025 Training by The Knowledge Academy equips delegates with essential skills to lead ISO 17025 audits effectively. Covering key concepts and audit techniques, it provides a comprehensive understanding of the standard, enabling professionals to contribute significantly to laboratory quality assurance. This course will be conducted by our highly experienced trainers.

Course Objectives:

  • To comprehend the fundamentals of ISO 17025 and its application in laboratory settings
  • To gain insights into auditing principles, techniques, and practices
  • To understand the role and responsibilities of a Lead Auditor
  • To learn how to plan, conduct, and report on ISO 17025 audits
  • To identify nonconformities and recommend corrective actions
  • To enhance communication and interpersonal skills for effective auditing

Upon completion of this course, delegates will possess the expertise to lead ISO 17025 audits, ensuring adherence to international standards and enhancing the overall quality and reliability of laboratory testing and calibration processes. This proficiency will open doors to career advancement and contribute to organisational excellence

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What’s included in this ISO 17025 Lead Auditor Course?

  • ISO 17025 Lead Auditor Examination
  • World-Class Training Sessions from Experienced Instructors 
  • ISO 17025 Lead Auditor Certificate
  • Digital Delegate Pack

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ISO 17025 Lead Auditor Exam Information

To achieve the ISO 17025 Lead Auditor, candidates will need to sit for an examination. The exam format is as follows: 

  • Question Type: Multiple Choice  
  • Total Questions: 30 
  • Total Marks: 30 Marks 
  • Pass Mark: 50%, or 15/30 Marks 
  • Duration: 40 Minutes  
  • Open Book/ Closed Book: Closed Book

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Why choose us

Ways to take this course

Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 17025 Lead Auditor. Engage directly with expert instructors, mirroring the classroom schedule for a comprehensive learning journey. Enjoy the convenience of virtual learning without compromising on the quality of interaction.

Unlock your potential with The Knowledge Academy's ISO 17025 Lead Auditor, accessible anytime, anywhere on any device. Enjoy 90 days of online course access, extendable upon request, and benefit from the support of our expert trainers. Elevate your skills at your own pace with our Online Self-paced sessions.

What our customers are saying

ISO 17025 Lead Auditor FAQs

Please arrive at the venue at 8:45am.
As a prerequisite of this training course delegates must have completed the ISO 17025 Internal Auditor certification. Candidates must have a basic knowledge of auditing to ensure that they fully understand the content of the course and gain sufficient skills.
This ISO 17025 Lead Auditor course is suited for individuals in the following roles: ISO 17025 Implementation Teams, Internal Auditors, Project Managers, Quality Executives, ISO 9001 Auditors
We are able to provide support via phone & email prior to attending, during and after the course.
Delegate pack consisting of course notes and exercises, Manual, Experienced Instructor, and Refreshments
This course is 5 days.
Once your booking has been placed and confirmed, you will receive an email which contains your course location, course overview, pre-course reading material (if required), course agenda and payment receipts
The training fees for ISO 17025 Lead Auditor certification in Canada starts from CAD4295
The Knowledge Academy is the Leading global training provider for ISO 17025 Lead Auditor.
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Resources are included for a comprehensive learning experience.

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"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"

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