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PROFESSIONAL COURSE · Courses, Quality Management

ISO 17025 Lead Assessor

Register for the ISO 17025 Lead Assessor Course to gain essential auditing skills and knowledge for laboratory management.

  • Practical, standards-based professional learning
  • Assessment and verifiable Cognicert certification
  • Flexible online, self-study and organisational delivery

Entry, exam and access at a glance

Prerequisites

Three years of professional experience, including two years at management level.

Exam and resits

100 questions in one hour. Pass mark: 70%. Your payment includes two exam attempts. A third or later attempt costs £100 per resit.

Cognicert reports an 87% pass rate.

Self-study access

Lifetime access for the enrolled learner. Access is personal and cannot be shared.

Overview
Register here Cognicert ISO 17025 Lead Assessor Course
Objectives
The “ISO 17025:2017 Lead Assessor” course provides comprehensive training in
  • Learn how to audit each and every ISO 17025: 2017 and ISO 17011 requirements
  • Learn basic auditing skills;
  • Implement methods to comply with the ISO 17025:2017 requirements.
  • Auditing process and techniques
  • Assessor’s skills and techniques
  • To examine the requirements of ISO 17025 from an Internal Assessor Perspective
  • Auditing reports process, corrective action and follow-up
  • Learn how to plan and conduct an internal ISO 17025 audit, and how to report audit results;
  • Learn how to effectively use root cause analysis as part of the ISO 17025 Laboratory procedure on corrective action
 
Benefits
of ISO 17025:2018 Types Of Audits Why Management System Audits are needed Lesson 2: Introduction to the Requirements of the ISO 17025:2018 Standard Interpretations of Key Terms Elements of a Laboratory System The ISO 17025:2018 Standard Eight Principles of Laboratory Management Continual Improvement Cycle Laboratory Management Process Model Laboratory System Requirements The Documentation Requirements of ISO 17025:2017 Management Responsibility Resource Management Product Realization Measurement, Analysis and Improvement Lesson 3: The Process Management Approach Process Management Approach The Planning Phase Establish Process Measurements Analyze the Process Design or Redesign the Process Process Mapping Lesson 4: Introduction to Document Control Elements of Documents Process Approach to Documentation Identifying Documents and their Owners Types of Documents Master Document List Document Control Revisions and Maintenance Tips for Document Writers Lesson 5: Introduction to Management Review Making Management Review relevant to Management What will be reviewed? Establishing the Objectives Planning the Management Review Output of Management Review Lesson 6: How to Deal with External Assessors – A Basic Guide for Internal Assessors What is an External Laboratory Audit? What should an Employee expect during an Audit? How should Employees interact with Assessors? Lesson 7: ISO 19011:2018 and ISO 17011:2017 Fundamentals of Internal Auditing Decide how to Audit Principles of Auditing Managing an Audit Programme Preparation & Planning Of Audits Preparation Of checklist Lesson 8: ISO 19011:2018 and ISO 17011:2017 Audit Activities Identification of Non-Conformities [N/C’s]. Documenting the Audit (Audit Report) Conducting Audit Follow-Up Practical Auditing Exercise Competence and Evaluation of Assessors. Lesson 9: Creating a Corrective Action Plan Who participates? What is Root Cause Analysis? When (and when not) to use Root Cause Analysis The Root Cause Analysis Process How to construct a Root Cause Analysis Checklist Examples of how a well-run Root Cause Analysis Process works Corrective and Preventive Actions
Audience
• Persons responsible for conducting internal and external audits according to ISO 17025:2017 requirements • Persons involved in the Laboratory management systems ISO 17025:2017
Content
 Lesson 1: Background and Development of ISO 17025:2017 Definition of ISO 17025:2017 History of Laboratory Major Changes in ISO 17025:2017 The Laboratory Management Principles
Delivery
  • Case Study
  • Individual Exercises
  • Role Play
  • Group Exercises
  • Group Presentation
  • Examination
  • Assessment and Qualification Learning is assessed through:
    • 4 hours open examination. Passing the exams qualifies the candidate for Cognicert ISO 17025 Lead Assesor (CPD Certificate)
    • Practical experience of 25 days with activity log qualifies participants for our Cognicert ISO 17025 Lead Assessor (Auditor Category) I.D Card and Certificate
    • Practical experience of 50 days with activity log qualifies participants for our Cognicert ISO 17025 Lead Assessor (Lead Auditor Category) I.D Card and Certificate
  • Self-Study Material, Exam and Certification  Online Training, Material, Exam and Certification  Classroom Training Location Here (Fee to be decided by delivery partners)
    Duration

    5 days

  • ONE STANDARD · FIVE LEARNING LEVELS

    Choose your ISO 17025 course

    Compare the focus and training duration of each level. Choose the level that fits your responsibilities; you do not need to book every level in sequence.

    View the complete ISO 17025 training pathway
    5 days

    ISO 17025 Lead Auditor

    Auditors and professionals preparing to lead an audit team or manage a complete audit programme.

    Existing course prices apply. View course details or contact Cognicert for fees.

    Contact Cognicert for this level’s syllabus and availability.

    Enquire about Lead Auditor
    5 days

    ISO 17025 Lead Implementer

    Managers, consultants and professionals responsible for establishing, maintaining or improving a system.

    Existing course prices apply. View course details or contact Cognicert for fees.

    Durations refer to the training programme. Check the individual course page or ask an adviser for assessment arrangements, study options and availability.

    BOOK WITH CLARITY

    Refunds, cancellations and transfers

    Refund and transfer choices depend on the course format, how much notice you give and whether digital content has been accessed. Contact learner care early and we will help you identify the best available option.

    Read the complete refund, cancellation and transfer policy →
    UPCOMING COURSE CALENDAR

    Training, exam and application dates

    Prices are per learner before any applicable UK VAT. A live-online intake costs more after its standard deadline because the published late fee is added. Self-study is priced separately and has no late-intake fee.

    TRAINING DATESEXAMDEADLINE & STATUSLIVE ONLINESELF-STUDY
    5–9 October 20269 October 2026Published intake — confirm availability
    Published late date passed. Contact Cognicert to confirm places before booking.
    Places are confirmed at booking, not guaranteed by this calendar.
    £1,250 £1,200 course fee + £50 late fee
    Choose this intake
    £500
    On-demand study; next exam shown at checkout.
    30 November–4 December 20264 December 2026Standard booking period
    Standard deadline: 2 November 2026. No late fee yet.
    Places are confirmed at booking, not guaranteed by this calendar.
    £1,200
    Choose this intake
    £500
    On-demand study; next exam shown at checkout.
    VERIFIABLE ACHIEVEMENT

    Check your Cognicert certificate

    Successful candidates receive a uniquely numbered Cognicert certificate that another person can check through our public certificate-verification service. This confirms the authenticity of a Cognicert-issued award; acceptance by an employer, regulator or external professional scheme depends on their requirements.

    View certificate verification →
    YOUR COURSE ADVISER

    Need help before enrolling?

    Lisa Williams
    Course and Business Development Adviser
    Monday–Friday, 09:00–17:00 UK time

    +44 20 3432 2505
    info@cognicert.com
    Self-study from £500Choose option & enrol

    Related Cognicert resources

    Cognicert Pharmaceutical GMP ProfessionalRead more →ISO 56001 Lead ImplementerRead more →ISO 9001 Lead AuditorRead more →
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