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ISO 17025 Course
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ISO 17025 Course

4.7

Master every requirement of ISO 17025 and position your laboratory for successful accreditation. This course covers the full standard — from organisational structure and resource management to measurement uncertainty and audit readiness. Whether you are pursuing initial accreditation or maintaining compliance, you will gain the practical knowledge to get it done right.

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What you will learn:

This course walks you through every clause of ISO 17025, from foundational terminology and organisational requirements to technical processes and management system obligations. You will learn how to establish personnel competence frameworks, manage equipment calibration, and build metrological traceability chains. The course covers method validation, nonconforming work management, and compliant result reporting. You will also develop risk-based thinking skills and learn how to design an internal audit programme. By the end, you will know exactly how to prepare for an accreditation assessment and respond to assessor findings with confidence.

How you study in practice ISO 17025 Course

How you practise ISO 17025 Course

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Course content

8 Chapters • 36 LessonsDuration between 4 and 360 hours (you decide)

Chapter 1See details

Foundations of ISO 17025

  • Lesson 1 • Key Terminology and Definitions

    Introduces precise vocabulary used throughout the standard to prevent misinterpretation. Accurate terminology is foundational for all subsequent compliance activities.

  • Lesson 2 • Introduction to Laboratory Accreditation

    Covers the concept of accreditation, its distinction from certification, and why it matters. Connects learners to the regulatory and commercial drivers behind ISO 17025 adoption.

  • Lesson 3 • History and Evolution of ISO 17025

    Traces the standard's development from earlier guides to its current version. Provides context for understanding why specific clauses exist and how they evolved.

  • Lesson 4 • Structure and Scope of the Standard

    Breaks down the standard's clause architecture and defines its applicability. Learners map each clause to a functional area of laboratory operations.

Chapter 2See details

Organisational and Structural Requirements

  • Lesson 1 • Legal and Organisational Identity

    Defines requirements for legal accountability and organisational documentation. Establishes the baseline structure every laboratory must demonstrate to an accreditation body.

  • Lesson 2 • Impartiality and Conflict of Interest

    Addresses threats to impartiality and mechanisms to identify and mitigate them. Impartiality is a non-negotiable requirement directly assessed during audits.

  • Lesson 3 • Roles, Responsibilities, and Authority

    Maps required roles including laboratory manager, technical manager, and quality manager. Clear authority lines prevent gaps in accountability during audits and operations.

  • Lesson 4 • Confidentiality and Information Security

    Outlines obligations to protect client data and laboratory information. Connects confidentiality requirements to both the standard and broader data protection principles.

Chapter 3See details

Resource Requirements

  • Lesson 1 • Metrological Traceability

    Explains the unbroken chain of calibrations linking measurements to national standards. Traceability is a core technical requirement assessed in every accreditation scope.

  • Lesson 2 • Externally Provided Products and Services

    Covers procurement, evaluation, and monitoring of subcontractors and suppliers. Outsourced activities must meet the same quality standards as in-house work.

  • Lesson 3 • Facilities and Environmental Conditions

    Specifies requirements for physical space, environmental monitoring, and access control. Inadequate facilities directly invalidate test and calibration results.

  • Lesson 4 • Equipment Management

    Establishes requirements for equipment identification, calibration, and maintenance. Proper equipment management is central to demonstrating metrological traceability.

  • Lesson 5 • Personnel Competence and Training

    Defines competence criteria for all staff performing or influencing laboratory activities. Competence records are a primary evidence source during accreditation assessments.

Chapter 4See details

Process Requirements: Pre-Examination

  • Lesson 1 • Review of Requests and Contracts

    Defines how laboratories must review client requests to confirm capability and resource availability. Contract review prevents scope mismatches and client disputes.

  • Lesson 2 • Method Selection and Validation

    Covers selection of standard methods, in-house methods, and validation requirements for each. Method validation data directly supports the technical credibility of results.

  • Lesson 3 • Sampling Procedures

    Addresses requirements for sampling plans, sample collection, and documentation. Sampling errors propagate through the entire measurement process if not controlled.

  • Lesson 4 • Sample Handling and Preservation

    Specifies identification, transport, storage, and disposal requirements for samples. Proper handling maintains sample integrity and protects result validity.

Chapter 5See details

Process Requirements: Examination and Results

  • Lesson 1 • Reporting Results

    Specifies mandatory and optional content for test reports and calibration certificates. Compliant reports protect the laboratory legally and communicate results unambiguously.

  • Lesson 2 • Measurement Uncertainty Estimation

    Introduces the concept, sources, and calculation of measurement uncertainty for test results. Uncertainty reporting is mandatory for calibration and increasingly expected for testing.

  • Lesson 3 • Ensuring Result Validity

    Covers quality control techniques including control charts, proficiency testing, and replicate analysis. Ongoing validity monitoring detects drift before it affects client results.

  • Lesson 4 • Nonconforming Work Management

    Defines how to identify, contain, and resolve work that does not meet requirements. Effective nonconformance handling prevents invalid results from reaching clients.

  • Lesson 5 • Technical Records and Raw Data

    Defines requirements for capturing, storing, and protecting original observations and data. Traceable records are the primary evidence of measurement integrity during audits.

Chapter 6See details

Risk-Based Thinking and Opportunities

  • Lesson 1 • Identifying and Exploiting Opportunities

    Shifts focus from risk avoidance to proactive identification of improvement opportunities. Opportunity management supports scope expansion and service quality enhancement.

  • Lesson 2 • Risk Communication and Reporting

    Covers how risk information is communicated to management and documented for auditors. Transparent risk reporting demonstrates mature quality system governance.

  • Lesson 3 • Applying Risk to Laboratory Processes

    Maps risk assessment to specific laboratory processes including sampling, testing, and reporting. Process-level risk analysis prevents failures before they generate nonconformances.

  • Lesson 4 • Risk Management Fundamentals

    Introduces risk identification, assessment, and treatment within a laboratory context. Risk-based thinking replaces prescriptive preventive action requirements from earlier versions.

Chapter 7See details

Management System Requirements

  • Lesson 1 • Control of Management System Documents

    Specifies how documents are reviewed, updated, and retired to prevent use of obsolete versions. Document control failures are among the most common audit findings.

  • Lesson 2 • Internal Audit Programme

    Defines planning, conducting, and reporting internal audits across all laboratory activities. Internal audits are the primary self-assessment tool before external accreditation reviews.

  • Lesson 3 • Management Review Process

    Covers inputs, outputs, and frequency requirements for formal management review meetings. Management review ensures top-level commitment and drives systemic improvements.

  • Lesson 4 • Corrective Actions and Continual Improvement

    Addresses root cause analysis, corrective action planning, and effectiveness verification. Systematic improvement distinguishes high-performing laboratories from minimally compliant ones.

  • Lesson 5 • Documentation System Design

    Establishes the hierarchy of policies, procedures, and work instructions required. A well-structured document system is the backbone of consistent laboratory performance.

Chapter 8See details

Accreditation Process and Audit Readiness

  • Lesson 1 • Pre-Assessment Preparation

    Covers gap analysis, evidence compilation, and staff preparation before the initial assessment. Thorough pre-assessment work reduces the number of findings during formal review.

  • Lesson 2 • Surveillance and Re-Assessment Cycles

    Explains ongoing surveillance visits, scope extensions, and periodic re-assessment requirements. Maintaining accreditation requires continuous readiness, not just initial compliance.

  • Lesson 3 • Responding to Nonconformances

    Provides a structured approach to analysing, correcting, and closing assessor-raised nonconformances. Timely and credible responses are critical to achieving accreditation decisions.

  • Lesson 4 • Accreditation Application and Scope Definition

    Explains how to define the accreditation scope, select an accreditation body, and submit an application. Scope definition errors cause costly delays and reassessments.

  • Lesson 5 • On-Site Assessment Process

    Describes the sequence of opening meeting, document review, witness testing, and closing meeting. Understanding assessor expectations reduces anxiety and improves performance.

Certification

Your valid completion certificate

This course is for you:

  • Laboratory technician: ready to understand the compliance framework behind daily tasks.

  • Quality manager: responsible for building or maintaining an accredited laboratory system.

  • Laboratory manager transitioning: moving from technical work into a compliance leadership role.

  • Regulatory affairs professional: expanding expertise into laboratory accreditation requirements.

  • Recent science graduate: entering a laboratory career in a regulated industry sector.

  • Consultant or auditor: adding ISO 17025 knowledge to an existing quality portfolio.

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