ISO/IEC 17025:2017 Standard

ISO/IEC 17025:2017 standards

This training course is designed to provide participants with a clear understanding of the contents, objectives, and significance of the regulations issued by the National Office for Accreditation (NOA) and the laboratory accreditation standard ISO/IEC 17025.

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Objectives

The course introduces the structure and content of the ISO/IEC 17025 standard and NOA regulations, enabling participants to:

  • Comprehend the requirements of ISO/IEC 17025 and NOA policies thoroughly
  • Apply the requirements of ISO/IEC 17025
  • Identify the current operational status of laboratories and necessary actions for compliance and continued accreditation

Target audience

This course is suitable for:

  • Laboratory personnel in all positions who need to understand ISO/IEC 17025 and its relation to current lab management regulations to build a compliant quality management system
  • Staff responsible for establishing and maintaining a lab management system according to ISO/IEC 17025
  • Individuals preparing to work in laboratories
  • New laboratory staff
  • Laboratory personnel preparing to implement a quality management system in accordance with ISO/IEC 17025 and apply for accreditation

Course content

The course covers:

  • History and development of the standard, its purpose
  • Management system approach
  • Overview of general requirements
  • Overview of resource requirements
  • Overview of process requirements
  • Overview of management system requirements
  • Laboratory accreditation activities
  • NOA’s relevant policies for laboratory accreditation
  • Q&A session

Related modules

1. Introduction
This training course is designed to provide participants with a clear understanding of the contents, objectives, and significance of the regulations issued by the National Office for Accreditation (NOA) and the laboratory accreditation standard ISO/IEC 17025.

2. Course Objectives
The course introduces the structure and content of the ISO/IEC 17025 standard and NOA regulations, enabling participants to:

  • Comprehend the requirements of ISO/IEC 17025 and NOA policies thoroughly
  • Apply the requirements of ISO/IEC 17025
  • Identify the current operational status of laboratories and necessary actions for compliance and continued accreditation

3. Target Audience
This course is suitable for:

  • Laboratory personnel in all positions who need to understand ISO/IEC 17025 and its relation to current lab management regulations to build a compliant quality management system
  • Staff responsible for establishing and maintaining a lab management system according to ISO/IEC 17025
  • Individuals preparing to work in laboratories
  • New laboratory staff
  • Laboratory personnel preparing to implement a quality management system in accordance with ISO/IEC 17025 and apply for accreditation

4. Course Content
The course covers:

  • History and development of the standard, its purpose
  • Management system approach
  • Overview of general requirements
  • Overview of resource requirements
  • Overview of process requirements
  • Overview of management system requirements
  • Laboratory accreditation activities
  • NOA’s relevant policies for laboratory accreditation
  • Q&A session

1. Introduction
This training course equips laboratories with the skills needed to develop, implement, and improve documentation effectively and in compliance with ISO/IEC 17025.

2. Course Objectives

  • Introduce the basic concepts and requirements for documentation and document control under ISO/IEC 17025
  • Provide methods for developing various types of laboratory documents in a simple, clear, and user-friendly manner
  • Guide the step-by-step process for effective document development

3. Target Audience
This course is suitable for:

  • Laboratory personnel assigned tasks related to drafting or reviewing documents
  • Management staff responsible for establishing and maintaining the laboratory’s documentation system
  • Individuals seeking foundational knowledge on laboratory documentation practices
  • Laboratory personnel preparing to implement a quality management system and apply for accreditation under ISO/IEC 17025

4. Course Content
Participants will gain knowledge and skills related to:

  • The concept of documentation systems
  • ISO/IEC 17025 requirements on documentation, including quality manuals, procedures, methods, and instructions
  • Basic structure of different document types
  • Development and control of documentation
  • Practical exercises
  • Q&A session

1. Introduction
This training provides knowledge and skills for laboratories to organize and conduct internal audits in compliance with ISO/IEC 17025 and NOA requirements.
The training is based on ISO 19011: Guidelines for auditing management systems and is applicable for both newly accredited laboratories and those seeking continual improvement.

2. Course Objectives

  • Understand the purpose and approach to internal audits per ISO/IEC 17025
  • Understand audit requirements and types of audits
  • Learn how to develop audit programs and plans
  • Understand requirements for internal auditors
  • Identify roles and responsibilities of internal auditors
  • Understand the internal audit process and required skills, including reporting

3. Target Audience
This course is suitable for:

  • Laboratory personnel assigned internal audit responsibilities
  • Managers responsible for the lab’s quality management system
  • Individuals intending to become internal auditors
  • Individuals seeking skills in internal laboratory auditing

4. Course Content

  • Overview and requirements of ISO/IEC 17025 on internal audits
  • Role of internal auditors
  • Internal audit process
  • Audit skills: checklist preparation, interviewing, evidence gathering, report writing
  • Case studies
  • Q&A session

1. Introduction
This course equips laboratory staff with the knowledge and methodology to select, verify, and validate test methods in accordance with ISO/IEC 17025 and NOA regulations.
It incorporates international guidance documents and best practices for various test methods and techniques.

2. Course Objectives
Participants will be able to:

  • Understand ISO/IEC 17025 requirements for method selection, verification, and validation
  • Understand concepts and classifications of test methods
  • Implement method selection, verification, and validation processes, including detailed planning, condition evaluation, experimental testing, statistical analysis, and precision criteria publication
  • Practice method validation

3. Target Audience
This course is suitable for:

  • Technical managers and method development staff
  • Laboratory staff aiming for technical leadership roles
  • Individuals seeking skills in method validation and verification

4. Course Content

  • Key concepts in method validation
  • ISO/IEC 17025 requirements on method validation
  • Test method types, advantages, and disadvantages
  • Concept of accuracy and related terms
  • Six-step method validation process: planning, condition assessment, experimental testing, statistical analysis, publication, and application
  • Case studies
  • Q&A session

1. Introduction
This training provides laboratory staff with the knowledge and methodology to evaluate measurement uncertainty for tests and calibrations in accordance with ISO/IEC 17025 and NOA regulations.
It incorporates international guidelines and best practices to ensure accurate and effective implementation.

2. Course Objectives
Upon completion, participants will:

  • Understand basic concepts of measurement uncertainty
  • Be familiar with relevant documents and guidelines
  • Learn fundamental rules and practices for evaluating measurement uncertainty
  • Learn step-by-step processes for evaluating and reporting measurement uncertainty

3. Target Audience
This course is suitable for:

  • Technical managers and method implementation personnel
  • Laboratory staff aiming for technical management roles
  • Individuals seeking skills in evaluating measurement uncertainty

4. Course Content

  • ISO/IEC 17025 and NOA requirements on measurement uncertainty
  • Concept of measurement uncertainty and related terminology
  • Various approaches to evaluating measurement uncertainty
  • Bottom-up approach
  • Top-down approach
  • Practical exercises
  • Q&A session

  1. Introduction
    This training course on quality assurance of testing/calibration results provides information and knowledge to ensure the validity of results and how to implement quality assurance systems in laboratories. It covers data handling, statistical tools, trend monitoring, and control charts to support result quality assurance.

The course also introduces participants to the policies of the National Office for Quality Accreditation (NOQA) regarding Proficiency Testing (PT) and Interlaboratory Comparisons (ILC), and how to implement these programs. Upon completion, participants will be capable of organizing an ILC program for their own laboratories.

  1. Objectives
    By the end of the course, participants will be able to:
  • Understand concepts related to ensuring the validity of test/calibration results;
  • Comprehend the requirements of ISO/IEC 17025 and NOQA regarding PT and ILC participation;
  • Organize and implement internal quality assurance programs;
  • Select appropriate PT providers and suitable PT programs;
  • Organize and evaluate ILC programs;
  • Analyze data from quality assurance programs;
  • Apply statistical tools to monitor and assess the validity of results.
  1. Target Audience
    This course is suitable for:
  • Laboratory management personnel responsible for technical operations and quality assurance;
  • Laboratory staff being trained for technical management roles;
  • Individuals seeking knowledge and skills in result quality assurance.
  1. Course Content
    Key topics include:
  • Concepts of quality assurance in test results;
  • Implementation of internal quality assurance systems;
  • NOQA policies on PT and ILC;
  • Selection and participation in PT programs;
  • Organization of ILCs;
  • Statistical tools for trend monitoring and data analysis.

  1. Introduction
    This course offers a comprehensive overview of ISO/IEC 17025 requirements, NOQA regulations, and best practices for operating an effective laboratory management system. It provides in-depth analysis of the management system's components, with emphasis on risk management and continual improvement.
  2. Objectives
    Upon completion, participants will be able to:
  • Understand and apply ISO/IEC 17025 in laboratory operations;
  • Recognize laboratory management concepts and tools;
  • Clarify roles and responsibilities within laboratory management;
  • Efficiently operate a management system that satisfies clients, regulatory bodies, and accreditation authorities;
  • Develop management skills and improve system performance;
  • Apply risk management and continuous improvement strategies.
  1. Target Audience
    This course is suitable for:
  • Laboratory managers;
  • Laboratory staff preparing for management roles;
  • Individuals interested in laboratory management.
  1. Course Content
    Topics include:
  • Requirements of ISO/IEC 17025 and NOQA;
  • Responsibilities of laboratory managers;
  • Tools and methods for laboratory management;
  • Practical exercises;
  • Q&A sessions.

  1. Introduction
    This course equips laboratory personnel with the knowledge and skills to conduct internal audits in accordance with ISO/IEC 17025 and NOQA requirements. It is based on ISO 19011 – Guidelines for auditing management systems.

Participants will learn to develop audit procedures, plan and execute internal audits, write audit reports, and identify opportunities for improvement. The course includes case studies and practical exercises simulating real-life audit scenarios.

  1. Objectives
    Participants will be able to:
  • Understand the purpose and methodology of internal audits;
  • Identify requirements of ISO/IEC 17025:2017 and ISO 19011;
  • Recognize types of audits and auditor qualification criteria;
  • Understand roles and responsibilities of auditors;
  • Prepare for and conduct internal audits;
  • Develop checklists and gather objective evidence;
  • Identify nonconformities and write audit reports.
  1. Target Audience
    This course is suitable for:
  • Managers responsible for laboratory quality systems;
  • Laboratory staff assigned to conduct internal audits;
  • Future internal auditors;
  • Individuals interested in internal auditing of laboratories.
  1. Course Content
    Key topics include:
  • Internal audit requirements of ISO/IEC 17025;
  • Auditor roles and audit process;
  • Audit skills including checklist preparation, interviewing, evidence gathering, and report writing;
  • Case studies and group work;
  • Q&A and final assessment.

  1. Introduction
    This course provides laboratory personnel with foundational knowledge of risk management principles and how to implement risk management systems. It includes procedure development, risk identification and classification, control measures, and effectiveness evaluation.

The training aligns ISO/IEC 17025 requirements with ISO 31000 principles to ensure laboratories can manage risks across all activities, including risks to impartiality.

  1. Objectives
    Participants will:
  • Understand core principles of risk management;
  • Apply risk management in laboratory operations;
  • Establish procedures for risk identification, assessment, mitigation, and monitoring;
  • Identify risks across all aspects of laboratory operations;
  • Develop skills to manage risk within the management system.
  1. Target Audience
    This course is suitable for:
  • Laboratory managers and quality/technical managers;
  • Laboratory staff involved in risk management;
  • Individuals preparing for management roles;
  • Individuals interested in laboratory risk management.
  1. Course Content
    Key topics include:
  • Concepts and principles of risk management;
  • ISO/IEC 17025 and NOQA requirements;
  • ISO 31000 framework and risk management process;
  • Development of risk management procedures;
  • Risk identification, classification, and control measures;
  • Case studies and group exercises;
  • Q&A sessions.

  1. Introduction
    This course provides laboratory personnel with an understanding of decision rules and how to report test/calibration results in compliance with technical specifications. It covers international standards and guidelines to help laboratories develop decision rules and report results accordingly.
  2. Objectives
    Participants will:
  • Understand the use of measurement uncertainty in decision-making;
  • Develop internal procedures for applying decision rules;
  • Apply decision rules to evaluate and report results in line with agreed technical specifications.
  1. Target Audience
    This course is suitable for:
  • Laboratory managers and quality/technical managers;
  • Staff responsible for result evaluation and reporting;
  • Individuals interested in result interpretation and decision rules.
  1. Course Content
    Key topics include:
  • Decision rule concepts, acceptance limits, and related terminology;
  • ISO/IEC 17025 and NOQA requirements;
  • Decision rules for one-sided limits with/without guard bands;
  • Decision rules for interval limits with/without guard bands;
  • Practical exercises;
  • Q&A sessions.

  1. Introduction
    This course provides comprehensive knowledge and skills for participants to fulfill the responsibilities of a Lead Assessor for laboratory assessments. It covers requirements for conducting assessments, assessor qualifications, and how to organize and carry out laboratory assessments in accordance with ISO/IEC 17025 and the National Office for Quality Accreditation (NOQA).

The course is based on ISO 19011 – Guidelines for auditing management systems, and includes process design, planning, execution, reporting of findings, and evaluation of laboratory management system effectiveness to support continuous improvement.

The course includes practical exercises, case studies, group work, and on-site simulation assessments to develop real-world skills and hands-on experience.

  1. Objectives
    Participants will:
  • Understand the purpose and approach to laboratory assessment under ISO/IEC 17025:2017 and ISO 19011;
  • Identify types of assessments and corresponding requirements;
  • Recognize criteria and competencies for assessors;
  • Understand the roles and responsibilities of lead assessors;
  • Master both theoretical and practical skills to conduct assessments;
  • Develop and implement assessment plans, schedules, documentation, and procedures;
  • Prepare and use checklists;
  • Gather objective evidence effectively;
  • Collaborate with assessment teams;
  • Identify nonconformities and write comprehensive reports.
  1. Target Audience
    This course is suitable for:
  • Laboratory managers and personnel responsible for establishing and maintaining laboratory management systems;
  • Staff assigned to assess laboratory operations;
  • Future laboratory assessors;
  • Individuals seeking skills in conducting laboratory assessments.
  1. Course Content
  • Overview of ISO/IEC 17025 and ISO 19011 requirements for laboratory assessment;
  • Roles and skills of assessors;
  • Assessment procedures;
  • Practical skills including checklist preparation, interviewing, evidence collection, and reporting;
  • Group exercises, simulations, and case studies;
  • Q&A session;
  • Final assessment.

Target Audience

This Course is Suitable for Anyone Who:

  • Needs to understand the requirements of ISO/IEC 17025
  • Is responsible for establishing their organization's management system
  • Is in charge of ensuring the laboratory’s compliance with ISO/IEC 17025
  • Works in a testing or calibration laboratory
  • Holds a management or quality control role

This course is also beneficial for testing and calibration laboratories considering or currently in the process of achieving accreditation under the ISO/IEC 17025 program by the BoA (Board of Accreditation).

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