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ISO/Iec 17025:2017

Course Description

ISO 17025, the international standard for the competence of testing and calibration laboratories, is of paramount importance for various reasons, especially for professionals involved in laboratory operations, quality management, and scientific research.

ISO 17025 provides guidelines to ensure that laboratories operate competently and are able to generate valid results. Learning this standard helps professionals understand how to maintain high technical standards in testing and calibration, which is crucial for ensuring the reliability and accuracy of laboratory results.

Compliance with ISO 17025 is often a prerequisite for laboratories to be recognized at an international level. This recognition is vital for laboratories that want to expand their services globally or need to have their results accepted in different countries.

Course Objectives

This course is a comprehensive program designed to provide participants with a comprehensive understanding and practical skills related to the standard ISO 17025 and give the participants the knowledge on how to design and develop laboratory documents and quality manuals. This course aim to equip participants with the knowledge and skills necessary to implement and manage an effective quality management system in laboratories, ensuring technical competence and compliance with ISO 17025 standards. The course will also cover topics needed to establish an internal quality audit program as required by ISO 17025, and to initiate the sequence of activities involved in scheduling, planning, conducting, reporting on and closing out internal quality audits.

At the end of the course the participants will:

Gain a thorough understanding of the requirements and guidelines of ISO 17025.

Gain skills to establish, implement, and maintain a quality management system in accordance with ISO 17025.

Understand the process of integrating ISO 17025 with existing quality management systems.

Acquire knowledge on ensuring technical competence in laboratory operations.

Learn about the various aspects of laboratory procedures, including sampling, testing, calibration, and data interpretation.

Learn how to effectively manage records and reports to maintain compliance and ensure traceability.

Gain skills to conduct internal audits to evaluate the effectiveness of the quality management system.

Learn about continuous improvement processes and how to apply them in a laboratory setting.

Understand the accreditation process for laboratories and the role of accreditation bodies.

Develop an understanding of risk assessment methodologies in laboratory environments.

Understand how to identify and manage non-conformities in laboratory processes.

Learn the steps for implementing effective corrective actions.

Enhance professional knowledge and skills in laboratory quality management.

Audience

This course is designed for professionals working in testing and calibration laboratories who need to understand the requirements and implementation of ISO/IEC 17025:2017 and their role in maintaining an effective laboratory quality management system:

Laboratory chemists, analysts, and technicians

Laboratory supervisors and laboratory managers

Quality assurance (QA) and quality control (QC) personnel

Laboratory quality managers and coordinators

Technical staff responsible for laboratory operations

Personnel involved in the implementation or maintenance of laboratory quality systems

Internal auditors in testing or calibration laboratories

Staff involved in laboratory accreditation processes

Prerequisites

No formal prerequisites are required. Relevant education or industry experience is beneficial.

Course Content

Introduction

History of ISO Organization

Hierarchy of accreditation of ISO

(IAF) and (ILAC)

The relation between ILAC and ISO organization

National Accreditation Bodies (NABs)

Conformity Assessment Bodies (CABs)

ISO 17000 family

Accreditation of ISO/IEC 17025: 2017

ISO/IEC 17025: 2017 outlines

History of ISO/IEC 17025: 2017 Method

Development of ISO 17025

Updating of ISO 17025

Steps for ISO 17025 Accreditation

Advantages of ISO 17025 Accreditation

ISO/IEC 17025: 2017 Method

Scope

Normative references

Terms and definitions

General requirements

Impartiality

Steps to insure impartiality

Confidentiality

Ways of ensuring confidentiality

Structural requirements

Resource requirements

Metrological traceability

Calibration

How to Obtain Measurement Traceability

Personnel requirements

Facilities and environmental conditions

Equipment requirements

Externally Provided Products and Services requirements

Statistical formulas used in ISO 17025: 2017

Descriptive Statistics

Measures of central tendency

Measures of Variation

Using excel sheet to calculate central tendency and Variation

The coefficient of variation (CV)

The coverage factor or 'k' value

Measurement Uncertainty

Expressing uncertainty of measurement

Error versus uncertainty

The importance of measuring uncertainty

Sources of uncertainties

Evaluation uncertainty of measurement

Type A evaluation

Type B evaluation

Standard uncertainty

Converting uncertainties from one unit of measurement to another

Combined uncertainty

Expanded uncertainty

Approaches to measurement uncertainty evaluation

The bottom-up or modeling approach

The top-down or experimental approach

Practice on determination of uncertainty by different approaches

compliance with specification

ISO 17025: 2017 Process requirements

Review of requests, tenders and contracts

Selection, verification and validation of methods

Method validation parameters

Sampling

Handling of test or calibration items

Technical records

Evaluation of measurement uncertainty

Ensuring the validity of results

Reporting of results

Complaints

Nonconforming work

Control of data and information management

ISO 17025: 2017 Management system requirements

Options (A , B)

Management system documentation (Option A)

Control of management system documents (Option A)

Control of records (Option A)

Actions to address risks and opportunities (Option A)

Improvement (Option A)

Corrective actions (Option A)

Internal audits (Option A)

Management reviews (Option A)

Guidelines for auditing management systems iso 19011 - 2018

Terms and definitions of auditing

Types of audits

Audit Principles

Behavior and characteristics of auditors

Sequence of quality audit

Steps of On-site audit

Preparing audit report

Practice and case studies on auditing on ISO 17025: 2017

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