Implementing ISO/IEC 17025:2017 Second Edition - The Ultimate Guide

Are you looking to enhance your laboratory's credibility and demonstrate its competence to clients and regulatory bodies? Implementing ISO/IEC 17025:2017 Second Edition may be the key to achieving that. This comprehensive guide will walk you through the necessary steps to meet the requirements of the latest edition and ensure your laboratory operates at the highest standards.

Understanding ISO/IEC 17025

ISO/IEC 17025 is an internationally recognized standard that specifies the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It provides a framework for laboratories to demonstrate their technical competence and ability to produce accurate and reliable results.

The second edition of ISO/IEC 17025, released in 2017, introduced significant updates and improvements to the previous edition. It aligns better with other international standards and focuses on risk-based thinking, process approach, and effective laboratory management. Adhering to this latest edition will give your laboratory a competitive edge and improve its overall performance.

Implementing ISO/IEC 17025:2017, Second Edition

by Manfred Böckl (Kindle Edition)

5 out of 5

Language	:	English
File size	:	15227 KB
Text-to-Speech	:	Enabled
Screen Reader	:	Supported
Enhanced typesetting	:	Enabled
Word Wise	:	Enabled
Print length	:	202 pages

FREE

Key Changes in ISO/IEC 17025:2017 Second Edition

The second edition of ISO/IEC 17025 brings several new elements and clarifications to enhance the standard's usability and relevance. Some of the key changes include:

1. Greater emphasis on impartiality: The new edition places more emphasis on the importance of impartiality in laboratory activities and decision-making processes. It requires laboratories to maintain transparency and identify potential conflicts of interest.
2. Risk-based approach: ISO/IEC 17025:2017 advocates for a risk-based approach to laboratory operations. It encourages laboratories to identify and mitigate potential risks throughout their processes to ensure the validity and reliability of test results.
3. Management system requirements: The second edition aligns with ISO 9001:2015, the standard for quality management systems. It emphasizes the need for strong leadership, process integration, and continuous improvement within the laboratory.
4. Additional focus on information technology: The updated version recognizes the growing role of information technology in laboratory operations. It addresses the validation and control of computerized systems used for data analysis and reporting.
5. Updated terminology and definitions: The second edition provides clearer definitions and updated terminology, ensuring better alignment with other international standards and enhancing global understanding.

Steps to Implement ISO/IEC 17025:2017 Second Edition

Implementing ISO/IEC 17025:2017 may seem like a daunting task, but with proper planning and execution, it can be a smooth process. Here are the key steps to successfully implement the second edition:

1. Gap Analysis

Start by conducting a thorough gap analysis of your current laboratory practices against the requirements outlined in ISO/IEC 17025:2017. Identify areas where you need to improve and develop an action plan to bridge the gaps.

2. Review and Update Policies and Procedures

Review and update your existing policies and procedures to align with the new edition. Pay particular attention to areas such as impartiality, risk management, and information technology. Ensure that your laboratory's policies clearly reflect the requirements of ISO/IEC 17025:2017.

3. Training and Competence Development

Provide appropriate training to your laboratory personnel to ensure they understand the changes introduced in the second edition. Foster a culture of continuous learning and competence development to meet the evolving needs of the standard and maintain high-quality operations.

4. Risk Assessment and Management

Implement a robust risk assessment and management process in your laboratory. Identify potential risks at each stage of the testing and calibration processes and establish mitigation strategies. Regularly review and update your risk management plan to adapt to changing circumstances.

5. Internal Audits

Conduct regular internal audits to assess your laboratory's compliance with ISO/IEC 17025:2017. Identify non-conformities, document findings, and develop corrective actions. Ensure that your internal audit program is thorough and objective.

6. Management Review

Engage your laboratory's management team in periodic reviews of the implemented changes. Assess the effectiveness of the new systems, identify areas for improvement, and drive continuous improvement initiatives.

7. External Assessment and Accreditation

Invite an external assessment body to evaluate your laboratory's conformity with ISO/IEC 17025:2017. Demonstrate your competence and commitment to meeting international standards. Once accredited, regularly undergo reassessments to maintain your accreditation status.

Benefits of Implementing ISO/IEC 17025:2017 Second Edition

Implementing ISO/IEC 17025:2017 Second Edition offers numerous benefits for your laboratory:

• Enhanced credibility and reputation
• Improved confidence from clients and regulatory bodies
• Increased customer satisfaction
• Operational efficiency and effectiveness
• Better traceability and comparability of results
• Reduced risks and errors
• Consistency in laboratory operations
• Improved decision-making based on reliable data
• Opportunities for international collaboration and recognition

Implementing ISO/IEC 17025:2017 Second Edition is a strategic move that will elevate your laboratory's performance and reputation. By meeting the requirements of this widely recognized standard, you will demonstrate your laboratory's competence and commitment to quality. Follow the steps outlined in this ultimate guide, and you will be well on your way to achieving ISO/IEC 17025:2017 accreditation.

Implementing ISO/IEC 17025:2017, Second Edition

by Manfred Böckl (Kindle Edition)

5 out of 5

Language	:	English
File size	:	15227 KB
Text-to-Speech	:	Enabled
Screen Reader	:	Supported
Enhanced typesetting	:	Enabled
Word Wise	:	Enabled
Print length	:	202 pages

FREE

The focus of this book is to demystify the requirements delineated within ISO/IEC 17025:2017, while providing a road map for organizations wishing to receive accreditation for their laboratories.

AS9100, ISO 9001:2015, and ISO 13485:2016 are standards that have been created to support the development and implementation of effective approaches to quality management, and are recognized blueprints for the establishment of a quality management system (QMS) for many diverse industries. Similar to these recognized QMS standards, ISO/IEC 17025:2017 for laboratory accreditation serves a unique purpose. It is not unusual for laboratories to retain dual certification in ISO 9001:2015 and ISO/IEC 17025:2017. However, ISO/IEC 17025:2017 contains requirements specific to the laboratory environment that are not addressed by ISO 9001:2015.

This book highlights those differences between ISO 9001:2015 and ISO/IEC 17025:2017, while providing practical insight and tools needed for laboratories wishing to achieve or sustain accreditation to ISO/IEC 17025:2017. For those currently or formerly accredited to the 2005 version of ISO/IEC 17025, an appendix outlines the changes between the 2005 and 2017 versions of the standard.