WHAT IS ISO/IEC 17025:2017?

ISO/IEC 17025:1999, General Requirements for the Competence of Testing and Calibration Laboratories, released in 1999, is the international standard for establishing calibration and testing laboratory quality management systems and recognizing laboratory technical competence through accreditation. ISO/IEC 17025:2017 was released in November 2017 to provide better alignment to the requirements of ISO 9001:2015.

This standard was drafted by International Organization for Standardization (ISO) Committee on Conformity Assessment (CASCO) Working Group (WG) 10, and replaced ISO/IEC Guide 25, General Requirements for the Competence of Calibration and Testing Laboratories, and EN 45001, General Criteria for the Operation of Testing Laboratories.
The release of ISO/IEC 17025:2017 is the latest stage in the process of developing laboratory quality and competence standards, which has been going on for more than 20 years. Let’s take a brief look at the history of this process.
The ISO/IEC 17025:2017 serves as a Quality Management System (QMS) for laboratories to improve their process of facilitating more accurate diagnostics, efficient treatment, and reduced errors in the laboratory process. This coincides with the ultimate goal in laboratory medicine which is to improve an organization’s overall QMS toward ensuring patient safety.

What is the Importance of ISO 17025?

Across industries, it’s highly encouraged to create a QMS that best fits the needs of an organization. This is to help improve the quality and efficiency of laboratory safety practices, processes, and systems.
The standard’s current version which is the ISO 17025:2017 is key to establishing guidelines and protocols that are aligned with Good Laboratory Practices (GLP). Ultimately, maintaining compliance with ISO 17025 standards can lead to creating replicable testing and calibration processes, thus eliminating the need for retesting.

What are the Requirements for ISO 17025?

It’s important for organizations to be aware of the various ISO 17025 requirements so that they can establish the necessary compliance protocols across the board. For starters, there have been notable changes introduced in the 2017 version from its previous 2005 version. Some of these include the following:

• The Management Requirements and Technical Requirements clauses previously included in the 2005 version were replaced with the clauses for General Requirements and Structural Requirements.
• Clauses 6 to 8 detailing the Resource, Process, and Management System Requirements were added.

With these, it’s worth mentioning that the 2017 version now specifies the general requirements needed to guide laboratories in their operations, especially when it comes to ensuring their competence and impartiality.

Prove the quality of your lab with ISO/IEC 17025

Do you work in a lab? Then you know better than anyone that your reputation hangs on the quality of your tests and calibrations. How can you prove that quality? By working with ISO/IEC 17025. This international management standard offers the best guarantee of correct and valid results.

What ISO/IEC 17025 Can Offer

ISO/IEC 17025 offers a host of benefits for labs, as well as for universities, research centres, governments, regulators and inspection bodies. We list them for you below:


• Qualitative Results:-At the end of the day, it’s all about quality. This standard puts the focus on your technical competence. So you always deliver correct and valid results.
• Lower costs:-By providing accurate results right away, you don’t incur unnecessary costs correcting errors.
• Digitisation:-Go digital with ISO/IEC 17025. This standard describes requirements for computer systems, digital files and online reports.
• Stronger Reputation:-Thanks to ISO/IEC 17025, you show the outside world that your results are reliable and meet all quality requirements
• Smoother Collaborations:-Do you sometimes work with other labs or organisations? This standard provides guidance for all parties involved and ensures wider acceptance of test reports and certificates between countries.
• Transparency:-Pure clarity, from quotation to reporting. Every step of your lab process is detailed
• In line with other standards:-ISO/IEC 17025 fits seamlessly with other standards such as ISO 9001 for quality management and ISO 15189 for quality management of medical labs. So you can proceed to professionalise smoothly.

Benefits of ISO/IEC 17025 Certification

Getting your lab accredited is not mandatory. But it’s definitely worth considering. Why?

• You boost your credibility with both internal and external clients.
• You prove not only the technical competence of your lab, but also your independence and impartiality.
• You can use test and calibration results abroad with confidence, as accreditation ensures that you meet all internationally applicable requirements.
• Easily, you increase your international standing, and your credibility

Getting started with ISO/IEC 17025

Want to know what your lab needs to do to ensure correct and valid results? Then purchase the international standard ISO/IEC 17025. This will immediately give you a complete overview of all the requirements for an effective quality management system. Good to know: the standard specifies ‘what’ you need to do, but leaves enough freedom in exactly ‘how’ you do it.
Want to know how to implement ISO/IEC 17025?
Making sure that your workers, managers, and leaders are well-informed and skilled in laboratory safety and quality practices is key to building a sustainablesystem of industry-standard processes. Provide ample training programs so that ISO 17025 compliance measures can be improved, strictly enforced, and maintained. Along the way, encourage employees to always practice putting consumer safety and legal obligations in mind and at the heart of what they do.

Control of data and information management

The laboratory information management system(s) used for the collection, processing, recording, reporting, storage or retrieval of data shall be validated for functionality, including the proper functioning of interfaces within the laboratory information management system(s) by the laboratory before introduction. Whenever there are any changes, including laboratory software configuration or modifications to commercial off-the-shelf software, they shall be authorized, documented and validated before implementation

Conclusion

ISO/IEC 17025:2017 represents progress and harmony, for before ISO/IEC 17025:2017 came on the scene, calibration and testing laboratories dealt with ISO/IEC Guide 25 and EN 45001, which contained overlapping and contradictory requirements. This problem has been eliminated by streamlining these two standards into one commonly used and more thorough set of quality and technical competence requirements.
For this reason, ISO/IEC17025:2017, the international solution to better laboratory quality, is having an enormous impact on thousands of calibration and testing laboratories around the world and is pointing them to accreditation.
As accreditation typically takes 12 to 18 months to complete, laboratories are advised to start moving now. Accreditation should not be put on the back burner. Laboratories shouldn’t delay accreditation, but should take full advantage of the competitive edge such status carries.
There are many benefits to be derived from implementing a well-structured laboratory management system such as ISO/IEC 17025:2017, and the accreditation process is rigorous and timely. For this reason, not to mention the high rate of failure that afflicts laboratories seeking accreditation for the first time, it’s a good idea to seek the services of an outside professional consulting firm.

A competent quality consultant can walk your laboratory through ISO/IEC 17025:2017 requirements and identify any problems that may halt the accreditation process.

For more information, kindly visit the dedicated Web page on ISO management system standards (www.iso.org/management-systemstandards) or contact our national ISO member from NAORAS Organization