A Guide to Understanding ISO 17025

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 difference between ISO 9001 and ISO 17025?

ISO 17025 and ISO 9001 are both intended for QMS. But what sets them apart is the scope and the requirements. The requirements for ISO 17025 are specific to testing and calibration laboratories only. Meanwhile, ISO 9001 applies to organizations in all industries.

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. It goes hand in hand with ISO 15189:2012, the ISO standard for medical-specific laboratories.

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.

Is ISO 17025 Mandatory?

While ISO 17025 isn’t required, there are numerous benefits to gaining an accreditation or certification. Following internationally recognized standards allows organizations to become at par with what’s considered competent and trusted in the industry. Hence, this helps significantly increase the public’s level of confidence and the trust of peers in the laboratories’ work.

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.

The ISO 17025 standard is comprised of the following clauses and elements:

1. Scope – Discusses the objective of the standard, who can use it, and what ISO 17025 is for
2. Normative References – Highlights brief details on how certain guides and standards are referenced in ISO 17025
3. Terms and Definitions – Defines the terminology used in the standard
4. General Requirements – Covers the two main requirements of the standard which are:
   • Impartiality (laboratories won’t let any commercial, financial, or other pressuring factors manipulate, compromise, or alter the quality of the testing results)
   • Confidentiality (laboratories are required to ensure that the results and other key information are kept private)
5. Structural Requirements – Outlines a laboratory’s basic organizational structure and components, its processes, and its adherence to an efficient management system
6. Resource Requirements – Contains the 6 clauses that specify the necessary components a laboratory must have:
   • General
   • Personnel
   • Facilities and environmental conditions
   • Equipment
   • Metrological traceability
   • Externally provided products and services
7. Process Requirements – Details the 11 key processes on how to improve and implement the efficiency of the standard’s requirements:
   • Review of requests, tenders, and contracts
   • Selection, verification, and validation of methods
   • 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
8. Management System Requirements – Emphasizes the two options available for organizations complying with the standard, the differences between the two, and the various activities involved in this section:
   • Options
     • Option A – Applies to laboratories that have separate QMS from any other management system
     • Option B – Applies to laboratories that are part of larger organizations or if they have their own established management systems aligned with ISO 9001:2015
   • Management system documentation
   • Control of management system documents
   • Control of records
   • Actions to address risks and opportunities
   • Improvement
   • Corrective actions
   • Internal audits
   • Management reviews

If you want to know more about this standard, click here to view a quick and comprehensive guide to understanding the ISO 17025 in PDF.

Certification and Training

What are the benefits of ISO 17025 accreditation?

Even if the standards and requirements are released by the ISO and the IEC, third-party enforcement agencies are in charge of implementing and monitoring compliance. They conduct audits on how an organization’s QMS when it comes to laboratory testing and calibration aligns with industry standards set out in the ISO 17025 standard.

Why Get an ISO 17025 Certification

Gaining an ISO 17025 certification merits an organization the following benefits:

• Proactive culture of safety
• Optimized quality management
• Established credibility
• Improved customer confidence

To get ISO 17025-certified, follow the practical steps outlined in our checklist guide.

ISO 17025 training

Making sure that your workers, managers, and leaders are well-informed and skilled in laboratory safety and quality practices is key to building a sustainable system 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.