In the world of metrology, industry-wide standards for operation are critical for easy, reliable collaboration between organizations, both in the public and private sectors — and the ISO/IEC 17025 plays a significant role in that collaboration.
In this article, we’ll explain what exactly the ISO/IEC 17025 is, how it differs from some other popular standards, why the ISO/IEC 17025 is important, the requirements for earning an ISO/IEC 17025 certification, and its importance in the field of calibration.
What Is ISO/IEC 17025?
ISO/IEC 17025 is an international standard of operation for any organization that conducts testing, sampling or calibration, including testing and calibration laboratories; the International Organization of Standardization (ISO), in partnership with the International Electrotechnical Commission (IEC), developed it in 1999. This standard helps ensure organizations implement and maintain a Quality Management System (QMS) that delivers reliable results. By promoting standardization in how organizations carry out quality management, ISO/IEC 17025 promotes easier collaboration between laboratories and other organizations around the world to accelerate global trade.
The ISO and IEC set and regularly update the standard to reflect current best practices based on changes in the market and to technology. As a result, there have been multiple versions of ISO/IEC 17025, including the now-retired ISO/IEC 17025:2005 and the current ISO/IEC 17025:2017.
Additionally, organizations can earn ISO/IEC 17025 certification for successfully implementing and maintaining operations based on the standard. This certification, which accredited certification organizations grant, can benefit any organization — from government and research and development laboratories to university research departments — that carries out sampling, testing, or calibration.
What’s the Difference Between ISO/IEC 17025 and ISO 9001?
There are, of course, many other certifications that labs can earn aside from ISO/IEC 17025. Another common certification is the ISO 9001. Both ISO/IEC 17025 and ISO 9001 help organizations develop robust QMS to improve performance. However, while ISO/IEC 17025 applies specifically to organizations that conduct testing, sampling, or calibration, ISO 9001 applies to organizations in all sectors — including manufacturing, non-profits, healthcare, and more — even if they don’t handle testing, sampling, or calibration.
Why Is ISO/IEC 17025 Certification Important?
Aside from facilitating collaboration among and between organizations, ISO/IEC 17025 certification has many other benefits.
Indicates Trustworthy Calibration Results
If a laboratory has an ISO/IEC 17025 certification, it’s a signal that their organization will provide highly accurate calibration services. While it’s not technically mandatory to have ISO/IEC 17025 certification, many regulatory bodies and organizations typically require it in order to officially accept results from a laboratory. ISO/IEC 17025 certification shows that a laboratory can adhere to standards and produce dependable results from their testing and calibration services.
Helps Improve Operations and Reputation
A lab with ISO/IEC 17025 compliance boosts its global reputation and credibility and can improve performance by meeting strict standards that can reduce mistakes and increase product quality. Regular ISO/IEC 17025 audits, which the ISO encourages and can be conducted either by trained internal staff or by an external organization with ISO/IEC 17025 accreditation, also help guarantee consistent performance and efficiency over time. These audits help identify improvements an organization can make to equipment, staff performance, standard adherence, and more.
Demonstrates Regulatory Compliance
Finally, the ISO/IEC 17025 certification process demonstrates that laboratories are compliant in following regulatory and safety requirements. Regulatory bodies and customers can feel confident that an ISO/IEC 17025 testing laboratory will not face legal issues and fines.
What Are the Requirements To Earn an ISO/IEC 17025 Certification?
Laboratories and other testing facilities earn the ISO/IEC 17025 certification by undergoing audits conducted by an accredited certification body. In terms of certification requirements, laboratories and organizations need to make sure they’ve properly implemented the requirements of the standard (which we’ll outline in the section below).
That said, there are some common steps and strategies that many organizations aiming to earn ISO/IEC 17025 certification typically follow:
- Get familiarwith the specific requirements outlined in the ISO/IEC 17025 standard.
- Conduct an internal gap analysis to determine which operational aspects of the laboratory or facility need improvement in order to meet the standard.
- Develop an implementation plan for getting the organization up to standard, including identifying SOPs that need to be updated or created and identifying training and education needs for staff.
- Implement changes, including updating SOPs and training and educating staff.
- Perform internal audits after a predetermined length of time post-implementation to determine what still needs adjusting in order to meet standard requirements.
- Research accredited certification bodies to determine which one meets the facility’s needs and budget.
- Select an accredited certification body after internal audits indicate the facility has been consistently meeting standard requirements for a predetermined amount of time.
- Proceed with the certification body’s instructions in order to secure certification.
Note that certification bodies do charge for their services, but fees vary depending on a variety of factors, including the size and operational scope of the laboratory being certified, the base pricing the certification body uses, and the type of service (initial certification, renewal, etc.).
What Are the Five Key Elements of ISO/IEC 17025?
Beyond following the steps outlined in the section above, any facility hoping to earn ISO/IEC 17025 certification must, of course, adhere to the requirements that the standard itself lists. It includes a few sections that provide helpful context and definitions for readers, but primarily, the ISO/IEC 17025 standard consists of five main sections:
General Requirements
This element, which appears as Section 4 of the full standard, covers impartiality and confidentiality, which are crucial for maintaining customer trust:
- Impartiality includes managing laboratory activities in a way that resists commercial and financial pressures.
- Laboratories must keep customer information confidential, except as required by law, authorized by contractual agreements, or when agreed upon between the laboratory and the customer.
Structural Requirements
The structural requirements, which appear as Section 5 of ISO/IEC 17025, include:
- Defining the organization and management structure of the laboratory and the responsibilities of personnel.
- Showing that the laboratory is legally responsible for its activities.
Resource Requirements
This section, which appears as Section 6, lists the required resources for a laboratory to manage and perform its activities, such as:
- Documentation of the work experience, training and evaluations of staff.
- Documentation of suitable facilities and environmental conditions that do not harm the validity of results.
- Equipment that has been properly calibrated and checked to provide valid results.
Process Requirements
The process requirements, listed as Section 7 of the standard, applies to a laboratory’s processes for improving efficiency, for example:
- A procedure for the review of requests, tenders and contracts.
- A sampling plan to ensure the validity of testing or calibration results, based on appropriate statistical methods.
Management System Requirements
These requirements, listed as Section 8 of the standard, actually have two options for organizations:
- Option A: For laboratories or facilities that have a QMS system that’s siloed off from any other management systems in use.
- Option B: For laboratories or facilities that are a part of a larger organization or for laboratories or facilities that already have a management system that aligns with ISO 9001:2015 (which we touched on earlier in this article).
Generally speaking, these management system requirements cover factors such as:
- The documentation and implementation of a QMS to meet the requirements of ISO/IEC 17025 and ensure high-quality laboratory results.
- Management and control of documentation.
- Documentation of systems for identifying opportunities for improvement, such as feedback, complaints, risk analysis, etc.
- Conducting ISO/IEC 17025 internal audits to evaluate the management system.
What Is Calibration in ISO/IEC 17025?
Within the context of the ISO/IEC 17025 certification, calibration by accredited laboratories ensures that calibrated equipment and its measurements are traceable to the International System of Units. In other words, this traceability means that measurement results are valid and can be compared globally.
Want to learn more about the importance of calibration based on standards like ISO/IEC 17025? Please see these resources: