All you need to know about ISO 17025:2017 accredited laboratories
When searching for a third-party laboratory to test products and raw materials, you may see the words “certified” or “accredited” thrown around with an alphabet soup of associations that can confuse even the most seasoned industry veterans.
Accreditations and certifications are valuable in any industry and the third-party laboratory industry is no different. When choosing a testing partner, it is important to understand the meaning behind any claim to certification or accreditation. Let’s spend some time exploring some of the finer points of this subject so you are well equipped to select the lab that is the best fit for your testing.
ISO 17025:2017, officially General Requirements for the Competence of Testing and calibration Laboratories, is a standard that outlines the key management system components that contribute to the competency and reliability of testing and calibration laboratories. Most importantly, those components ensure that the laboratory is able to operate impartially, without the influence of conflicting interests. Essentially, ISO/IEC17025:2017 is the industry standard for managing a competent testing or calibration laboratory.
Laboratories using this industry standard do so with pride, seeking accreditation from independent accrediting bodies. (Accrediting bodies being independent organizations that are qualified to evaluate a laboratory’s adherence to the standard)
We have highlighted some frequently asked questions to clarify common topics around ISO 17025:2017.
Who establishes the requirements for ISO 17025:2017?
ISO = International Organization for Standardization. ISO is a non-governmental, international organization with representation from 167 countries and almost any field with laboratory testing. It is an important distinction that ISO does not actually accredit laboratories, but establishes, and maintains the requirements outlined in ISO 17025.
If ISO does not accredit laboratories, who does?
The International Laboratory Accreditation Cooperation (ILAC) is the global organization that governs the accreditation community and ensures that the accreditation process is consistent globally. This organization approves organizations (accrediting bodies) around the world to assess conformance of laboratories to appropriate ISO standards.
ILAC also maintains a mutual recognition arrangement that ensures that a laboratory’s accreditation is recognized globally, and that results from accredited testing activities will be accepted confidently by any organization requiring ISO17025 Accreditation.
At Eurofins, we use A2LA and Perry Johnson Laboratory Accreditation (PJLA) for accreditation.
What types of labs can be ISO accredited?
Laboratory accreditations are available to calibration, testing, medical devices, inspection services, and many others. Since Eurofins is a global leader in testing, inspection, and certification services, ISO 17025:2017 is the minimum standard for quality, reliability, and impartiality.
How does a lab become ISO 17025:2017 accredited?
The process for a laboratory to obtain accreditation is a bit more involved than completing an application and paying a fee.
A laboratory wishing to obtain ISO17025 accreditation must first become familiar with the requirements outlined in the document. There are many routes a laboratory can take to gain this familiarity, including training and independent consultation.
The laboratory will typically partner with an accrediting body who will provide additional requirements to help the laboratory establish a management system that satisfies the requirements of the standard.
Once ready, the laboratory will submit an application to the accreditation body with a myriad of documents and records that describe and document the established Management System, and a specific list of technical methods the laboratory seeks to accredit.
And thus begins a roughly 6 month cycle of assessments, corrective actions and approvals. During this time, a contracted assessor, representing the accrediting body, will evaluate the laboratory, and provide an initial report of the laboratory’s conformance to the ISO standard. The laboratory is given an opportunity to respond to the assessor’s findings, and update the management system accordingly. When all parties agree that the laboratory’s management system conforms to the minimum requirements, a certificate and scope of accreditation are presented. It is only after the certificate has been received that the laboratory can make claims to accreditation.
Accreditation is not a lifelong credential. It must be renewed every 2 years through the process of surveillance assessments, where the accrediting body reviews any changes to the laboratory, the management system, and its capabilities, before providing a renewed accreditation certificate.
Why does my laboratory note that some results are not covered on its ISO Accreditation?
Accreditation to ISO17025:2017 requires that the laboratory maintain a detailed scope of accreditation that includes the specific methods that have been evaluated during the accreditation process. There are cases where the laboratory performs testing that has not been evaluated by the accrediting body. There are many reasons that a laboratory does not claim accreditation for certain activities.
Regardless, if you require accredited testing, it is important to ask your laboratory if they are accredited for the testing you require. If the laboratory is not accredited for a particular test, don’t be afraid to ask if it can be added. Laboratories often extend their scope of accreditation if there is an emergent industry need.
What is a Management System?
A management system, formally Quality Management System (QMS), is a system used to document the policies, procedures, documents and records that, together, form the foundation by which laboratories can provide the highest quality data and test results. The management system defines roles and responsibilities of all individuals within the laboratory’s organization, as well as strict guidelines for ensuring staff training, technical competency, equipment qualification, and supplier approvals are all in place and effective. The management system also defines the methods a laboratory must use to ensure that laboratory processes are followed, and that risks to result reliability are identified and reduced.
What is the difference between accreditation and certification?
While these terms are often used interchangeably by the general public, there are some main differences. Certifications are often found in the context of company registrations. There is not typically an on-site assessment associated with certifications.
Approvals are often related to specific organizations, regulating bodies, or customers, where the laboratory may be evaluated based on the requirements of a specific program. In this case, representatives from the approving organization will audit the laboratory for compliance. Eurofins laboratories welcome approval audits for customers and their testing needs. Please contact your account manager to request more information.
Accreditations, however, have the specific distinction that the process involves an independent assessment of the laboratory. Similar to a state inspection on your car, laboratory partners can be confident that an accreditation provides an independent assurance of the laboratory’s competence. (Note: There is no option for a laboratory to be ISO17025 approved, certified, or verified, the only available credential for ISO17025 is Accredited!)
A word to the wise, the distinction of ISO 17025 Accredited is placed on specific areas of testing that are explicitly listed in the scope of accreditation. While the components of the management system may be present and applicable to all testing in a laboratory, any reference to accreditation applies only to accredited testing.
Why should I care that my testing lab is ISO accredited?
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- International standard – meet international market expectations
- Signals that the lab meets global industry regulations for quality and accuracy
- Shows lab operates competently and generates valid results
- Can have confidence in their quality systems and quality of results
- Improves international trade and relations because results from an ISO accredited lab will be accepted and trusted internationally
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