--- type: "WebPage" title: "COFRAC-accredited chemical analysis laboratory according to ISO 17025" description: "Are you looking for an accredited ISO 17025 laboratory that also meets the requirements of ISO 9001? The FILAB laboratory, COFRAC ISO 17025 accredited for chemical analysis, supports you with validated methods, a high level of technical expertise, and rigorous..." resource: "https://filab.fr/en/about-us/accreditations-en/laboratory-analysis-iso-17025/" tags: ["EN", "pll_61273ac738038"] timestamp: "2026-08-18T09:26:45Z" published: "2021-08-26T06:55:02Z" language: "en" author: "bwa" --- # COFRAC-accredited chemical analysis laboratory according to ISO 17025 Are you looking for an accredited **ISO 17025** laboratory that also meets the requirements of ISO 9001? The [**FILAB laboratory**, COFRAC ISO 17025 accredited](https://tools.cofrac.fr/fr/organismes/fiche.php?entite_id=12073583) for [chemical analysis](https://filab.fr/nos-prestations/analyse/analysis-chimiques/), supports you with validated methods, a high level of technical expertise, and rigorous quality control. ### Your needs: ensuring the reliability and compliance of your analysis thanks to a COFRAC-accredited ISO 17025 laboratory ### What is a COFRAC laboratory? A **COFRAC laboratory** is a laboratory accredited by the French Accreditation Committee (COFRAC). COFRAC is the French body responsible for **accrediting laboratories****for testing**, calibration, measurement and analysis, as well as certification and inspection bodies, according to internationally recognized standards. ### What is COFRAC accreditation? L**COFRAC accreditation**demonstrates the technical competence and reliability of the results produced by a laboratory. It guarantees that the **laboratory complies with strict standards** in terms of quality, staff competence, testing and calibration methods, [technical equipment](https://filab.fr/en/our-technical-resources.md) used, measurement traceability, and quality management. ### Definition of the ISO 17025 standard The **[ISO 17025 standard](https://www.iso.org/fr/ISO-IEC-17025-testing-and-calibration-laboratories.html) is an international standard** that defines the general requirements for the competence of calibration and testing laboratories. This standard sets out the criteria for the quality and competence of laboratory activities, including quality management, **staff competence, method validation, quality assurance of results, and measurement traceability**. What are the main criteria to meet for an ISO 17025-accredited laboratory? Clearly define the **scope of its accreditation**, meaning the specific types of tests or calibrations for which it is accredited. Implement a documented **quality management system** that complies with the standard's requirements. Have the **skills** and appropriate qualifications to carry out the tests or calibrations for which the laboratory is accredited. Have validated methods to ensure the reliability and accuracy of the methods used by the laboratory Put procedures in place to**ensure the quality of the results**produced, including the management of nonconformities and corrective actions. Be able to demonstrate the **traceability of its measurements** ### Why use an ISO 17025-accredited laboratory? iso 17025 accredited laboratory ## A COFRAC- and ISO 17025-accredited laboratory offers a guarantee of quality and competence in the field of chemical analysis. These distinctions ensure the reliability of results, their compliance with the most stringent international standards, and their traceability to recognized reference standards. As such, a COFRAC laboratory is considered capable of providing reliable and accurate test or measurement results, which is essential in many fields such as pharmaceuticals, the drug industry, and chemistry. ## Our solutions: FILAB provides reliable and compliant chemical analysis as a COFRAC-accredited ISO 17025 laboratory The FILAB laboratory offers chemical analysis and high value-added expertise services, some of which are carried out under [accreditation](https://filab.fr/en/about-us/accreditations-en.md) to COFRAC ISO 17025 STANDARD. In addition, FILAB has the experience and [analytical equipment](https://filab.fr/en/our-technical-resources.md) to guarantee its industrial clients reliable analysis services, in compliance with the requirements of ISO 17025. ## Accreditation An ISO 17025 laboratory is called upon when it is necessary to guarantee metrological reliability and the traceability of chemical analysis, whether to: - check the purity of raw materials, - verify the regulatory compliance of finished products, - characterize trace contaminants - produce robust data for R&D and quality audits. A COFRAC- and ISO 17025-accredited laboratory offers a guarantee of quality and competence in the field of chemical analysis. ### Our accreditations for medical devices ISO 17025 FOR THE MEDICAL DEVICE INDUSTRY FILAB is the first French laboratory to obtain COFRAC ISO 17025 accreditation for the chemical characterization of medical devices in accordance with current standards - HCT, COT & inorganic residues according to [ISO 19227 ](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227.md) - Chemical characterization according to the standard [ISO 10993-18](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-material-chemical-characterization.md) - Material degradation testing: [ISO 10993-13](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/iso-10993-13-medical-devices-characterization.md) : polymers, [ISO 10993-14](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/identification-and-quantification-of-degradation-products-on-ceramic-medical-devices-according-to-iso-10993-14.md) : ceramics, [ISO 10993-15](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/study-of-degradation-products-in-your-medical-devices-according-to-iso-10993-15.md) : metals ### Our accreditations for nanomaterials ISO 17025 FOR THE NANOMATERIALS INDUSTRY FILAB laboratory is the first and only independent French laboratory to be COFRAC ISO 17025 accredited for **nanomaterial classification using SEM-EDX technology!** - [Nanometric classification](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-nanomaterial.md) of your matrices - Size and shape distribution of [nanoparticles](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-nanomaterial/laboratory-analysis-nanoparticle-characterization.md) ### Our accreditations in pharmaceutical products ISO 17025 FOR THE PHARMACEUTICAL INDUSTRY In addition, FILAB is the **first French laboratory** to obtain COFRAC ISO 17025 accreditation for impurity analysis in [pharmaceutical](https://filab.fr/en/sectors-of-activity/analysis-industry-pharmaceuticals.md) matrices. - [Elemental impurity analysis](https://filab.fr/nos-prestations/analyse/laboratoire-analysis-ich-q3d/) according to ICH Q3D ### Our accreditations in cosmetics ISO 17025 FOR THE COSMETICS INDUSTRY [Heavy metal analysis](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-heavy-metal/analysis-heavy-metals-raw-materials-cosmetic-products.md) in cosmetic products by ICP ## FILAB, ISO 17025 Laboratory Materials covered by ISO 17025 analysis As an ISO 17025 accredited laboratory, FILAB provides analysis on a wide range of samples and matrices: **medical devices, polymer materials, metals, textiles, medical implants, chemicals, and more**. analysis can cover chemical composition, physical properties, and resistance to environmental conditions. The benefits of an ISO 17025 accredited laboratory Using an ISO 17025 accredited laboratory guarantees the quality and reliability of the analysis. This international accreditation certifies that the laboratory meets strict standards in terms of technical competence, quality management, and impartiality. You can therefore be confident that the tests comply with international standards. Regulations covered by an ISO 17025 laboratory An ISO 17025 accredited laboratory carries out analysis in compliance with international and national regulations across many sectors, such as the pharmaceutical and medical industries. The results are recognized by authorities as proof of compliance, making it easier to bring products to market. This includes medical devices, for which the analysis are linked to ISO 10993 for biocompatibility. Technical resources available in an ISO 17025 laboratory FILAB has state-of-the-art technical resources to ensure precise and reliable analysis. Our equipment includes advanced analytical tools such as gas chromatography (GC-MS), mass spectrometry (MS), electron microscopy, and X-ray diffraction. These techniques make it possible to characterize in detail the chemical, physical, and mechanical properties of the materials and products tested. The expertise of our technical teams also ensures a rigorous interpretation of the results obtained, guaranteeing their validity and compliance with current standards. Practical examples of ISO 17025 - **Metallic materials (fixed scope)** : Standard physico-chemical analyses. - **Cosmetics and pharmaceuticals (flexible scope)** : - Heavy metal determination by ICP-AES and ICP-MS according to the European Pharmacopoeia and USP 233. - Contaminant identification by SEM-EDX and Binocular Micro-Infrared. - Particle counting by Optical Microscopy, according to USP 788/789. - Organic contaminant determination by GC-MS and LC-UV. - Nanomaterial characterization by SEM-EDX and SP-ICPMS. - Surface analysis by BET and laser particle size analysis. - **Medical devices and chemical products (flexible scope)** : - Hydrocarbon and Total Organic Carbon (TOC) analysis. - Particle counting by Optical Microscope (ISO 10993-19, USP 788). - Particle identification by SEM-EDX and µ-FTIR. - Analysis of mineral and organic residues according to ISO 10993-18. - Completeness by gravimetry. Detailed scopes available on[www.cofrac.fr](http://www.cofrac.fr) – Accreditation No.: 1-1793. ### Carry out your COFRAC analysis with a multi-accredited laboratory | **Business Sector** | **COFRAC Analysis Type & Services** | **Accreditation Standards and References** | **COFRAC Laboratory Distinction** | | --- | --- | --- | --- | | **Medical Devices (MD)** | Chemical characterization, HCT, TOC and inorganic residue testing. Degradation testing. | **ISO 19227** **ISO 10993-18** **ISO 10993-13, 14, 15** | **1st French laboratory** accredited for the chemical characterization of MDs. | | **Nanomaterials** | Nanoscale classification of matrices. Measurement of nanoparticle size distribution and shape. | **ISO 17025** (SEM-EDX technique) | **Only independent laboratory** in France accredited for SEM-EDX classification. | | **Pharmaceutical Industry** | Analysis of elemental impurities and screening in complex matrices. | **ICH Q3D** (Under ISO 17025) | **1st French laboratory** accredited for impurity analyses in pharmaceutical matrices. | | **Cosmetics** | Determination and analysis of heavy metals in finished products and raw materials. | Analysis by **ICP** (Under ISO 17025) | Recognized expertise in **a****nalysis COFRAC** for the safety of cosmetic products. | ## Looking for a COFRAC laboratory? To ensure the reliability of your results and the compliance of your products, FILAB carries out a wide range of **analysis under COFRAC accreditation** (according to ISO 17025). Choosing a **COFRAC laboratory** like FILAB gives you international recognition for your test reports. Contact us and consult our full scope of accreditation on the COFRAC website. ## FAQ What are COFRAC’s missions? COFRAC, or the French Accreditation Committee, is responsible for recognizing the technical competence of conformity assessment bodies (laboratories, certification bodies, etc.) in France. COFRAC is in charge of accrediting these bodies according to the international standards and benchmarks in force in order to guarantee their impartiality, independence, and reliability. **COFRAC accreditation** thus helps build trust among clients of accredited bodies in the quality of the services provided. COFRAC also plays an important role in promoting accreditation among businesses, public authorities, and the general public. Why is it important to choose a COFRAC accredited laboratory? It is important to choose a **COFRAC-accredited laboratory according to ISO 17025** because this standard defines the requirements relating to the technical competence and impartiality of testing and calibration laboratories. COFRAC ISO 17025 accreditation therefore ensures that the laboratory has been assessed and recognized for its ability to carry out tests and calibrations in the areas covered by its scope of accreditation, while complying with the requirements of the standard. Choosing a COFRAC ISO 17025 accredited laboratory therefore ensures that the results provided by the laboratory are reliable, accurate, and relevant to the user's needs. In addition, COFRAC ISO 17025 accreditation is an international recognition of the laboratory's competence, which can facilitate the recognition of test or calibration results abroad. How can you verify the validity of a laboratory’s ISO 17025 accreditation? There are several ways to verify the validity of **a laboratory's COFRAC ISO 17025 accreditation**. Here are some steps to follow: - Check for an accreditation certificate: the COFRAC-accredited laboratory must be able to provide a valid accreditation certificate, which indicates the scope of accreditation and the validity period. [View the FILAB accreditation certificate](https://tools.cofrac.fr/annexes/sect1/1-1793.pdf). - Consult the list of accredited bodies: COFRAC publishes a list of accredited bodies on its website. Using the search engine available on the website, it is possible to check whether the laboratory appears in this list. - Identify the accreditation scope: the scope of accreditation is important because it specifies the tests or calibrations for which the laboratory has been assessed. It is therefore important to identify whether the laboratory's accreditation scope covers the tests or calibrations for which you wish to use its services. - Check the validity period: it is important to verify that the accreditation is still valid and has not expired in the meantime. The validity period is specified on the accreditation certificate. - Contact COFRAC: if doubts remain about the validity of a laboratory's accreditation, it is possible to contact COFRAC directly, which can confirm whether the laboratory is indeed accredited and whether its accreditation is valid. How does the audit for a laboratory’s COFRAC ISO 17025 accreditation work? The audit for **a laboratory's COFRAC ISO 17025 accreditation** takes place in several stages. Here are the main ones: 1. Audit preparation: before the audit, the laboratory must prepare a number of documents, such as the quality manual, standard operating procedures, work instructions, etc. These documents will be reviewed by the auditor to verify their compliance with ISO 17025. 2. Document review audit: at this stage, the auditor examines the documents prepared by the laboratory to ensure that they meet the requirements of ISO 17025. The auditor may also ask laboratory staff questions to clarify certain points. 3. On-site audit: this stage involves assessing the laboratory's technical competence and compliance with the requirements of ISO 17025. The auditor directly observes the laboratory's activities, reviews test or calibration records, interviews staff, and may carry out tests or calibrations in the presence of laboratory personnel. 4. Audit report: at the end of the audit, the auditor writes an audit report describing the findings, any nonconformities, and recommendations. The laboratory may then be required to implement corrective actions to address the identified nonconformities. 5. Accreditation decision: finally, after receiving the audit report, the COFRAC accreditation committee makes a decision regarding the laboratory's accreditation. If accreditation is granted, the laboratory receives an accreditation certificate and may then use the COFRAC logo on its documents. What is ISO 17025? **ISO 17025** is an international standard that specifies the general requirements for the competence of calibration and testing laboratories. It defines the criteria laboratories must meet to ensure the reliability, accuracy, and validity of their analysis and measurement results. ISO 17025 accredited laboratories must demonstrate that they have robust quality management systems, adequate technical competence, and validated testing methods. This accreditation is recognized internationally and helps ensure that the results produced are reliable and accepted by regulatory bodies and industry. What is the difference between COFRAC and ISO 17025? COFRAC and ISO/IEC 17025 are two **distinct entities** but they are linked in the field of laboratory accreditation. Unlike COFRAC, which is specific to France, ISO/IEC 17025 is an international standard used worldwide to assess laboratory competence. In short, COFRAC is the French body that grants accreditation to **laboratories in France,** while ISO/IEC 17025 is an international standard that specifies competence requirements for calibration and testing laboratories and is used worldwide. A laboratory can be accredited by COFRAC by meeting the requirements of ISO/IEC 17025, among other COFRAC-specific criteria. What are the requirements of ISO 17025? The **ISO 17025** standard imposes several essential requirements that testing and calibration laboratories must meet in order to be accredited. These requirements fall into two main categories: management requirements and technical requirements. > Management requirements: - **Documentation** : establish and maintain comprehensive documentation describing the processes, procedures, and records necessary for compliance. - **Document control** : ensure that documents and procedures are properly identified, updated, and distributed. - **Continuous improvement** : implement procedures to monitor, evaluate, and continuously improve the effectiveness of the management system. - **Internal audit** : carry out internal audits to verify the laboratory's compliance with the standard and identify areas for improvement. - **Complaint handling** : provide procedures for handling and resolving customer complaints effectively. > Technical requirements: - **Staff competence** : The laboratory must demonstrate that its staff are trained, qualified, and competent to perform analyses and tests. - **Measuring equipment** : Equipment must be properly maintained, regularly calibrated, and suitable for the tests performed. - **Test methods** : The test methods used must be validated and comply with national or international standards. - **Measurement traceability** : Measurements must be traceable to national or international standards, thereby ensuring the reliability of results. - **Sample handling** : Samples must be properly identified, handled, and stored to avoid any contamination or degradation. - **Measurement uncertainty** : The laboratory must be able to calculate and understand the measurement uncertainty associated with its test results. These requirements are designed to ensure that the FILAB laboratory, accredited to ISO 17025, produces accurate, reliable results that meet regulatory expectations and customer needs. How does an ISO 17025 accredited laboratory help the pharmaceutical industry ensure the quality of its products? In the [pharmaceutical industry](https://filab.fr/en/sectors-of-activity/analysis-industry-pharmaceuticals.md), an ISO 17025 accredited laboratory carries out purity, stability, and composition analysis of active substances and excipients used in medicines. These tests are essential to ensure that products meet the safety and efficacy standards imposed by health authorities, while also ensuring traceability and manufacturing compliance. What is ISO 17025? ISO 17025 defines the competence and quality requirements for testing and calibration laboratories. What is an ISO 17025 certified laboratory? A laboratory is not ISO 17025 certified, but ISO 17025 accredited. In France, this accreditation is granted by COFRAC. The laboratory is recognized as capable of producing reliable, accurate, and traceable results. What is the ISO standard for laboratories? The main international standard for testing and calibration laboratories is ISO/IEC 17025. What is the difference between ISO 9001 and ISO 17025? - ISO 9001: general quality management standard, applicable to any organization - ISO 17025: standard specific to laboratories, which adds the demonstration of technical competence to ensure the reliability of results. As an ISO 17025 accredited laboratory by COFRAC, we meet the requirements of ISO 9001. What is the price of a COFRAC analysis and how can i get a quote? Send your specifications through our contact form or by email. The **price of a COFRAC analysis** is tailored to your needs (matrix, volume, limits). FILAB is committed to getting back to you within **24 to 48 hours**.