Your needs: to cooperate with a competent laboratory having ISO 17025 accreditation
The FILAB laboratory is accredited by COFRAC according to the standard ISO 17025 for chemical analyses. With our COFRAC accreditation and ISO 17025 compliance, you can be sure of accurate, reliable and traceable results. Find out how FILAB, experts in chemical analysis, can meet your most demanding analytical needs.
What is a COFRAC laboratory?
A COFRAC laboratory is a laboratory accredited by the COmité FRançais d’ACcréditation (COFRAC). COFRAC is the French body responsible for accrediting testing, calibration, measurement and analysis laboratories, as well as certification and inspection bodies, according to the internationally recognised standards.
What is COFRAC accreditation?
COFRAC accreditation attests to 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 skills, testing and calibration methods, technical equipment used, traceability of measurements and quality management.
ISO 17025:2005 is intended for use by laboratories that are developing
their management system for quality and
administrative and technical activities
It can also be used by a number of organisations, including laboratory customers, regulatory authorities and bodies.
The latter use it on condition that they are engaged in activities to confirm or recognise the competence of laboratories.
Definition of ISO 17025
ISO 17025 is an international standard that defines the general requirements for the competence of calibration and testing laboratories. This standard establishes criteria for the quality and competence of laboratory activities, including quality management, staff skills, method validation, quality assurance of results and traceability of measurements. What are the main criteria for an ISO 17025 accredited laboratory?
What is the ISO 17025 standard?
Why use an ISO 17025 accredited laboratory?
An ISO 17025-accredited laboratory provides assurance of quality and expertise in the field of chemical analysis.
This accreditation guarantees the reliability of results, their compliance with the most rigorous international standards, and their traceability to recognised reference standards.
A COFRAC laboratory is therefore considered to be 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 solution: to provide reliable analytical services while complying with the ISO 17025 standard
The FILAB laboratory offers high added-value chemical analysis and expertise services, some of which are carried out under COFRAC ISO 17025 accreditation.
In addition, FILAB has the experience and analytical resources to guarantee its industrial customers reliable analysis services in compliance with the requirements of ISO 17025.
Our accreditations on Medical Devices
FILAB is the first French laboratory to obtain COFRAC ISO 17025 accreditation for the chemical characterisation of medical devices according to the standards in force
- HCT, COT & inorganic residues in accordance with ISO 19227
- Chemical characterization according to the standard ISO 10993-18
Our accreditations on Nanomaterials
FILAB is the first and only independent French laboratory to be COFRAC ISO 17025 accredited for the classification of nanomaterials using the SEM-EDX technique!
- Nanometric classification of your matrices
- Distribution en taille et en forme des nanoparticules
Our accreditations on Pharmaceuticals
FILAB is also the first French laboratory to obtain COFRAC ISO 17025 accreditation for the analysis of impurities in pharmaceutical matrices.
- Elemental impurity analysis according to ICH Q3D
Our accreditations on Cosmetics
- ICP analysis of heavy metals in cosmetic products
FILAB, ISO 17025 laboratory
Materials covered by ISO 17025 analysis
FILAB, as an ISO 17025 accredited laboratory, provides analysis on a variety of samples and matrices: medical devices, polymeric materials, metals, textiles, medical implants, chemicals, and more. Analyses can cover chemical composition, physical properties, and resistance to environmental conditions.
The advantages of an ISO 17025 accredited laboratory
Using an ISO 17025-accredited laboratory guarantees the quality and reliability of your analyses. This international accreditation certifies that the laboratory complies with strict standards in terms of technical skills, quality management and impartiality. So you can be sure that the tests comply with international standards.
Regulations covered by an ISO 17025 laboratory
An ISO 17025-accredited laboratory carries out analyses that comply with international and national regulations in a wide range of sectors, including the pharmaceutical and medical industries. The results are recognised by the authorities as proof of conformity, making it easier for products to be placed on the market. This includes medical devices, for which the analyses are linked to the ISO 10993 standard for biocompatibility.
The technical resources available in an ISO 17025 laboratory
FILAB has state-of-the-art technical resources to ensure accurate and reliable analyses. Our equipment includes advanced analytical tools such as gas chromatography (GC-MS), mass spectrometry (MS), electron microscopy and X-ray diffraction. These techniques enable detailed characterisation of the chemical, physical and mechanical properties of the materials and products tested. The expertise of our technical teams also ensures that the results obtained are rigorously interpreted, guaranteeing their validity and compliance with current standards.
Practical examples of ISO 17025
Metallic materials (fixed span) : Standard physico-chemical analyses.
Cosmetics and pharmaceuticals (flexible scope):
Determination of heavy metals by ICP-AES and ICP-MS in accordance with the European Pharmacopoeia and USP 233.
Identification of contaminants by SEM-EDX and Binocular Micro-Infrared.
Particle counting by Optical Microscopy, in accordance with USP 788/789.
Determination of organic contaminants by GC-MS and LC-UV.
Characterization of nanomaterials by SEM-EDX and SP-ICPMS.
Surface analysis by BET and laser granulometry.
- Medical devices and chemicals (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-IRTF.
Analysis of mineral and organic residues in accordance with ISO 10993-18.
Gravimetric completeness.
Detailed scopes available at www.cofrac.fr – Accreditation no. 1-1793.
COFRAC, or the French Accreditation Committee, is responsible for recognising the technical competence of conformity assessment bodies (laboratories, certification bodies, etc.) in France. COFRAC is responsible for accrediting these bodies in accordance with current international standards and benchmarks in order to guarantee their impartiality, independence and reliability. COFRAC accreditation gives customers of accredited bodies confidence in the quality of the services provided. COFRAC also plays an important role in promoting accreditation among companies, public authorities and the general public.
It is important to choose a laboratory that is COFRAC accredited to ISO 17025 because this standard defines the requirements for the technical competence and impartiality of testing and calibration laboratories. COFRAC ISO 17025 accreditation therefore guarantees that the laboratory has been assessed and recognised for its ability to carry out tests and calibrations in the fields covered by its scope of accreditation, in compliance 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 needs of the user. In addition, COFRAC ISO 17025 accreditation is recognition of the laboratory's competence at international level, which can facilitate recognition of test or calibration results abroad.
There are several ways of checking the validity of a laboratory's COFRAC ISO 17025 accreditation. Here are a few 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 period of validity.
View the Filab accreditation certificate.
Consult the list of accredited bodies: COFRAC publishes a list of accredited bodies on its website. You can use the search engine on the website to check whether the laboratory is on the list.
Identify the scope of accreditation: 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 scope of accreditation actually covers the tests or calibrations for which you want to use its services.
Check the period of validity: it is important to check that the accreditation is still valid and has not expired in the meantime. The period of validity is specified on the accreditation certificate.
The audit for COFRAC ISO 17025 accreditation of an analysis laboratory takes place in several stages. Here are the main ones:
- Preparing for the audit: 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 examined by the auditor to check that they comply with the standard. These documents will be examined by the auditor to check that they comply with ISO 17025.
- Document audit: during 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 questions of laboratory staff to clarify certain points.
- On-site audit: this stage consists of assessing the laboratory's technical skills and compliance with the requirements of ISO 17025. The auditor makes direct observations of the laboratory's activities, examines test or calibration records, interviews staff and may carry out tests or calibrations in the presence of laboratory staff.
- Audit report: at the end of the audit, the auditor draws up an audit report describing the audit findings, any non-conformities and recommendations. The laboratory may then be required to take corrective action to rectify any non-conformities identified.
- Accreditation decision: finally, after receiving the audit report, the COFRAC accreditation committee takes a decision on the laboratory's accreditation. If accreditation is granted, the laboratory receives an accreditation certificate and can then use the COFRAC logo on its documents.
ISO 17025 is an international standard that specifies the general requirements for the competence of calibration and testing laboratories. It defines the criteria that laboratories must meet to guarantee 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 skills and validated test methods. This accreditation is recognised internationally and ensures that the results produced are reliable and accepted by regulatory bodies and industry.
COFRAC and ISO/IEC 17025 are two distinct but related bodies in the field of laboratory accreditation.
Unlike COFRAC, which is specific to France, ISO/IEC 17025 is an international standard used throughout the world to assess the competence of laboratories.
In short, COFRAC is the French body that issues accreditation to laboratories in France, while ISO/IEC 17025 is an international standard that specifies the 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 criteria specific to COFRAC.
ISO 17025 imposes a number of 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 that describes the processes, procedures and records necessary for compliance.
Document control: ensuring that documents and procedures are correctly identified, updated and distributed.
Continuous improvement: implementing procedures to monitor, evaluate and continuously improve the effectiveness of the management system.
Internal audit: carrying out internal audits to check that the laboratory complies with the standard and to identify areas for improvement.
Complaints management: provision of procedures to manage and resolve customer complaints effectively.
> Technical requirements :
Staff competence: The laboratory must demonstrate that its staff are trained, qualified and competent to carry out analyses and tests.
Measuring equipment: The equipment must be well maintained, regularly calibrated and suitable for the tests carried out.
Test methods: The test methods used must be validated and comply with national or international standards.
Traceability of measurements: Measurements must be traceable to national or international standards, thus ensuring the reliability of results.
Sample management : Samples must be correctly identified, handled and stored to avoid 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 intended to ensure that FILAB's 17025-accredited laboratory produces accurate, reliable results that meet regulatory expectations and customer needs.
