ISO 17025 accredited laboratory analysis

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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

In the pharmaceutical industry, an ISO 17025-accredited laboratory performs purity, stability, and composition analyses of the active ingredients and excipients used in medicines. These tests are essential to ensure that products meet the safety and efficacy standards imposed by health authorities, while ensuring traceability and manufacturing compliance.

ISO 17025 defines the competence and quality requirements for testing and calibration laboratories.

A laboratory is not ISO 17025 certified, but rather ISO 17025 accredited. In France, this accreditation is granted by COFRAC. The laboratory is recognized as capable of producing reliable, accurate, and traceable results.

The main international standard for analytical and calibration laboratories is ISO/IEC 17025.

• ISO 9001: a general quality management standard applicable to any organization
• ISO 17025: a standard specific to laboratories, which adds the requirement for demonstrating technical competence to ensure reliable results.

As a laboratory accredited to ISO 17025 by COFRAC, we meet the requirements of the 9001 standard.