Med'In QARA - Control and testing laboratories
Support for ISO 17025 Compliance for Your Laboratory
COFRAC accreditation toISO 17025 is a guarantee of quality and competence for a laboratory. Whether you choose to become accredited or simply upgrade your laboratory to an accreditable level, Med'In QARA offers comprehensive support to medical device manufacturers wishing to structure, optimize and upgrade their in-house laboratory (R&D or Quality Control) to ISO 17025.
With over 10 years' experience in the management of testing and quality control laboratories, and two COFRAC accreditations to my credit, I bring solid expertise to the field. This experience guarantees tailor-made support to optimize and bring your laboratory activities into compliance.
Optimizing organization and implementing the quality system
Med'In QARA helps you structure your internal testing processes(Method), define appropriate procedures and set up the laboratory's quality system, based on the so-called 5M approach.
The approach typically begins with a gap analysis between current practices and ISO 17025 requirements, to identify areas for improvement.
The implementation of quality documentation ensures that every laboratory activity complies with the required standards, and that practices(labor) are standardized, thus facilitating accreditation. It covers all stages, from sample management(Material) to results documentation, ensuring total traceability and transparency.
Controlling the working environment(Milieu) means optimizing laboratory organization, which is essential for efficient, compliant management. Med'In QARA guides you in (re)organizing your laboratories.
Transposition of technical standards into test methods and Method Validation
Transposing technical standards into test methods adapted to the specific needs of the laboratory is a crucial step in method control, by creating operating procedures that are respected by all and not subject to interpretation(Labour).
Med'In QARA guides you in the creation of robust test methods, based on your test and inspection standards, ensuring that each test method is rigorously validated(R&R guarantee, measurement uncertainties, etc.) to guarantee its reliability and reproducibility, a key requirement of ISO 17025.
Support in instrument metrology and estimation of measurement uncertainties
A testing laboratory needs impeccable metrology management(Moyen). Med'In QARA can help you set up a metrological management system for your instruments, to ensure their accuracy and reliability.
Estimating and understanding measurement uncertainties is also essential for quantifying margins of error and ensuring the reliability of results. Good metrological management enhances the credibility and quality of the measurements produced.
Preparing for COFRAC accreditation audit
Internal audits are also offered to ensure ongoing compliance and prepare the team for the final audit. This support makes it easier to obtain accreditation by setting high quality standards.
Key benefits
Med'In QARA provides dynamic, rigorous support to ensure that your laboratory is optimized, compliant and ready for ISO 17025 accreditation, helping to boost the quality and efficiency of your testing and R&D activities.
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