Med'In QARA - Control and testing laboratories
ISO 17025 compliance support for your laboratory
COFRAC accreditation to ISO 17025 is a guarantee of quality and competence for a laboratory. However, it remains optional for a manufacturer's in-house laboratory.
However, 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 and/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 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 (Man) 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 (Medium) means optimizing laboratory organization - an essential point for efficient, compliant management - and controlling the working environment (environmental conditions such as temperature, pressure, etc.). With two laboratory revamps to my credit, Med'In QARA can help you organize or reorganize 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 fundamental step in method control, by creating operating procedures that are understood, respected by all and not subject to interpretation (Man).
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 gage, 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 requires impeccable metrological management (Machine). Med'In QARA can help you set up this management system for your instruments, ensuring that their accuracy and reliability are maintained, and that they are consistent with the measurements taken (device specifications and process parameters).
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 possible COFRAC accreditation to ISO 17025, thereby enhancing the quality and efficiency of your R&D and control activities, and producing reliable, reproducible results to guarantee control of your in-house testing for design verification and process validation.
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