Health
Subject to increasingly stringent regulations (COFRAC accreditation in accordance with NF EN ISO 15189, HAS certification, etc.), medical biology laboratories and healthcare facilities are facing new requirements.
OUR RANGE OF SERVICES FOR HEALTHCARE ESTABLISHMENTS
To support you, Qualilab has developed a consulting offer tailored to the specific needs of the healthcare sector.
Staff training (ISO 15189, Management of the Information System in accredited laboratories, internal auditors, etc.)
Conducting internal audits, pre-accreditation mock audits, and information system audits
Information System Management and Software Validation:
Drafting specifications
Support for implementing an LIS (Laboratory Information System)
Software validation and maintenance of validated status
Implementation of a Risk Management System (ISO 31000-2018, AMDEC, SWOT, 5M, etc.)
Assistance with implementation and day-to-day management of the Management System
Coaching for Quality managers (especially during onboarding)
Post-COFRAC evaluations support:
Management of identified non-conformities
Management of suppliers and service providers…
Analytical support (method validation, analytical validation, analytical transfer, etc.)
oUR TRAINING COURSEs
As a certified training organization, Qualilab offers training modules certified specifically designed for healthcare facilities:
- 1Q1 : Conducting internal audits
- 1Q8 : ISO 17025 and ISO 15189 - Information system management
- 1Q9 : ISO 15189 v2022 Accreditation of medical biology laboratories
- …
Why choose Qualilab
With our proven experience and expertise in working with healthcare institutions, we offer a complete, end-to-end solution..
Our strength lies in a multidisciplinary team of experts in accreditation, healthcare (compliance pharmacists).
Qualilab also works with independent experts in a wide range of technical areas (biologists, IT specialists, statisticians, etc.).
Our approach is based on official standards and the technical guides of COFRAC and the OECD.
A team at your service
Our team is here to guide and support you in managing your project. Our consultants are available to provide insights into the scope and content of our services, if needed.
