Quality management of in vitro diagnostics (IVD) in laboratories

Quality requirements for in-house IVD

From May 26, 2024, healthcare facilities such as laboratories for the manufacture and use of in-house IVDs will require a quality management system adapted to the IVDR.

Here, the IVDR explicitly requires laboratories to comply with the EN ISO 15189 standard "Medical laboratories - Requirements for quality and competence", and other national regulations and accreditation requirements as appropriate.

However, EN ISO 15189 does not cover the manufacture and development of in vitro diagnostics, which is why corresponding parts from other standards must also be implemented.

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The most efficient way to meet the requirements for in-house IVDs is to consider DIN EN ISO 13485 (chapter 7).

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Find out more about what you should know about DIN EN ISO 13485 for in-house IVDs

What laboratories you should consider for QMS(Quality Management System)

DIN EN ISO 15189 defines the special requirements for the quality and competence of medical laboratories. It is intended for use by medical laboratories in developing quality management systems and assessing their own competence. This standard is not intended to serve as a basis for certification of laboratories. However, laboratory clients, regulatory bodies and accreditation bodies may use ISO 15189 certification to confirm or recognize the competence of medical laboratories.
ISO 15189 also requires an internal quality control system. In Germany, this is the guideline of the German Medical Association for quality assurance of laboratory medical examinations.(Rili-Bäk).

DIN EN ISO/IEC 17025 "General requirements for the competence of testing and calibration laboratories" specifies general requirements for the competence, impartiality and uniform operation of laboratories. It contains requirements for laboratories so that they can demonstrate that they work competently and are capable of producing valid results: This requires a well-structured QM system. Laboratories that comply with this standard will also generally operate in accordance with the principles of ISO 9001. ISO/IEC 17025 contains additional requirements for technical competence that are not covered by ISO 9001:2000.

Whether ISO 13485, ISO 9001, ISO 15189 or ISO 17025: You have questions? We have answers!

Also check out our latest blog on QM.

Our quality management services for in-house IVDs:

Are you a manufacturer of in-house IVDs and wondering which standards you should consider for establishing your QM system? We will be happy to advise you in detail and develop a meaningful quality management system together with you.

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From GAP analysis to the development of processes, procedural instructions and work instructions - we actively support you and find individual solutions to suit your needs.

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