Surgical Instruments Reprocessing in CSSD

 

Certification according to EN ISO 13485:2016

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Who are we

Swiss Certification Services

has been incorporated in 2017 in order to answer to the need of certification body specialized in the field of Central Sterile Service Department (CSSD) in Switzerland, Germany, France and Austria. The company is located in Switzerland with the headquarter in Olten.

 

Why creating a certification body exclusively dedicated to central sterile services department?

The CSSD is playing a crucial role in the safety of the patient. The sterilization department needs to set up reliable industrial processes and be able to demonstrate that the reprocessing parameters are maintained. In addition, this department is acting as an expert within the healthcare facility for any question related to the reprocessing of medical devices, during their complete life cycle. Therefore, it is mandatory that your certification body is well aware of the requirements specific to the reprocessing of medical devices and has experts in the field.

Our expertise

Steam

Ethylene Oxide

Plasma

Hydrogen Peroxide

Formaldehyde

The following aspects must be taken into consideration during an audit of a quality management system:

  • Relationship with the internal departments (purchasing, hygiene, biomedical, technic, transport, operating theater, …)
  • Regulatory requirements (applicable local requirements, standards and directives, …)
  • Infrastructure (maintenance, qualification, follow-up, consummables, …)
  • Control of processes (cleaning, disinfection, packaging, sterilization, storage)
  • Monitoring of processes (periodic control based on the risk associated, KPI, monitoring of parameters, …)
  • Applying the classifications rules (RKI, Spaulding, …)
  • Process Validation (cleaning-disinfection, sterilization, packaging)
  • Traceability (load release, load documentation, software validation)

Our Team

Michael Maier

Michael Maier

Lead Auditor - Executive Director - HMS

Graduated Engineer in Biomedical - Experience in the reprocessing of surgical instruments - Diploma in CSSD (DGSV / SGSV) - Auditor in the field of medical devices since 2002

Moritz Hoyer

Moritz Hoyer

Lead Auditor - Head of Certification, Certification Committee

Graduated Engineer in Biomedical - Experience in the reprocessing of surgical instruments - Diploma in CSSD (DGSV / SGSV) - Auditor in the field of medical devices since 2013

Philippe Etter

Philippe Etter

Certification Committee - Lead Auditor

Biomedical engineer EPFL - University diploma for reprocessing of medical devices in healthcare settings - Auditor since 1998