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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

Hydrogen Peroxide

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

Home Page

By |

 

Surgical Instruments Reprocessing in CSSD

 

Certification according to EN ISO 13485:2016

1
1

Our expertise

Steam

Ethylene Oxide

Hydrogen Peroxide

Wo 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.

 

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

Philippe Etter

Philippe Etter

Auditor - Head of Management System

Therapeutic technologist (M.Sc. Life Science) with focus on implementation and maintenance of quality management systems as well as technical documentation.

Michael Maier

Michael Maier

Lead Auditor - Executive Director

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

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

Contact

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Baslerstrasse 44 | 4600 Olten | Switzerland
contact@swiss-certification-services.com
+41 (0)62 213 84 32

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    Impartiality

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     The principle of impartiality is one of the core value of Swiss Certification Services SA, therefore the top management is fully committed to provide impartial assessment of each client in order to establish, maintain and enhance public confidence and trust to the following parties: 

    • Clients 
    • Customers of the organizations whose management systems are certified 
    • Governmental authorities 
    • Non-governmental organizations 
    • Consumers and other members of the public 

    In order to ensure impartiality of certification activities, Swiss Certification Services SA ensures that any member of the company are free of:

    • Self-interest (e.g. Financial, Reputation, … ) 
    • Self-review (e.g. Own work, Former client as a consultant, …) 
    • Familiarity (e.g. Relationship, Trust not based on objective evidence, …) 
    • Intimidation (e.g. Pressure from clients or other parties, …)

    Full impartiality Policy:

    Complaints & Appeals

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    Complaint

     

    If you are not satisfied with the services provided by Swiss Certification Services, you can trigger the complaint process.

    Complaints are handled according to the internal procedure SOP-501 – Complaint Handling, as follow:

    • Acknowledgement
    • Collecting informations
    • Assessment of informations
    • Definition of corrective actions
    • Deciding if the complaint must be made public

    Appeal

     

    If you disagree with the certification decision of Swiss Certification Services, you have 15 days to trigger the appel process.

    Appeals are handled according to the internal procedure SOP-601 – Appeals Handling, as follow:

    • Acknowledgement
    • Collecting informations
    • Assessment of informations
    • Definition the most suitable action

      Certification Mark

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      Making reference and use of the certification mark

       

      Following a successful certification of your quality management system, you are authorised to use the Swiss Certification Services’ certification mark, in order to communicate your commitment to quality to your clients and end users.

      As this certification mark is intended to provide trust regarding the quality and safety of the company activities, you must comply with some basic rules in order to safeguard its reputation.

      Swiss Certification Services SA will take actions to deal with incorrect references to certification status or misleading use of certification documents, marks or audit reports. Actions can range from suspension of certification to publication of the transgression and legal actions through withdrawal of the certification.

      Detailed descriptions of the rules to be followed:

      Auditing & Certification Process

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      Auditing Process Overview

      Scope

      Swiss Certification Services is providing certification for Quality Management Systems according to ISO 13485:2016.

      Detailed Auditing Process

      Process when compliance is established

      After stage I and stage II audit and providing that non-conformities have been adequately handled, the certification board will grant certification

      After surveillance 1 or surveillance 2 audit and providing that non-conformities have been adequately handled, the certification board will decide maintain the validity of the certification

      After the renewal audit and providing that non-conformities have been adequately handled, the certification board will renew the certification

      If the customer submit proof of proper handling of major non-conformities, within 6 months, the certification board will restore the certification

      If a scope extension is requested by the customer, the certification board will decide if an audit needs to be conducted prior to grant the extension and upon completion of the required activities, the scope extension will be granted

      Process when compliance is not proved

      The certification will be refused if the client failed to resolve major non-conformities, within 3 months after the second stage II audit

      The certification will be suspended in the following cases:

      • The QMS has persistently or seriously failed to meet certification requirements (including requirements for the effectiveness of the QMS)
      • The client doesn’t allow surveillance/recertification audits to be conducted at the required frequencies
      • The client has made a voluntary requested suspension.

      The certification will be withdrawn in the following cases:

      • The client has failed to resolve the issues that have resulted in the suspension in the allocated time (in some cases, the scope can be reduced)
      • The client created repeated obstacles to surveillance/recertification audits scheduling.
      • The client has made a voluntary requested for withdrawal.
      • The client has deliberately lied / hide information from the audit team to cover fraud / illegal actions.

      The certification scope will be reduced in the following cases:

      • The client has failed to resolve the issues that have resulted in the suspension in the allocated time.
      • The client has made a voluntary request for scope reduction.

      Geographical Areas

      Switzerland

      Germany

      Austria