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.

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)

Steam

Ethylene Oxide

Hydrogen Peroxide

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)

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Change Notice

 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:

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

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.

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