Providing quality products is central to Silhouet-Tone. We are among the few companies in the industry to meet the international quality requirements ISO 9001 and ISO 13485. Our european-made motors meet international electrical safety standards and are TUV or UL certified. They also comply with the European Union’s technical standards and are CE marked. Our top quality, FSC-certified wood is sourced from environmentally-conscious and sustainable logging companies. In addition to that, Silhouet-Tone is a medical device establishment licenced by the Department of Health of the Government of Canada and manufactures medical devices certified by Health Canada.
ISO 9001 & ISO 13485
The ISO 9000 family of standards is related to quality management systems and designed to help organizations to meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product. Over a million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today.
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a quality management system governing the design and manufacture of medical devices. ISO 13485 is now considered to be inline standard and requirement for design, manufacture, export and sales of every medical device.
TUV certification represents a formal acknowledgment by the TUV (Technischer Überwachungsverein, or Technical Inspection Association) that a company complies with the industry standards. TUV forms a global company involved in the definition of standards as well as in assessing the safety and the quality of products.
Health Canada is the Canadian statutor body responsible for any therapeutic product including medical devices. Medical Devices Bureau reviews devices to assess their safety, effectiveness and quality before authorize the sale of medical devices in Canada.
Forest Stewardship Council (FSC)
Global Forest Certification is an international certification and labeling system dedicated to promoting responsible forest management of the world’s forests. This means that forests are evaluated to meet FSC’s strict environmental and social standards. Fibre from certified forests is then tracked all the way to the consumer through the FSC Chain of Custody system. FSC-certified wood, paper and other forest products are then sold with the FSC label by certified companies in the marketplace. FSC enables businesses and consumers to make informed choices about the forest products they buy, and create positive change to keep our forests healthy for generations to come.
Canadian Standards Association
CSA (Canadian Standards Association) is a non-profit organization established in Canada in 1919 that administers and coordinates the industrial standardization system in Canada. Based on the MRA (Mutual Recognition Agreement), cross-certification has been granted between the U.S. and Canada. Provincial laws in Canada stipulate that electrical appliances connected to a public power source (commercial power source) must conform to CSA Standards. To show that a product conforms to CSA Standards, the manufacturer or seller needs to obtain CSA-UL certification or CSA certification.
Federal Communications Commission
FCC (Federal Communications Commission) is a federal government agency in the U.S. that administers communication, telegraph, and radio waves. FCC includes regulations for electrical appliances (industrial, scientific, and medical). Devices which intentionally emit radio waves cannot be sold in the U.S. without FCC certification. A product which has obtained the FCC certification shows the FCC mark.