Sheroski AB works with various regulatory bodies to ensure our products meet the rigorous standards of the industry we serve. Sheroski AB has obtained certification in various areas related to quality assurance and best practices.

Quality Policy:

Sheroski AB is committed to achieving customer satisfaction by consistently providing ODM/OEM solutions, products and support to the global health care sectors. We continue to build on our history of developing products that provide reliable and durable solutions for dental & surgical procedures. We demonstrate our commitment through the continual review and improvement of our product quality and quality management system. This quality policy serves as the basis for setting measurable quality objectives and business metrics. Each member of our organization participates in this ongoing pursuit of quality excellence. Our QMS conforms to the internationally recognized ISO 9001:2015 and ISO 13485:2016 standards and applicable regulatory and classification requirements

CE Mark

Sheroski’s CE marking indicates a product’s compliance with EU legislation and so enables the free movement of products within the European market. By affixing the CE marking to a product, a manufacturer declares, on his sole responsibility, that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (EEA, the 28 Member States of the EU and European Free Trade Association (EFTA) countries Iceland, Norway, Liechtenstein). This also applies to products made in other countries which are sold in the EEA. All of Sheroski’s products sold into the European Union have the CE Mark.

ISO 9001:2015

ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact ISO 9001 has been implemented by millions of companies and organizations in over 170 countries. Sheroski AB has been ISO 9001:2015 certified since 2020.

ISO 13485:2016

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Sheroski AB has been ISO 13485:2016 certified since 2020.

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