ISO 9001:2015 Quality Management System
The main objective of ISO 9001 is to improve the overall performance of the Organization and create a strong foundation for sustainable development initiatives. The implementation of ISO 9001 evaluates the overall framework of operation of an organization so that it aims at the customer satisfaction. ISO 9001 increases the productivity and profitability of the Organization within the respective legislative and regulatory frameworks and identifies risks and opportunities for improvement. In many cases, ISO 9001 is a prerequisite for the participation of an Organization in tenders and agreements with other organisations.
Ministerial Decision ΔΥ8δ/Γ.Π. οικ/1348
Principles and Guidelines of Good Practice for the Distribution of Medical Devices
Companies active in the distribution of medical devices in Greece are obliged to comply with the requirements of Ministerial Decision D.Y.8.d/Government Gazette 1348.16.01.2004. The acquisition of a Certificate of Compliance, in accordance with the requirements of the Ministerial Decision, is a condition of the legal operation of any company involved in the marketing, handling and technical support of medical devices