ISO 9001:2015 - Quality Management System
We support your company in developing and implementing its first Quality Management System (QMS), in line with the requirements of the revised standard (ISO 9001:2015).
We also offer special training courses which will help your employees cope with the particular requirements of the revised standard (ISO 9001:2015).
Especially for distributors of medical devices in Greece, we can incorporate requirements of the relevant legislation (Y.A.ΔΥ8δ/Γ.Π. οικ./1348/2004 - ΦΕΚ 32/Β/16-1-2004) in a quality management system according to ISO 9001:2015.
For healthcare organizations, ISO has developed the international standard ISO 15224:2016. The standard incorporates EN ISO 9001:2015 and adds interpretations, explanations, examples and additional requirements. Healthcare organizations may be audited and certified for their compliance to the requirements of ISO 15224 or ISO 9001 or both.
You may read and/or download additional information on quality management systems here: