Sumed are currently certified to ISO 9001: 2008, and we are in the midst of intergrating our management systems to incorporate ISO 13485: 2012, ISO 14001: 2015, and ISO 9001: 2015.
We hope to be certified by this spring!
See below the scope of our integrated quality and environmental management system: for more detail see the policies attached.
The scope of the QMS applies to the manufacture, supply and distribution of medical devices for the treatment and prevention of chronic wounds, including wheelchairs and beds for medical use. The supply, manufacture, clean and repair of products for the prevention of and treatment of chronic wounds and the supply and calibration of pressure monitoring devices.
The scope of the EMS includes all activities, products and services carried out at Sumed’s manufacturing and warehouse facility based in Hadfield, Glossop.
Our EMS includes the needs and expectations of interested parties including compliance obligations and takes into account external and internal issues, which may affect the intended outcomes of the management system.