Quality assurance
- Compliance with all relevant legislation including EN 13485 (2003); ISO9001 (2008); Medical Devices Directive 93/42 EEC
- Bespoke specialised units
- Independently managed and financed
- Not bound by EU procurement rules
- Nuffield HSSU enables our hospital to maintain the highest standards of sterile surgical instruments for use in our Theatres and as the link with the HSSU hub you will be a key member of the Theatre team.
- A bespoke re-useable medical device (instruments) decontamination service from a purpose built unit at one of 6 locations throughout England with access to fully supported and expert mobilisation and transition planning.
Our service is audited by the Notified Body SGS Ltd and identified as compliant with the following international standards and Directives:
Medical Devices Directive 93/42/EEC (and amending Directive 2007/47/EC effective March 2010);
ISO45001 Health and Safety Management System
ISO14001 Environmental Management System
ISO 13485:2003- Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.
Nuffield Health HSSU risk management strategy is based on ISO 14971:2009 – Medical Devices – Application of Risk Management for Medical Devices