Quality Policy Statement
UroPharma is engaged in the business of design and manufacture of medical devices.
The objective of this policy is to confirm our commitment to meeting the quality standards required by our customers in the delivery and services that we provide.
The policy itself is the subject of continues review for improvement opportunities to ensure the ongoing effectiveness of the Quality Management System.
In order to facilitate this, the business has implemented a Quality Management System that conforms with the provisions of:
EN ISO 13485:2016 - Quality Management Systems for Medical Devices
The Medical Device Directive MDD 93/42/EEC
European Medical Device Regulation MDR (EU) 2017/745
United States FDA CFR 21-820 legislation
The Quality Management System provides integrated management of all aspects of the business that are documented in Standard Operating Procedures (SOPs) and documented information for all processes throughout the business to ensure:
The Organization regularly reviews the requirements of customers and feedback, and where appropriate adopts continues improvement initiatives.
The policy and processes continue to be appropriate by initiating regular reviews to check their effectiveness and ongoing relevance.
Responsibilities for quality are established by communicating those responsibilities to all employees.
The system is effectively implemented by undertaking relevant skills training and conducting appropriate and ongoing quality awareness training.
The Organization will take into consideration all aspects of its medical devices, its general safety and performance requirements, patient suitability and user safety to ensure the device safety and efficacy. This will require a Risk Analysis that will identify all inherent risks relating to the medical devices; its outputs and as such these risks will be mitigated and will be subjected to rigorous risk reduction.
The storage and distribution of products is strictly controlled with respect to product security and hygiene, with warehousing areas providing environmental controls appropriate to the process employed.
Finally, this policy applies to all employees within the Organization and is our commitment to:
“Delivering Better Quality Treatments through Targeted Therapy”