Quality Assurance

At BCAS Biomed we have a robust quality management system designed around managing risk in medical devices. We have been successfully supporting our customers in providing safe and effective patient care since 2005.

We are certified by the British Standards Institute to both BS EN ISO 13485 and BS EN ISO 9001 Quality Management Systems standards.

Our ongoing certification to these standards provides assurance to our customers of the high standard of medical device management they receive from BCAS Biomed and confidence that we meet all applicable regulatory requirements related to maintaining equipment, on their behalf.

We support our customers in maintaining a risk management system, and work with them to ensure compliance with BS EN ISO 14971, Application of Risk Management to Medical Devices standard.

Effective quality management results in more effective, efficient, and importantly, safer practices. BCAS Biomed facilitate our customers providing safe and effective patient care.

We are committed to continuous improvement and are regularly reviewing our own systems and services to ensure that we provide the optimal customer, and therefore patient, experience.

Our quality focus encompasses all areas of our business:

  • Staff Training: We are particularly proud of our team of specialised Biomed Engineers and work to maintain and improve their skill levels and competencies
  • Customer Service: all of our employees are engaged in some level of customer service, but most importantly our engineers, team leaders and key account managers working face to face with our customers and our team of experienced service desk operatives, who speak with our customers regularly to ensure that all of their service needs are met
  • Process and Supplier Review: we regularly audit our various sites, workshops, systems, processes and suppliers as part of our continuous improvement programme
  • Monitoring and Managing Field Safety Notices on behalf of our Clients
  • Record Management: we keep full records of all device service and maintenance history, which has complete audit trails and is accessible to our customers

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