Quality Assurance

Quality Accreditation

Avicenna Surgical operate a quality management system that ensures we continue to deliver the standard of product quality and service our customers require.

Driven from the very top of the Avicenna Surgical organisation, our commitment to quality runs in parallel with all our business processes. We place the highest importance on fulfilling the requirements of all our business stakeholders, and continuously seek to exceed their expectations wherever possible.

We operate a unique and bespoke Quality Management system that ensures our ongoing accreditation to ISO 13485:2016 and ISO 9001:2015, and work with BSI and SGS to ensure our compliance and regulatory obligations are consistently met. Our comprehensive and expansive Quality Management System has met with the enthusiastic approval of our Notified and Approved Bodies, and it’s flexible nature allows us to quickly adapt to new requirements and legislation.

Our quality culture also extends to Avicenna suppliers, who are carefully selected on the basis of their ability to meet our high standards, while our team is constantly seeking feedback from customers to ensure their needs are met and explore any opportunities or recommendations. Overall, we aim to ensure a mutually beneficial and open partnership with our customers and suppliers, so that all parties can collaborate on quality improvements and new innovations.

MD 704213 FS 685547 EMS 751485

Day-to-day quality activities at Avicenna Surgical include but are not limited to:

  • Vigilance – we operate a variety of processes to ensure we gather as much intelligence and feedback from our marketplace as possible, which helps us minimise risk and drive product and service improvements
  • Risk management – the mitigation of risk forms the foundation of all of our business activities, including overarching business continuity down to the control of product-based risk in accordance with ISO 14971:2019
  • QC inspection – our production processes have inspection steps built in at all stages, to ensure that only the highest quality products are released to our customers
  • Data analysis – we have set strict quality and business objectives, which we monitor and review on a regular basis
  • Auditing – all processes and departments of our organisation are subject to our internal audit regime, a practice that we also extend externally to our suppliers
  • Training and development – we are committed to getting the very best from our team by providing opportunities for growth and development wherever possible
  • Infrastructure – the Avicenna facility operates under 5S guidelines and a strict maintenance regime, a philosophy that also extends to our suppliers