Quality excellence governs all we do.

Our consistent approach to manufacturing and supplying the highest quality products, ensures that we not only surpass our customer service requirements but that we also conform to all applicable regulatory requirements. Delivering these standards is the primary business KPI, within the BBI Group.

Each operational site measures their success against this primary objective via a range of processes, these include:

  • Rigorous internal audit processes
  • Certification / notified body audits
  • Regulatory body audits
  • Customer satisfaction results
  • Customer site audits
  • Product performance evaluations
  • Regulatory Controls

Operating in an ever changing regulatory landscape, our BBI sites pride themselves on being market leaders, having effective change controls in place to support regulatory changes. Our position ensures that all products developed and manufactured are fit for purpose, and comply with individual country specific regulations and/or safety requirements that are applicable to our business.


We understand the importance of an effective SIPOC (Suppliers – Inputs – Process – Outputs – Customers) process and stringent controls are applied, across all of our outsourced processes.

In our aim to achieve process excellence, we ensure that all internal processes are:

  • Monitored
  • Measured
  • Effectiveness maintained
  • Continually improved

We pride ourselves on fully supporting our customers and partners, at each stage of product development – from robust design and development through to product registrations.

Our People

Rigorous recruitment, training and development of all BBI Group personnel is evident from the level of expertise within the business.

All personnel have annual objectives, which are aligned with strategic business objectives, ensuring that everyone understands the importance of surpassing customer and quality requirements. Being part of this critical process ensures that our personnel recognise and value their individual contribution, as process owners.

Quality Control & Quality Assurance

Each site follows strict Quality Control and product release protocols, which coupled with effective Quality Assurance processes ensure our products meet stringent product quality, safety and customer requirements.

Our business success, is proof of our commitment to compliance and customer service and further demonstrated by our certified Quality Management Systems.

You will find links to our ISO certifications in the table below:


Site Document(s)
Group Quality Policy
Cape Town SA ISO 13485:2016 certificate
Crumlin ISO 13485:2016 certificate
Porton Down ISO 13485:2016 certificate
Sittingbourne ISO 13485:2016 certificate
Edinburgh ISO 13485:2016 certificate
Portland, Maine ISO 13485:2016 certificate
Freiburg ISO 9001:2015 certificate
ISO 13485:2016 certificate

Get in Touch…

If you have a query regarding our compliance status, please contact our Global Quality team by emailing quality@bbisolutions.com