Our Quality Management System (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction, aligned with our strategic direction. It is expressed as the organisational structure and goals, policies, processes, documented information and resources needed to implement and maintain it. It is a reflection of what our organisation does, how it is done and how it is managed.
We are committed to ensuring our products, services and staff meet the requirements of the following international standards:
ISO 9001 - Quality Management System for the provision of computerised cognitive testing systems and consultancy for academic research, pharmaceutical and healthcare customers, including associated training, technical support and data processing services.
ISO 13485 - Quality Management System for the provision of computerised cognitive testing systems and consultancy for clinical assessment by healthcare and research professionals.
Cambridge Cognition also ensures that national and international statute, law or guidelines appropriate to our products and services and client requirements are followed appropriately. These include Data Protection and Privacy, Good Practices Regulation, Title 21 of the Code of Federal Regulations, and meeting regulatory guidelines on Medical Device Reporting and Medical Device Databases.
The British Standards Institution (BSI) a respected, world classed organisation with over 100 years of expertise is our ‘Notified Body’ and provides us with rigorous regulatory and quality management reviews and product certifications.
The Medicines & Healthcare products Regulatory Agency (MHRA) is our ‘Regulatory Authority’, responsible by law for safeguarding public health by ensuring that healthcare products and medical equipment meet appropriate standards of safety, quality, performance, effectiveness and are used safely.