ISO 13485 is based on the ISO 9001:2008 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.

Benefits of certification:

◆ Customer satisfaction – through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements

◆ Reduced operating costs – through continual improvement of processes and resulting operational efficiencies

◆ Improved stakeholder relationships – including staff, customers and suppliers

◆ Legal compliance – by understanding how statutory and regulatory requirements impact the organization and its customers

◆ Improved risk management – through greater consistency and traceability of products and use of risk management techniques

◆ Proven business credentials – through independent verification against recognized standards

◆ Ability to win more business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector