ISO 13485 Certification
ISO 13485 Medical Devices Management Systems.
ISO 13485 CertificationISO 13485 Medical Devices Management Systems
ISO 13485 is based on the ISO 9001:2000 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.
The standard contains specific requirements for manufacture, installation and servicing and calls for:
- Implementation of a Quality Management System with several enhancements
- Risk Management approach to product development and product realisation
- Validation of processes
- Compliance with statutory and regulatory requirements
- Effective product traceability and recall systems
Who can use ISO 13485?
ISO 13485 contains requirements that are essential for any organisation operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organisations whose services support medical device manufacturers.
What are the benefits of ISO 13485 Registration?Customer satisfaction
through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements.Reducing 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 organisation and its customers.Improved risk management
through greater consistency and traceability of products and use of risk management techniques.Ability to win more business
Procurement specifications often require certification as a condition to supply, so gaining certification opens doors.Proven business credentials
through independent verification against recognised standards.Ability to win more business
particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.