What is ISO 13485?
ISO 13485:2016 is based on the ISO 9001 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.
Helps you with
- Quality Control
- Risk Management
- Legal Compliance
- Traceability and Recall
- Process Improvement
- Product Improvement
- Operational Efficiency
Steps to Certification
Complete a Quote Request Form so that we can understand your company and requirements. You can do this by completing either the online quick quote or the online formal quote request form. We will use this information to accurately define your scope of assessment and provide you with a proposal for certification.
Once you’ve agreed your proposal, we will contact you to book your assessment with an NQA Assessor. This assessment consists of two mandatory visits that form the Initial Certification Audit. Please note that you must be able to demonstrate that your management system has been fully operational for a minimum of three months and has been subject to a management review and full cycle of internal audits.
Following a successful two stage audit, a certification decision is made and if positive, then certification to the required standard is issued by NQA. You will receive both a hard and soft copy of the certificate. Certification is valid for three years and is maintained through a programme of annual surveillance audits and a three yearly recertification audit.