Ashcon has ISO9001 certification it demonstrates that we have been independently audited and have a formalized set of business processes in place. We have:
- A quality policy
- A quality management system
- Comprehensive procedures covering all business processes
- Monitoring and control systems in place to ensure that processes are effective
- Record keeping
- Defect checking
- Corrective actions to resolve defects
- Regular reviews and internal audits of your processes and their effectiveness
- Continuous improvement
ISO 13485 is similar in many ways to ISO 9001 but is specifically for the design and manufacture of medical devices.
A positive external assessment of ISO 13485 conformance is authorisation to CE identify your medical device and sell it within the European Union.
Evidence of ISO 13485 is also a positive step in demonstrating compliance with the 21 CFR 820 Quality System Regulation for Medical Devices sold in the USA