We are consultants; we are also certified ISO auditors. Every day we help companies by:
- Implementing new ISO 13485:2016 Quality Management Systems for Medical Devices
- Implementing system upgrades
- Resolving audit nonconformances
- Performing internal audits
- Providing training
- Witnessing certification and surveillance audits
Based on ISO 9001, the most widely used quality standard applicable to all types of organizations, the newly revised ISO 13485:2016 is the quality standard specific to medical devices. It incorporates many of the quality management principles of 9001 with enhanced requirements for regulatory compliance.
ISO 13485:2016 is a stand-alone standard. This means an organization can become certified to this standard without also implementing a system which satisfies all the requirements of ISO 9001:2015. However, many companies certify to both ISO 9001 and ISO 13485 to ensure a comprehensive and robust quality management system.