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.