The new standard of the EN 9100 series is based on the ISO 9001-2015 release. The standardization champagne over the last years was successful and a full harmonization over all “Management Systems” standards has been achieved. This makes life a lot easier and more effective. A few open issues still need to be addressed:

1. the certification bodies working hard on their internal processes
2. the Auditor face a equally complex challenge. They must go though an comprehensive training and exam. Only 25% have passed up to now.
3. IAQG OASIS must release the online tool for the audit management. This will greatly improve the quality of planning, communication and documentation of the audit, when operational.
4. the organization must adopt their processes and management scheme to the new requirements of the standard. Significant changes are:
   • implementation of the risk based thinking
   • implementation of knowledge management
   • implementation of human factor management
   • controlling product safety including counterfeit parts
   • design and development is also applicable when manufacturing processes need to be developed and validated

Keep up-to-date and monitor the information at IAQG-OASIS…