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:
- the certification bodies working hard on their internal processes
- the Auditor face a equally complex challenge. They must go though an comprehensive training and exam. Only 25% have passed up to now.
- 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.
- 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