Aims
Determine and implement required changes for new sites under acquisition, ensuring compliance with required standards (ISO 9001 and ISO 13485) and integration with existing global management systems. This process is ongoing for each new acquisition.
Role
Internal quality consultant and subsequent lead implementer.
Key Points
- Align quality management systems for acquisitions with global systems.
- Manage transition using a risk-based approach.
- Ensure local legal requirements are fulfilled.
Successes
- Determined gaps for German and Romanian sites and implemented required changes successfully.
- Determined no change requirements for the new UK site but provided linkages into existing management systems.
- ISO 9001 audits of new acquisitions post-alignment were all successful.
Skills
- Gap analysis
- ISO 9001 requirements
- ISO 13485
- Change management
- Document updates or creation
- Training provision
Tools used
- Word
- Powerpoint