Feature NMÉ, ETA Modification Involving a Contract Manufacturer New Product – Evaluation New Product – Standard Compliance Foreign Manufacturing
Client briefing✅✅✅✅✅
Process documentation✅✅✅✅✅
Schedule planning✅✅✅✅✅
Project implementation✅✅✅✅✅
NMÉ/ETA support (application, docs)❌❌✅❌✅
Standard project support❌❌❌✅✅
ÉMI coordination❌❌✅✅✅
Review/update existing handbook✅❌❌❌❌
Delivery of production control handbook✅❌❌❌❌
Preparation of production control handbook❌✅✅✅✅
Finalization of handbook❌❌✅✅✅
Examination of subcontractor system❌✅❌❌❌
Regulations for subcontractor❌✅❌❌❌
Documentation in English❌❌❌❌✅
On-site consultation❌❌✅✅✅
Laboratory testing (extra fee)❌❌❌✅✅
Calibration equipment review❌❌✅✅✅
Performance declaration (275/2013 or 305/2011)✅✅✅✅✅
Internal audit✅✅✅✅✅
Related documentation and corrections✅✅✅✅✅
Delivery of full documentation✅✅✅✅✅
Pre-filled template documents✅✅✅✅✅
Client briefing on delivered documentation✅✅✅✅✅