Involving a Contract Manufacturer

Applicable in the case of contract manufacturing.
(The client is the manufacturer and has the product or parts of the product manufactured through contract manufacturing.)

Package contents:

• Client notification

• Process recording

• Schedule development

• Project implementation

• Inspection of the contract manufacturer’s control system

• Preparation of the factory production control manual

• Preparation of the regulation(s) for monitoring the contract manufacturer

• Client training

• Preparation of the declaration of performance based on Annex III of Government Decree 275/2013 or EU Regulation 305/2011

• Conducting 1 internal audit

• Preparation of related documentation (in case of discrepancies, agreement on corrective actions and verification of their implementation)

• Handover of the complete documentation to the client

• Verification of the existence of required template documents

• Client notification about the delivered documentation