eQMS for contract manufacturers and critical suppliers

Contract manufacturers sit in someone else's device master record and in their own quality system. The records have to show both.

ISO 13485 clause 4.1.5 says the organization that outsources a process stays responsible for it. Clause 7.4 says the buyer must control the supplier. If you are the contract manufacturer, you are on the receiving end of those clauses and you still need your own QMS: incoming materials, production records, nonconforming product, CAPA, and often your own suppliers. Customers will audit you. An MDSAP auditing organization may audit you if you are a critical supplier in scope.

HAVGATE supplier management is written first for the buyer. As a contract manufacturer you can still use it for your sub-tier suppliers, and you can use audit management for internal audits and for the customer audits you host. CAPA should make ownership explicit when the customer owns the design action and you own the process correction. Document control holds your procedures, not your customer's device master record, unless the quality agreement says you maintain a copy.

Quality agreements should name change notification, traceability, nonconforming product and who speaks to the regulator. Store the agreement as a controlled document and keep the operational points on the customer or supplier record you actually review. Re-evaluation dates apply to your suppliers even when you are busy being audited yourself.

Pricing and the trial are the same published plans as for a legal manufacturer. There is no separate contract-manufacturer price. There are also no customer names on this page.