Lot traceability for medical manufacturing

Medical device plants operating under ISO 13485 must tightly control the origin of all raw materials. AMS provides lot traceability, certificates of analysis (COA) and change notification records, helping customers meet audit requirements from certification bodies and regulators.

A single lot of adhesive of unknown origin can cause an entire lot of finished products to be held or recalled. That is why material lot control is an integral part of a medical device plant's quality management system.

What ISO 13485 requires for incoming materials

The standard requires manufacturers to evaluate and select suppliers, clearly specify purchasing requirements, verify purchased products and maintain traceability. For implantable or long-term contact devices, traceability must extend down to each raw material lot used for each finished product lot.

Documentation AMS provides with every shipment

• Certificate of analysis (COA) with the actual test results for the lot.
• Original manufacturing lot number, manufacturing date and expiration date.
• Up-to-date safety data sheet (SDS) and technical data sheet.
• Biocompatibility, RoHS and REACH certificates on request.
• Shipping temperature records for cold-storage materials.

Managing changes from the manufacturer

Changes to an adhesive's formulation, manufacturing site or raw material sources can affect product validation files. AMS acts as the link that receives product change notifications (PCNs) from the manufacturer, forwards them to customers with a preliminary assessment and helps supply samples so plants can revalidate when necessary.

Medical customers are not just buying a bottle of adhesive; they are buying consistency over many years. We keep records for every lot delivered so that when a traceability request arises, the plant can receive the information as quickly as possible.

Quality Department Representative, AMS Vietnam

Internal procedures at the AMS warehouse

1. Inspect packaging, labels and COA on receipt from the manufacturer.
2. Enter goods into the warehouse management system by lot number and expiration date.
3. Ship on a first-expired, first-out basis, and do not mix lots in one package when the customer requests it.
4. Keep delivery records by customer code and lot number for two-way traceability.

Supporting supplier audits

AMS is ready to work with customers' quality departments during supplier audits, completing questionnaires and providing evidence of its management system.

Lot records are retained for at least the customer's product lifecycle or as specified in the quality agreement signed between the two parties.

Medical device plants that need fully documented material supply can contact AMS Vietnam for support.