ISO 13485 Cl 7.5.8
Clause 7.5.8 of ISO 13485:2016, titled Product Identification, emphasizes the importance of identifying products, components, and materials at every stage of manufacturing, from the receipt of raw materials to final product delivery. The main objective of this clause is to ensure proper traceability and to prevent any mix-up between conforming and nonconforming items.
ISO 13485 Product Identification methods may include serial numbers, lot numbers, barcodes, color codes, or electronic tracking systems, depending on the nature and complexity of the medical device. Organizations must establish and maintain documented procedures to describe how product identification is controlled and maintained throughout the realization process.
In addition to identifying the product, organizations are required to clearly indicate the status of the product at all times—whether it is under inspection, accepted, rejected, reworked, or released.
This helps prevent the use of unapproved or nonconforming materials and ensures that only verified and approved products proceed through the process. Status identification may be managed through physical labels, electronic systems, or tagging methods that make the product’s quality and inspection stage easily recognizable to all personnel involved.
Effective product identification and status control also ensure strong traceability, linking each product to its corresponding Device History Record (DHR), Device Master Record (DMR), and quality inspection reports.
This linkage supports efficient recall management, complaint investigations, and regulatory audits. Maintaining robust identification practices not only demonstrates compliance with ISO 13485 requirements but also safeguards the integrity and reliability of the medical device throughout its lifecycle.
Frequently Asked Questions
When should product identification begin and end?
What are acceptable methods for product identification?
Acceptable methods include serial numbers, batch or lot numbers, barcodes, RFID tags, color codes, or electronic tracking systems. The method chosen should be suitable for the type of product and ensure that identification is not lost or damaged during handling and processing.
What does “status identification” mean in this clause?
Status identification refers to clearly marking the current condition or approval stage of a product, such as “Under Inspection,” “Accepted,” “Rejected,” “Reworked,” or “Released.” It ensures that only approved and verified products are used or shipped, preventing unintentional use of nonconforming items.
What kind of records should be maintained for product identification?
Records such as Device History Records (DHRs), Device Master Records (DMRs), batch production records, inspection logs, and labeling records must be maintained. These documents provide evidence that identification and status control were maintained at all stages.
What are auditors likely to check for Clause 7.5.8 compliance?
Auditors will check for documented procedures describing identification methods, evidence of identification and status labeling in use, segregation of conforming/nonconforming products, and record linkage between product and inspection results. They may also trace a product backward from shipment to raw material receipt.