ISO13485 - 7.5.3 Identification and traceability

7.5.3.1 Identification The organization shall identify the product by suitable means throughout product realization, and shall establish documented procedures for such product identification.

The organization shall establish documented procedures to ensure that medical devices returned to the organization are identified and distinguished from conforming product [see 6.4 d)].

7.5.3.2 Traceability

7.5.3.2.1 General The organization shall establish documented procedures for traceability. Such procedures shall define the extent of product traceability and the records required (see 4.2.4, 8.3 and 8.5).

Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

NOTE Configuration management is a means by which identification and traceability can be maintained.

7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices In defining the records required for traceability, the organization shall include records of all components, materials and work environment conditions, if these could cause the medical device not to satisfy its specified requirements. The organization shall require that its agents or distributors maintain records of the distribution of medical devices to allow traceability and that such records are available for inspection. Records of the name and address of the shipping package consignee shall be maintained (see 4.2.4).

7.5.3.3 Status identification The organization shall identify the product status with respect to monitoring and measurement requirements. The identification of product status shall be maintained throughout production, storage, installation and servicing of the product to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is dispatched, used or installed.