ISO 13485 Standard - 7.5.3 Identification and Traceability E-mail Identification

The ISO 13485 standard separates the issue and implementation of activities and means of distinction, management, and control of the medical device into three main topics: identification, traceability, and status, describing specific requirements for each. In the spirit of the standard we will discuss each in specific detail. Identification is a serious issue that does not receive enough attention throughout our daily productive lives. I have often encountered items and products in production and storage halls where it was difficult to tell what their status was, when were they were produced, and to whom they belonged. This meant that I needed to conduct investigations and interrogations, and to trouble many people in order to receive the desired answers. Fortunately the ISO 13485 standard demands the exact definition and documentation of the all activities and elements related to identification.

According to the ISO 13485 standard, the manufacturer is expected to establish the systematic identification of its business activities and process outputs throughout the material flow into categories and characters that are in accordance with predefined needs. The objective of the identification is to ensure that products at all levels and stages of the realization process will be identified regarding their production, change, and quality status. The identification shall also eliminate the risk of mixing products, parts, or materials from different origins or with different status. Products with incorrect identification could be incorrectly submitted to a process, delivered to the customer, or may initiate contamination of other products. Through the assignment of activities, means, measures, and identifiers throughout the material flow— such as codes, tags, or product serial numbers—they will be uniquely identified. The production elements that are to be identified include:

  • Raw materials, components, and parts
  • Materials used for the production
  • Lots or batches
  • Finished goods
  • Defective or returned goods

A correct definition and implementation of identification will provide full transparency regarding the medical device:

  • It will allow the identification and tracking of all of the elements mentioned above throughout the realization processes until the delivery or disposal of the medical device; that is, storage of raw materials, components and other materials used for production, tracking inventory in process, storage of finished goods, distribution installation and service.
  • In case quality problems occur, the identification shall support the traceability of the medical device, facilitate fault diagnosis, and assist the organization in detecting defective products.
  • The identification shall provide information regarding the product’s usability status and (where applicable) shall relate to the expiry date or shelf life of materials.
  • Identification will ensure that those realizing the product use the appropriate materials, components, or items.
  • The identification shall eliminate the risk of mixing products with different status.
  • The identification shall indicate to the user when the product was manufactured or assembled, how it was done, and by whom.
  • The identification will answer risk management requirements. For example the ability to identify product characteristics related to the risk analysis or the ability to relate risks, typical hazardous situations, the associated harm and controls to a medical device through identification.

Integration of Risk Management

When planning the identification means and activities, the outputs of risk management shall be referred; and when the controls of risks are to be implemented through certain identifiers, they shall be applied; for example, serial number, model, version, production date, and expiry date. On some parts or areas of the medical device residual risks may remain and require a routine control. In order to implement the control effectively, specific identifiers are to be attached to the medical device. Such requirements may appear on the risk management plan.

Customer and Regulatory Requirements

When required, the method of identification shall integrate customer requirements for identification with its identification and traceability methods—requested labels, barcodes, qualities, protocols, or markings. In some cases, the identification will be part of the packaging instructions. When the customer delivers materials, parts, or components for assembly or use in the realization process, they will be identified. International standards, directives, or regulations related to the realization of medical devices such as the ISO 11137, ISO 11140, ISO TR 17665, or the ISO 10993, specifically require the implementation of identification methods of the materials, products, process entities, or agents that are under their scope. Requested documentation such as specific forms, and test or work instructions shall be planned and implemented. Records that are needed to prove the performance of the requirements will be maintained.

This webpage contains only a fragment of the chapter 7.5 Production and service Provision from the book: ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry published by:

CRC Press

 You may purchase the book through:



Complete Guide to Quality Management in the Medical Device Industry

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