How ISO 13485 Is Implemented

How ISO 13485 is implemented

ISO 13485:2012 is the most widely applied medical-device quality management standard in its field. It is aligned with current regulatory requirements and is structured to make compliance with those requirements practical for manufacturers and their suppliers. Implementing the standard therefore supports regulatory compliance, product quality, and customer satisfaction at the same time.

The practical implementation of ISO 13485 is organized around product risk. The risks associated with a medical-device product should be assessed and tracked throughout the product lifecycle. Every risk analysis should be recorded and retained as evidence.

Medical-device risk assessment is also a core part of product quality, not a separate exercise carried out only for regulatory purposes.

Required inputs and outputs of risk assessment

The inputs and outputs of the risk-assessment process should be documented and, as a minimum, should cover the items listed below:

• Intended use and description of the medical device and its components
• The list of risks identified through the risk assessment
• Methods used to minimize identified hazards
• Identification of the team carrying out the hazard analysis
• Environmental risk assessment
• Clinical commentary on the medical device
• Identification of interactions between the medical device and other devices or medicinal products
• Electromagnetic or other energy emissions of the medical device into its surroundings
• Environmental emissions of the medical device
• Defined periodic maintenance of the medical device
• Defined service life of the medical device
• Effects of long-term use of the medical device
• Definition of how many times the medical device can be used
• Test result documentation for the medical device, where applicable
• Customer-satisfaction records
• Corrective and preventive actions
• Management review activities

These elements together make the risk file auditable and give the internal quality team and the certification auditors a clear evidence trail during Stage 1 and Stage 2 audits.