ISO 9001 Post-Market Surveillance

ISO 9001 is a quality management standard that provides guidelines for organizations to establish and maintain an effective quality management system (QMS). While ISO 9001 does not specifically address post-market surveillance, it does require organizations to continually monitor and improve the effectiveness of their QMS.

As part of this requirement, organizations are expected to establish processes for monitoring customer satisfaction and complaints, which can include post-market surveillance activities. These processes should be designed to identify and address any issues or nonconformities related to products or services after they have been delivered to customers.

ISO 9001 also requires organizations to establish and maintain procedures for product recall and investigation of customer complaints, which are important elements of post-market surveillance. These procedures should include requirements for identifying and assessing the root cause of problems, implementing corrective and preventive actions, and tracking the effectiveness of these actions.

Additionally, ISO 9001 requires organizations to periodically review the performance of their QMS to ensure that it remains effective and meets the organization's needs. This review should include an assessment of post-market surveillance activities to identify opportunities for improvement.

Overall, while ISO 9001 does not specifically address post-market surveillance, it provides a framework for organizations to establish processes for monitoring and improving the effectiveness of their QMS, which can include activities related to post-market surveillance.

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