How to Implement ISO 13485 Advisory Notices
The International Organization for Standardization (ISO) creates and publishes thousands of different standards and requirements. Businesses and organizations around the world purchase and implement ISO standards to reassure customers that their organization is at least as robust as the ISO standard requires. ISO standard 13485 pertains to the quality management systems of companies involved in the manufacture of medical devices. One of the unique aspects of ISO 13485 is the requirement that companies communicate advisory notices providing any supplementary information that could affect the device after their product has been delivered.
Create a system to issue advisory notices during the creation of the Quality Management System and quality manuals required by ISO 13485. Make sure the advisory notice procedure involves when it is appropriate to issue an advisory notice, as well as the company procedure for dealing with the response from the advisory notice. To be ISO 13485 compliant, every step of the advisory notice process must be documented and maintained according to the created procedure.
Utilize customer feedback and the production quality controls inherent in an ISO 13485 Quality Management system to identify and determine if an advisory notice needs to be issued. The Anson Group website states that advisory notices are issued to provide supplementary information or to discuss appropriate actions in the use of medical devices, the modification of medical devices, the destruction of medical devices and the return of medical devices to the supplier. Product recalls are a common reason to issue an advisory notice.
Create an advisory notice that succinctly explains the concern or modification that caused the notice to be issued.
Forward the notice to any applicable recipients. Depending upon company policy and local regulations, this may include any customers that purchased the product or local governing bodies.
Handle any feedback according to the procedures laid out in the company's quality manual. For example, in the case of a recall, the procedure may simply be to issue a credit to the customer, or it may involve the issuance and documentation of a replacement product that has passed a more strict set of quality testing. The detail involved in advisory notice feedback is only as complicated as government regulations and your company's quality management system says it has to be.
Maintain records of all advisory notice details as required by company procedures.