Justification records are maintained for non-valid complaints. If the complaint is declared to be non-valid due to substantial reasoning (for example, the defect resulted from mishandling of the device, misinterpretation of a particular issue as a defect, etc.), the customer is notified and no further proceedings are made.
#Iso 13485 compliance iso
The organization is mandated, according to ISO 13485:2016, to implement a complaint-handling procedure that addresses the following: Moreover, clause 8.2.2 of ISO 13485:2016 defines the procedural requirements of complaint handling for medical device suppliers. ISO 13485 considers complaints to be one of the mandatory inputs in management review (in the scope of clause 5.6.2 (b)), unlike ISO 9001:2015. ISO 13485:2016 addresses complaint handling more clearly than ISO 9001:2015 – for example, involving complaints in risk management or identifying complaint-handling procedural requirements.
On the other hand, ISO 13485:2016 specifies the scope of a complaint by defining it as a “written, electronic, or oral communication that alleges deficiencies” in the following aspects of a medical device: ISO 9001:2015 defines a complaint as an expression of dissatisfaction with a product or service, which is filed by a customer and received by an organization. ISO 13485 deals with medical devices, and as the severity of adverse effects of these devices is quite high, the standard emphasizes additional controls for complaint management. Complaint management is an important part of customer relationship management and like every other quality standard, ISO 13485:2016 emphasizes strong controls over complaint handling. Therefore, during the production, sales, and other customer-related processes, complaints are a vital and integral part of this industry. Medical devices, implants, and surgical instruments are critical healthcare products in which consumers and practitioners look for high precision and accuracy.