Complaint Handling Procedure (SYS-018)

The purpose of this complaint handling procedure is to define the requirements for documenting product complaints and investigations.

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SYS 018 complaint handling procedure 1024x606 Complaint Handling Procedure (SYS 018)

Customer Feedback and Complaint Handling Procedure

The purpose of this four-page procedure is to define your company’s requirements for gathering customer feedback, documenting product complaints, and complaint investigations. The procedure was last updated in 2021 for compliance with the European device regulations (i.e., Regulation 2017/745). The procedure is also compliant with FDA regulation 21 CFR 820.198 and the applicable sections of the Canadian Medical Devices Regulation (CMDR). This is the primary document meeting the applicable regulatory requirements for gathering customer feedback and complaint handling as defined in your company’s Quality System Manual (POL-001).

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Customer Feedback and Complaint Handling Procedure Complaint Handling Procedure (SYS 018)
SYS-018 Customer Feedback and Complaint Handling Procedure
SYS-018 Customer Feedback and Complaint Handling Procedure
Price: $299.00

Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. 

What is included with this procedure?

The complaint handling procedure includes the following documents:

  • SYS-018 A D2 Customer Feedback and Complaint Handling (Procedure in Word format)
  • LST-011 A D1 Complaint Register (i.e., Complaint Log in Excel format)
  • FRM-020 A D2 Complaint Record (Form in Word format)


Customer Feedback and Complaint Handling Procedure Complaint Handling Procedure (SYS 018)

 To view all available procedures click here

To review a sample Medical Device Academy procedure click below:

managment review sample SOP Complaint Handling Procedure (SYS 018)

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