Improvement General: The manufacturer shall identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. The manufacturer shall establish documented procedures for the issue and implementation of advisory notices. These procedures shall be capable of being implemented at any time. Records of all customer complaint investigations shall be maintained. If investigation determines that the activities outside the manufacturer's organisation contributed to the customer complaint, relevant information shall be exchanged between the organisations involved. If any complaint is not investigated, justification shall be documented. Any correction or corrective action resulting from the compliant handling process shall be documented. Manufacturer shall notify the adverse event to the regulatory authority and establish documented procedures for the same.