13485 P-833 Product Recall and Advisory Notice

ISO 13485:2016 Procedure - Product Recall and Advisory Notice - describes the process used to determine and control the recall and withdrawal of medical devices for cause, the issuance of advisory notices, and generation of regulatory reports, if required. Addresses the Medical Device Report, outlines responsibilities of the Compliance Administrator and Committee, and covers Recall/Advisory Notices.

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13485 P-833 Product Recall and Advisory Notice Sample page

Purpose:

This procedure describes Management Responsibilities for the Quality Management System (QMS) at Your Company.

Responsibilities:

Top Management is responsible for establishing the Quality Policy and reviewing it for continuing suitability.
Top Management is responsible for Communicating the Quality Policy, the importance of meeting regulatory, statutory and customer requirements.
Top Management is responsible for identifying the Key Processes to be included in the QMS.
Top Management is responsible for identifying the data required for effective review of the QMS.
Top Management is responsible for identifying the management review team.
It is the responsibility of the management review team to schedule and conduct management review meetings in compliance with this procedure.
The Management Representative is responsible for collecting summary reports and data from the responsible functions and for ensuring adequate employee awareness of the regulatory and customer requirements.
The management review team members are responsible for bringing information and progress reports on action items assigned to them at previous management review meetings, information on planned changes that could affect the QMS, quality planning needs and activities and recommendations for improvements to the QMS.