Preparation of Standard Operating Procedure
Preparation of Standard Operating Procedure
Reference: D & C Act, Medical Device Rule -2017, ISO 13485:2018, EU Medical Device Regulation etc.
1. Objective
This document outlines the steps to create a Standard Operating Procedure (SOP) for preparing Standard Operating Procedures. It is intended to provide a clear and standardized approach to document creation.
2. Scope
This standard operating procedure is applicable for preparing, reviewing, and approving the standard operating procedure at the Bhargava Consulting Group.
3. Responsibility
3.1. The department head is responsible for ensuring that the SOP for the department is prepared, reviewed, and approved.
3.2. The process owner is responsible for preparing the SOP of the process.
3.3. The department in charge, second in command, or department head is responsible for the review of the SOP of the department.
3.4. The Quality head or Management Representative is responsible for the approval of the SOP.
3.5. The senior person next in command is responsible for the case of process owner is not available.
4. Reference
4.1. ISO 13485: 2016 – Medical Device Quality Management System.
4.2. ISO 9001: 2015 - Quality Management System
4.3. EU- MDR 2017/745(746) – Medical Device Regulation (EU)
For more details and comments, please visit us at www.bhargava.net.in or contact us via email at Bhargava@bhargava.net.in.
This content is restricted, and no one is allowed to publish it without the written consent of Bhargava Consulting Group.