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Preparation of Standard Operating Procedure

Title

Preparation of Standard Operating Procedure

Category

QMS

Reference

QUALITY STANDARDS, ISO 13485, ISO 9000, 21 CFR 820

Preparation of Standard Operating Procedure
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 process SOP.

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