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SOP Control of Records

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20 views1 page

SOP Control of Records

Uploaded by

gadha peter
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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GENIUS ORTHO Document No.

: QA/OP/019

Issue No.: 01
SURVEY NO 281/4, PLOT NO 1/2, NR.
UMIYA INDUSTRIAL ZONE 3, RIBDA,
Rev. No.: 00
RAJKOT, GUJARAT, 360311
Effective Date: 01/04/2018
TITLE: SOP CONTROL OF
Review Date: 01/04/2018
RECORDS
Page No.: 1 of 1

Purpose This ensures effective control, maintenance, and retrieval of all documents and
records related to the quality management system to support compliance,
quality, and regulatory requirements.
Scope This covers the review, approval, updating, accessibility, and retention of all
documents and records within the quality management system throughout their
lifecycle.
Responsibility Q. C. Manager / Q. A. Manager / Departmental Head / Technical Director

Procedure
 Identification and Storage:

 Purpose: Maintain records to show compliance and the effective functioning of the quality
management system.
 Requirements: Ensure records are clear, easily identifiable, and accessible when needed.

 Procedure:

 Develop: Create and implement procedures to manage records through their entire lifecycle.
 Processes Include:
o Identification: Label records for easy recognition.
o Storage: Store records securely to prevent loss or damage.
o Protection: Safeguard records from unauthorized access and physical harm.
o Retrieval: Facilitate easy access to records when required.
o Retention: Define and adhere to retention periods.
o Disposal: Dispose of records appropriately when they are no longer needed.

 Retention:

 Minimum Period: Retain records for at least five years from the date of product release.
 Regulatory Compliance: Follow additional retention requirements as dictated by relevant
regulations.

Function Prepared By Reviewed By Approved By

Designation

Signature

Date

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