Description
This document is a Standard Operating Procedure (SOP) Word Template for Control of Records.
Features
- Fully implementable for a paper-based or a electronic Quality Management System (QMS)
- Customisable without restrictions (parts highlighted in yellow help you to know where to customise the document)
- Compliant with ISO 13485:2016
- Tested and approved several times in EU medical devices companies
11 pages
Template version: 1.0
Table of Content
1. Purpose
2. Scope
3. References
3.1. Parent procedure(s)
3.2. Related procedure(s)
3.3 External Reference(s)
4. Acronyms & Definitions
5. Responsibilities
5.1. Management Representative
5.2. Functional Heads
5.3. Top Management
6. Procedure
6.1. Requirements applicable to Records
6.2. Identification of Records
6.3. Collection of Records
6.4. Access and Protection of Records
6.5. Storage and Maintenance of Records
6.6. Archiving of Paper Records
6.7. Disposition of Records
6.8. Customer and Legal Requirements for Disposition
7. Records
7.1. Archives
8. Annexes
8.1. Good Documentation Practice Requirements
8.2. Key Records and Retention Periods
Sample:
