Template – SOP Controlled Documents (v.1.0)

Template – SOP Controlled Documents (v.1.0)


SKU: AA003 Category: Tags: ,


This document is a Standard Operating Procedure (SOP) Word Template for Controlled Documents.


  • 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

Customers purchasing the document will received the next versions for free.

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 and Definitions
5. Responsibilities
6. Procedure
6.1. Identification of Controlled Documents
6.1.1. Department Numbers
6.2. Format of Documents
6.3. Periodic review
6.4. Retention period
6.5. Creation, update and obsoletion
6.6. Approval manifestations
6.7. Audit Trail
6.8. Distribution of Controlled Documents
7. Records 9
8. Annexes 9
8.1. Two-letter language code based on ISO 639-1 9



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