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January 24, 2021

Template: SOP Document and Record Control

Dr. Oliver Eidel
ISO 13485

This is a free template, provided by OpenRegulatory.

A preview of the template is shown below. You can download it as Word (.docx), PDF or markdown file.

The template license applies (don't remove the copyright at the bottom).

Download as:
Beginning of template

SOP Document and Record Control

ISO 13485:2016 Section Document Section
4.2.4 (All)
4.2.5 (All)

Summary

This SOP describes how documents and records are handled.

General Considerations

This whole template assumes that you’re using Google Drive and Google Docs for your QMS. If you’re using something else, then.. good luck. Just kidding. You need to customize it, of course. There’s specialized QMS software out there which makes some of these tasks easier and lots of other tasks harder :)

Documents are expected to change over time, whereas records are created once and not altered significantly afterwards.

Documents are saved in the Quality Management System (QMS) which is a folder in Google Drive.

All documents are written in English.

Naming

Documents are named according to this schema:

TYPE-NAME

Where “type” refers to an abbreviation of the document type (see below) and “name” refers to the actual document name. An example would be:

SOP-Integrated Software Development

Document Type Abbreviations

There probably will be more types in the future when I add more templates. For now, this covers all types of the templates on openregulatory.com.

Abbreviation Description
SOP Standard Operating Procedure (Process Description)
LIS List

Record Storage

Records are not necessarily stored in the QMS folder in Google Drive. They also may reside in other applications. This is where records are currently stored:

Add all your tools which stores data which is mentioned in your QMS.

Retention Periods

Documents and records shall be stored for at least 15 years after their respective device (if they were related to one) was placed on the market.

Process Steps

1. Document Creation

This assumes you have three folders in your GDrive: “drafts”, “under review” and “released”.

New documents can be created by anyone in the company in the “drafts” folder.

Participants
Any employee
Input Output
Content New Document (draft)

2. Document Ready for Review

Once a document is ready for review, its author moves it to the “under review” folder. Importantly, the author selects appropriate reviewers and approvers and notes them at the bottom of the document.

Participants
Any employee
Input Output
Document (draft) Document (under review)

3. Document Review

The respective reviewer(s) and approver(s) review the document. If changes are required, they create comments in the Google Doc and/or suggest changes. If the review is successful, they sign their initials at the bottom of the document.

Participants
Designated reviewer(s) and approver(s)
Input Output
Document (under review) Document (review successful)

4. Document Release

Now you’ll also have to train your employees on the newly-released SOP. I’ll write some more documentation for that at another time..

The QMO moves the document to the “released” folder.

Participants
QMO
Input Output
Document (review successful) Document (released)

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

End of template

Questions?

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