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.
- GitHub (Issues, Pull Requests)
- ZenDesk (Customer Support Tickets)
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) |
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Please don’t remove this notice even if you’ve modified contents of this template.