sop-document-record-control

Copy the text below to a new Google Doc.

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. The goal is to understand how documents are typically structured and in what states they can be as they move from draft to release. It’s similarly important to always have the most recent document available at the specified location while ensuring that changes to documents can be traced.

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.

All documents are written in English.

Document Names

Documents are named according to this schema:

ASSOCIATED PROCESS-TYPE-NAME

Where “associated process” can be abbreviated in capital letters and “type” refers to an abbreviation of the document type (see below). “Name” refers to the actual file name. An example would be:

SWD-SOP-Integrated Software Development

For released documents, we add a “-a” suffix (as in: approved) to the document name. An example would be:

SWD-SOP-Integrated Software Development-a

For archived documents, we add a “-archived_ARCHIVE DATE” suffix to the document name. An example would be:

SWD-SOP-Integrated Software Development-archived_2021-03-01

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
AM Attachment
LIS List
SD Supporting Documentation
SOP Standard Operating Procedure (Process Description)
TPL Template

Retention Periods

QMS documents and records shall be stored for at least 10 years after their archival date.

Technical Documentation shall be stored for at least 10 years after the lifecycle of the respective device has ended.

Review Periods

We review our QMS documents typically once per year to ensure they remain up to date.

Our core and safety processes as defined in the quality management manual must be reviewed at minimum once per year. All other processes and associated documents can be reviewed every three years once they have been reviewed before without any findings.

QMS Document List

We keep an overview list of all QMS documents, including document type, release date, next review date and respective process owners.

Process Steps

Handling of Documents

1. Creation of Documents

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

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

New documents can be created by anyone in the company in the “drafts” folder. Naming of documents follows the general considerations of this SOP (see above). Standard Operating Procedures (SOP) should specify a process owner responsible to typically update, review and release all associated documents.

Participants
Any employee
Input Output
Content New Document (draft)

2. Documents 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. Review of Documents

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
Process owner and/or designated reviewer(s) and approver(s)
Input Output
Document (under review) Document (review successful)

4. Release of Documents

The Process Owner moves the document to the “released” folder and assignes “-a” to the document name as outlined by the general considerations for document naming.

Access to the “released” folder is restricted to prevent unauthorized changes to released documentation.

The QMO (and, if applicable, the process owner) decide if employee training is required. In general, training for minor changes/corrections is not necessary.

Participants
QMO, Process Owner
Input Output
Document (review successful) Document (released)

5. Changes to Documents

If changes need to be made to a document, any employee with knowledge about the document and those changes can perform them. For that, the currently-released document is copied to the “drafts” folder and edited by the employee. After finishing the edit, it moves to the Document Ready for Review stage (step 2), following the same steps as above.

A QMS change can trigger a substantial change so you’ll have to assess that when changing documents. Will come up with a method for that in the future, but for now, you have to come up with your own.

Note: A QMS change can trigger a substantial change. The changed document shall be assessed for whether it resembles a significant QMS change through <add method>

Participants
Any employee
Input Output
Document (released) Document Copy (draft)

6. Archiving of Documents

Documents get archived if they become obsolete or a newer released version becomes available. For that, the Process Owner moves the document to the “archive” folder and assignes a respective archiving date following the general considerations for document naming in this SOP. We observe retention periods as outlined in this SOP and delete documents as soon as the retention period expired.

Participants
Process Owner
Input Output
Document (released) Document (archived)

Handling of Records

1. Creation of Records

We create records as required by our processes. If available, we use templates and checklists for the creation of records. Naming conventions as outlined for documents do not apply. Records should include an author name and the date of creation.

Participants
Any employee
Input Output
Content, Template Document (if applicable) New Record

2. Review and Release of Records

Unless specified differently in a template or SOP, records do not typically require a review and release process.

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

3. Storage of Records

Records are not necessarily stored in our QMS folder. They also may reside in other applications as specified per respective processes. This is where records are typically stored:

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

4. Changes to Records

Records are not significantly altered after release. Where significant changes are required, we rather create a new record and archive the old one. Non-substantial changes (e.g. spelling mistakes) are considered corrections only, assessed and added on a case-by-case basis.

Participants
Any employee
Input Output
Record (released) Record (updated)

5. Archiving of Records

Records are archived if they become obsolete or a new released version becomes available. For that, the process owner moves the records to a respective archiving location. If possible, we follow the general considerations for document names and add the archiving date to the record name. We observe retention periods as outlined in this SOP and delete records as soon as the retention period expired.

Participants
Process Owner
Input Output
Record (released) Record (archived)

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