| ISO 13485:2016 Section | Document Section |
|---|---|
| 4.2.4 | All |
| 4.2.5 | All |
Overview
This SOP outlines the procedures for managing documents and records within the organization. It ensures clarity on document structure, states during the document lifecycle, and facilitates traceability of document changes. The most recent versions of documents must always be accessible at designated locations.
| Process Owner | \ |
| Key Performance Indicators | \ |
General Considerations
This template assumes the use of Google Drive and Google Docs for the QMS. If you are using a different tool, the process must be tailored accordingly. Specialized QMS software may simplify some tasks while adding complexity to others. Specify the platform used for managing and storing QMS documents in this section.
Documents are dynamic and may evolve over time, while records are typically finalized and minimally altered after creation.
All documents are to be prepared in English.
Document and Record Naming
Documents must follow this naming convention:
ASSOCIATED PROCESS-TYPE-NAME
- Associated Process: Abbreviated in uppercase letters.
- Type: Abbreviation of the document type (refer to the table below).
- Name: Descriptive file name.
Example: SWD-SOP-Integrated Software Development
For approved documents, append a “-a” to the file name:
Example: SWD-SOP-Integrated Software Development-a
For archived documents, include a “-archived_ARCHIVE DATE” suffix:
Example: SWD-SOP-Integrated Software Development-archived_2021-03-01
Product records are labeled with the device number, version, and associated process:
Example: PR1-V1.2-SWD-SWDP-Software Development Plan
Document Type Abbreviations
| Abbreviation | Description |
|---|---|
| AM | Attachment |
| LIS | List |
| SD | Supporting Documentation |
| SOP | Standard Operating Procedure (Process Description) |
| TPL | Template |
Retention Periods
- QMS Documents and Records: Retained for at least 10 years after archiving.
- Technical Documentation: Retained for at least 10 years after the respective device’s lifecycle ends.
Review Periods
QMS documents are reviewed periodically based on a risk-based approach:
- Category A: Following initial release or a new version, documents are reviewed within 6 months. If no updates are required, the status changes to Category B.
- Category B: After one cycle without changes, documents are reviewed annually. If updates are needed, the status reverts to Category A; otherwise, the status advances to Category C.
- Category C: After two cycles without changes, documents are reviewed every 3 years. If updates are necessary, the status resets to Category A.
- Core and Safety Processes: Reviewed annually (maximum Category B).
- Audit Findings or Corrective Actions: The QMO may set shorter review periods.
A master list of all QMS documents, including type, release date, next review date, and process owners, is maintained.
Process Steps
Document Management
1. Document Creation
Documents are created and saved within the QMS folder in Google Drive. Drafts are stored in the “drafts” folder. Naming conventions must be adhered to, and SOPs should specify process owners responsible for updates and reviews.
| Participants |
|---|
| Any employee |
| Input | Output |
|---|---|
| Content | New Document (draft) |
2. Moving Documents to Review
Once ready for review, the author moves the document to the “under review” folder, selecting reviewers and approvers and noting them within the document.
| Participants |
|---|
| Any employee |
| Input | Output |
|---|---|
| Document (draft) | Document (under review) |
3. Document Review
Reviewers provide feedback, make suggestions, or approve the document. Successful reviews are marked with initials at the document’s bottom.
| Participants |
|---|
| Process owner, designated reviewers, approvers |
| Input | Output |
|---|---|
| Document (under review) | Document (review complete) |
4. Document Release
Approved documents are moved to the “released” folder, renamed with a “-a” suffix, and access is restricted to prevent unauthorized changes. Training is provided as necessary.
| Participants |
|---|
| QMO, Process Owner |
| Input | Output |
|---|---|
| Document (review complete) | Document (released) |
5. Document Revisions
Revisions are initiated by copying the current version into the “drafts” folder, editing it, and following the review process. Substantial changes require evaluation to ensure continued regulatory compliance.
| Participants |
|---|
| QMO, Any employee |
| Input | Output |
|---|---|
| Document (released) | Document Copy (draft) |
6. Archiving
Archived documents are moved to the “archive” folder, renamed according to guidelines, and retained based on defined periods.
| Participants |
|---|
| Process Owner |
| Input | Output |
|---|---|
| Document (released) | Document (archived) |
Record Management
1. Record Creation
Records are created using templates or checklists where applicable and must include the author’s name and creation date.
2. Record Review and Release
Unless specified otherwise, records do not require formal review or release processes.
3. Record Storage
Records are stored in designated locations, including external tools like GitHub or ZenDesk, depending on the process.
4. Record Revisions
Significant changes to records result in the creation of a new record. Minor corrections are addressed case by case.
5. Record Archiving
Obsolete records are archived in designated folders, adhering to retention policies.