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Document Control Procedure Class II

The Document Control Procedure establishes a system for managing quality documents within the Quality Management System for Class II medical devices. It outlines responsibilities, procedures for document creation, identification, change control, distribution, and retention. Compliance with regulatory requirements and internal policies is emphasized throughout the document.

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hairulanuarsuli
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94 views2 pages

Document Control Procedure Class II

The Document Control Procedure establishes a system for managing quality documents within the Quality Management System for Class II medical devices. It outlines responsibilities, procedures for document creation, identification, change control, distribution, and retention. Compliance with regulatory requirements and internal policies is emphasized throughout the document.

Uploaded by

hairulanuarsuli
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Document Control Procedure

1. Purpose
To establish a system for control of all documents that form part of the Quality Management
System (QMS) for Class II medical devices.

2. Scope
Applies to all quality documents including SOPs, work instructions, specifications, forms,
and records.

3. Responsibilities
QA is responsible for document control. Document owners ensure timely revision and
accuracy.

4. Procedure
4.1 Document Creation
- Document drafted by functional owner.
- Reviewed and approved by QA and Management.

4.2 Document Identification


- Each document assigned unique ID, revision level, and effective date.

4.3 Document Change Control


- All revisions require Document Change Request (DCR) form.
- Changes reviewed and approved prior to release.

4.4 Distribution and Access


- Only current versions available at point-of-use.
- Electronic access managed via document control system.

4.5 Obsolete Documents


- Archived with watermark or removed from circulation.
- Retained for at least device lifecycle.

4.6 Document Retention


- Documents retained per regulatory requirements and internal policy.
5. References
ISO 13485:2016 Clause 4.2.4
21 CFR Part 820.40

6. Records
- Master Document Register
- DCR Forms
- Approval Records

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