Document Control System Audit Checklist [FREE PDF]
Quality managers and document controllers use this checklist to audit the document control system per ISO 9001:2015 Clause 7.5 documented information requirements for creation, update, and control.
- Industry: Manufacturing / General
- Frequency: Annually
- Estimated Time: 20-25 minutes
- Role: Document Controller
- Total Items: 8
- Compliance: ISO 9001:2015 Clause 7.5, 21 CFR Part 11
Document Control System
Verify document creation, approval, and revision control.
- Are documents reviewed and approved for adequacy before issue?
- Are current revision statuses clearly identified on all controlled documents?
- Are obsolete documents prevented from unintended use?
- Control system notes
Distribution & Retention
Verify document distribution and retention practices.
- Are current documents available at all points of use?
- Are records retained per the documented retention schedule?
- Are electronic documents backed up with protection against unauthorized changes?
- Distribution notes
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Why Use This Document Control System Audit Checklist [FREE PDF]?
This document control system audit checklist [free pdf] helps manufacturing / general teams maintain compliance and operational excellence. Designed for document controller professionals, this checklist covers 8 critical inspection points across 2 sections. Recommended frequency: annually.
Ensures compliance with ISO 9001:2015 Clause 7.5, 21 CFR Part 11. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Document Control System Audit Checklist [FREE PDF] cover?
This checklist covers 8 inspection items across 2 sections: Document Control System, Distribution & Retention. It is designed for manufacturing / general operations and compliance.
How often should this checklist be completed?
This checklist should be completed annually. Each completion takes approximately 20-25 minutes.
Who should use this Document Control System Audit Checklist [FREE PDF]?
This checklist is designed for Document Controller professionals in the manufacturing / general industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.