Document Control System Bundle

Who This Kit Is For

Organisations needing a full document control framework, not just training, including SOPs, master lists and change control tools.

The Compliance Problem It Solves

• Ad hoc document control with multiple spreadsheets and no single source of truth.
• Untraceable changes, missing approvals and uncontrolled templates.
• Audit findings that current versions are not consistently available at points of use.

What You Get In This Kit

• Document control SOP covering creation, review, approval, issue and obsolescence.
• Master Document List and change control log templates.
• Document numbering, classification and access control guidance.

How This Kit Reduces Your Audit Risk

• Provides a single, controlled mechanism for document creation and revision aligned with clause 4.2.4.
• Improves transparency of change history and approvals.
• Supports consistent distribution of current documents across the organisation.

How To Implement It (Step-by-Step)

1. Download the bundle and configure numbering, classifications and roles to your organisation.
2. Populate the Master Document List and migrate existing documents into the system.
3. Adopt the change control log and process for all future document changes.
4. Audit usage regularly to ensure compliance and refine processes as needed.

Technical & Regulatory Alignment

• Built for: ISO 13485:2016 clauses 4.2.3 and 4.2.4.
• Typical use: full document control across all QMS documentation.
• Document type: document control system bundle.