Master Document List Template - ISO 13485

ISO 13485:2016 QMS Template - Master Document List

Enhance your Quality Management System with our ISO 13485:2016 compliant Master Document List template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

• Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
• Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
• Compliance Assurance: Utilizing our template helps you maintain an effective Master Document List, demonstrating robust quality management as required by ISO 13485:2016.

How Will a Master Document List Help My Organisation?

• Instant Overview: Provides a quick view of essential information related to QMS documents, such as document title, revision number, and issue date.
• Revision Tracking: Easily check if documents are due for revision, ensuring you always use the most up-to-date version.
• Good QMS Practice: Demonstrates good Quality Management System practices, essential during internal and external audits.
• Staff Access: Ensures all staff can review the list to confirm they are using the correct and most current documents.
• Audit Efficiency: Facilitates easy navigation and sampling of documents during audits.

Does Maintaining a Master Document List Mean Listing Every Single Worksheet or Note?

No, only QMS procedures, forms, templates, and records must be listed, along with external standards and regulations used for compliance. However, you may also include work instructions, standard operating procedures, and other company documents to demonstrate best practices, though this is not required.

Who is Responsible for the Master Document List?

• Management Representative: Your organization will appoint a Management Representative responsible for maintaining the Master Document List.
• Delegation: The Management Representative may appoint a delegate to manage the documentation.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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