Document Control Procedure - ISO 13485

ISO 13485:2016 QMS Template - Document Control Procedure (QMS.4.2.4 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Document Control Procedure 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 effective document control, demonstrating robust quality management as required by ISO 13485:2016.

What is a Document Control Procedure?

A Document Control Procedure defines the process for generating, reviewing, and modifying documents within a specific scope, including:

• Control of major changes within an organization
• Documents required for regulatory purposes/compliance
• Documents of external origin required for QMS purposes

It determines the responsibility for each activity within the scope of document control and includes processes for managing significant changes.

How Will a Document Control Procedure Benefit My Organisation?

Implementing a Document Control Procedure offers several key benefits:

• Review and Retention: Simplifies document review during annual evaluations or management review meetings.
• Organisation and Standardisation: Enhances organization and standardization across all business documentation.
• Identification and Control: Facilitates the identification and location of documents during internal/external audits and sets controlled access for approved users.
• Prevention of Deterioration or Loss: Establishes archived folders for referencing previous document versions and effective backup systems to prevent catastrophic loss.

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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