Control of Records Procedure - ISO 13485

ISO 13485:2016 QMS Template - Control of Records Procedure (Q.M.S.4.2.5)

Enhance your Quality Management System with our ISO 13485:2016 compliant Control of Records 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 control over records, demonstrating robust quality management as required by ISO 13485:2016.

Why Do You Need a Control of Records Procedure?

Maintaining control of records is crucial for demonstrating compliance with ISO 13485 requirements. An effective control of records procedure ensures:

• Regulatory Compliance: Demonstrate due diligence to internal and external auditors and competent authorities.
• Organized Records: Keep all QMS records secure, easily identifiable, and retrievable, ensuring they are accessible to approved members of your organization.

What Does Controlling Your Organisation’s Records Involve?

Effective record control within your Quality Management System includes:

• Secure Storage: Ensure all records are stored securely with a defined archive process.
• Retention Periods: Align record-keeping retention periods with the medical device's lifetime or applicable regulatory requirements.
• Document Management: Appoint document owners and approvers for all QMS procedures, forms, templates, and records.
• Change Tracking: Make all changes easily recognizable to maintain transparency and accountability.
• Accessibility: Store controlled records in a way that makes them easily identifiable and retrievable to approved members.

Benefits of the Control of Records Template

• Defined Process: Helps you set up a procedure that meets the requirements of the standard necessary for demonstrating compliance.
• Audit Facilitation: Enables auditors to review your records control process, showcasing your commitment to quality management.

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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