Control of Documented Information - ISO 9001

Control of Documented Information - ISO 9001

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ISO 9001:2015 QMS Template - Control of Documented Information (QMS.7.5.3 - QP)

Elevate your Quality Management System with our ISO 9001:2015 compliant Control of Documented Information template, crafted by the experts at Patient Guard. Our Quality Assurance and Regulatory Affairs document templates are meticulously developed by seasoned professionals, ensuring they meet every clause and section of the standard or regulation they address.

Why Choose Our Template?

  • Expertly Curated: Our templates are designed by experienced Quality Assurance and Regulatory Affairs specialists, guaranteeing compliance with ISO 9001:2015 requirements.
  • 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: Using our template helps you establish a robust document control procedure, ensuring your organization meets ISO 9001:2015 standards for managing documented information.

Importance of a Document Control Procedure

Maintaining a control procedure for documented information is crucial for:

Review and Retention of Documents:

  • Simplifies document navigation during annual reviews or management review meetings.
  • Enhances organization and standardization across business documentation.

Identification and Control:

  • Facilitates identifying and locating documents ahead of and during external/internal audits.
  • Establishes controlled access for approved users.

Prevention of Deterioration or Loss of Documents:

  • Provides archived folders for referencing previous document versions.
  • Implements effective backup systems to prevent catastrophic document loss.

Defining Responsibilities:

  • Clarifies responsibilities for each activity within the scope of Document Control.
  • Includes processes for managing major changes within an organization.

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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