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ISO 13845 Control of Documents Procedure Template
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 Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.Easy Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.Compliance 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,
Control of major changes within an organizationDocuments required for regulatory purposes/complianceDocuments of external origin required for QMS purposesIt 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
Review and Simplifies document review during annual evaluations or management review meetings.Organisation and Enhances organization and standardization across all business documentation.Identification and Facilitates the identification and location of documents during internal/external audits and sets controlled access for approved users.Prevention of Deterioration or Establishes archived folders for referencing previous document versions and effective backup systems to prevent catastrophic loss.
Why Choose Our Template?Expertly Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.Easy Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.Compliance 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,
Control of major changes within an organizationDocuments required for regulatory purposes/complianceDocuments of external origin required for QMS purposesIt 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
Review and Simplifies document review during annual evaluations or management review meetings.Organisation and Enhances organization and standardization across all business documentation.Identification and Facilitates the identification and location of documents during internal/external audits and sets controlled access for approved users.Prevention of Deterioration or Establishes archived folders for referencing previous document versions and effective backup systems to prevent catastrophic loss.
8 pages, Kindle Edition
Published June 1, 2024
About the author
Alex Lewis
39 booksLibrarian Note: There is more than one author in the GoodReads database with this name.
This is Alex^Lewis, where ^=space. (default profile)
This is Alex^Lewis, where ^=space. (default profile)
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