Product Realisation Planning Template - ISO 13485

Product Realisation Planning Template - ISO 13485

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ISO 13485:2016 QMS Template - Product Realisation Planning Procedure (QMS.7.0.0 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Product Realisation Planning 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 an effective product realisation planning process, demonstrating robust quality management as required by ISO 13485:2016.

What is Product Realisation Planning?

Product realisation encompasses the collection of processes involved in a product's life cycle, from conception to completion. Product Realisation Planning defines controls such as:

  • Quality Objectives and Regulations: Ensuring all quality goals and regulatory requirements are met.
  • Processes, Documents, and Resources: Identifying necessary procedures, documentation, and resources.
  • Checks and Criteria for Product Acceptance: Establishing the required checks and acceptance criteria.
  • Risk Management Processes: Documenting one or more processes for risk management.
  • Record Keeping: Maintaining the necessary records.

Why Do I Need to Carry Out Product Realisation Planning?

The ISO 13485 standard requires organizations to determine and document the above controls. Having a clear product realisation plan in place ensures:

  • Effective Analysis: Agreed-upon documentation and specifications make it easier to analyze completed work.
  • Outcome Modeling: Establishing a model for desired outcomes becomes feasible.
  • Goal Achievement: Each step taken is towards attaining the desired outcome for your medical device.

Why Patient Guard?

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