Quality - Policy - Quality Plan

Quality - Policy - Quality Plan

$200.00 AUD

The process outlined in this document will ensure that your company complies with relevant clauses of ISO 13485 (5.4), 21 CFR (820), and EU MDR/IVDR.

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Purpose of Document

A quality plan is a tool to illustrate how you intend to:

  • Create devices which meet customer requirements,
  • Ensure operations meet internal quality goals,
  • Maintain compliance with regulatory requirements and quality frameworks,
  • Facilitate traceability and objective evidence of product quality,
  • Create a baseline for training, and
  • Link to SOPs and records.

Scope of Document/s

A medical device quality plan ties together the Company’s strategic quality goals with activities, by detailing how the manufacturing organisation will create high-quality medical devices. A quality plan may be highly actionable, illustrating the specific details of how your company will meet customer requirements in daily operations.

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