Quality-SOP-QualityPlanning-cover

Quality - SOP - Quality Planning

$250.00 AUD

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

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Purpose of Document

Quality planning is an essential quality management process used by Top Management to plan how a company will meet its strategic goals and implement its Quality Policy.

The purpose of this procedure is to describe the quality planning process of your company which is used to:

  • Determine applicable standards and regulations
  • Manage process and product changes
  • Define the Quality Policy and top-level Company/Quality Objectives
  • Commit the necessary resources and training
  • Prioritise activities and/or projects if required
  • Establish key performance indicators
  • Define contingency plans, and
  • Assign responsibilities and due dates.

An effective and well-communicated quality planning process ensures your compliance with 21 CFR 820, ISO 13485 (5.4) and EU MDR/IVDR.

Scope of Document/s

This procedure applies to the quality planning process performed by Company’s Top Management at least annually. The resulting Quality Plan applies to the entire Company organisation.

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