Quality Policies, SOPs and Forms Bundle

Quality Policies, SOPs and Forms Bundle

$7,250.00 AUD

This bundle includes the full suite of Quality Management Documents to support compliance to clauses 4 & 5 of the QMS 13485 : 2016, FDA 21CR F820 (new Quality Management System Requirements), MDR (2017/745), IVDR (2017/746). 

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Email after purchase

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Please view more information below. After purchase, you will be sent an email with a link to download the Word, Excel, PDF or Zip file.

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Purpose of Document

This bundle package will provide you with all the SOP, Policies and Form documents required to support compliance to clauses 4 & 5 of the QMS 13485 : 2016, FDA 21CR F820 (new Quality Management System Requirements), MDR (2017/745), IVDR (2017/746). 

Scope of Document/s

Included in the downloadable ZIP file are the following:

Standard Operating Procedures:

  • Writing an SOP
  • Document and Data Control
    Record Control
  • Management Responsibility
  • Management Review
  • Quality Planning
  • Continual Improvement of the QMS
  • Supplier Qualification
  • Corrective and Preventive Actions
  • Internal Quality Audits
  • Customer Complaints, Feedback and Enquiries
  • Data Analysis and Reporting
  • External Audits
  • Data Security and Disaster Recovery
  • Risk Management
  • Purchasing
  • Non-Conforming Product

Policies:

  • Quality Manual
  • Quality Policy
  • Quality Objectives
  • Privacy and Confidentiality Policy
  • Quality Plan
  • HIPAA

Forms:

  • SOP Template
  • Management Review Agenda and Minutes
  • Quality Plan (Template)
  • Quality Risk Management Form
  • Supplier Qualification Survey
  • Internal Audit Report
  • Quality Agreement (Template)
  • Master Services Agreement (Template)
  • Corrective and Preventive Action Form
  • Corrective and Preventive Action Log
  • Supplier Register
  • Risk Management Plan
  • Clinical Use and Safety Characteristics
  • Hazards Analysis
  • Risk Management Report
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