Quality - Policy - Quality Manual

Quality - Policy - Quality Manual

$700.00 AUD

The Quality (Company) Manual is an external-facing document that serves as a comprehensive summary outlining the Company’s quality management system (QMS) in compliance with applicable regulations, standards, and internal policies and procedures. It demonstrates simultaneous compliance with the applicable clauses of ISO 13485:2016, 21 CFR 280 (QSR), MDR (2017/745) and IVDR (2017/746).

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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 Quality Manual has been written to be compliant with ISO 13485: 2016, 21 CFR 820 and MDR (2017/745) and IVDR (2017/746). Your Company will need to carefully review the recommended text and inclusions against your specific products, jurisdictional requirements, and the layout of your QMS.

All SOPs, Policies and Forms referenced herein, are available in the DevDx document library and have been allocated identifiers according to function/process/business unit (Refer Appendix 1). These documents are all cross-referenced for ease of use and can be used with minimal customization “out of the box”. Your Company can accept the document identifiers as is or will need to change them to suit your needs.

Scope of Document/s

The Policies, SOPs, Work Instructions or Forms stated in this Quality Manual apply to all applicable operations and activities at your company.

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