ISO 13485:2003 to 13485:2016 Quality Manual
Upgrade Package

Save Time, Save Money, and Simplify Certification with the RIGHT QMS!

Includes 1 Free ISO 13485:2016 Online Training


Save the time and resources required to design and document an ISO 13485 Quality Management System. ISO 13485 Store has created most of it for you. The key to an effective Quality Management System is designing the documentation for efficiency and ease of use. Our documents, edited by professional technical writers, have been written in Microsoft Word so you can easily edit and customize them to make them your own. When you have questions, our experts are only an email away.

Begin with this fully documented ISO 13485:2003 to 13485:2016 Quality Manual that has been used for successful registrations across the globe. You will appreciate its ease of use – simple yet thorough. Why make it complicated?

The QMS Upgrade will:

  • Provide the tools and instructions you need to conduct your QMS Analysis
  • Provide detailed instructions to use to compare your current systems to the requirements of ISO 13485:2016.
  • Help you identify the requirements that your organization is already meeting, and those that need to be addressed
  • Give you the information you need to determine resources and a timeline for your project.

The QMS Upgrade Instructions features:

  • A detailed instructions covering every section of changes in ISO 13485:2016
  • Guidance on what to look for to evaluate your current processes and their compliance to ISO 13485:2016
  • Space for notes


  • 13485:2003 to 13485:2016 Quality Manual Instructions
  • Quality Policy Template & Sample
  • Quality Manual
  • Procedures
  • Forms referenced by the Quality Manual and Procedures
  • 3 Templates to create additional Procedures, Forms and Work Instructions
  • Technical Support

*Includes 1 Free ISO 13485:2016 Online Training (30-days to complete training).

13485:2016 QMS Procedures and Forms Matrix

Product Details

Product Type: Digital

Price: $597.00

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Which version is right for me?
  • Choose 13485:2016 to create a new 13485 Quality Management System
  • Choose 13485:2003 to 13485:2016 QMS instructions to modify your existing 13485 QMS to meet the 13485:2016 requirements
  • Choose 13485:2016 FDA QMS Upgrade to develop an integrated management system that is 13485 and FDA.QSR (21 CFR 820) compliant as of April 2016 (this is the reference date of the CFR)
  • Choose ISO 9001:2015 / 13485:2016 QMS to align ISO 13485:2016 (8 section format) with ISO 9001:2015 (10-Section Annex L Format).
    • This QMS is for organizations (like Contract Manufacturers) who want ONE QMS for both ISO 9001:2015 and ISO 13485:2016.
    • Quality Management System Templates covering both the ISO 9001:2015 (Annex L 10-section format) and ISO 13485:2016 (8-Section format) in ONE combined, Annex L manual.

If you plan to reconfigure your existing quality manual completely by yourself, you can use either of the Upgrade Instructions to create everything on your own. They will tell you where to make the changes but will NOT provide any procedure or form templates for the new requirements.


Price Each 13485:2003 to 13485:2016 QMS 13485:2016 QMS 13485:2016 FDA with QMS 13485:2016 / 9001:2015 Combined QMS
Your Price
ISO 13485:2016 Quality Manual (not sold separately) $97.00 N N
ISO 13485:2003 to 2016 Upgrade Instructions $199.00 N
ISO 13485:2016 to FDA Upgrade Instructions $199.00 N
ISO 13485:2016 / 9001:2015 Combined Quality Manual (not sold separately) N/A N
ISO 13485:2016 Procedures $300.00 26 26 27 26
ISO 13485:2016 Forms $100.00 48 48 50 65
ISO 13485:2016 Flow Charts $75.00 23 23 23
* ISO 13485:2016 Online Training $24.00 N N N N
Support FREE N N N N
Your Price

*Includes 1 Free ISO 13485:2016 Online Training (30-days to complete training).