Quality Manual Template Part 1 (ISO 13485, Medical Device)

Quality Manual Template Part 1 (ISO 13485, Medical Device)

199  (excl. GST/VAT)


Why it is useful

Having a quality manual is required by the ISO 13485 and it is strongly recommended to have one also for compliance with the Quality System Regulation (QSR). The quality manual will act as a starting point for the QMS.

How to use it

1. You may use this procedure template in your quality management system after adapting it to your needs and removing the informative text.
2. Use the template as an inspiration while authoring your own quality manual.
3. Use the template as a benchmark to check your own existing quality manual.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before the review of the document.
All texts that are not blue are example texts that can and should be edited by you and tailored to your situation.
Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text updated to suit your situation.



If you have questions about the content of the template, you may ask questions in the support forum. The support forum is accessible on this link when you are logged into your Medical Device HQ account.

Need quality management training and a course certificate?

Should want to learn more about using the template or quality management in general, it is covered in two of our public training courses: Introduction to Quality Management for Medical Devices and ISO 12385 and Quality Management for Medical Devices and ISO 12385 blended course. Our blended courses combine a self-paced online course first followed by a live virtual classroom session.

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