ISO 13485 Quality Manual for Medical Devices

If you wish to document an ISO 13485 quality system yourself, you may purchase our "Customize It Yourself" Quality Manual for only $349.  This manual was designed for small businesses, and will save you months of documentation time, significantly reducing your costs.  Our ISO 13485:2016 quality manual for medical devices includes 25 procedures, and 42 forms/checklists which you customize specifically for your needs.  You will receive sensible/flexible procedures which, when implemented, will reduce paperwork to a minimum and will enable you to significantly improve the quality of your products/services.  

This documentation complies with both ISO 13485:2016 and the FDA’s CFR 21 Part 820: Quality System Regulation.  

Testimonial: "Your ISO 13485 documents are great!  We are way ahead of this effort."      William Malenius, Vice President, Chief Operating Officer, Applied Cardiac Systems

Quality Manual Sample  

Order Quality Manual (Item #9)

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ISO 13485 Quality Manual for Medical Device Software

If you are a manufacturer of medical devices which includes software, or where the software is the actual medical device, our ISO 13485 Quality Manual for Medical Device Software will meet your needs.  This manual complies with ISO 13485:2016 and IEC 62304:2006.  It includes 25 procedures, and 42 forms/checklists which you customize specifically for your needs.  You will receive sensible/flexible procedures which, when implemented, will reduce paperwork to a minimum and will enable you to significantly improve the quality of your products/services.  This documentation also complies with the FDA’s CFR 21 Part 820: Quality System Regulation. 

Order Quality Manual (Item #23)

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Since its foundation in 1901 as the Engineering Standards Committee, BSI Group has grown into a leading global independent business services organization providing standard-based solutions in more than 120 countries.

BSI Group:

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Overview of CE Marking for Medical Devices eLearning from BSI

Overview of ISO 14971:2007 eLearning from BSI

ISO 13485:2016 Certification Kit

If you are implementing a medical device quality management system for the first time, we recommend our ISO 13485:2016 Certification Kit for only $795.00.   This kit includes the following products: 

A pre-written quality manual, including 25 associated procedures and 42 forms/checklists  

VQC Advisor computer-based training/advisory program

Suggested implementation plan which can be modified to your needs

Computer-Based ISO Internal Auditor Training (unlimited number of students)

ISO Internal Auditor Training for Small Business Kit (includes a PowerPoint presentation and exercises and forms in MS Word format)

Order Certification Kit

ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes has been released on February 25, 2016 and provides a quality management systems model for medical device manufacturers to meet regulatory requirements.  ISO 13485:2016 includes a process model similar to that of ISO 9001:2008 but requires additional documented procedures that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The new ISO 13485:2016 does not reference the requirements of ISO 9001 but provides medical device manufacturers with a stand alone standard for quality management systems that need to demonstrate compliance to regulatory requirements.

In the United States, the Food and Drug Administration (FDA) does not intend to change the Quality System Regulation (QSR) in Title 21 Code of Federal Regulations Part 820.  US medical device manufacturers with international sales will need to maintain quality system compliance to both the FDA QSR and ISO 13485 quality system standards.  

If you are seeking a quality manual for medical devices that complies with the FDA's CFR 21 Part 820: Quality System Regulation, click here: Quality Manual for Medical Devices

If you are seeking a New Product Development and Introduction Process, click here: New Product Development and Introduction