ISO
13485 Quality Manual for Medical Devices
ISO
13485 Quality Manual | ISO 13485
Quality Manual for Medical Device Software | ISO 13485
Certification Kit
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
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William Malenius, Vice President, Chief Operating Officer, Applied Cardiac Systems
Quality Manual Sample
Order Quality Manual (Item #9)
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)
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 Consultant
Software
What
is ISO 13485?
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
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