What is
ISO 13485:2016?
ISO 13485: 2016 (Medical devices —
Quality management systems — Requirements for regulatory purposes) is an
ISO standard that represents the requirements for a comprehensive quality
management system for the design and manufacture of medical devices. Though it
is tailored to the industry’s quality system expectations and regulatory
requirements, an organization does not need to be actively manufacturing
medical devices or their components to seek certification to this standard. ISO
13485: 2016 applies to design, development, production, installation and
servicing of medical devices. Compliance is a measure of your ability to meet
customer and legal requirements.
ISO 13485:2016 Benefits:
·
Increased access to more markets worldwide with
certification
·
Outline how to review and improve processes
across your organization
·
Increase efficiency, cut costs and monitor
supply chain performance
·
Demonstrate that you produce safer and more
effective medical devices
·
Meet regulatory requirements and customer
expectations
Certification process
·
Complete a profiling form to customize a quote
for your organization detailing the cost, planning and time required.
·
Conduct a pre-audit to determine if your
organization already fulfills the requirements for ISO 13485:2016 and identify
areas for improvement.
·
Stage 1 site visit by our auditors to verify the
profile submitted during your application and determine your readiness for
Stage 2.
·
Stage 2 on-site audit by MOODY auditors.
·
Propose and implement corrective actions, if
any.
·
Receive your audit report and certificate from
committee.
Why choose MOODY?
MOODY is a
global leader in management systems solutions, having issued various management
systems certifications to date. Our dedicated and experienced auditors across
the globe can speak your language and help you explore the possibility of
integrating your ISO 13485:2016 certification initiative with other management
systems. We can also act as a one-stop provider for all your quality
certification needs by offering bundled product testing and certification
services. With the MOODY certification mark, you demonstrate your commitment to
delivering quality products and services.