ISO
13485 specifies requirements for a quality management system where an
organization needs to demonstrate its ability to provide medical
devices and related services that consistently meet customer and
applicable regulatory requirements. Such organizations can be
involved in one or more stages of the life-cycle, including design
and development, production, storage and distribution, installation,
or servicing of a medical device and design and development or
provision of associated activities (e.g. technical support). ISO
13485 can also be used by suppliers or external parties that provide
product, including quality management system-related services to such
organizations.
ISO
13485 certificates are issued by independent firms authorized by
national Ministries of Health to conduct audits of manufacturers
quality systems. ISO 13485 certificates are never issued by a
Ministry of Heath itself.
Barile ISO9001 Consulting
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Benefits
of ISO 13485:
-
Expand Market Access:
National
regulatory authorities require or strongly prefer that manufacturers
marketing, medical products in their countries have a third-party
audited and certified management system in place. Investing in such a
system speeds access into those countries that require it, and
expedites market entry into the others.
-
Reduce Cost Of Sales:
Your
certification establishes your company’s credibility and commitment
to quality. Because the task of explaining the specifics and
demonstrating the effectiveness of your quality system is more
straightforward, it takes less time to earn your prospective
customers’ trust and confidence.
-
Improve Performance:
Based
on a uniform and widely-accepted system of process control, your
company’s certified management system helps you improve your
products and processes. This can foster improved relationships with
your suppliers, business partners, and customers, and gives you a
real advantage in the marketplace.
ISO
13485
registration allows the company to focus its research and understand
its roles, rights and authorities. BarileConsulting Services LLC
helps business organizations throughout the United States with ISO13485 Consulting. To know more about our ISO certificate consulting
services, check our business website today. You can also dial (440)
628-8271 to get instant help from our service executives.
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