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ISO 13485 is a stand-alone QMS standard, derived from the
internationally recognized and accepted ISO 9000 quality
management standard series. ISO 13485 adapts the ISO 9000
process-based model for a regulated medical device manufacturing
environment. While ISO 13485 is based on the ISO 9001 process
model concepts of Plan, Do, Check, Act, it is designed for
regulatory compliance. Thus it is more prescriptive in nature
and requires a more thoroughly documented quality management
system.
ISO 13485 was written to support medical
device manufacturers in designing quality management systems
that establish and maintain the effectiveness of their
processes. It ensures the consistent design, development,
production, installation, and delivery of medical devices that
are safe for their intended purpose. A medical device
organization can implement to help demonstrate compliance to
laws and regulations of the medical device industry.
ISO
13485 was written to support medical device manufacturers in
designing quality management systems that establish and maintain
the effectiveness of their processes. It ensures the consistent
design, development, production, installation, and delivery of
medical devices that are safe for their intended purpose.
High quality Services. We aim to improve our technology so as to meet the exacting demands.
To achieve total customer satisfaction, we'll do our greatest to know our customer’s requirements.
Affordability is an important factor affecting low-income consumer demand for a variety of basic Service.
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ISO Certification is International System of Assessment of Management
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