ISO 13485 is an
international standard for the design, manufacture and distribution of medical
devices. ISO 13485:2012 is the latest version by ISO. This standard is based on the
ISO 9001:2008 process model approach.
ISO 13485 certification
process based approach which define, implement, and improve effectives of
quality management system that they expected by customers and regulatory
requirements. The main aim of ISO 13485:2012 is to facilitate harmonized
medical device regulatory requirements for quality management systems.
ISO 13485 Certification is closely aligned to
other management standards such as ISO 9001, ISO 14001 and OHSAS 18001
providing a great opportunity for integration and synergy with other quality
systems.
BENEFITS OF
IMPLEMENTING ISO13485 STANDARDS:
The main internal
benefits of 13485 standard is that it indicate a preventive approach to
assuring medical device quality which the process inspection and rejection are
done at the end of the manufacturing line.
· Its provides a systematic framework for to define, implement, measure
and analyze the process of business operation and customer opinion.
· It provides a systematic framework on monitored base that resulting in
less waste and fewer complaints.
· Reduction of operating costs, reduction of nonconforming products costs,
raw materials, energy and other resources saving.
·
This standard focused to improve the performance in areas such as sales,
product delivery, and process efficiency.
·
Its reduce costs as a result of minimizing product failures.
· Through ISO 13485 standard organization access to the competitive edge
with our independently.
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