ISO
13485- Quality Management System For Medical Devices Manufacture
ISO 13485 is a
quality system standard for organizations that design, develop,
produce or service medical devices. It intends to promote
harmonization in the medical device industry and set a basis for
quality system regulations worldwide. All requirements of
ISO13485 are specific to organizations manufacturing medical
devices, regardless of the type or size of the organization.
The certification of a quality management system, specifically
for medical devices to ISO 13485 proves advantageous, and in
many cases essential, for medical companies which export their
products to global markets. Some of the additional requirements
relate to design controls, process controls (including
environmental controls), special processes, traceability, record
retention, and regulatory actions, which are more critical for
the medical device industry. |
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An ISO 13485 compliant management system adopt a risk management
approach which includes assessment to identify & estimate risk,
uses risk controls and techniques with a view to eliminate
hazardous situations throughout product realization.
Adopting this standard is beneficial to the organization in many
ways:
• It demonstrates the manufacturer's ability to supply medical
devices & related services that are compliant with all
regulatory requirements
• Assures the customers that the product complies with all
relevant product & service-oriented technical standards &
regulations
• Emphasizes the cleanliness & sterility in the production area,
which in turn increases efficiency & enhances safety at the
workplace
• Organization establishes for risk management throughout the
product realization.
ISO Certification
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