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ISO 13485/13488: Medical device industry
Overview
ISO 13485/13488 is a quality standard for organisations that
design, develop, produce or service medical devices. It is
intended to promote harmonisation in the medical device industry
and set a basis for quality system regulations worldwide.
It includes specific requirements for medical devices and
excludes some of the requirements of ISO 9001 that are not
appropriate to the medical device industry. All requirements
of ISO 13485/134588 are specific to organisations providing
medical devices, regardless of the type or size of the organisation.
ISO 134585/134588 certification
Doctors and medical professionals use sophisticated medical
devices on an everyday basis. ISO 13485/13488 is a single
standard for all classes of medical devices and its scope
includes design and manufacture. It is a key regulatory consideration
for allowing medical device manufacturers to market their
products around the globe.
Manufacturers of high-risk medical products must be associated
with a notified body to vouch for the product's quality. This
is achieved through product testing and auditing of the manufacturer's
quality management system.
TUV India is a notified body for all medical products. It certifies
products and QM systems for the European market as well as for
non-European countries.
Benefits of adoption
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Demonstrates the manufacturer's ability
to supply medical devices and related services that are
compliant with all regulatory requirements |
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Adoption of this standard assures the customers
that the product complies with all relevant product and
service-oriented technical standards and regulations |
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Cleanliness and sterility in the production
area increases efficiency and enhances safety at the workplace
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Certification process
The certification process is a multiple-step process. The certification
cycle is described briefly:
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Application for certification from client |
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Offer from TUV India |
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Offer acceptance from client and order
confirmation by TUV India |
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Preaudit (optional) |
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Certification audit |
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Issue of certificate on successful completion
of certification audit |
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Surveillance audits at defined interval |
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Recertification audit |
TUV's services
In an age when medical advances are characterised by state-of-the-art
equipment, the ISO 13485/13488 standard has gained much importance.
The standard pertains to the business processes concerning
critical medical equipment manufacture, testing, compatibility,
endurance, installations and delivery. TUV India and TUV Nord
are renowned for their specialised audit pool for ISO 13485/
13488 certifications.
Contact us
Mr. Shrikant Kulkarni
General
Manager, Certification operation
Tel: 022-6647 7000
Email: kulkarni@tuv-nord.com
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