ISO 13845 is a Quality Management System for Medical Device and adopt a risk
management approach
to identify risk throughout the medical device product realization and such identified risks are
managed
to eliminate hazardous situations in medical device.
ISO 13845 Standard clauses and requirement are applicable to all types of
organizations irrespective of
size or nature and applicable to all like Hospital, Health Care, Trading, Manufacturing, Service
Companies, Software, Construction, Medical Devices in India. SQM offers ISO 13485 Certification in
all
cities, India.
ISO 13845 Standard requirement not only addresses the regulatory requirements
applicable for medical
device realization but also for device specific and customer specific requirement that have
potential
adverse impact and risk on the product. Organization who wish to adopt ISO 13485 standard, the
clause
of the standard clearly define and require how the ISO 13485 regulatory and customer specific
requirements are addressed.
Adoption of ISO 13485 Standard requirements by Medical Device Manufacture also reduces trade
barrier to enter into international market such as Europen Market. This Certification is voluntary,
even,
adopting and obtaining ISO 13485 certification allows medical device manufacturer to meet Quality
System requirement of European Medical Device Directives such as EU directive 93/42/EEC and in Vitro
Medical Device Directive 98/79/EC, Active Implantable Medical Device Directive
90/835/EEC.
Some key benefits for certification to ISO 13485 are :
Faster Cycle Times
Waste Reduction
Systematic Process Improvement
Enhanced Customer satisfaction
Effective Regulatory Compliance
Employees satisfaction and motivation
Cost Effective process
Efficiency Increased
Product safe environment