ISO
13485 offers medical device manufacturers
an avenue to effective management systems.
ISO 13485: 2003 represents the requirements
that medical device manufacturers must incorporate
into their management systems. The current document
supersedes its 1996 incarnation as well as EN
46001, EN 46002 and ISO 13488.
Though
based on ISO 9001, 13485 removes 9001’s
emphasis on continual improvement and customer
satisfaction. In its place is an emphasis on
meeting regulatory as well as customer requirements,
risk management and maintaining effective processes,
namely the processes specific to the safe design,
manufacture and distribution of medical devices.
13485
is in part designed to produce a management
system that facilitates compliance to the requirements
of customers and—preeminently—various
global regulators. While being certified to
13485 does not fulfill the requirements of either
the FDA or foreign regulators, the certification
aligns an organization’s management system
to the requirements of the FDA’s Quality
System Regulation (QSR) requirements as well
as many other regulatory requirements found
throughout the world. Therefore, 13485 certification
serves to create a management system that can
be thought of as a framework on which to build
compliance to various regulatory and customer
requirements.
Christian
Lupo, general manager of Ann Arbor, MI-based
NSF International Strategic Registrations states,
“If the proper management system framework
is in place it should facilitate the identification
and implementation of country-specific requirements
for the management system of medical device
manufacturers. ISO 13485 is not specific enough
to contradict country specific requirements,
and should serve as a baseline management system
for all.”
13485
dictates that risk management must be thoroughly
documented and conducted throughout a product’s
entire lifecycle, from initial concept to delivery
and post-delivery. However, the standard leaves
the specifics to a related standard, ISO 14971:
2001, Application of Risk Management for Medical
Devices. While 13485 states that a manufacturer’s
management team is charged with the management
of device-related risks and the development
of risk management plans, 14971 defines a list
of steps to be taken by management in order
to fulfill risk-related requirements. While
it is not mandatory that a manufacturer be 14971
certified in order to attain 13485 certification,
being certified to the former standard can ease
the attainment of certification to the latter.
“The
fact that ISO 13485 counsels the application
of ISO 14971 speaks to its importance for those
seeking 13485 certification,” says Mairead
Ridge, marketing associate for IBS America (Lexington,
MA). “Compliance programs for both standards,
when implemented together, can help manufacturers
build an enterprise program for risk management
and quality assurance.” Evidencing the
consistent assessment and mitigation of risks
throughout all stages of a product’s lifecycle
is important for achieving certification to
both 13485 and 14971.
What
is the cost of ISO 13485: 2003?
A guidance price list is provided as part of
our information pack. For a fixed, written quotation
however, we require a few more details. These
can be submitted us via a short email,
on our landline number (052) 4270087 or Cell
(321) 7454444.
