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What is an ISO13485
The ISO13485/ EN46000 is Europe medical treatment
apparatus quality management system standard, it
increased the special request of the medical treatment
apparatus profession on the foundation of ISO9000,
putting forward the stricter control to the product
marking, the process control...etc. request. At
all sell go toward Europe the total body nation
of the medical treatment apparatus products all
have already requested to take the marking of CE
compulsory. To want the certificate of CE of acquire
the authority organization, in addition to needing
to pass the product in addition to corresponding
the test, still need to be examine through a system
of ISO13485.Various medical treatment apparatuses
and equipments that export the state in Europe must
satisfy the request of total body in Europe medical
Directive 93/42/ EEC. Carry out the system of ISO13485/
EN46000 can be regarded as to satisfy the instruction
93/42/ EEC to request one of the conditions. Currently
the our country medical treatment apparatus management
bureau has already rule the business enterprise
that all applications medical treatment apparatus
produces the permit must build up the ISO13485 quality
management system, with this business enterprise
that eliminates those and do not have the ability
of produce.
The cause that ISO13485
establish
Because the medical treatment apparatus is a special
product that saves life and to help injured people,
defends the disease cure, pressing the in general
use request of the ISO9000 standard only is not
enough to the norm, organized to promulgate the
ISO13485 for this ISO:1996 version standard( YY/
T0287 and YY/ T0288)s, put forward the appropriation
request to the quality management system that the
medical treatment apparatus produces the business
enterprise, attain the safety for the quality of
the medical treatment apparatus valid rise good
promote the function. In the past this standard
was in the ISO9001:Special request of the increment
medical treatment apparatus profession but establishment
in 1994 standard foundations of. Therefore satisfy
the ISO13485 to also match the ISO9001:1994 of request.
Ever since ISO9001:2000 standards promulgate hereafter,
the ISO/ TC210 discusses again and again, promulgating
the new ISO13485 in 2003:2003 international standards,
the new standard and old standard compare bigger
change to move, it had the characteristics of many
medical treatments apparatus profession. The ISO13485
is an independent standard, not a standard of ISO9001
in the medical treatment apparatus profession of
implement guidebook, both can't and permit. Currently
most medical treatments equipments produces the
factory house while build up the quality management
system, start chase the ISO9001:2000 versions+ ISO13485:2003
versions+ the attestation of CE is a all-in-one
solution.
The characteristics of the standard of ISO13485:
※ New the standard is special emphasize of is satisfy
the request of the law laws.
※ The ISO13485 standard is complement that requests
to the product technique
※ The standard of ISO13485 have no process mode
diagram
※ The ISO13485 standard in concerning provision
that deletes to reduce
This has the more detailed provision in should
standard 1.2 sections" application". All
requests of this standard are organizations that
aims at to provide the medical treatment apparatus,
the type or the scale that organize in spite of.
If the laws requests to allow to control to carry
on delete to reduce to the design and developments,
then deleting to reduce in quality manage system
it is reasonable that they can think. These laws
can provide another a kind of arrangement, these
arrangements want to take into the elucidation in
quality manage system. The organization contain
responsibility insure to reflect to control to the
design and development in avowal of match this standard
of delete to reduce.
※ The standard of ISO13485 emphasize" keep
its usefulness"
※ According to the characteristics of the medical
treatment apparatus profession, the place of the
standard of ISO13485 for the formation document
procedure request increase.
※ The standard of ISO13485 combines the medical
treatment apparatus profession characteristics,
increasing many professional provision.
※ The new standard of ISO13485 is an independent
standard, its chapter structure although with ISO9001:2000
same, some chapter contents also with ISO9001 homology,
but because of standard of ISO13485 according to
the characteristics of the medical treatment apparatus
profession, outstanding the law laws request, downplayed
the customer satisfaction, deleted to reduce the
ISO9001:2000 of some importance request, so satisfy
the ISO13485 request, be unequal to at the same
time satisfy ISO 9001:2000 of request.
Management
Project
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