
Product Quality
1. All the Titanium implants manufactured and/or finished in the
production plant have been manufactured with materials which observe
the ISO standard 5832-3:1990 about titanium 6 aluminium 4 vanadium
alloy, for implants for surgery.
2. All the cobalt-chromium implants manufactured and/or finished
in the production plant have been manufactured with material which
observe the ISO standard 5832-4:1996 about cobalt-chromium-molybdenum
casting alloy, for implants for surgery.
3. That all the stainless steel implants manufactured and finished
in the production plant by Orthopeasia Co., Ltd. have been manufactured
with materials which observe the ISO standard 5832-1:2000 about
stainless steel implants for surgery (AISI 316 LVM)
4. In every consignment of raw material, we demand the certificate
of the results of composition of chemical analysis, of the mechanical
characteristic and the microstructure.
5. All the surgical instruments manufactured and/or finished in
the production plant have been manufactured with materials which
observe the ISO standard 7153-1 about metallic materials for surgical
instruments.
6. The company has a guarantee process for the application of a
Quality Manual based on the ISO standard 9001Quality Systems-Model
for quality assurance in design/development, production, installation
and servicing.
7. The personnel who works in anything that effects to quality receives
continuous training.
8. All the implants in stainless steel and titanium for surgery
observe the ISO standard 6018:198 about general requirements for
marking, packaging and labelling of the orthopaedic implants.
9. All the stainless and titanium implants for surgery once finished
are submitted to a 100% inspection of the final appearance characteristic.
10. The company has its installations authorised and all the product
of itscatalogue registered and authorised of the food and drug administration
ministry of public health of Thailand. ref.no. 1002.02/000388
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