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

 
 

©Copyright by Orthopeasia Co., Ltd.
33/11 Moo 10, Theparak Rd., Bangpla,
Bangplee, Samutprakarn 10540 Thailand
Tel. (66) 2730-1791-2 Fax. (66) 2312-3310

E-mail :
orthope@orthope.com