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ISO 9001 : 2015 Quality Management System
ISO14001:2015
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OHSAS 18001 IS NOW ISO 45001
Occupational Health and Safety Management System
ISO 22000 : 2005
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ISO 27001:2013
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ISO 13485 Medical Devices
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Hazard Analysis Critical Control Point
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ISO 13485 Medical Devices

Benefits of Implementing ISO13485 standards:

 

The main internal benefits of 13485 standard is that it indicate a preventive approach to assuring medical device quality which the process inspection and rejection are done at the end of the manufacturing line.

  • Its provides a systematic framework for to define, implement, measure and analyze the process of business operation and customer opinion.
  • It provides a systematic framework on monitored base that resulting in less waste and fewer complaints.
  • Reduction of operating costs, reduction of nonconforming products costs, raw materials, energy and other resources saving.
  • This standard focused to improve the performance in areas such as sales, product delivery, and process efficiency.
  • Its reduce costs as a result of minimizing product failures.
  • Through ISO 13485 standard organization access to the competitive edge with our independently.

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Certification Procedure

The Certification Procedure is a multiple-step process. The certification cycle is described briefly:

  • Application for certification from client
  • Offer from HLR
  • Offer acceptance from client and order confirmation by HLR
  • Pre audit (optional)
  • Certification audit – (Stage 1 + Stage 2)
  • Issue of certificate on successful completion of certification audit
  • Surveillance audits at defined period
  • Recertification audit after 3 years