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ISO 13485 Medical Devices
ISO 13485 is an international standard for the design, manufacture and distribution of medical devices. ISO 13485:2012 is the latest version by ISO, published in 24th July 2003. This standard is based on the ISO 9001:2008 process model approach.
ISO 13485 is process based approach which define, implement, and improve effectives of quality management system that they expected by customers and regulatory requirements. The main aim of ISO 13485:2012 is to facilitate harmonized medical device regulatory requirements for quality management systems.
ISO 13485:2012 is closely aligned to other management standards such as ISO 9001, ISO 14001 and OHSAS 18001 providing a great opportunity for integration and synergy with other quality systems.
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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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