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Counseling on IATF16949/ISO13485

Given the intriguing business opportunities seen in the automotive and medical equipment industries, major high-tech manufacturers have entered into the associated blue sea. However, different from consumer electronics, the two aforementioned industries have relatively high technical thresholds for entry. In addition, the related requirements for safety management in the production have become increasingly strict. Besides ensuring their products comply with the certification regulations, manufacturers must establish dedicated quality control systems for the automotive and medical equipment industries so that the product quality in continual shipments complies with the associated regulations and acceptance standard by clients.

What iST Can Offer You
The representative quality management systems for automotive and medical equipment industries are IATF16949 and ISO13485, respectively, with both established on the foundation of the traditional quality management system ISO9001 and added with new technical regulations exclusively for the two industries. iST is very familiar with these two regulations and hence able to counsel manufacturers in establishing their own IATF16949 and ISO13485 and expand the business coverage by passing the examinations of premium automotive and medical equipment industries.

Service Scope 
On the standard for automotive quality management:
Familiar with the 5 core tools and related requirements by the automotive electronics certification regulations by AIAG (Automotive Industry Action Group); assists the manufacturers to generate the technical documents acknowledged by clients (sampling) and counsels the manufacturers to establish the complete IATF16949 quality management system for automotive suppliers.

On the standard for medical equipment quality management:
Familiar with medical regulations and requirements by the medical electronics certification regulations; assists the manufacturers to generate the ISO14971 medical equipment risk evaluation and technical documents for safety management and counsel the manufacturers to establish the complete ISO 13485 medical equipment quality management system and obtain the sales approval.
Please contact nearest location for inquiries :
USA Taiwan ─ Hsinchu China ─ Shanghai Kunshan Beijing Shenzhen Japan
Other services you may be interested in:
Automotive Electronics Reliability Test
Challenges facing the medical electronics industry in 2014
Structure Observation
Surface Analysis

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