ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

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ISO 13485:2016

ISO 9001:2015 specifies requirements for a quality management system when an organization:<ul><li>Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements</li><li>Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements</li></ul>

ISO 9001:2015

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In October 2016, a new International Standard, IATF 16949:2016, replaced ISO/TS 16949:2009. The goal of this International Standard is the development of a quality management system that:<ul><li>Provides for continual improvement</li><li>Emphasizes defect prevention</li><li>Includes specific requirements and tools from automotive industry</li><li>Promotes reduction of variation and waste in the supply chain</li></ul>This International Standard, coupled with applicable customer-specific requirements, defines the fundamental quality management system requirements for automotive production, service and/or accessory parts organizations.

IATF 16949:2016

OptiMIM's Portland location is a leader in the metal injection molding (MIM) industry. It has positioned itself as an innovative company with over 60 million parts produced annually out of the 55,000 square foot plant. Their MIM engineers have a combined 200 years of MIM engineering experience, and provide innovative designs along with high quality products at competitive costs. OptiMIM Portland offers:<ul><li>26 molding machines ranging from 40-125 tons</li><li>Six CNC Machining Centers</li><li>Five debind ovens</li><li>Ten sintering furnaces</li><li>QuickMIM (rapid prototyping)</li><li>One Mahr and two OGP CMM inspection systems</li><li>PCpk – Advanced Predictive Process Mode</li></ul>

OptiMIM Portland

OptiMIM - Portland - L3

OptiMIM Global’s Hyderabad facility is a world-class manufacturing center located in one of India’s leading industrial regions. Specializing in metal injection molding (MIM), this advanced site produces high-precision, complex metal components for a broad range of industries, including automotive, medical devices, consumer electronics, industrial, and aerospace. With a strong commitment to quality, innovation, and efficiency, OptiMIM Global Hyderabad plays a key role in supporting our customers worldwide. OptiMIM Global offers:<ul><li>End-to-End MIM Solutions – Full-service support from design and prototyping to high-volume production and secondary operations</li><li>Advanced Tooling Capabilities – High-precision multi-cavity mold design and manufacturing</li><li>Conformal Cooling Technology – Enhanced part consistency and reduced cycle times</li><li>Comprehensive Post-Processing – In-house debinding, sintering, machining, and assembly services</li><li>Quality-Certified Production – ISO-certified systems ensure consistent quality and compliance</li><li>Facility Highlights</li><li>State-of-the-art MIM production equipment</li><li>More than 110 CNC machines supporting precision tooling</li><li>650+ employees, including highly skilled engineers and technical specialists</li><li>Global logistics and supply chain integration for seamless customer delivery</li></ul>

OptiMIM Global Private Limited

OptiMIM Global - India - L3

OptiMIMの品質、環境責任、従業員の安全に対する取り組みについて、その認証を通じてご覧ください。

認証

ISO 13485:2016

ISO 9001:2015

IATF 16949:2016

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