Driving the Future: Transforming the EV & AV Industry

Omnex is at the forefront of the Electric and Autonomous Vehicle (EV & AV) revolution, helping to shape the industry by contributing to the development of EVAV standards. As the first North American organization to offer intacs® certified Automotive SPICE® training, we have also been a leader in Functional Safety training and consulting since 2009.

Our expertise extends to E-Mobility, where we support the transition from traditional mechanical systems to mechatronic and electronic systems with cutting-edge platform solutions. Our comprehensive services include the EVAV Software Platform—an integrated solution for managing compliance, quality assurance, and advanced product development in the Electric and Autonomous Vehicle industry.

We provide integrated training and consulting for IATF 16949, Automotive SPICE®, ISO 26262 Functional Safety, Agile APQP, ISO/SAE 21434 Cybersecurity, SOTIF (ISO 21448), and Supply Chain Best Practices. With our 7 Levers approach, Omnex empowers OEMs and Tier Ones to build safe, reliable, and high-quality EV & AV products that meet global standards.

Achieving Zero Defects and On-Time Delivery in Aerospace Manufacturing

Omnex has been at the forefront of the aerospace industry for over 35 years, helping OEMs and suppliers implement Best-In-Class Management Systems that go beyond compliance to achieve operational excellence. As active members of AAQG and IAQG, we played a key role in drafting AS9100 and introducing APQP and PPAP into aerospace, setting the foundation for robust quality management.

Our expertise includes integrating AS9100 with ISO 14001 (Environmental), ISO 45001 (Occupational Health & Safety), ISO 27001 (Information Security), and Social Responsibility standards to deliver comprehensive, unified management systems. We also specialize in risk management, new product launch, and advanced product quality planning (APQP) with aerospace-specific standards like AS9145, AS13004 (PFMEA and Control Plans), and AS13006 (Process Control).

Ensuring Quality & Compliance in Medical Device Manufacturing

With over 30 years of experience in developing, documenting, and implementing management systems, Omnex has established itself as a leader in quality and compliance solutions for medical device manufacturing. Our expertise spans ISO 13485, FDA 21 CFR 820, EU MDR, and MDSAP, enabling seamless global market access.

As medical devices become increasingly integrated with advanced software and electronics, the FDA mandates robust cybersecurity measures to safeguard patient safety and data integrity. Omnex understands these critical requirements and incorporates cybersecurity best practices into our quality and compliance frameworks.

As active participants on the technical committee for medical devices, we contributed to drafting key standards such as ISO 13485, ISO 14971 (Risk Management), and ISO 62304 (Software). Additionally, Omnex originated key concepts and methods for "Dashboard" style Business Operating Systems (BOS/QOS), aligning mission, vision, and strategic objectives into cascading Key Performance Indicators (KPIs) for consistent quality improvements.

With a focus on risk management, regulatory compliance, process efficiency, and cybersecurity, Omnex delivers comprehensive training, consulting, and auditing solutions to help organizations maintain the highest quality standards while meeting evolving industry regulations.

Driving Excellence in High-Tech / Semiconductors

Omnex has been a trusted partner to the semiconductor industry since 1990, providing training and implementation support to nearly every major semiconductor company worldwide. For over 15 years, Omnex partnered with the Semiconductor Assembly Council (SAC), serving as the sanctioned trainer for quality and quality-related tools for SAC members.

Omnex played a pivotal role in shaping industry standards by co-authoring the ISO/TS 16949 Semiconductor Supplement and collaborating with the Automotive Electronics Council (AEC) to draft the Semiconductor Supplement to the ISO/TS 16949 standard.

Whether it's training, implementation, auditing, or software solutions, Omnex continues to empower semiconductor companies with the expertise and tools needed to achieve sustained quality and operational excellence.

Strengthen Your Supply Chain Security with SCS 9001™

In an era of rising cyber threats, SCS 9001™ R2.0 sets the global benchmark for supply chain security across telecom, cloud, IoT, and beyond. This standard ensures trust, compliance, and resilience by defining robust security controls for hardware, software, and services.

Omnex is at the forefront of shaping supply chain security standards. We played a key role in helping write SCS 9001™ and have partnered with TIA (Telecommunications Industry Association) to provide comprehensive training and support for SCS 9001™ implementation.

Currently, Omnex is collaborating with TIA on TL 9000 and is poised to offer training and support for this critical standard as well.

Driving Excellence in General Manufacturing

Omnex helps manufacturers improve efficiency, quality, and compliance through Lean Six Sigma, supply chain optimization, and management systems. With $4 billion in industry savings, we integrate best practices into process improvement and automation using EwQIMS® software. Backed by 35+ years of global expertise, we provide tailored solutions for industries ranging from energy and banking to consumer goods.