Management Systems

Introduction
Quality, Environmental, Health & Safety, and Security
Automotive
Aerospace
Medical Devices
Hi-Tech Semiconductors
General Manufacturing

Management Systems

At Omnex, we don’t just implement standards—we help write them. Our consultants actively participate on ISO and SAE committees, contributing to standards like ISO 9001, ISO 14001, ISO 45001, ISO 13485, ISO 14971, and SAE Functional Safety, among others.

We have helped develop key AIAG manuals such as APQP/PPAP, FMEA (SAE J1739), SPC, MSA, Sub-tier Supplier Management, and the ISO/TS 16949 Semiconductor Supplement in collaboration with the Automotive Electronics Council.

As active members of global ISO and SAE committees, Omnex ensures that our solutions reflect the latest best practices in Quality, Environmental, Safety, and Security management systems—enabling us to serve our customers with unmatched insight and impact.

Omnex helps organizations in Automotive, Aerospace, Medical Devices, and Hi-Tech sectors build world-class systems that reduce risk, boost efficiency, and drive sustainable success.

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Quality, Environmental, Health & Safety, and Security

Omnex helps organizations implement and strengthen management systems aligned with global standards like ISO 9001 (Quality), ISO 14001 (Environmental), ISO 45001 (Occupational Health & Safety), and SCS 9001™ (Supply Chain Security).

We played a key role in helping write SCS 9001™ and have partnered with the Telecommunications Industry Association (TIA) to offer end-to-end training and implementation support. As active members of these standards committees, we provide practical insight that ensures compliance, enhances resilience, and reduces operational risk.

Our Expertise Includes:

ISO 9001:2015 – Quality Management System: Elevate quality standards and customer satisfaction through streamlined processes and continuous improvement.
ISO 14001:2015 – Environmental Management System: Minimize environmental impact and demonstrate your commitment to sustainability.
ISO 45001:2018 – Occupational Health and Safety Management System: Safeguard your team by fostering a safe and healthy work environment.
ISO 27001:2022 – Information Security Management System: Protect sensitive data and maintain information security with industry-leading practices.
SCS 9001™ – Supply Chain Security Management System: Enhance supply chain security and digital trust through standardized risk and compliance controls.

Omnex helps organizations integrate multiple standards, such as ISO 9001, ISO 14001, and ISO 45001 into a unified Integrated Management System.

Simplify IMS implementation and maintenance with Omnex’s expertise and our QHSE Software.

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Automotive

Omnex is a global leader in automotive quality and compliance, with over 35 years of experience shaping industry standards. Our consultants have played a key role in writing many of the automotive standards we implement, including QS-9000 and Core Tools manuals (APQP, SPC, FMEA, MSA, PPAP). As active members of global standard committees, we collaborate with OEMs and Tier One suppliers to provide industry-leading training, consulting, and software solutions. Read More

Core Automotive Standards

IATF 16949:2016 – Automotive Quality Management System: Drive product quality and customer satisfaction through robust quality management practices.
Automotive Core Tools (APQP, PPAP, MSA, SPC, FMEA): Implement core automotive quality tools for consistent performance and reliability.
Control Plan: Develop comprehensive control plans to ensure consistent quality throughout the manufacturing process.
AIAG-VDA FMEA: Failure Modes and Effects Analysis: Identify and mitigate potential risks in product and process design.
CQI – Continuous Quality Improvement (CQI-9, CQI-11, CQI-12, CQI-15, CQI-17, CQI-23): Optimize manufacturing processes with industry-specific quality assessments.
VDA 6.3: Ensure process capability and product quality through structured process audits.
VDA 6.5: Maintain consistent product quality and customer satisfaction with systematic product audits.
VDA 5 – Measurement Systems Capability: Assess measurement processes to ensure accuracy and precision.
VDA 19 – Technical Cleanliness: Ensure technical cleanliness of automotive components and systems.
PSCR – Product Safety and Conformity Representative: Ensure product safety and regulatory compliance through dedicated management practices.

E-Mobility

ISO 26262:2018 – Automotive Functional Safety: Safeguard safety-critical functions with a structured approach to functional safety.
ASPICE (Automotive SPICE®): Enhance software development processes to meet automotive quality standards.
ISO/SAE 21434:2021 – Automotive Product Cybersecurity: Strengthen vehicle cybersecurity from design to production.
ISO 21448:2022 (SOTIF) – Safety of the Intended Functionality: Address hazards resulting from performance limitations and ensure the safety of intended functionalities in automated driving systems.

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Aerospace

Omnex has been at the forefront of aerospace quality and compliance, contributing to the development of AS9100 and introducing APQP and PPAP to the aerospace industry. As active members of AAQG and IAQG, we integrate AS9100 with standards like ISO 14001, ISO 45001, and ISO 27001 to deliver unified management systems. Our expertise spans risk management, new product launches, and advanced product quality planning, supported by aerospace-specific standards such as AS9145, AS13004, and AS13006. Read More

Our Expertise Includes:

AS9100D – Quality Management Systems for Aerospace: Establish a robust framework for consistent quality in aerospace manufacturing and maintenance.
AS9110C – Quality Management Systems for Aerospace Maintenance Organizations: Implement quality practices specifically tailored for maintenance, repair, and overhaul (MRO) services.
AS9120B – Quality Management Systems for Aerospace Distributors: Manage quality assurance throughout the distribution of aerospace parts and components.
NADCAP – National Aerospace and Defense Contractors Accreditation Program: Achieve accreditation for special processes and products, demonstrating compliance with aerospace standards.

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Medical Devices

As an active member of writing committees for key standards like ISO 13485, ISO 14971 (Risk Management), and ISO 62304 (Software), Omnex helps medical device manufacturers meet FDA requirements and achieve global market access. With expertise in risk management and regulatory compliance, we provide training, consulting, and auditing solutions tailored to the medical device industry. Read More

Our Expertise Includes:

ISO 13485:2016 – Medical Devices Quality Management System: Ensure consistent design, production, installation, and servicing of medical devices.
21 CFR Part 820 – FDA Quality System Regulation (QSR): Meet U.S. regulatory requirements for medical device manufacturing.
ISO 14971:2019 – Risk Management for Medical Devices: Implement risk assessment and mitigation strategies throughout the product lifecycle.
IEC 62304 – Medical Device Software – Software Life Cycle Processes: Develop and maintain medical device software with rigorous lifecycle management.
Cybersecurity for Medical Devices: Understand and implement FDA-recognized cybersecurity best practices to protect patient safety and ensure device integrity across the product lifecycle.

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Hi-Tech Semiconductors

Since 1990, Omnex has helped shape semiconductor industry standards, co-authoring the ISO/TS 16949 Semiconductor Supplement and collaborating with the AEC. As a sanctioned trainer for SAC members for over 15 years, we deliver training, implementation, auditing, and software solutions that drive quality and operational excellence in the semiconductor sector. Read More

IATF 16949:2016 – Automotive Quality Management System: Drive product quality and customer satisfaction through robust quality management practices.
ISO 9001:2015 – Quality Management System: Establish a foundation of quality and consistency in product development and service delivery.
ISO 27001:2022 – Information Security Management System: Protect sensitive data and manage cybersecurity risks effectively.
ISO 26262 – Functional Safety for Road Vehicles: Ensure functional safety for electronic and electrical systems in automotive applications.
ASPICE – Automotive SPICE (Software Process Improvement and Capability Determination): Enhance software development processes for embedded automotive systems.
ISO/SAE 21434 – Cybersecurity Management System: Safeguard vehicle systems against cyber threats.

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General Manufacturing

Omnex helps manufacturers enhance efficiency, quality, and compliance through Lean Six Sigma, supply chain optimization, and management systems. With over 35 years of global expertise and $4 billion in industry savings, we integrate best practices and automation with our EwQIMS® software. Our tailored solutions span industries from energy to consumer goods, driving measurable results and sustainable improvements. Read More

ISO 9001:2015 – Quality Management System: Elevate quality standards and customer satisfaction through streamlined processes and continuous improvement.
ISO 14001:2015 – Environmental Management System: Minimize environmental impact and demonstrate your commitment to sustainability.
ISO 45001:2018 – Occupational Health and Safety Management System: Safeguard your team by fostering a safe and healthy work environment.

Training Webinars & White papers Case Studies

A. Gap Analysis / Discovery

Omnex conducts a Diagnostic Gap Analysis to assess the effectiveness & conformance of your system.

F. PRODUCT CERTIFICATION

Omnex will conduct Safety Case Review, Cybersecurity Case Review, and Confirmation Measures Review to ensure the safety and security of the product before PPAP. Get your products certified to Automotive SPICE®, Functional Safety, and Cybersecurity by one assessment team (ANAB and intacs™ accredited).

E. ASSESSMENTS & AUDITS

Omnex can conduct internal audits, supplier audits, and/or product certification audits for first-party and second-party audits and assessments for Automotive SPICE®, Functional Safety, and Product Cybersecurity. Assessments focus on projects, while Audits focus on Systems.

Management Systems Gap Analysis and Implementation

B. TRAINING & PERSONNEL CERTIFICATION

Omnex has over 300 Training and Personnel certification programs that can be availed by your employees through classroom, virtual, or E-Learning platforms.

C. Consulting, Implementation, & Coaching

Omnex can undertake the implementation projects for your company. Starting with the gap, we work with your team to close the gaps and also to implement a system that can drive excellence in your organization. Let us help you with any management system of your choice, integrated management system, stand alone or integrated Automotive SPICE®, Functional Safety, and Product Cybersecurity.

D. DIGITAL COLLABORATION SOFTWARE PLATFORMS

Omnex’s fully digital and AI-infused Collaboration Software Platform is a revolutionary solution that encompasses all aspects of quality management.

Omnex's strengths lie in our Consulting, Implementation and coaching, training and personnel certification, and our Digital Collaboration Platforms. Today, Management Systems have to encompass digital transformation and electronic workflows.

Let us show you how Omnex does this through the below illustration:

A. Gap Analysis / Discovery

Omnex conducts a Diagnostic Gap Analysis to assess the effectiveness & conformance of your system.

B. TRAINING & PERSONNEL CERTIFICATION

Omnex has over 300 Training and Personnel certification programs that can be availed by your employees through classroom, virtual, or E-Learning platforms.