EV-AV Free Resources

Our SMEs at Omnex have been working on creating content that helps our customers on the changes going on in our industry. The shift from gasoline and diesel vehicles to Electric and Autonomous vehicles has brought about unprecedented change. We hope the webinars and whitepapers below will help you in your transition into these new areas.

device manufacturers face regarding the feasibility of implementing an effective Business Management System (BMS) that will add to its bottom line.

Medical device manufacturers are commonly faced with many organizational and other interested party requirements for implementing multiple management systems, including ISO 13485, ISO 14001, and ISO 45001, to name a few. From a financial perspective of ROI, each of these management system standard’s requirements demand considerable resources and effort in developing, implementing and maintaining the system.

The real challenge is how to integrate all of these different management systems in a single, cost effective, and profitable manner without losing integrity of each system. As a renowned implementer and trainer of various standards, John Pappachan will discuss some proven methods and solutions to overcome the obstacles and implement a system that will create value for organizations. Some of the concerns we will discuss in this webinar will be:

What to Integrate?

  • This webinar will explore the opportunities of integrating ISO 13485, ISO 14971, ISO 14001 and ISO 45001 for medical device manufacturers.

Why to Integrate?

  • Integrate to manage the challenges of implementing and maintaining multiple Management System Standards (MSSs) considering:
      - The enormous effort and resource requirement to implement and maintain each standard separately.
      - ROI – an Integrated Management System saves costs on:
    • Implementations
    • Internal audits
    • Third party audits

How to Integrate?

  • How to integrate will be discussed in the webinar. We hope to see you there.

on results of laboratories. Nothing is more important than correct and standardized lab results. In November 2017, ISO published a new revision to the ISO 17025 standard. It has been revised to integrate with ISO 9001:2015 and other newer standards including ISO 5189 Quality of Medical Laboratories and ISO/IEC 17021 audit requirements for certification bodies. To keep it consistent with newer standards, it now includes the “process approach.” This standard also includes an option to incorporate and integrate it with ISO 9001:2015. The International Standards Organization and International Laboratory Accreditation Cooperation (ISO/ILAC) communique states – “Conformity with this standard also means that the laboratory generally operates a management system in accordance with the principles of ISO 9001.”

In ISO 17025:2017, all of the clause numbers of the standard have been revised from the previous version. Additionally, it has been updated with regards to many of the latest information technologies and incorporates the use of computer systems, electronic records and electronic results. Not only has the scope been revised, but it now includes the concept of “risk based thinking.”

There are many challenges to implementing ISO 17025, from the “process approach” to the incorporation of the latest information technologies. This webinar will highlight 18 of the new or changed requirements, discuss the transition deadlines, and the process needed to become ISO 17025:2017 certified. Omnex has worked with thousands of labs worldwide implementing and auditing ISO 17025 and ISO 9001 standards. Join us as we share our ISO 17025 knowledge and experience in this Omnex webinar presented by Dave Barber, Omnex Senior Consultant, and Omnex’s ISO 17025 Champion.

reflect the evolving nature of the aerospace industry. For aerospace organizations, simply creating documents and obtaining certifications is no longer enough and remote auditing is already occurring. Moving forward, aerospace organizations need to use a more digital approach for QMS development, implementations, and to drive processes that help them improve quality, cost reductions, delivery performance, and electronically controlled functions. In this webinar, Omnex will discuss some Best In Class digital collaboration platforms and techniques for organizations standardize processes, planning, document control, process development, and APQP.

Not all aerospace organizations are well equipped for an effective QMS in this electronic age. More and more OEMs are implementing supplier programs centered on AS9145 for establishing improved Operational Controls that are derived from FMEAs. With this new standard, the industry is moving to incorporate Advanced Product Quality Planning (APQP) and the Production Part Approval Process (PPAP) as systems and methods. In this webinar, we will also discuss a practical software platform for Risk Based Thinking using APQP, PPAP, and FMEAs that also integrates into your QMS.

The leading organizations in the aerospace industry now require their management to monitor and improve their performance in real time. To remain competitive, organizations must keep improving and must be adaptable to dramatic changes in the “new normal” of the remote/virtual era. Is your organization ready?

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EV/AV Whitepapers

Implementation roadmap - Expectations for supply chain - electric and autonomous vehicles

The purpose of this paper is to provide a clear and concise roadmap for all automotive suppliers so that they may integrate standards, implement systems and processes which are now expected by the industry (OEMs) and their (Tier 1) customers.

An introduction to Automotive SPICE for beginners

This paper describes Automotive SPICE (ASPICE), a process capability model which is used in the automotive industry and its benefits of implementation.

Automotive cybersecurity and controls

This paper talks about automotive cybersecurity which is fundamentally different from other the types of security such as enterprise information technology (EIT), the smart grid, process control, and the internet of things (IoT).

Considerations of functional safety, Automotive SPICE, and cybersecurity in automotive new product development

Read Omnex CTO’s most recent white paper on how electric and autonomous vehicles are birthing new technologies and expanding supply chains resulting in increased design and production complexity.

Introducing the new AIAG-VDA FMEA - Understanding the changes

This Whitepaper explains the changes, first from a VDA approach and then the AIAG approach. This article also explains in brief about DFMEA.

EV/AV Webinar Recordings

Automotive cybersecurity - Integration with functional safety and ASPICE

This webinar discusses key issues particularly with process flow, HARA, integration and integrating service security function and safety, modeling aspects and Analysis aspects including safety.

Safety products, and electric & autonomous (EV & AV) vehicle standards

Product development in autonomous vehicles will need to incorporate IATF 16949 and risk prevention techniques that have long used

Electric and autonomous vehicle market for high tech industries and automotive standards

The largest car manufacturers are shifting their products from diesel and internal combustion engine vehicles to electric and autonomous vehicles.

IATF 16949 grand finale and AIAG-VDA FMEA update

Missed our webinar on our third and final update on IATF 16949? No worries! You can now listen to the complete webinar here.

Effectively implementing IATF 16949, ISO 26262, and Automotive SPICE in hi-tech industries

The electronics and software content continues to increase each time with new car introduced to the market

The New ISO 26262 2nd edition - changes and highlights

This webinar will discuss the impacts andthe changes on existing and new implementations of the standard.

Conducting functional safety audits and assessments for ISO 26262

Functional safety ISO 26262 requires functional safety assessors to conduct assessments, audits, and confirmation reviews.

Latest updates to IATF 16949 and customer CSRs

Join Omnex for a “hot off the presses” webinar covering the latest updates to IATF 16949 and related CSRs.

IATF 16949 requirements for embedded software - Automotive SPICE

As the electronics and software content in each new car introduced to the market continues to exponentially grow…

The disruption in the automotive market - EV/AV vehicles - What it means to you

The internal combustion engine (ICE) is being replaced by Electric Vehicles (EV), including hybrid electric vehicles (HEV), leading to a disruption of the automotive industry as we know it...

Cyber-insecurity? How to secure your systems against a hack attack — ISO/IEC 27001

Because of the criticality of information security, certification to (ISO/IEC 27001) has become one of the most important and sought after certifications in the world.

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