the offices for Design and Corporate, but extend to manufacturing systems as well.

As the share of electronics and software content in each new car introduced to the market continues to exponentially grow, the list of challenges faced with delivering safe and innovative products meeting customer requirements also increases. Just in 2019, more than 2.5 million cars by Nissan, GM, Mazda, VW, Ford, Toyota, and Chevrolet were added to the recall list due to some form of software failure.

Technological breakthroughs in Advanced Driver Assistance Systems (ADAS) and autonomous driving/parking/braking are also bringing safety anomalies and failures. The focus on mechatronics and software/hardware failures is driving product safety standards (ISO 26262 Functional Safety) and guidelines to improve software development processes (Automotive SPICE®).

In addition to these changes, many organizations need to implement IATF 16949, which is an ISO 9001 derivative focused on the Automotive Industry. The number of mandatory requirements in IATF 16949 is much more than ISO 9001, as shown below:

“Shall” Count:
9001:2015: 132
IATF 16949: 281

IATF 16949 brings with it a set of five methodologies or Core Tools (APQP, PPAP, SPC, MSA, and FMEA) as they are known in the automotive industry. The addition of all of these standards creates a new level of complexity to the entrepreneurial and fast moving electronics industry. Omnex has worked with Hi Tech industries since the mid-1990s, first helping to write a predecessor to IATF 16949, a semiconductor supplement to ISO/TS 16949. Our history of implementations with the world’s leading Hi Tech organizations have expanded our experience and knowledge to effectively allow us to provide guidance for IATF 16949, ISO 26262, and Automotive SPICE® to any organization, worldwide.

Join this webinar to learn more about Automotive SPICE®, IATF 16949’s requirements for embedded software, and how they are important for the success of your organization.

This standard establishes the requirements for risk management in determining the safety of a medical device by the manufacturer during the product’s life cycle. This standard is an important link to ISO 13485, establishing a framework for risk analysis, evaluation, control, and review. It also specifies a procedure for the review and monitoring of the device during production and post-production phases. Join this webinar as we explore the specific changes found in the latest ISO 14971:2019 from the 2007 version. This webinar will provide you with a working knowledge of the update, and introduce users to ISO/TR 24971:2019 as a guidance document for ISO 14971:2019. Finally, this webinar will help you determine the changes (if any) that might be necessary within your organization’s Risk Management System.