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Enterprise Digitalization of  APQP 3rd Edition & Control Plans V.1

The automotive industry is evolving rapidly, and so are the demands for efficient, integrated, and AI-powered solutions for APQP 3rd Edition and Control Plans.

Publish Date:November 27, 2024

Rigorous Safety Analysis and Design of ADAS and ADS – Implications on Tools

Ensuring the safety of Automated Driving Assistance Systems (ADAS) and Automated Driving Systems (ADS) is a growing concern with the increasing use of self-driving vehicles, trucks, and robotaxis.

Publish Date:September 27, 2024

Leveraging Artificial Intelligence for Enhanced Product Quality: A Comprehensive Guide

In today's hyper-competitive business landscape, ensuring high-quality products is paramount for companies striving to maintain a competitive edge. With the advent of Artificial Intelligence (AI), organizations across various industries are witnessing a transformative shift in how they approach qual

Publish Date:September 24, 2024

Best Auditing Practices using Software

An audit tells an organization whether it is adhering to statutory and regulatory requirements and established objectives. However, a lack of preparation, an integrated digital platform, and other factors can lead to wasted time.

Publish Date:December 14, 2022

Implementing Medical Device Standards into a Quality Management System

Start-up Medical Device companies consistently develop devices which they expect will greatly improve patient Quality of Life. Generally, through consultant regulatory help it is fairly easy to get the regulatory filings done which include device classification. However, when it comes to the Quality

Publish Date:September 22, 2022

Reverse FMEA - A new and upcoming Customer Specific Requirement

For more than 60 years, Failure Mode and Effect Analysis has been used as an engineering development tool, to evaluate and mitigate risk in product and process designs. This tool has been used to thoroughly analyze potential design weaknesses and estimate failure frequency.

Publish Date:May 15, 2022

AS13100 What’s New and  How Significant is IT?

The Aerospace Engine Supplier Quality (AESQ committee under SAE) recently released AS13100, Quality Management System Requirements for Aero Engine Design and Production Organizations. Unsurprisingly, its release has become a hot topic in the aerospace and defense industry supply chain.

Publish Date:April 01, 2022

Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) is a global initiative intended to accelerate medical device regulatory harmonization by allowing a single regulatory audit to satisfy the requirements of multiple jurisdictions. The MDSAP intends to allow competent auditors from MDSAP-recognized Audit

Publish Date:January 24, 2022

Implementing an Information Security Management System (ISMS) based on TISAX

The objective of information security risk management is the early identification, evaluation, and treatment of risks to achieve the protection objectives of information security. It thus enables the organization to establish appropriate measures (aka Controls) to protect the most valuable IS, IT as

Publish Date:January 10, 2022

TIA initiative - SCS 9001

The SCS 9001 is a Supply Chain Security Management System. Security here refers to both Information Security and Product Security. In other words, the security of the IT Assets in the organization and the security of the products designed and manufactured. When the SCS 9001 standard references “secu

Publish Date:December 14, 2021