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Implementing Medical Device Standards into a Quality Management System (QMS)

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

ISO 45001 – Occupational Health & Safety Management System

ISO 45001:2018, OHS Management System requirements standard sets the background and requirements and organization to ensure the health and safety of its workers and others who enter its premises.

Publish Date:November 27, 2021

Gate4SPICE Event "Role of ASPICE in Functional Safety, SOTIF and Cybersecurity Standards

Companies implementing ISO 26262 Functional Safety, ISO 21448 SOTIF and ISO 21434 Cybersecurity will need to leverage ASPICE in their respective implementations.

Publish Date:November 02, 2021

Move From Fmea 3 Rd To 4 Th Editions

The 4th edition of FMEA contains discussions that will allow organizations with a mature FMEA process to go beyond the basic implementation and not be subject to nonconformances by auditors who only have a cursory knowledge of the FMEA process or attempt to audit to the manual as a standard.

Publish Date:August 31, 2021

Whitepaper: Virtual Supplier Quality Management Solution powered by AI

Read Omnex Systems’ latest Whitepaper written by our CTO, Mr. Chad Kymal and Antony John, VP, Omnex Systems to understand how Omnex’s comprehensive Supplier Quality Management Suite, powered by AI allows organizations to manage their suppliers effortlessly by utilizing a central repository of suppli

Publish Date:August 12, 2021