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 |
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 |
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 |
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 |
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 |
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 |
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 45001:2018, 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 |
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 |
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 |