FDA Issues New Draft Guidance Documents to Strengthen the 510(k) Program and QMS Requirements for Medical Devices
The FDA has issued three draft guidance documents refining the 510(k) program. What they change for medical device QMS requirements.
ISO 9001 and Voice of the Customer (VoC): Capturing Customer Perceptions for Quality Management System Success
How Voice of the Customer and Quality Function Deployment connect to ISO 9001:2015, and why the PDCA cycle still underpins all of it.
AS13000: Elevating Quality and CAPA Processes in the Aerospace Supply Chain
AS13000 sets the standard for problem solving and CAPA across the aerospace supply chain. What it requires and how to meet it.
Harmonizing Global Standards: Navigating MDSAP, ISO 13485, and the Role of Intelligent QMS Solutions
MDSAP promises one audit instead of many. How it works alongside ISO 13485 and where an intelligent QMS makes the difference.
Bridging Tradition & Tech: The Evolution of Total Productive Maintenance in Modern Automotive Excellence
Total Productive Maintenance began in post-war Japan and still shapes automotive excellence. How TPM works in a modern digital plant.
Navigating ITAR in the Age of SaaS
ITAR and SaaS do not sit together easily. What defense and aerospace organizations need to know before moving systems to the cloud.
Sustainable Excellence: 4 Profitable Green Technologies for Companies to Invest in with an EHS Management System
Four green technologies that pay back, and how an EHS management system helps you evaluate, implement and measure each one.
Ford’s PPAP Customer Specific Requirements Updated: Keeping up with PPAP CSR Changes with PPAPQuest
Ford has updated its PPAP customer specific requirements. How to keep pace with CSR changes without rebuilding your process each time.
Streamlining APQP and PPAP Management for Automotive Program Managers with ProjectQuest
Automotive program managers juggle APQP and PPAP against shifting standards. How ProjectQuest keeps both moving without dropped tasks.
From Responsibility to Results: Harnessing Scope 3 Emissions in ESG Reporting with EHS Management System Software
Scopes 1, 2 and 3 decide the credibility of your ESG reporting. How EHS management software helps you handle Scope 3 emissions properly.