The Hidden Cost of Shortcuts: Why We Risk It and What It Means for Quality Management
By Julius DeSilva Have you ever walked down the stairs with your hands full—coffee…
ISO 13485: QMS Requirements of Medical Devices for Regulatory Purposes
By IJ Arora, Ph.D. ISO 13485:2016 is a standard that addresses quality management system…
Counterfeit Medical Devices with QMS: Strategies for Ensuring Product Authenticity and Quality in a Global Supply Chain
By Gurpriya Kaur Introduction The rise of counterfeit medical devices poses significant threats to patient…
A Comprehensive Overview of Internal Audits
By Auditor Training Co Internal audits are essential tools for organisations seeking to enhance their…
Identifying Non-Conformities in Audits: A Guide for New Auditors
By Julius DeSilva As an auditor with over 15 years of experience, I’ve seen how…
Leveraging ISO 9001:2015 to Build a Solid Foundation for Work Health & Safety and Environmental Practices
By QPro Australia Pty Ltd In today’s rapidly evolving business landscape, ensuring the well-being of…
Comprehensive Audit Management: The Backbone of Organizational Excellence
By Wilson Fernandez Audit management is a cornerstone of organizational governance, ensuring that processes, systems,…
The Role of Clinical Evaluation Reports (CER) in Medical Device QMS
Introduction The medical device industry is highly regulated, ensuring the safety and performance of devices…
Understanding CAPA (Corrective and Preventive Actions) in Medical Device QMS
by Gurpriya Kaur Introduction Corrective and Preventive Actions (CAPA) are critical components of any Quality…
The Benefits of Implementing An Environmental Management System for Your Business
Prioritizing environmental sustainability isn’t just a trend: it’s a vital strategy for securing the health…