Risk-Based Thinking in ISO 13485 (and How It’s Different from ISO 9001)
Risk-based thinking is one of those phrases that is mentioned frequently within ISO management system…
The Future of Smart Implants: Quality and Compliance Challenges
Introduction The healthcare landscape is undergoing a quiet revolution—one that resides not in hospitals or…
Types of Challenging Auditees – and How to Engage Them Effectively
By Julius DeSilva In every audit, auditors will encounter a diverse range of personalities—some cooperative,…
Shifting Mindsets: From Tick-Box Culture to Strategic Management Systems
By Wilson Fernández Introduction For small and medium-sized enterprises (SMEs) and organisations seeking to implement…
Climate Change and ISO 9001: A New Era of Business Responsibility and Regulatory Compliance
By Wilson Fernández Introduction As the global climate crisis intensifies, regulators and standards bodies alike…
Clarifying the Role of MS Auditors and Managers: Bridging the Gap in Organisational Expectations
By Wilson Fernández In many organisations, top management, department heads, and business leaders sometimes express…
Integrating Standards for Safe Nuclear Expansion
By IJ Arora, Ph.D. As nuclear energy regains attention as a low-carbon solution, organizations…
ASQ Phoenix Section Webinar: “Demystifying Internal Audits”
The webinar, “Demystifying Internal Audits,” will occur on July 10 in association with the monthly…