What Oxebridge's Paris Misunderstood About ISO 7101: Clause Logic vs Commentary Control
Oxebridge’s recent blog on ISO 7101 offers praise for the healthcare standard’s clarity and ambition—but it also reveals a deeper misunderstanding of how clause logic works in regulated environments. While the post celebrates ISO 7101’s improvements over ISO 9001, it misses key structural, legal, and implementation nuances that define the standard’s real-world impact.
Misunderstanding #1: Annex SL Is the Villain
Oxebridge blames ISO 9001’s shortcomings on Annex SL, calling it “bafflingly bad.” But Annex SL isn’t the enemy—it’s a framework for harmonization, not a content dictator.
- ISO 7101 didn’t “crack the case” by escaping Annex SL
- It leveraged it strategically, adding healthcare-specific clauses that complement, not contradict, the core structure
Clause logic isn’t about escaping Annex SL—it’s about layering relevance on top of it.
Misunderstanding #2: Risk Management Isn’t Just a Buzzword
Oxebridge applauds ISO 7101 for requiring a risk register—but frames ISO 9001’s “risk-based thinking” as cowardice. That’s a false equivalence.
- ISO 9001 allows flexibility for non-healthcare sectors
- ISO 7101 mandates risk registers because patient safety demands it
- The difference isn’t weakness—it’s contextual clause logic
Clause 6.1 in ISO 9001 isn’t vague—it’s sector-neutral. ISO 7101 is sector-specific by design.
Misunderstanding #3: Certification Isn’t Just About AB Interest
Oxebridge claims ANAB and UKAS are “disinterested” in ISO 7101 due to legal risk. But the real issue is scheme maturity and auditor competence.
- Healthcare audits require clinical and regulatory expertise
- ABs aren’t avoiding ISO 7101—they’re assessing liability and readiness
- Certification isn’t a blog-triggered rollout—it’s a clause-backed ecosystem
You don’t launch a healthcare QMS scheme with snow-shoveler logic.
PhilippineCMI’s Clause-Backed Position
We support ISO 7101’s ambition—but we also recognize:
- The need for local licensing, not just global accreditation
- The importance of auditor qualification, not just standard enthusiasm
- The role of implementation logic, not just editorial praise
Final Trap Thought
Oxebridge celebrates ISO 7101’s clarity—but misunderstands its complexity. Clause logic isn’t just about writing better standards—it’s about applying them with accountability.
Zyrus A. Oyong, CEO
Zyrus Oyong is the founder and Chief Strategist of Bluestar Certification Management Inc., a catalyst for clause-driven reform in the ISO consultancy space. With over a decade of experience navigating ISO 9001, ISO 14001, ISO 45001, and ISO 21001 standards, he has earned a reputation for strategic clarity, fearless advocacy, and ethical disruption.
Zyrus is a vocal critic of shallow auditing practices and misinformation in the compliance industry, using satire, blog exposés, and trap visuals to expose contradictions and defend clause integrity. He is the creative force behind BluestarCMI’s most provocative thought pieces, including “They Say They’re Experts—But Are They?” and the viral Coloring Book Audits Trap Series.
He is currently transitioning BluestarCMI into Philippine Certification Management Inc., a national platform for transparent consultancy, ethical ISO education, and clause-logic empowerment. His work continues to shape public discourse, influence accreditation culture, and ignite critical thinking among certification seekers, consultants, and auditors alike.