Strivenn Thinking

What is ISO 42001 and Why Should Life Science Companies Care?

Written by Matt Wilkinson | Oct 15, 2025 12:04:21 PM

AI is everywhere right now, in pitch decks, product launches, nearly every "next big thing" campaign on LinkedIn and even within your browser and search engine results. But here's the problem: most marketers are talking about AI without truly understanding the responsibilities that come with using it.

 

Enter ISO 42001. It's not just another checkbox or certification. It's the world's first international standard for how organisations manage AI responsibly, and in life sciences, that means everything.


So, what is ISO 42001, really?

Think of ISO 42001 as ISO 9001, but for AI. It defines how to govern, deploy, and monitor artificial intelligence in a way that's ethical, transparent, and safe.


It calls for clarity around how models make decisions, assigns real accountability when AI is used in workflows, and builds in guardrails to identify and mitigate risks. And perhaps most importantly, it ensures that humans stay in control.


In life sciences, where compliance, claims, and data ethics are non-negotiable, these principles aren't a luxury, they're the baseline.


Why it matters for life science marketers

If you're building campaigns around diagnostic data, clinical outcomes, or regulated tools, you already know compliance is non-negotiable. Yet the marketing world's approach to AI has been the opposite: move fast, prompt everything, worry later.


Life science companies don't have that luxury. ISO 42001 offers a framework that aligns with the same discipline your regulatory and quality teams already follow. It connects AI innovation with the structured governance life science marketing has always required – and that makes it the bridge between "AI hype" and operational reality.


Will governance kill the creative spark?

Some worry that adding structure will stifle innovation. But in life sciences, speed without compliance isn't innovation, it's risk. The truth is, the fastest path to AI success is structured experimentation within trusted guardrails. That's what ISO 42001 is designed for.


What smart teams are doing now

Forward-thinking marketers are already:

  • Mapping their AI touchpoints (content, analytics, automation) to 42001's risk areas
  • Establishing internal "AI steering groups"
  • Partnering with consultancies that demonstrate compliance literacy, not just AI capability

Bottom line: knowing how to use AI isn't enough. If you don't understand how to govern it, you're a risk, not an asset.


The takeaway

For life science companies, ISO 42001 isn't an abstract compliance exercise – it's the foundation for trustworthy, scalable AI adoption. It's how you move from "playing with prompts" to building AI literacy and systems your quality team would actually sign off.


And for agencies serving this industry, understanding ISO 42001 is no longer optional. It's the new baseline for credibility.


At Strivenn, we've made ISO 42001 part of our DNA, because it's not just about using AI, it's about using it well. We're proud to be the only life science marketing consultancy (that we know of) with certified AI Management Systems practitioners trained on ISO 42001. That means we don't just follow the rules, we help you lead responsibly.