How Technical Writers Navigate Compliance for SOPs
May 28, 2025
Dear Mr. Higgonbottom,
As a technical writer, how do you familiarize yourself with the specific compliance requirements of different industries—such as ISO standards, FDA regulations, or OSHA guidelines—when developing SOPs for your clients?
Dear Curious in Compliance,
Ah yes, the ever-shifting terrain of regulatory requirements—where one misstep can summon an auditor faster than you can say “nonconformance.”
As a technical writer, navigating this landscape isn’t just part of the job—it’s practically a sport. Fortunately, it’s one where preparation beats speed every time.
My first step? I get my hands on the actual standards.
Whether it’s ISO 9001, 21 CFR Part 11, or OSHA 1910, I treat these documents like maps: dense, occasionally cryptic, but essential for getting where I need to go.
I don’t read them cover to cover (unless I’m trying to cure insomnia), but I do hone in on the sections that matter—scope, definitions, documentation requirements, and anything peppered with “shall,” “must,” or “required.” Those words are your compliance compass.
Next, I tap into the most valuable resource of all: people.
Compliance officers, quality managers, legal teams, and frontline subject matter experts—they’re the ones who can tell you how the standards actually play out on the ground. They know where the gaps are, what the auditors nitpick, and what processes have evolved beyond the regulation’s last revision.
Then comes the writing.
I structure SOPs not just for functionality, but to clearly demonstrate compliance. That means building in traceability, referencing source regulations where relevant, and using language that’s both accessible and audit-ready.
I aim to create documents that can be understood by a new employee, a seasoned inspector, and everyone in between.
Finally, I remind myself that standards evolve. What’s compliant today may be outdated tomorrow, so staying curious—and just a bit paranoid—helps keep my work fresh and defensible.
So, how do I understand compliance? I study, I ask, I write with precision, and I always leave room for a healthy respect for the fine print.
Yours in clarity and compliance,
