When cosmetic manufacturers first start working toward ISO 22716 compliance, internal audits often feel overwhelming. You’ve got multiple processes, countless records, and a team that’s already stretched thin. I’ve seen this scenario many times — teams relying on generic templates that barely scratch the surface of what the standard really expects.
That’s exactly why we created this ISO 22716 Internal-Audit Checklist. It’s built to guide you through every clause, step by step. You’ll know what to look for, what evidence to collect, and how to turn audit findings into improvement opportunities — not just paperwork.
If you’re serious about passing your next GMP audit with confidence, this checklist gives you the structure and insight you need. And yes, you can download it, customize it, and make it your own.
Understanding the ISO 22716 Internal Audit Requirements
The internal audit is one of the most powerful tools in your quality system — when used properly. Under Clause 8.2 of ISO 22716, internal audits help verify whether your GMP processes are being followed consistently and effectively.
Think of it as your internal reality check before an external auditor ever walks in. The goal isn’t to catch people doing things wrong — it’s to confirm your system works as intended.
In my experience, the most successful cosmetics companies treat internal audits like performance reviews for their processes. They schedule them regularly, involve cross-functional staff, and use results to make real changes.
Pro tip: Keep your internal audit schedule flexible. If you’ve just launched a new product line or changed suppliers, add that area to your audit plan right away.
Common pitfall: Treating audits as a once-a-year event. ISO 22716 expects ongoing verification, not just an annual tick-the-box exercise.
What’s Inside the ISO 22716 Internal-Audit Checklist
Your checklist is organized around the key sections of ISO 22716. Here’s what it covers — and why each one matters:
Premises & Equipment – Checks for cleanliness, maintenance, calibration, and suitability.
Personnel & Training – Verifies hygiene practices, training records, and staff competence.
Production & In-Process Controls – Ensures traceability, contamination prevention, and batch documentation.
Quality Control & Laboratory Practices – Focuses on testing accuracy, sample management, and recordkeeping.
Deviations & CAPA – Reviews how issues are identified, investigated, and closed.
Documentation Control – Confirms proper version control and document approval processes.
Pro tip: Tailor the checklist to reflect your facility’s structure. A small cosmetics lab won’t have the same processes as a large contract manufacturer.
Example from the field: A mid-sized skincare company once discovered through their internal audit that their calibration certificates had expired months ago. They fixed it before the external audit — and turned a potential major non-conformity into a success story.
How to Use the Internal-Audit Checklist Effectively
A good checklist is only as useful as how you use it. Here’s how I guide clients through the process:
Plan your audit – Define scope, objectives, and frequency.
Assign trained auditors – Ideally, people who aren’t auditing their own work areas.
Use the checklist actively – Don’t just tick boxes; ask “show me” questions and review actual evidence.
Rate your findings – Use simple categories like Compliant, Observation, or Non-conformity.
Follow up quickly – Track corrective actions to closure and verify effectiveness.
Pro tip: Link every finding to its ISO 22716 clause number. It shows auditors you’ve done thorough clause-by-clause verification.
Common mistake: Focusing too much on paperwork and missing process interviews. Talking to production operators often reveals issues management never sees — like shortcuts or unclear instructions.
Downloading and Customizing Your ISO 22716 Internal-Audit Checklist
Once you download the checklist, you’ll find it’s fully editable — available in Excel and Word formats. Here’s what’s inside:
Clause references for each ISO 22716 requirement
Key audit questions and expected evidence
Space for notes, status, and corrective actions
A rating system for compliance status
This setup saves hours of formatting time. You can simply adapt it to your internal audit program — rename sections, add specific production areas, or include your own risk levels.
Pro tip: Keep a version history. Over time, you’ll see how your system improves and where trends emerge.
Real example: One cosmetic-cream manufacturer used the checklist to align three sites. Within six months, they reduced repeat non-conformities by 40% — just by standardizing how each site recorded and tracked audit results.
Using the Checklist to Prepare for Certification
Here’s where the checklist becomes your certification safety net. Internal audit results feed directly into your management review and demonstrate to certification bodies that you’re maintaining and improving your GMP system.
When auditors see a structured internal-audit trail — with evidence, actions, and follow-ups — it tells them your system is alive, not just documented.
Pro tip: Compile results from your last two internal audits before your certification audit. It paints a strong picture of continuous improvement.
Common pitfall: Ignoring small observations. What seems minor internally can become a major finding during certification if it repeats.
FAQs About the ISO 22716 Internal-Audit Checklist
Q1: How often should we conduct internal audits? At least once a year, but more often if there are big changes in your process, facility, or personnel. Some clients run quarterly mini-audits on critical areas.
Q2: Can we use the same checklist for multiple facilities? Absolutely — just customize it for each site’s unique layout, process, and risk level. A one-size-fits-all approach rarely works well.
Q3: What format does the checklist come in? It’s provided in both Excel and Word so you can choose the one that fits your workflow best — editable, printable, and ready to use immediately.
Take Control of Your ISO 22716 Compliance
Internal audits don’t have to be a stress point. With a solid checklist and a clear process, you’ll uncover gaps early, strengthen your quality system, and walk into your certification audit with confidence.
At QSE Academy, we’ve helped hundreds of cosmetic companies achieve ISO 22716 GMP compliance — from boutique brands to multinational labs. The difference always comes down to preparation.
Ready to get started? [Download Your ISO 22716 Internal-Audit Checklist Now] and make your next audit the easiest one yet.
👋 Hi, I’m HAFSA, and for the past 12 years, I’ve been on a journey to make ISO standards less intimidating and more approachable for everyone.
Whether it’s ISO 9001, ISO 22000, or the cosmetics-focused ISO 22716, I’ve spent my career turning complex jargon into clear, actionable steps that businesses can actually use.
I’m not here to call myself an expert—I prefer “enthusiast” because I truly love what I do.
There’s something incredibly rewarding about helping people navigate food safety and quality management systems
in a way that feels simple, practical, and even enjoyable.
When I’m not writing about standards, you’ll probably find me playing Piano 🎹, connecting with people, or diving into my next big project💫.
I’m an engineer specialized in the food and agricultural industry
I have a Master’s in QHSE management and over 12 years of experience as a Quality Manager
I’ve helped more than 15 companies implement ISO 9001, ISO 22000, ISO 22716, GMP, and other standards
My clients include food producers, cosmetics manufacturers, laboratories, and service companies
I believe quality systems should be simple, useful, and efficient.
