Why You Should Care About Potential ISO 22716 Revisions
If you’re running a cosmetic manufacturing business, ISO 22716 is probably the backbone of your operations. It defines how you produce, store, and handle your products safely and consistently. But here’s the thing — it’s been almost two decades since ISO 22716 was first published in 2007.
In the world of fast-moving beauty tech, e-commerce, and digital traceability, that’s a long time. Industry whispers and early draft discussions suggest that a revision may be coming soon — and it could reshape how cosmetic Good Manufacturing Practice (GMP) is implemented globally.
In my experience working with manufacturers across ASEAN and Europe, the biggest compliance setbacks always happen during transitions. Companies wait until the new version is published, then scramble to catch up. This guide helps you get ahead — to understand what’s being discussed, what might change, and what you can do now to prepare.
Background – Current Status of ISO 22716 and Why Revisions Are Likely
ISO 22716:2007 remains the internationally recognized guideline for cosmetic GMP. It outlines everything from personnel and premises to production and complaint handling. But several factors are pushing for an update:
Regulatory shifts – frameworks like the US MoCRA (Modernization of Cosmetics Regulation Act) and evolving EU regulations have introduced new safety, traceability, and reporting requirements.
Technological advancements – digital production records, automation, and remote auditing weren’t mainstream in 2007. They are now.
Global harmonization pressure – regulators want consistency across industries, so ISO standards need to keep up.
A draft initiative called GMP-MS-716 has already been mentioned in ISO’s technical committees — signaling early efforts to modernize ISO 22716.
Pro Tip: Subscribe to ISO TC 217 updates or your national standards body newsletter. That’s usually where the first public review drafts appear.
Common Mistake: Waiting for the final revision before acting. By then, training, documentation updates, and audits can become last-minute headaches.
What We Know So Far – Key Signals from Industry Discussions
Let’s be clear: no official draft is public yet, but several credible sources have outlined potential directions. Here’s what’s emerging:
The revision will modernize GMP expectations for digital documentation, traceability, and data integrity.
It might introduce a risk-based approach, similar to how ISO 9001 and ISO 13485 now structure their requirements.
Environmental and sustainability factors — currently excluded — may start to appear in supporting clauses.
One global industry report noted that ISO’s Technical Committee is likely considering alignment with modern regulatory frameworks, especially MoCRA and the EU Cosmetic Regulation (EC 1223/2009).
In my experience, when ISO starts referencing external frameworks, it’s a clear sign the update will tighten record-keeping and accountability.
Pro Tip: Use this transition period to assess how “digital” your GMP really is. If you’re still managing batch logs in Excel or PDFs, now’s the time to modernize.
Potential Areas of Revision – What to Watch and Why It Matters
4.1 Risk-Based Approach & Modern Manufacturing
ISO 22716 has traditionally been procedural. The upcoming version might lean toward a risk-based framework, meaning you’ll have to show you understand and mitigate risks in every process — not just follow steps.
Actionable Insight: Start mapping your processes by risk level — especially automation, cleaning validation, and changeovers. Pro Tip: Build risk assessments into your batch record templates now. Common Mistake: Assuming old SOPs will fit the new model. Risk-based GMP requires critical-thinking documentation, not checkbox procedures.
4.2 Enhanced Traceability & Data Integrity
Expect stronger focus on digital traceability and data authenticity. Think audit trails, version control, and secure electronic records.
Example: One of my clients in Thailand upgraded to a cloud-based document system last year. When a regulator asked for records, they pulled the entire production history within minutes — that’s where the standard seems to be heading.
Pro Tip: Audit your current digital systems. Can you trace a batch from raw material to shipment in under 10 minutes? If not, that’s your improvement target.
Right now, ISO 22716 explicitly says it doesn’t cover environment or worker safety. But newer standards (like ISO 45001 and ISO 14001) are influencing this space. Future revisions may require at least referencing sustainability or safety in GMP documentation.
Actionable Insight: Start adding environmental impact and safety notes into your procedures — even if it’s just an annex. Pro Tip: During audits, this shows proactive thinking and corporate responsibility.
4.4 Global Harmonization with Regulatory Frameworks
The beauty industry is moving toward a single compliance language. Expect ISO 22716 to better align with:
The EU Cosmetics Regulation (EC 1223/2009)
US FDA MoCRA GMP requirements
ASEAN Cosmetic Directive Annex II
Pro Tip: Use this moment to harmonize your QMS globally. One integrated GMP manual with regional annexes is more efficient than multiple local versions.
Common Mistake: Keeping isolated systems per country. When ISO 22716 updates, those silos become costly to merge.
4.5 Digital Auditing & Remote Verification
Post-COVID, audits have changed. Many are remote or hybrid. The new ISO 22716 might formalize digital audit readiness, ensuring your GMP data is remotely accessible and verifiable.
Actionable Step: Digitize your core documents — SOPs, cleaning logs, calibration records. Set clear version control and user access levels.
Example: A Singapore-based manufacturer implemented a digital log system in 2023. When external auditors reviewed them remotely, the process took hours instead of days. That’s the efficiency regulators now expect.
How to Prepare – Practical Steps Before the Revision Arrives
If you want to be ahead of the curve, here’s how to start:
Run a gap analysis using the areas above as your checklist.
Digitize critical processes — especially document control and traceability.
Train your team on risk-based thinking and data integrity basics.
Review supplier compliance — make sure their systems will align too.
Monitor ISO updates quarterly through TC 217 or your national standards body.
Pro Tip: Don’t wait for a consultant to tell you what’s changing. Build revision-readiness into your 2025 QMS objectives.
Risks & Challenges – What Could Go Wrong
Even good intentions can go sideways during transitions. Here’s what to watch:
Delay risk: The revision might take longer than expected. Keep your current system active and improve incrementally.
Dual compliance: When the new version arrives, both old and new may overlap temporarily. Keep a mapping matrix ready.
Supplier gap: Smaller suppliers may not upgrade systems fast enough. Communicate early and set expectations.
Pro Tip: Plan a 6-month “parallel phase” after publication — it’s less stressful than sudden adoption.
FAQs – Clarifying Common Questions
Q1: When will the new ISO 22716 be published? There’s no confirmed date, but ISO’s technical committee has discussed modernization drafts under “GMP-MS-716.” That means a revision is in motion.
Q2: Will I need a new certificate immediately? No. Usually, ISO allows a transition period of 2–3 years for re-certification after a revision is published.
Q3: What happens to my 2007 certificate? It remains valid until the transition ends. But early adopters often benefit — auditors appreciate proactive updates.
Moving Forward with Confidence
Revisions are coming, and they’ll likely focus on modernization, traceability, and risk-based control. If you start adapting now, you’ll not only comply faster — you’ll operate more efficiently.
ISO 22716 has served the cosmetics industry for nearly two decades. The upcoming changes aren’t a threat — they’re an opportunity to strengthen your systems and reputation.
After guiding countless manufacturers through similar transitions, I’ve seen one truth hold: the companies that start early, win early.
Next Step: If you want to future-proof your GMP system, download QSE Academy’s ISO 22716 Revision-Readiness Checklist, or book a consultation to assess your current compliance gap.
👋 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.
