If you plan to manufacture or export your cosmetic product, you have probably heard of ISO 22716. This standard has become a globally recognized reference for good manufacturing practices in the cosmetics sector, and many importers and distributors ask about it before working with any factory. Here we explain what it is and what it covers.
What Is ISO 22716?
ISO 22716 is an international standard published by the International Organization for Standardization that sets out guidelines for good manufacturing practices specific to cosmetics. In other words, it is a structured, detailed translation of quality, hygiene and documentation principles into the specific context of the cosmetics industry, covering production, control, storage and shipment.
What Does the Standard Cover?
It spans several areas that work together to ensure consistent quality, including:
- Personnel: qualifications, training, hygiene and responsibilities
- Premises: facility design to prevent contamination and ease cleaning
- Equipment: fitness for purpose, maintenance and calibration
- Raw and packaging materials: receipt, control, storage and traceability
- Production: processing instructions and in-process controls
- Finished product: release criteria, storage and shipment
- Quality control and documentation: testing, records and full traceability
- Handling deviations, complaints and recalls: clear procedures for problems
Is ISO 22716 Mandatory?
The legal status varies by market. In some markets, compliance with cosmetic GMP is a regulatory requirement, and ISO 22716 is a recognized way to demonstrate it. In others, it is not mandatory by name but remains a strong competitive advantage and a sign of seriousness. It is always best to check with the relevant regulatory authority in your target market for the exact requirements.
Applying the Standard vs. Being Certified
There is an important difference between a factory that applies ISO 22716 principles and a factory that is certified to ISO 22716 by an independent auditing body. Application means genuinely following the practices; certification adds documented external verification. Both have value, but certification often eases entry into export markets and shortens negotiations with partners.
Why This Matters for Brand Owners
When your factory conforms to ISO 22716, you gain a solid foundation for quality and traceability, and your product files become more ready for registration and export. When negotiating with factories, ask about their level of conformity and the documents they can provide to support your product file in the markets you target.
What Happens During an ISO 22716 Audit
For brands unfamiliar with the process, an audit can sound intimidating. In practice, it follows a fairly predictable structure whether the factory is pursuing certification or a customer is running its own supplier audit.
Documentation Review
Auditors typically start on paper: standard operating procedures, training records, batch documentation, supplier qualification files, and records of past deviations or complaints. A factory that struggles to produce these documents quickly is usually a factory still building its quality system, not one that has embedded it.
Facility Walkthrough
The audit then moves to the production floor, checking that what is written matches what actually happens: how raw materials are stored and identified, how equipment is cleaned between batches, how personnel move between areas, and how finished products are labeled and released. Gaps between documentation and practice are the most common findings.
Questions to Ask Your Potential Manufacturer
Before signing a private-label agreement, a short conversation about quality systems can save significant trouble later. Useful questions include:
- Do you operate according to ISO 22716 principles, and are you certified or self-compliant?
- Can you share a sample batch record or certificate of analysis for a product similar to mine?
- How do you handle a deviation or an out-of-specification result during production?
- What is your process if a customer reports a complaint after a product has shipped?
Clear, specific answers to these questions are usually a better signal of real quality culture than a certificate alone.
At Assil Ouargane in Morocco, we operate according to good manufacturing practice principles in producing our natural products, and we offer private-label manufacturing with documentation support for brands targeting export markets. To request a quote or more information, contact us through our website.