CSQ CERTIFICATION
The CSQ Certification Program and applicable standards were built around ISO/IEC 17067
ISO 22716 Certification: Cosmetics GMP Audits & Certification Services
ISO 22716 is the international Good Manufacturing Practices (GMP) standard for cosmetics, covering production, control, storage, and shipment. Published by the International Organization for Standardization and referenced by EU Regulation 1223/2009 and aligned with U.S. FDA MoCRA expectations, ISO 22716:2007 certification demonstrates your commitment to product safety and quality.
Kiwa ASI serves cosmetics manufacturers, packagers, labelers, and distributors worldwide, from initial certification through surveillance and recertification.
- 17-Clause GMP Standard
- 3-Year Certification Cycle
- EU & FDA Aligned
What is ISO 22716 Certification?
ISO 22716 is the international standard for Good Manufacturing Practices (GMP) in the cosmetics industry, published by the International Organization for Standardization (ISO). The standard provides guidelines across 17 clauses covering every aspect of cosmetic product production, control, storage, and shipment. ISO 22716:2007 is the current version, adopted by the International Cooperation on Cosmetic Regulations (ICCR) — comprising the United States, Canada, the European Union, and Japan — as the global baseline for cosmetics GMP compliance. Major retailers, regulatory authorities including the European Commission and U.S. FDA, and international trading partners require or expect ISO 22716 certification.
The standard was developed to harmonize cosmetics GMP guidelines worldwide. The ICCR's adoption in 2007 gave ISO 22716 unique regulatory weight: EU Regulation 1223/2009 explicitly references it as the presumptive standard for demonstrating GMP compliance for all cosmetic products sold in Europe. In the United States, the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 introduced mandatory GMP requirements for cosmetics manufacturers, and ISO 22716 aligns closely with those expectations. This dual-market alignment makes ISO 22716 certification a strategic foundation for companies distributing cosmetics internationally.
For cosmetics manufacturers, contract packagers, and private-label distributors, ISO 22716 certification is more than a regulatory checkbox. It is a structured system for controlling raw material quality, production consistency, hygiene standards, and traceability — reducing recalls, protecting brand reputation, and opening doors to global supply chains that require third-party verified GMP compliance.
International GMP Standard
ISO 22716 is the only internationally harmonized GMP standard specific to cosmetics, covering production through shipment across 17 clauses and 311 recommendations.
EU Regulation 1223/2009 Aligned
The European Cosmetics Regulation explicitly references ISO 22716 as the presumptive standard for GMP compliance. Certification adds the standard to your Product Information File (PIF).
ISO 22716:2007 Current Version
Published in 2007 and confirmed current through periodic ISO review. Adopted by ICCR member countries (U.S., Canada, EU, Japan) as the global cosmetics GMP baseline.
MoCRA-Ready Framework
The U.S. FDA's MoCRA legislation requires cosmetics GMP compliance. ISO 22716 provides a documented, auditable framework that aligns with emerging FDA requirements.
Who Needs ISO 22716 Certification?
Who needs this certification?
ISO 22716 applies to any organization involved in the production, control, storage, or shipment of cosmetic products. The standard's scope is broad, covering the full supply chain from raw material handling through finished product distribution.
COSMETIC MANUFACTURING
Cosmetics Manufacturers & Formulators
Companies that manufacture skin care, hair care, color cosmetics, fragrances, oral care, and personal hygiene products. Includes both brand-owned manufacturing facilities and contract manufacturers producing cosmetics for multiple brands.
CONTRACT SERVICES
Contract Packagers & Labelers
Third-party facilities that fill, package, label, or assemble finished cosmetic products on behalf of brand owners. ISO 22716 certification covers the packaging and labeling environment, equipment hygiene, and product integrity controls.
RAW MATERIALS
Raw Material & Ingredient Suppliers
Suppliers of cosmetic-grade raw materials, active ingredients, preservatives, colorants, and fragrance compounds. Certification demonstrates quality controls from material receipt through storage and dispatch to cosmetics manufacturers.
DISTRIBUTION
Distributors & Warehousing Operations
Facilities responsible for the storage, handling, and distribution of finished cosmetic products. ISO 22716 covers storage conditions, inventory management, and shipment controls that maintain product quality throughout the distribution chain.
PERSONAL CARE
Personal Care & Hygiene Product Makers
Manufacturers of soaps, body washes, deodorants, toothpaste, sunscreens (non-drug), baby care products, and bath products. These products fall under the cosmetics classification in the EU and many international markets.
PRIVATE LABEL
Private-Label & White-Label Brands
Brand owners who outsource manufacturing but need to demonstrate GMP compliance to retail partners, regulatory authorities, and consumers. ISO 22716 certification at the manufacturing site satisfies supply-chain due diligence requirements.
Note: ISO 22716 does not cover pharmaceutical products, medical devices, or cosmetic products classified as drugs under national regulations. Research and development activities and distribution of finished products at the point of sale are also outside the standard's scope.
ADVANTAGES
What are the advantages?
ISO 22716 certification delivers measurable business advantages across regulatory compliance, market access, and operational performance.
Global Market Access
ISO 22716 is recognized in over 180 countries as the cosmetics GMP benchmark. Certification opens access to the European Union (where it satisfies Regulation 1223/2009), ASEAN member states, Mercosur countries, and major international retailers that require third-party verified GMP from suppliers.
EU & FDA Regulatory Compliance
EU Regulation 1223/2009 requires GMP compliance for all cosmetics sold in Europe — ISO 22716 is the referenced standard. In the U.S., MoCRA's GMP requirements align with ISO 22716 principles. A single certification framework addresses both regulatory environments.
Reduced Audit Fatigue
ISO 22716 certification satisfies cosmetics GMP requirements across multiple markets, eliminating redundant customer audits and second-party supplier assessments. Retailers and brand owners that require GMP documentation accept ISO 22716 certificates from accredited certification bodies.
Stronger Quality & Safety Systems
Certification drives systematic improvements in raw material controls, production hygiene, equipment calibration, quality testing, traceability, and personnel training. These operational controls reduce batch failures, product complaints, and recall risk.
Competitive Differentiation
In a market where consumers and retailers increasingly demand transparency and verified quality, ISO 22716 certification distinguishes your operation from uncertified competitors. Certification is a powerful trust signal for retail buyers, private-label partners, and end consumers.
Regulatory Preparedness
With MoCRA's GMP requirements being finalized and increasing harmonization of international cosmetics regulations, ISO 22716 certification positions your facility ahead of evolving regulatory requirements. The standard maps to FDA expectations, EU mandates, Health Canada guidelines, and ASEAN cosmetics directives.
How to Prepare for ISO 22716 Certification
Most organizations achieve ISO 22716 certification within 6 to 12 months of starting preparation. The following 7 steps provide a structured path from initial gap analysis through successful certification.
01
Obtain & Study ISO 22716:2007
Purchase the current standard from ISO or your national standards body. Review all 17 clauses and 311 recommendations. Identify which requirements apply to your specific operations, manufacturing, packaging, storage, and/or distribution. Build a requirements matrix mapping each clause to your current practices.
02
Conduct a Gap Analysis
Perform a systematic assessment of your current operations against every applicable clause of ISO 22716. Document gaps between your current practices and the standard's requirements. Kiwa ASI offers pre-assessment services to help identify gaps before the formal certification audit.
03
Develop Your GMP Documentation
Build or update your quality manual, standard operating procedures (SOPs), batch manufacturing records, specifications, and forms to meet ISO 22716 requirements. Ensure your documentation system covers document control, record retention, and archiving as specified in Clause 17.
04
Implement Facility & Equipment Controls
Address premises requirements including area segregation, ventilation, lighting, cleaning programs, and pest control (Clause 4). Establish equipment calibration schedules, cleaning validation protocols, and preventive maintenance programs (Clause 5). Ensure raw material storage meets the standard's conditions.
05
Train Your Team
Develop a comprehensive training program covering GMP principles, hygiene practices, and role-specific procedures for all personnel who handle cosmetic products or materials. Document training records, competency assessments, and refresher training schedules as required by Clause 3. Contact US.Info@kiwa-asi.com for training resources.
06
Conduct Internal Audits
Establish an internal audit program as required by Clause 16. Train internal auditors on ISO 22716 requirements and audit techniques. Conduct at least one full internal audit covering all applicable clauses before your certification audit. Document findings, corrective actions, and management review outcomes.
07
Schedule Your ISO 22716 Certification Audit
Contact Kiwa ASI to schedule your Stage 1 and Stage 2 certification audits. Prepare by ensuring all documentation is current, internal audit findings have been addressed, and your team is ready for the on-site assessment. Request a quote or call 1 (800) 477-0778 to get started.
Why Choose Kiwa ASI for ISO 22716 Certification?
With nearly a century of product safety and quality expertise and operations in 30+ countries through the global Kiwa network, Kiwa ASI brings unmatched depth to cosmetics GMP certification.
ACCREDITED
ANAB-Accredited Certification Body
Kiwa ASI (ASI Food Safety, LLC) is accredited by ANAB, the largest multi-disciplinary accreditation body in the Western Hemisphere. Our ISO 22716 certification is issued under accredited programs, providing internationally recognized assurance of your GMP compliance.
EXPERTISE
Nearly a Century of Product Safety Experience
Our auditors bring deep technical expertise in cosmetics manufacturing, personal care, and consumer product safety. With auditor qualifications spanning FSSC 22000, BRCGS, ISO 22716, and cGMP standards, we understand the complexity of multi-standard compliance.
EFFICIENCY
Responsive Scheduling & Clear Communication
Kiwa ASI provides straightforward scheduling, clear pre-audit communication, and timely report delivery. Our audit teams work with your production schedules and deadlines, minimizing disruption while delivering thorough, actionable audit findings.
COMPREHENSIVE
Integrated Training & Consulting Support
Through ASI Training and Consulting, LLC (operated separately from our accredited certification body), we offer GMP training programs, gap analysis services, and implementation support to help you prepare for a successful ISO 22716 certification audit.
PARTNERSHIP
Global Kiwa Network
As part of Kiwa, a global testing, inspection, and certification (TIC) organization operating in 30+ countries, Kiwa ASI connects your ISO 22716 certification to a worldwide infrastructure. Multi-site operations benefit from coordinated audit scheduling and consistent standards across geographies.
Frequently Asked Questions About ISO 22716 Certification
ISO 22716 certification verifies that a cosmetics manufacturer, packager, or distributor operates in compliance with internationally recognized Good Manufacturing Practices (GMP). Published by the International Organization for Standardization (ISO), the standard covers all aspects of cosmetic product production, control, storage, and shipment. Certification is important because EU Regulation 1223/2009 requires GMP compliance based on ISO 22716 for all cosmetics sold in Europe, and the U.S. FDA's MoCRA legislation aligns closely with its principles. Certification demonstrates product safety, quality, and regulatory readiness to retailers, regulators, and consumers worldwide.
ISO 22716:2007 provides guidelines across 17 clauses covering personnel, premises, equipment, raw materials and packaging materials, production, finished products, the quality control laboratory, treatment of out-of-specification products, waste management, subcontracting, deviations, complaints and recalls, change control, internal audits, and documentation. The standard addresses every stage from raw material receipt through finished product shipment, ensuring consistent quality and safety throughout the cosmetic product lifecycle.
The current version is ISO 22716:2007, published by the International Organization for Standardization. Despite the 2007 publication date, this version remains the active international standard for cosmetics GMP. It was adopted by the International Cooperation on Cosmetic Regulations (ICCR) — formed by the United States, Canada, the European Union, and Japan — as the global baseline for cosmetics GMP guidelines. ISO periodically reviews its standards, and ISO 22716:2007 has been confirmed as current through the most recent review cycle.
An ISO 22716 certificate is valid for a maximum of 3 years. During the certification cycle, annual surveillance audits are required to verify continued compliance. At the end of the 3-year cycle, a full recertification audit is conducted. If critical non-conformities are found during surveillance and not corrected within the required timeframe, the certificate may be suspended or withdrawn before its expiration date.
A typical ISO 22716 certification audit takes 2 to 3 days for a single-site operation. The exact duration depends on factors including facility size, the complexity of manufacturing processes, the number of product lines, and whether the site also holds other certifications. A Stage 1 (documentation review) audit is usually 1 day, followed by a Stage 2 (on-site system audit) of 1 to 2 days. Surveillance audits are generally shorter, typically 1 to 2 days.
ISO 22716 is specifically designed for cosmetics Good Manufacturing Practices, addressing production, storage, control, and shipment of cosmetic products with industry-specific requirements for raw materials, formulation, and hygiene. ISO 9001 is a general quality management system standard applicable to any industry. While ISO 9001 focuses on customer satisfaction and process improvement, ISO 22716 focuses on product safety and GMP compliance specific to cosmetics. For companies selling into the EU, ISO 22716 certification directly satisfies the GMP requirement under EU Regulation 1223/2009 — ISO 9001 does not.
Non-conformities are classified as major or minor. A major non-conformity indicates a significant gap in the GMP system that could compromise product quality or safety, requiring corrective action within a defined timeframe (typically 30 to 90 days) before the certificate can be issued or maintained. A minor non-conformity identifies an isolated lapse that does not threaten overall system effectiveness but still requires documented corrective action. If corrective actions are not implemented satisfactorily, the certification body may escalate the finding or withhold certification.
Yes, you can transfer your ISO 22716 certification to Kiwa ASI from another accredited certification body. The transfer process involves a review of your current certificate status, previous audit reports, and any outstanding non-conformities. Kiwa ASI will conduct a transfer audit to verify ongoing compliance. Transfers can typically be aligned with your existing audit cycle to minimize disruption. Contact Kiwa ASI at US.Info@kiwa-asi.com to begin the transfer process.
es, you can transfer your ISO 22716 certification to Kiwa ASI from another accredited certification body. The transfer process involves a review of your current certificate status, previous audit reports, and any outstanding non-conformities. Kiwa ASI will conduct a transfer audit to verify ongoing compliance. Transfers can typically be aligned with your existing audit cycle to minimize disruption. Contact Kiwa ASI at US.Info@kiwa-asi.com to begin the transfer process.
The U.S. FDA's Modernization of Cosmetics Regulation Act (MoCRA), enacted in December 2022, requires cosmetics facilities to follow Good Manufacturing Practices. While the FDA has not formally adopted ISO 22716 as its official GMP standard, the principles and requirements of ISO 22716 align closely with MoCRA expectations. Many U.S. cosmetics manufacturers use ISO 22716 as their GMP framework to demonstrate compliance. As the FDA finalizes its cosmetics-specific GMP rulemaking, ISO 22716 certification provides a strong documented foundation for regulatory readiness.
All consulting services are offered through ASI Training and Consulting, LLC. All activity is conducted separately from our accredited certification body, ASI Food Safety, LLC, in order to safeguard against any conflicts of interest.