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ISO 22716 is the international Good Manufacturing Practices (GMP) guideline for cosmetics, covering production, control, storage and shipment. Kiwa ASI audits cosmetic and personal care manufacturers and packagers against ISO 22716, clause by clause, so your customers get independent evidence of GMP, and your team gets a clear read on where you stand for EU Regulation 1223/2009 and FDA's coming MoCRA GMP rules.
Last updated September 29, 2026
A cosmetics GMP specialist will reach out to discuss your site, scope, scheduling and pricing.
ISO 22716 certification is independent, third-party evidence that a site makes, packages, tests, stores and ships cosmetic products under Good Manufacturing Practices. The standard, ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices, is published by the International Organization for Standardization (ISO/TC 217). It gives organizational and technical guidance for controlling the human, technical and administrative factors that affect product quality, from raw material receipt to shipment of the finished product.
ISO last reviewed and confirmed the standard in 2022, so the 2007 edition is current, and no new edition is in development. In the European Union, EN ISO 22716 is the harmonised standard for cosmetics GMP: following it gives a presumption of compliance with the GMP requirement in Regulation (EC) No 1223/2009.
ISO 22716 is written as guidance ("should"), not as a management system standard. An audit checks whether your site's GMP achieves what each clause describes. See the 17 clauses below.
ISO 22716 is written specifically for cosmetic products. It covers personnel, premises, equipment, materials, production, finished products, quality control, deviations, complaints and recalls, change control, internal audit and documentation.
EU law requires cosmetics to be made under GMP. The European Commission published EN ISO 22716:2007 as the harmonised standard in 2011, so following it gives a presumption of compliance.
FDA's 2013 draft cosmetic GMP guidance drew on ISO 22716, and Health Canada endorses its use. Cosmetics regulators first agreed to take ISO GMP standards into consideration through ICCR in 2007.
No law requires an ISO 22716 certificate. Kiwa ASI's ISO 22716 audit is an independent third-party audit against ISO 22716:2007. It isn't covered by ASI Food Safety, LLC's ANAB accreditation, which is for SQF and CanadaGAP.
ISO 22716 applies to the production, control, storage and shipment of cosmetic products. Companies get certified when an EU importer, retailer or brand-owner customer asks for independent evidence of GMP, or to prepare for FDA's cosmetic GMP rules under MoCRA.
Sites that make skin care, hair care, color cosmetics, fragrances, bath and personal care products under their own or a customer's brand.
Contract manufacturers that need to show GMP to the brand owners and private-label customers they make product for.
Operations that fill, package or label finished cosmetic products, where line clearance, batch coding and packaging controls matter.
Companies that outsource manufacturing and want their contract manufacturer's GMP independently verified, for their EU Product Information File or their own customers.
U.S. manufacturers supplying the EU market, where the Responsible Person's Product Information File must include a statement on GMP compliance.
Outside ISO 22716's scope: research and development, and distribution of finished products (the standard also leaves personnel safety and environmental protection to other rules). In the U.S., products that are also drugs, such as sunscreens, antiperspirants, anti-dandruff shampoos and fluoride toothpastes, must also meet FDA's drug cGMPs. Kiwa ASI confirms your scope before scheduling.
An independent ISO 22716 audit gives customers evidence they can review and gives your team an outside read on the GMP controls regulators expect.
Following EN ISO 22716 gives a presumption of compliance with the GMP requirement in EU Regulation 1223/2009, and an audit report backs up the GMP statement in your Product Information File.
MoCRA requires FDA to set cosmetic GMP regulations consistent, as far as practicable, with national and international standards. Building on ISO 22716 now prepares you for them.
An audit report and certificate that retailers, EU importers and brand owners can review when they approve you as a manufacturer.
One independent report can be shared with several customers, which can reduce the number of second-party GMP audits you host.
Controlled materials, equipment, production, deviations and change control reduce out-of-specification batches, complaints and recall risk.
Retailer-driven cosmetic programs such as NSF/ANSI 455-3 list ISO 22716 as a normative reference, so your GMP system maps to what buyers audit against.
Clauses 1 and 2 set the scope and definitions. Clauses 3 through 17 carry the guidance, each opening with a principle. These are the areas auditors look at most closely, with the clauses that cover them.
People with the training, hygiene and responsibilities for their jobs.
Buildings designed and kept to protect the product.
Equipment that is fit for purpose and under control.
Control of everything that goes into or around the product.
Manufacturing and packaging done to documented instructions.
Release decisions based on tests and data.
Control beyond the production line.
How the site handles things that go wrong or change.
The system checks itself and keeps its records.
The full text of ISO 22716:2007 is available from ISO or your national standards body. See what the audit covers, clause by clause.
A Kiwa ASI ISO 22716 audit is an on-site assessment of your cosmetics GMP against clauses 3 through 17 of the standard. The auditor reviews your procedures and records, walks the production, packaging, laboratory and storage areas, interviews staff, and traces a batch from raw material receipt through release and shipment. If your site only fills and packages, the audit covers the clauses that apply to what you do. Audit length depends on your facility, products, processes and scope, and Kiwa ASI confirms it in your quote.
| Clause | What the auditor checks |
|---|---|
| 3. Personnel | Organization chart, responsibilities, training and its records, hygiene and health rules, visitors |
| 4. Premises | Defined areas, flows of materials and people, surfaces, lighting, ventilation, pipework and drains, cleaning, maintenance, pest control |
| 5. Equipment | Design and installation, calibration, cleaning and sanitization, maintenance, authorized use |
| 6. Raw materials and packaging materials | Purchasing and specifications, receipt, identification and status, release, storage, re-evaluation, water quality |
| 7. Production | Documents at each stage, start-up checks, batch numbering, weighing and measuring, in-process controls, packaging line clearance and batch coding |
| 8. Finished products | Release against acceptance criteria, storage, shipment, returns |
| 9. Quality control laboratory | Test methods, acceptance criteria, results, out-of-specification results, reagents and reference standards, sampling, retained samples |
| 10. Out-of-specification product | Investigation, and authorized decisions to reprocess or destroy rejected product and materials |
| 11. Wastes | Types, flows, containers and disposal of waste |
| 12. Subcontracting | Written contracts, responsibilities of the contract giver and acceptor, evaluation of subcontractors |
| 13. Deviations | Authorization of deviations with supporting data, corrective action |
| 14. Complaints and recalls | Complaint review, investigation and follow-up; recall procedure and records |
| 15. Change control | Approval of changes that could affect product quality |
| 16. Internal audit | Internal audits by competent, designated personnel, findings and follow-up |
| 17. Documentation | Types of documents, writing, approval and distribution, revision, archiving |
Most major markets require cosmetics to be made under GMP, but each writes its own rules. ISO 22716 is the shared reference point.
Regulation (EC) No 1223/2009 requires cosmetics to be made under GMP (Article 8). Manufacturing in line with EN ISO 22716 gives a presumption of compliance, the Product Information File must include a GMP statement, and authorities can order recalls for GMP failures.
MoCRA, signed December 29, 2022, directs FDA to set cosmetic GMP regulations consistent, as far as practicable, with national and international standards. FDA missed the 2024 and 2025 deadlines, and as of September 2026 hasn't proposed the rule; its regulatory agenda lists it as a long-term action.
Health Canada endorses the use of ISO 22716 and encourages all cosmetic manufacturers to follow GMP. The Food and Drugs Act bans selling cosmetics made or stored under unsanitary conditions.
These markets have their own cosmetics GMP rules: the ASEAN Guidelines for Cosmetic GMP, China's Cosmetics Production Quality Management Standard (in force since July 1, 2022) and Brazil's ANVISA regulation. An ISO 22716 system is a strong base, but check each market's rules.
What MoCRA already requires: facility registration and product listing (enforced since July 1, 2024), safety substantiation, serious adverse event reports to FDA within 15 business days, and FDA records access and mandatory recall authority. Businesses with average U.S. cosmetic sales under $1 million a year are exempt from the GMP and registration requirements, unless they make products such as eye-area, injected, internal-use or long-wear (over 24 hours) products.
Start with the standard and the rules for the markets you sell into, then use them for your gap assessment and internal audits.
Also making supplements, food or packaging? Compare Kiwa ASI's cGMP audits and dietary supplement cGMP audits.
The main cost is audit time. Kiwa ASI quotes it from your facility size, number of employees, products and processes, and which activities are in scope. Budget across three areas:
The on-site ISO 22716 audit, quoted for your site from the audit time it needs.
cGMP and internal auditing courses for your team (Kiwa ASI course prices).
A copy of ISO 22716, plus the procedures, records, calibration, cleaning or facility repairs needed to close gaps.
Request a quote for audit pricing for your site.
Preparing for an ISO 22716 audit takes 9 steps in three phases: building your GMP system (steps 1–6), the audit (7–8) and staying audit-ready (9).
Buy ISO 22716:2007 from ISO or your national standards body, and map which activities your site performs: manufacturing, filling and packaging, testing, storage and shipment. Check whether any products are also drugs in your markets.
Compare your practices and records with clauses 3 through 17, and with the GMP rules of each market you sell into.
Build the documentation clause 17 describes: procedures, instructions, specifications, batch records and forms, with approval, revision and archiving under control.
Set up defined areas and flows, cleaning and sanitization, pest control, and calibration and maintenance of equipment.
Qualify suppliers, set specifications, control receipt and status of materials, follow batch instructions, and release finished products against acceptance criteria.
Train staff in GMP, hygiene and their procedures, keep training records, and run a full internal audit as clause 16 describes.
Tell Kiwa ASI about your site, products and processes. We confirm your scope, quote the audit and schedule it around your production.
The auditor reviews documents and records, inspects the site and equipment, interviews staff and traces a batch against ISO 22716.
Correct any nonconformities and their root causes, keep records current, handle deviations, complaints and changes through your system, and plan your next audit.
Live virtual Kiwa ASI courses for the GMP and internal audit skills an ISO 22716 audit depends on.
An 8-hour course on GMP fundamentals: quality management systems, documentation control, personnel, facilities and equipment, deviations, CAPA and data integrity. Built on Kiwa ASI's food cGMP program; the GMP principles carry over to cosmetics.
8 contact hours · Live via Zoom · 8:30 AM–4:30 PM CT
Dates on request. Ask about upcoming dates
Plan, run and report internal audits, the self-check ISO 22716 clause 16 describes, so you find gaps before an auditor does.
Full day · Live online · 8:30 AM–2:30 PM CT
Dates on request. Ask about upcoming dates
Need GMP training for 6+ people at your site? Ask about on-site private training.
Audits that follow the standard clause by clause, from a team backed by Kiwa's global network.
Our audit follows ISO 22716's own clauses, so every finding maps to a clause you can look up.
Each audit is assigned to an auditor with the qualifications, experience and impartiality for your scope.
Kiwa ASI also audits food, packaging and dietary supplement sites against cGMP, SQF and FDA rules, which helps when one site makes more than one product type.
We confirm your scope, audit dates and logistics in writing and plan the audit around your production schedule.
Part of Kiwa, a testing, inspection and certification group operating in more than 30 countries.
Kiwa ASI training is delivered separately from audits and certification, and taking it has no bearing on your audit outcome.
ISO 22716 certification is an independent, third-party audit showing that a site makes, packages, tests, stores and ships cosmetic products under the Good Manufacturing Practices in ISO 22716:2007. The audit covers clauses 3 through 17: personnel, premises, equipment, raw and packaging materials, production, finished products, the quality control laboratory, out-of-specification product, wastes, subcontracting, deviations, complaints and recalls, change control, internal audit and documentation.
No. Certification is voluntary. What the law requires is GMP itself: the EU Cosmetics Regulation requires cosmetics to be made under good manufacturing practice, and in the U.S., MoCRA directs FDA to set cosmetic GMP regulations, which FDA hasn't issued yet. Companies usually get certified because EU importers, retailers or brand-owner customers ask for independent evidence of GMP.
ISO 22716:2007 has 17 clauses. Clauses 1 and 2 are the scope and definitions. Clauses 3 through 17 give guidance on personnel, premises, equipment, raw materials and packaging materials, production, finished products, the quality control laboratory, treatment of out-of-specification product, wastes, subcontracting, deviations, complaints and recalls, change control, internal audit and documentation. See the 17 clauses.
ISO 22716 doesn't apply to research and development or to distribution of finished products, and it doesn't cover personnel safety or environmental protection, which it leaves to the company and other rules.
Yes. ISO last reviewed and confirmed ISO 22716:2007 in 2022, so it remains current. As of September 2026, ISO's cosmetics committee (ISO/TC 217) has no revision of ISO 22716 in development.
It's the recognized route. Article 8 of Regulation (EC) No 1223/2009 requires cosmetics to be made under good manufacturing practice, and says compliance is presumed when manufacture follows the relevant harmonised standards published in the Official Journal. EN ISO 22716:2007 was published as that harmonised standard in April 2011. The Product Information File must also include a statement on GMP compliance.
No one can say yet. MoCRA requires FDA to issue cosmetic GMP regulations that are consistent, as far as practicable, with national and international standards, but as of September 2026 FDA hasn't proposed them, even though the statute set deadlines of December 2024 for a proposed rule and December 2025 for a final rule. FDA's 2013 draft cosmetic GMP guidance drew on ISO 22716, so an ISO 22716 system is a strong base for the coming rule.
Facility registration and product listing (FDA has enforced them since July 1, 2024), safety substantiation for each product, and reports of serious adverse events to FDA within 15 business days. FDA also has mandatory recall authority and can access records in certain cases. GMP regulations are still to come.
Mostly. Businesses with average U.S. cosmetic sales under $1 million a year over the previous three years are exempt from MoCRA's GMP and facility registration requirements. The exemption doesn't apply to products that contact the eye's mucous membrane, are injected, are meant for internal use, or alter appearance for more than 24 hours.
Not on their own. In the U.S., products such as sunscreens, antiperspirants, anti-dandruff shampoos and fluoride toothpastes are drugs as well as cosmetics, so they must also meet FDA's drug cGMP regulations. Tell us your product list and we'll confirm the scope.
ISO 9001 is a general quality management system requirements standard for any industry. ISO 22716 is a GMP guideline written for cosmetics, covering plant activities from raw material receipt to shipment of finished products. They complement each other: ISO 9001 doesn't replace cosmetics GMP, and ISO 22716 isn't a full quality management system standard.
NSF/ANSI 455-3 is a cosmetics GMP audit standard backed by retailers and manufacturers through GRMA. It lists ISO 22716:2007 and FDA's 2013 draft cosmetic GMP guidance as normative references, so a site built on ISO 22716 already covers much of its ground. If a customer names a specific program, confirm which certificate they'll accept.
No. Kiwa ASI's ISO 22716 audit is an independent third-party audit against ISO 22716:2007. It isn't covered by ASI Food Safety, LLC's ANAB accreditation, which is for SQF and CanadaGAP. If a customer requires accredited certification, ask which accreditation they accept before you schedule.
ISO 22716 itself doesn't set a certificate term: each certification program does. Many issue three-year certificates with annual surveillance audits. Kiwa ASI confirms the certificate term and surveillance schedule for your site when it quotes.
It depends on your facility size, number of employees, products and processes, and which activities are in scope. Kiwa ASI confirms the audit length when it quotes, and plans the on-site days around your production schedule.
It depends on how much of your GMP system is already documented. Sites with written procedures, batch records and a working internal audit program need less time than sites starting from scratch. A gap assessment against clauses 3 through 17 shows how much work is left.
Training records, cleaning, sanitization and pest control records, equipment calibration and maintenance, supplier specifications and receipt records, batch manufacturing and packaging records, laboratory results and retained samples, release records, deviations, complaints and recalls, change control, internal audits and document control. Clause 17 covers how documents are approved, revised and archived.
Yes. Tell us who certifies you now and share your current certificate and last audit report, including any open nonconformities. Kiwa ASI reviews them, confirms your scope and plans your audit to fit your current cycle where possible.
Cost depends mainly on audit time, which Kiwa ASI quotes from your facility size, employees, products, processes and scope. Budget as well for a copy of the standard, training and any documentation or facility improvements. Call 1 (800) 477-0778 or request a quote for your site.
Tell us about your site, products and processes, and we'll confirm your scope, quote your audit and schedule it around your production.
Kiwa ASI's ISO 22716 audit is an independent third-party audit against ISO 22716:2007. ASI Food Safety, LLC is accredited by ANAB to ISO/IEC 17065 for the SQF codes and CanadaGAP; that accreditation doesn't cover ISO 22716. Kiwa ASI training is delivered separately from certification.