ISO 22716:2007
ISO 22716 certification for cosmetics good manufacturing practices
Independent confirmation that cosmetic products are made, controlled, stored and shipped under good manufacturing practices.
- Valid for
- 3 years
- Surveillance
- Years 1 and 2
- Verification
- Public register
Accredited and empanelled
What is ISO 22716?
ISO 22716 gives guidelines for good manufacturing practices (GMP) in the production, control, storage and shipment of cosmetic products. It covers the people, premises, equipment, materials and documentation that determine whether a cosmetic product is made consistently and safely.
The current edition is ISO 22716:2007. It is a guideline rather than a management system standard, so the audit concentrates on plant practice: hygiene, segregation of materials, cleaning and sanitation, weighing and batch records, laboratory control, handling of out-of-specification results, deviations, complaints and recalls, and change control.
In the European Union, the Cosmetics Regulation (EC) No 1223/2009 requires cosmetic products to be manufactured under GMP, and ISO 22716 is the harmonised standard that gives a presumption of conformity. Brand owners, responsible persons and retailers in other markets use it the same way when they qualify manufacturers.
Who it is for
- Cosmetics and personal care manufacturers
- Contract and private label manufacturers
- Filling and packing operations
- Exporters supplying the EU, UK or Gulf markets
- Warehouses storing and shipping finished cosmetic products
What sets audit time and cost
Expect eight to twelve weeks from application to decision, with Stage 2 scheduled while products in scope are being manufactured.
- Number of production and filling lines
- Range of product types, such as emulsions, powders and aerosols
- Number of sites and staff
- In-house laboratory or outsourced testing
- Subcontracted manufacturing or packing
Why it matters
What ISO 22716 gives you
- 01
Evidence for EU market access
Certification gives responsible persons documented, third-party evidence that products are made under GMP.
- 02
Fewer batch failures
Controlled materials, cleaning and weighing reduce contamination, mix-ups and out-of-specification batches.
- 03
Easier customer audits
Brand owners can rely on a verifiable GMP certificate rather than repeating full audits of their own.
- 04
Traceable batches
Batch documentation and retained samples support complaint investigation and targeted recalls.
The audit
What our auditors examine
- 01
Personnel and hygiene
Training, health and hygiene rules, protective clothing and control of visitors in production areas.
- 02
Premises and equipment
Layout and flow, segregation, cleaning and sanitation, and calibration and maintenance of equipment.
- 03
Raw materials and packaging
Supplier approval, receipt, sampling, release, storage and identification of raw materials and packaging materials.
- 04
Production
Manufacturing and packaging instructions, line clearance, in-process controls and batch records.
- 05
Quality control laboratory
Test methods, specifications, sampling, retained samples and handling of out-of-specification results.
- 06
Complaints, recalls and change control
Investigation of complaints, recall procedures, deviations, change control and internal audit.
How certification works
Every accredited certificate follows the same three-year cycle, with each step recorded and the result published in our register.
01
Application and quote
Tell us your scope, sites and headcount. We calculate audit time under the accreditation rules and send a fixed quote and audit plan.
02
Stage 1 audit
We review your documented management system, scope and readiness, and agree the Stage 2 plan. Any gaps are reported so you can close them first.
03
Stage 2 audit
Auditors check that the system works in practice: interviews, records and observation across the scope. Nonconformities are raised in writing.
04
Certification decision
Once corrective actions are accepted, a reviewer who did not take part in the audit makes the decision. Your certificate is issued and listed in the public register.
05
Surveillance audits
Shorter audits in the first and second years after certification confirm the system is maintained and improving. The register shows your current status throughout.
06
Recertification
Before the three-year certificate expires, a recertification audit reviews the whole system and renews the certificate for another cycle.
Related standards and audits
Often certified or audited alongside this one, sometimes in a single combined audit.
ISO certification
ISO 9001
Independent assessment of your quality management system against ISO 9001:2015, by an accredited certification body.
ISO certification
ISO 14001
Independent certification of how your organisation identifies, controls and reduces its environmental impact.
ISO certification
Product certification
Independent confirmation that specified products and models conform to the standards or specifications named on the certificate.
ISO 22716 questions
We audit; we do not consult.
To keep certification independent, we never design, build or fix the systems we audit, and decisions are made by people who did not take part in the audit. Read our impartiality policy.
Plan your ISO 22716 certification
Tell us your scope, sites and timeline. We reply with an audit plan and a fixed quote.