한
ENISO 22716 Cosmetics — Good Manufacturing Practices
The international standard for how cosmetics must be made — hygiene, premises, equipment, raw materials and records.
This standard is not covered by our IAS or UAF accreditation scopes. ITS certifies it under its own scheme. See our accreditations →
What this certification proves
You cannot prove a cosmetic is safe by testing it afterwards. Opening a batch to test it destroys what you would sell, and contamination will not be found by checking one or two units.
ISO 22716 therefore controls the process of making it, not the result. It asks who made it (personnel), where (premises), with what (equipment and raw materials), how (production) — and whether records exist for all of it. An audit does not ask «is this product good?». It asks «would the same product come out the same way if you made it again next month?»
Who this is for
- Cosmetics manufacturers and contract manufacturers (OEM/ODM)
- Cosmetics exporters — EU cosmetics regulation requires GMP compliance
- Suppliers whose brand customers require GMP
🌱 How this relates to ESG
S SocialMaps directly onto the S (Social) pillar. Because it governs the safety of something applied to the body, it is direct evidence for product-safety questions.
- Korea's K-ESG guideline, S domain «consumers» — asks for a product safety management system; the GMP certificate answers it
- GRI 416 (Customer Health and Safety) — product safety impact assessment and non-compliance incidents. Deviation and recall records are the evidence
- Brand-owner supply-chain due diligence — cosmetics OEM/ODM customers inspect supplier hygiene directly. Third-party certification greatly reduces that burden
- Clause 11 covers waste management, which contributes some evidence on the E side — though environmental performance itself belongs to ISO 14001
What certification gives you
- Proves the manufacturing hygiene level required for export — EU cosmetics regulation requires GMPRequest audit duration and fees →
- Reduces contamination and mix-up risk, which is what causes recallsSee the 8-step process →
- Requirements largely overlap Korea's CGMP, so one effort serves bothCheck a certified organisation →
- Can replace a brand owner's own hygiene inspection during supplier registrationCertification mark rules →
- Deviations, complaints and recalls become records you can investigate, not storiesSee ISO 9001 →
How the requirements are structured
This is the overall shape of what the standard asks for. Working through it in this order is a sensible way to prepare.
| Clause | Title | In plain terms |
|---|---|---|
| 3 | Personnel | Who is qualified to do what, and how hygiene training is delivered. |
| 4 | Premises | Zoning, flow, cleaning and pest control — the «where» conditions. |
| 5 | Equipment | Cleaning, sanitising, maintenance and calibration of production equipment. |
| 6 | Raw and packaging materials | Incoming inspection, storage, release and supplier control. |
| 7 | Production | Manufacture to the batch instruction, with in-process checks, labelling and records. |
| 8 | Finished products | Release decision, storage, shipment and returns. |
| 9 | Quality control laboratory | Test methods, reagents, reference samples and test records. |
| 10 | Out-of-specification product | How product that fails to meet specification is judged and handled. |
| 11 | Wastes | How waste is separated, stored and disposed of. |
| 12 | Subcontracting | Contracts and verification when manufacturing or testing is outsourced. |
| 13 | Deviations | Recording and judging occasions when things did not go as specified. |
| 14 | Complaints and recalls | Receiving complaints and running a product recall. |
| 15 | Change control | Reviewing and approving changes to materials, process or equipment before they happen. |
| 16 | Internal audit | Checking yourselves so you find problems first. |
| 17 | Documentation | Keeping and controlling all of the above as documents and records. |
※ This is a summary written to help you, not the text of the standard. Please refer to the published standard for the exact requirements.
Before you apply, please check
Having these in place makes the audit considerably smoother. If you are not ready yet, you are still welcome to get in touch — we will set out what to do first, with a timeline.
- Is there a batch manufacturing instruction and record for each product, and is it actually completed?
- Are there hygiene training and health status records for operators?
- Are there cleaning and sanitising records for equipment and vessels?
- Are there incoming inspection and supplier evaluation records for materials and packaging?
- Is there a deviation form, with real recorded cases?
- Have you carried out at least one internal audit yourselves? (required before the audit)
- Is there a documented recall procedure, and have you run a mock recall?
- Have you decided the scope — which plants and product ranges?
You can apply for ISO 22716 certification here
Tell us your organisation’s size and the standards you need, and we will send you the audit duration and a fee proposal. You are free to decide after seeing it.
Tel 02-786-9242Email info@itscert.or.krFax 02-6940-9317
※ ITS Certification Body does not provide management system consultancy. Auditing and consultancy must remain separate. What we can do is explain the certification process and what you need to have in place.
Which audit division handles this
Audits against this standard are carried out by our 식품·화장품심사본부. See the organisation chart →