ISO 22716 certification of good manufacturing practices for cosmetics
In Bulgaria, we certify to ISO 22716 — the standard for good manufacturing practices for cosmetic products. It is for the manufacturers, packers, laboratories and warehouses that cosmetics pass through before reaching the customer. The audit is conducted in Bulgarian, and you will receive a tailored quote within two hours.
- Who it is formanufacturing and packaging
- Auditin Bulgarian, at your premises
- Quotewithin 2 hours during business hours
The standard at a glance
What is ISO 22716?
ISO 22716 is the international standard providing guidelines on good manufacturing practices (GMP) for cosmetic products. It covers production, control, storage and shipment — everything that determines whether the product in the jar is the same as in the formula and the documents.
The current edition is ISO 22716:2007. The European Regulation (EC) No 1223/2009 on cosmetic products requires manufacturing to comply with good manufacturing practice, and where the harmonized standard EN ISO 22716 is followed, compliance with that practice is presumed. That is why the standard is the practical way to show that your manufacturing meets the Regulation.
The standard is written for the product’s entire path through the company — people, premises, equipment, raw materials and packaging, production, finished product, laboratory, deviations, complaints and documentation. It does not cover research and development activities or the distribution of finished products.
It is important to know: an ISO 22716 certificate is not an authorization to place products on the market. The responsible person under the Regulation has other obligations too — safety assessment, product information file, notification. The certificate demonstrates that your manufacturing practices meet the standard.
Who ISO 22716 is for
- Cosmetics manufacturers Creams, shampoos, make-up, perfumery, hygiene products.
- Contract manufacturing Companies that manufacture for other brands and have to prove it to their clients.
- Packaging and warehouses Packers, fillers and warehouses the product passes through before dispatch.
- Control laboratories Testing of raw materials, intermediate and finished products.
ISO 22716 · the pillars
What good practice rests on
The standard is organized in chapters, but in practice it all comes down to three things. The auditor checks all three — on site, on the production floor, not just in the folders.
- 1People and premises
Trained staff with clear responsibilities and hygiene rules. Premises and equipment laid out so that there are no mix-ups, contamination or errors.
- 2Materials and production
Receipt and inspection of raw materials and packaging, production according to approved instructions, control of every batch and a clear status for every material.
- 3Control and traceability
Laboratory, deviations, complaints and recalls, change control, internal audit — and documentation that allows every batch to be traced.
What the auditor looks for on the production floor
- 1Material statusWhether it is immediately clear what is quarantined, approved or rejected.
- 2Batch recordWho produced the batch, when, with which raw materials and to which formula.
- 3CleaningRecords showing that equipment has been cleaned between different products.
- 4DeviationsWhat happened when something did not go according to the instructions.
- 5TraceabilityFrom the finished product back to the raw materials and forward to the customer.
The most common nonconformities are not in the formula but in material status and missing cleaning records.
ISO 22716 · the product’s path
From raw material to dispatch
The standard follows the product through the company. At every step there is a requirement — and a record that proves it has been met.
- 1Receipt
Raw materials and packaging are inspected and placed in quarantine until approved.
- 2Production
According to approved instructions, with a batch record and in-process control.
- 3Control
The laboratory tests the batch and releases or rejects it.
- 4Storage
Under suitable conditions, with a clear status and a “first expired, first out” rule.
- 5Dispatch
Only approved batches, with documents that allow traceability and recall.
| Step | Requirement | Evidence | Common mistake |
|---|---|---|---|
| Receipt | Check against the specification | Inspection report and status label | Raw material used before approval |
| Production | Work to an approved formula | Signed batch record | A change made “on the fly” without a record |
| Control | Testing according to a method | Laboratory report | Release without a report |
| Storage | Suitable conditions and status | Temperature records and orderly storage | Mixed statuses in one place |
How ISO 22716 certification works
The process is the same for every organization and follows ISO/IEC 17021-1, the international standard for certification bodies. Only the audit duration differs — it depends on the number of employees, the sites and the complexity of the activity.
The process in detail- 01 Enquiry and quoteYou describe your activity, number of employees and sites. You receive a quote with the scope, audit duration and price.within 2 hours during business hours
- 02 Contract and audit planOnce the contract is signed, we agree the dates, the scope and the audit team.dates that suit you
- 03 Stage 1 — readiness reviewThe auditor reviews the scope, the formulas and specifications, the manufacturing instructions and the procedure for deviations and complaints, and assesses whether the practices are ready for audit.documents, scope, readiness
- 04 Stage 2 — on-site auditThe audit checks the production floor — material status, batch records, cleaning, the laboratory, the warehouse and the traceability of selected batches.in Bulgarian, at your premises
- 05 Corrective actionsIf nonconformities are found, you are given a deadline to correct them and submit evidence.only if needed
- 06 Decision and certificateAn independent certification decision and issue of the certificate by CERTIND S.A.after an actual on-site audit
What the price of ISO 22716 certification depends on
The price of the certificate is not fixed, because it is calculated from several factors, including the audit days your organization requires, which are determined under the mandatory document IAF MD 5.
ISO certification pricingComplexity and sector
The types of products, the number of lines and whether you have your own laboratory.
Number of sites
Production sites and warehouses in scope.
Number of employees
Full-time and part-time staff.
Number and type of standards
When the system is integrated with ISO 9001, the audit is usually shorter.
A consultant to implement the system is a separate cost. A certification body cannot provide consultancy to the organizations it certifies — this is an impartiality requirement under ISO/IEC 17021-1.
Describe your activity, number of employees and sites — within two hours during business hours you will receive a quote with scope and price.
Exact quote within 2 hoursQuestions and answers
Frequently asked questions about ISO 22716
Answers to the questions our clients ask most often before certification.
Is ISO 22716 mandatory?
The certificate is not mandatory, but good manufacturing practice is. Regulation (EC) No 1223/2009 requires cosmetics manufacturing to comply with it, and conformity with the harmonized standard EN ISO 22716 creates a presumption that this is the case. The certificate is the independent proof.
Is the certificate an authorization to sell the product?
No. It demonstrates good manufacturing practices. The responsible person under the Regulation has other obligations too — safety assessment, product information file and notification before placing on the market.
Is ISO 22716 certification accredited?
No. The scheme is outside the scope of CERTIND S.A.’s accreditation. The certificate is issued after an actual on-site audit. The accredited quality standard is ISO 9001.
Can it be combined with ISO 9001?
Yes, and it is a common combination. ISO 9001 organizes the entire management system, and ISO 22716 adds the specific requirements for cosmetics manufacturing. The common part is audited once.
How long is the certificate valid?
Three years. Surveillance audits are carried out in the second and third years, and after the end of the cycle comes recertification, which keeps the certificate valid.
Standards that combine with ISO 22716
The standards that clients in the cosmetics sector combine most often.
All standards
ISO 9001Quality managementThe accredited foundation — the management system into which good manufacturing practice fits.To the standard 
ISO 22000Food safetyFor manufacturers of food supplements and products on the borderline between cosmetics and food.To the standard HACCPCritical control pointsHazard analysis — useful also where the product is ingested or comes into contact with mucous membranes.To the standard
ISO 22716 · Free quote
ISO 22716 certification
Describe your products, the organization’s locations, number of employees and types of standards — within two hours during business hours you will receive a quote with the scope, audit duration and an all-inclusive price.
- Sectorcosmetic products
- Auditin Bulgarian, at your premises
- Quotewithin 2 hours during business hours