The ISO 22716 Certification Process

The ISO 22716 Certification Process

Companies that have built and put the ISO 22716 cosmetics GMP system into operation can apply to Sistem Patent Kalite, the certification and consultancy firm, to obtain the ISO 22716 certificate. ISO 22716, published in 2007, covers the same family of good manufacturing practice controls for cosmetics. Once the cosmetics company has its quality management system in place against the standard, it applies to Sistem Patent Kalite for the ISO 22716 cosmetics GMP certificate.

Our certification work runs in two stages. In the first stage, we review the documentation the company has produced during the system build. This is effectively a pre-check. We share any gaps or errors we see with the company so they can be fixed before the on-site audit. In the second stage, we send qualified auditors to the company's own site to run the full audit. During that stage, we monitor how well the company's operation matches the ISO 22716 standard. After the audit, the auditors produce a report and submit it to Sistem Patent Kalite. On the basis of the report, we decide whether the company is entitled to receive the certificate and, where the outcome is positive, issue and deliver the ISO 22716 cosmetics GMP certificate.

What Each Stage Looks Like in Practice

The documentation review focuses on the quality manual, the procedures, the production records, the deviation and recall workflow, and the training records. The on-site audit walks through the production areas, the warehouse, the laboratory (where relevant), and the release process, and the auditors speak to production staff to confirm that the documented system is in live use. Where major nonconformities are raised, the company addresses them and the auditors verify the fix before the certificate is issued.

For more information on the ISO 22716 cosmetics GMP certification process, or to implement the system and obtain the certificate, contact the experienced managers and staff at Sistem Patent Kalite, with consultancy offices in Istanbul, Izmir, Ankara, Bursa, Adana, Antalya, Eskisehir, Konya, and Kayseri.