ISO 22716

ISO 22716 is an international standard developed by the International Organization for Standardization (ISO). It defines the general requirements for implementing Good Manufacturing Practices (GMP) in the cosmetics industry. This standard provides a comprehensive management system that ensures the quality and safety of cosmetic products, covering all stages of production, storage, control, and distribution.

ISO 22716 can be applied by any business involved in the production, packaging, storage, and distribution of cosmetic products. It is targeted at cosmetics manufacturers, production facilities, quality control laboratories, cosmetics logistics companies, as well as suppliers of raw materials and packaging who want to ensure compliance with Good Manufacturing Practices.

Developing a Good Manufacturing Practices System according to ISO 22716 involves the following stages:

• Identifying legal and regulatory requirements for the production and distribution of cosmetics
• Establishing procedures for hygiene, raw materials control, equipment management, and quality control
• Organizing facilities, personnel, and processes to ensure product safety and quality
• Training personnel in the requirements of Good Manufacturing Practices
• Continuously evaluating, reviewing, and improving the system through internal audits and non-conformity reports

The complexity of implementing ISO 22716 depends on the size of the business, the complexity of its production processes, and its existing quality practices. Companies that already have a quality management system can more easily adapt to the standard’s requirements. Collaborating with specialized consultants can streamline the process and ensure full compliance with regulatory requirements.

Several certification bodies in Greece are accredited by the Hellenic Accreditation System (ESYD) or by equivalent organizations to issue relevant certificates, depending on the company’s activity. The certification process involves evaluating the company’s compliance with its production and quality control procedures, assessing the Good Manufacturing Practices System against the standard’s requirements, and reviewing its practical implementation.

Once the evaluation is successfully completed, the Certification Body issues a Certificate of Conformity valid for three years. If there are significant deviations, corrective actions must be taken by the company before the certificate is issued. Minor deviations must be resolved by the next assessment.

The certificate remains valid as long as scheduled periodic assessments are carried out by the Certification Body—at least once a year—to confirm continued compliance with the specified requirements.

Companies that adopt ISO 22716 can enjoy multiple benefits, such as:

• Ensuring the quality and safety of cosmetic products, minimizing contamination risks and failures
• Complying with legislative and regulatory requirements, such as EU Regulation (EC) 1223/2009 for cosmetics
• Increasing consumer trust by demonstrating the company’s commitment to quality and hygiene
• Improving internal organization through clear procedures for production, storage, and distribution
• Enhancing competitiveness, as ISO 22716 certification is often a requirement for international collaborations in the cosmetics sector

The time required to develop and certify a Good Manufacturing Practices System depends on the size of the company, the complexity of the production process, the adequacy of the infrastructure, and staff involvement. For small businesses, it typically ranges from 2 to 4 months, while larger organizations may need a longer preparation period.