Who is it for?

The ISO 22716 standard was developed for the cosmetics industry and addresses the specific requirements of companies operating in this sector. Although ISO 22716 certification is voluntary, implementing the standard’s guidelines is essential. This is because it serves as a tool for fulfilling the obligation imposed by the EU directive:

• manufacturing cosmetics in accordance with Good Manufacturing Practices (GMP),
• and maintaining documentation confirming the operation of an appropriate quality management system within the company.

EU Regulation No. 1223/2009 applies to all entities involved in the production of cosmetics:

• raw material manufacturers,
• finished product manufacturers,
• importers, exporters, and distributors (who are required to ensure that the products they place on the market have been manufactured in accordance with GMP principles).

The ISO 22716 standard is intended for entities that wish to:

• confirm that their management system meets legal requirements,
• improve their processes in the areas of production, control, storage, and transport of cosmetic products.

Information about the standard

The ISO 22716 standard is a quality management system for the cosmetics industry. Since its guidelines include the principles of Good Manufacturing Practice, it is also sometimes referred to as Cosmetics GMP. The ISO 22716 standard was developed as an extension of the ISO 9001 guidelines to include industry-specific aspects.

ISO 22716/Cosmetic GMP provides guidelines regarding the quality of cosmetic production, as well as responsibilities related to their transport and storage. Demonstrating compliance of these processes with ISO 22716 guarantees the introduction of a safe product to the market.

The ISO 22716 standard describes requirements regarding:

• staff training,
• the design and operation of facilities,
• production procedures and hygiene,
• packaging quality,
• product quality control,
• proper storage and transport,
• waste disposal in accordance with health and safety regulations,
• use of subcontractors,
• complaints and product recalls,
• internal audits,
• documentation system.

Benefits of Implementation

Implementation and certification to ISO 22716/Cosmetic GMP guarantees the creation of a product that is safe for health. It also contributes to the company’s development and growth in market value. In addition to documented compliance of the company’s operations with applicable laws, the benefits of implementing the ISO 22716 standard include:

• improved quality of cosmetic products,
• reduced risk of placing a product on the market that does not meet the required standards,
• the ability to quickly detect and respond to non-conformities,
• proper staff training,
• alignment of the company’s infrastructure with the highest quality standards,
• reduction of operating costs associated with the proper operation of equipment,
• the creation of transparent documentation of the company’s operations, facilitating administrative tasks,
• increased competitiveness of the company in the market,
• a positive brand image and increased trust among customers and business partners.