Over the years, Q-Point gained experience with different quality and sustainability standards in the cosmetics, food supplement and medical devices industry. Q-Point is able to support your organisation in the field of Cosmetics GMP / ISO 22716 and ISO 13485 for medical devices. The following issues can be part of our support:
• creating and implementing a quality management system
• conducting internal audits and assistance with external audits
• providing training on hygiene and other quality aspects
• advice regarding sustainability, quality and legislation
Laws and regulations for cosmetics are laid down in the European Cosmetics Regulation (1223/2009/EC). Every cosmetic product has been extensively evaluated for safety before it reaches the market. Consumer risk should be assessed and there are requirements in the field of information on labels and packaging. The new Medical Device Regulation (due first half of 2017) was extended considerably and requires more of the medical device manufacturers.
ISO 13485 (version 2016) emphasises on compliance with legislation. The ISO standard BS EN ISO 22716:2007 Cosmetics GMP Guidelines for Good Manufacturing Practices is applicable for producers that, according to the Food and Drugs act, have to produce cosmetics in accordance with good manufacturing practices. The norm states which codes of conduct are applicable, what the requirements are for working areas and equipment, what to do with waste etcetera. NVWA oversees the implementation of existing requirements.