CERTIFICATIONS

Blueberry is certified for the following regulations:

Certified UNI EN ISO 9001 – demonstrates that the quality management system of the company has been recognised as fully compliant to an excellency standard. In details it focuses on :

• quality management system
• accountability management
• resources management
• production
• measurements
• analisys and improvement

Certified UNI EN ISO 22716 – In addition to meeting the requirements of the European regulations it responds to the market requirement to ensure the highest level of safety, transparency and objectiveness of information data on the product.

This enables also:

• verification of compliancy to EN ISO 22716:2008 (GMP);
• verification of data files system, or rather the manual verification of GMP Quality and manual procedures during the production, control and conservation, plus the shipment of cosmetic products.;
• gap analysis EN ISO 22716:2008 (GMP), evaluates the state of the art of the production and also the impact it might have, thus it must obtain GMP compliance.

Certified UNI EN ISO 14001 – certifies that the organisation has an adequate management system and keeps under control the environmental impact in all the activities thus, seeking improvement in a coherent, efficient and sustainable manner with a focus on: 

• definition and formalisation of environmental policy;
• identification and evaluation of environmental impact caused by accidents, potential dangerous/hazardous emergency situations;
• knowledge of the current environmental regulations and ongoing monitoring of the laws about to be issued;
• ability to determine priorities and to define specific aims and planned results ;
• updated knowledge of daily planning of activities, control, monitoring, audit and tests, in order to assure compliancy and the importance of environmental policy.

Certified UNI CEI EN ISO 13485:2016, certifies that the company posses all the requirements concerning the quality management in order to produce and provide medical grade devices and related services. All of these devices are manufactured in compliance with client requirements and all regulations that applies to medical devices. The scope concerns ” planning, developing and producing third party non active and non sterilised medical devices,  as liquid, paste, gel or cream, for dermatological and gynaecological use”.