ISO 13485 certification
Production certification and registration of certificates
The international standard ISO 13485:2016 ("Medical devices - Quality management systems - Requirements for regulatory purposes") regulates the establishment and implementation of quality management systems at enterprises engaged in the production of medical devices, machinery and equipment. It is the basis for the certification of quality management systems in companies that manufacture or distribute medical devices - or that are involved in their production as part of the supply chain.
In Ukraine, DSTU ISO 13485:2018 is a mandatory requirement for the implementation of medical devices by market operators at any stage: from full-cycle production to one link in the supply chain. DSTU ISO 13485:2018 applies exclusively to the territory of Ukraine. Certification according to DSTU ISO 13485:2018 (as opposed to passing the ISO 13485:2016 certification procedure) is a prerequisite for Ukrainian medical device manufacturers, and vice versa, for those who want to work with Ukrainian honey.
The European Union (EU) Regulation (EC) No 1223/2000 requires that cosmetic products be manufactured in accordance with Good Manufacturing Practice (GMP)
ISO 22716:2007 is an international standard for Good Manufacturing Practices (GMP) for cosmetics. ISO 22716 defines the requirements for documenting and regulating the production, control, storage and shipment of cosmetic products and products with similar hygiene requirements.
DSTU EN ISO 22716:2015 Cosmetics. Good manufacturing practice (GMP). Guidelines for good manufacturing practice (EN ISO 22716:2007) are adopted as national standard by the method of "confirmation" by the designation
The Cosmetics GMP certification according to ISO 22716 proves that your company's processes comply with good manufacturing practice.
The international standard ISO 22000:2018 "Food safety management systems (FSMS) - Requirements for any organisation in the food chain" is a standard harmonised with quality management, environmental management and certification standards that sets uniform requirements for HACCP systems.
This international standard is aimed at establishing safety management systems and is intended to be used by all organisations involved in the chain of production, supply and sale of food products. According to this standard, the food chain is a sequence of stages and operations that include the manufacture, processing, distribution, storage and processing of food and food products, from primary production to consumption. The production chain is seen as a single process during which all factors that may lead to the manufacture of substandard and hazardous products should be eliminated.
In accordance with the Law of Ukraine "On Basic Principles and Requirements for Food Safety and Quality", all persons engaged in the production or introduction of food products must apply HACCP systems without exception (Article 81 of the Law).
Compliance with the HACCP concept is mandatory for all companies that produce, process or sell food.