Passed FDA and ISO 13485 certification, passed UL factory audit and obtained UL certification, passed Wal-Mart factory, SMETA factory audit and Disney factory verification
The Sedex Member Ethical Trade Audit (SMETA) is one of the most widely used forms of social and ethical auditing in the world. SMETA is an auditing methodology that provides a compilation of best practice ethical audit techniques. It is designed to help auditors conduct high-quality audits covering all aspects of responsible business practices, including labor, health and safety, environmental and business ethics. SMETA is designed to allow suppliers to share audits with multiple customers, meet multiple customer requirements and reduce duplication in social and ethical audits. SMETA has three elements: • General best practice guidelines for conducting ethical trade audits • General Audit Report Format • General corrective action plan format Nearly 20,000 SMETA audits are uploaded to the Sedex platform each year. Each SMETA review is accompanied by a unique reference code to ensure that the SMETA review is properly verified. It can be used for regular site auditing or Sedex offline auditing tools. SMETA is available in English, Spanish and Chinese.
WAL-MART
Walmart factory The Wal-Mart audit is also known as the Wal-Mart Ethical Standards Review. Through Wal-Mart employees working with suppliers and factories, training and promoting local laws and regulations, as well as Wal-Mart standards, pursuing continuous improvement of ethical standards , maintaining maintaining the goodwill of the Wal-Mart brand, developing long-term business partnerships with suppliers and winning investors Trust and support. Wal-Mart's supplier standards cover the health, safety, compensation, working hours, forced labor, child labor, discrimination , compliance and procuratorial rights of Wal-Mart's designated third-party auditors. An audit process is implemented to ensure that the manufacturer's products meet the requirements of the supplier's standards.
Underwriter Laboratories Inc
UL is the abbreviation of Underwriter Laboratories Inc. UL Security Labs is the most authoritative laboratory in the United States and the world's largest private security testing and identification organization. It is an independent, profitable professional organization that tests public safety. It uses scientific testing methods to determine the hazards or hazards to life and property of various materials, equipment, products, equipment, buildings, etc.; to determine, prepare and promulgate appropriate standards, and to help reduce and prevent life. The property may lose information and conduct fact-finding. UL certification is a non-mandatory certification in the United States, mainly used for the detection and certification of product safety performance. The scope of certification does not include the EMC (electromagnetic compatibility) characteristics of the product. In short, it is primarily engaged in product safety certification and commercial safety certification, with the ultimate goal of obtaining fairly safe products for the market and helping to protect personal health and property. Regarding product safety certification as an effective means of eliminating technical barriers to international trade, UL is also playing an active role in promoting the development of international trade.
ISO-13485
ISO 13485:2003 is a management standard applicable to the regulatory environment: it is clearly defined as the quality management system requirements of the regulations. In the international arena, medical equipment is not only a general listed product operating in a commercial environment, but also subject to national and regional laws and regulations, such as the US FDA, the European Union MDD (European Medical Device Directive) and the Chinese medical device regulations. Therefore, the standard must be legally regulated by the regulatory environment and must take full account of the risks of medical device products and require risk management throughout the implementation of the medical device product. Therefore, in addition to special requirements, it can be said that ISO13485 is actually ISO9001 under the medical device regulatory environment. The United States, Canada and Europe usually use ISO 9001, EN 46001 or ISO 13485 as the requirements for quality assurance systems, and the establishment of medical device quality assurance systems is based on these standards.
Introduction To FDA Certification
The US Food and Drug Administration (FDA) is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulator, FDA's role is to ensure the safety of food, cosmetics, pharmaceuticals, biologics, medical devices and radioactive products produced or imported in the United States. It was one of the first federal agencies to protect consumers as their primary function. Food, medicine, cosmetics and medical devices approved by the FDA are safe for humans. In nearly 100 countries, such as the United States, only commercial, clinical applications can be manufactured through FDA-approved materials, equipment, and technology.
Global Security Verification
GSV is an acronym for Global Security Verification and is the three main components of Wal-Mart audits, namely counter-terrorism. The inspection contents are related to the safety, warehouse, packaging, loading and transportation of the factory. After passing the GSV audit, you will receive a GSV certificate from the US Customs. The mission of the GSV system is to work with suppliers and importers around the world to promote the development of a global safety certification system that helps all members strengthen safety and risk control, improve supply chain efficiency and reduce costs. Developed by former senior customs officers and supply chain security experts, the GSV system is a highly transparent, broad-based, and most recognized supply chain security compliance and validation standard. This global supply chain security service system combines expertise and technology to integrate supply chain security into business operations through industry collaboration, helping importers and suppliers reduce the risk of cross-border shipments while accelerating the destination market. time. GSV's advanced scoring system is globally recognized for all types of international import security systems, including C-TPAT, AEO, PIP and WCO. Evaluation results can be shared by multiple importers, saving costs.
Cosmetics-Good Manufacturing Practices
In November 2007, the International Organization for Standardization (ISO) established the quality management system standards for the cosmetics industry, namely ISO22716:2007 Cosmetics - Good Manufacturing Practices. This standard provides cosmetic manufacturers with operational guidelines for production, control, and storage.
Disney Factory Advantage
(1) Establish a management system that meets international requirements and can be internationally recognized to improve the brand's ability to compete actively. (2) Promote consumers to build positive emotions on products; dream content management system (3) Stabilize cooperation with purchasers, broaden new markets, and lay a solid foundation for long-term development; (4) Improve management systems, improve relationships with employees, increase productivity, and increase profits; (5) Minimize potential business risks.
GMPC
GMP “is an abbreviation for Good Manufacturing Practices, which means “Good Practices” or “Good Manufacturing Practices.” It is an autonomous management system that pays special attention to the quality of products and the implementation of health and safety in the production process. In short, GMP requires food production enterprises to have good production equipment, reasonable production technology and perfect quality management. Strict inspection system ensures that the World Health Organization (WHO) requires final products. The quality of the food quality management system (including food safety and hygiene) meets the specific requirements of the company's quality management system. The International Health Organization stipulates that the drug will be exported from 1992. It must be produced in accordance with GMP regulations and must be prepared for drug transportation. It has been used in most countries of the world. Government Pharmaceutical companies and medical experts widely recognized, pharmaceutical companies and hospital preparation room and excellent quality management system is necessary.