The difference between GMP and ISO13485

Hello, the relationship between medical device GMP and ISO9000, ISO13485 is like this: \x0d\\\x0d\\ medical device GMP - for China, it is for the system assessment \x0d\ISO13485-. -is not a system regulation in China and is not required for sales in China; \x0d\ISO9000-is not for medical device companies. \x0d\\\\\x0d\ I will give you a brief introduction of these three below, I hope it will help you. \x0d\\\x0d\\ Medical device GMP: \x0d\\\x0d\ GMP is the abbreviation of English GOODMANUFACTURINGPRACTICE, the Chinese meaning is "product production quality management standard". The World Health Organization defines GMP as a regulation that guides the production and quality management of food, pharmaceutical and medical products. \x0d\\\x0d\\GMP is a set of mandatory standards for the pharmaceutical, food and other industries, requiring companies to meet the hygiene and quality requirements of raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control and other aspects of the relevant national regulations, to form a set of actionable operating practices to help companies to improve the health of the corporate environment, timely detection of problems in the production process, and to improve. Briefly, GMP requires pharmaceutical, food and other production enterprises should have good production equipment, reasonable production process, perfect quality management and strict testing system to ensure that the final product quality (including food safety and hygiene) in line with regulatory requirements. \x0d\\\\x0d\\ China's Ministry of Health on July 11, 1995 issued Wei Drug Fa (1995) No. 35 "Notice on the Development of GMP Certification of Drugs". Drug GMP certification is a system whereby the state implements GMP supervision and inspection of drug manufacturing enterprises (workshops) and drug varieties and obtains recognition according to the law. Although the international concept of pharmaceuticals includes veterinary drugs, only a few countries, such as China and Australia, separate GMP for human drugs from GMP for veterinary drugs. \x0d\\\x0d\\ drug GMP certification is carried out at the national and provincial levels, and according to the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, the drug supervision and management departments of the people's governments at the provincial level or above shall organize the certification of drug manufacturers in accordance with the Good Manufacturing Practices for Pharmaceuticals and the implementation methods and steps for implementation prescribed by the drug supervision and management department of the State Council; the certification of drug manufacturers in line with the Good Manufacturing Practices for Pharmaceuticals; the certification of drug manufacturing enterprises in line with the Good Manufacturing Practice for Pharmaceuticals", the certificate shall be issued. Among them, the certification of drug manufacturing enterprises producing injectables, radioactive drugs and biological products prescribed by the drug supervision and management department of the State Council is the responsibility of the drug supervision and management department of the State Council. \x0d\\\\x0d\\ISO9000: \x0d\ISO9000 quality assurance system is the root of the development and growth of enterprises, ISO9000 does not refer to a standard, but a category of standards collectively. It is all international standards developed by TC176 (TC176 refers to the Technical Committee on Quality Management Systems), and is the best-selling and most common product among the more than 12,000 standards of ISO. \x0d\\\\\x0d\ISO (International Organization for Standardization) and IAF (International Accreditation Forum) issued a joint communiqué on August 20, 2008 (the year of the eon), agreeing to smooth conversion of the world's most widely used quality management system standard and the implementation of ISO 9001:2008 certification. \x0d\\\\x0d\\ISO9001:2008 standard is based on eight years of practice by approximately one million ISO9001-certified organizations in 170 countries around the world, and expresses ISO9001:2008 requirements more clearly and unambiguously and enhances compatibility with ISO14001:2004. \x0d\\\x0d\ 2008 version of ISO9001 "Quality Management System Requirements" international standard is scheduled to be released by the end of 2008 GB/T19001-2008 "Quality Management System Requirements". 1 year after the release of the ISO9001:2008 standard, all certificates of certification issued by accredited certification bodies are ISO9001:2008 certificates; An internal auditor, known as an internal quality system auditor, is usually a person who is proficient in both the ISO9001:2008 international standard and familiar with the management of the organization. According to the requirements of the new ISO9001:2008 standard, organizations that implement the new ISO9001:2008 standard are required to conduct an internal quality audit at least once a year, so organizations that implement ISO9001:2008 usually need to train a group of internal auditors. Internal auditors can be part-time staff from various departments, so internal auditors play an important role in the proper operation and improvement of the quality system within an organization. \x0d\\\x0d\\ISO13485: \x0d\\x0d\ISO13485:2003 standard, the full name of the standard is "Medicaldevice-Qualitymanagementsystemsforregulation" (Medicaldevice-Qualitymanagementsystem- requirementsforregulatory). The standard was developed by the SCA/TC221 Technical Committee for Standardization of Quality Management and General Requirements for Medical Devices and is a stand-alone standard based on ISO 9001:2000. The standard specifies quality management system requirements for relevant organizations, but is not a guide to the implementation of the ISO9001 standard in the medical device industry. \x0d\\\x0d\ The standard has been widely implemented and applied around the world since its release in 1996, and a new version of the ISO13485 standard was officially released on July 3, 2003. Unlike the ISO9001:2000 standard, ISO13485:2003 is a management standard applicable in a regulatory environment: from the name it is clear that it is a quality management system requirement for regulatory purposes. Medical devices in the international are not only general listed commodities operating in a commercial environment, it is also subject to the supervision and management of national and regional laws and regulations, such as the U.S. FDA, the European Union's MDD (European Union Medical Devices Directive), China's "Regulations for the Supervision and Administration of Medical Devices". Therefore, the standard must be bound by law and operate in a regulatory environment, and at the same time, it must give full consideration to the risks of medical device products and require risk management in the whole process of medical device product realization. Therefore, in addition to the specialized requirements, it can be said that ISO13485 is actually ISO9001 in the medical device regulatory environment.\x0d\\\x0d\ The United States, Canada and Europe generally to ISO9001,, EN46001 or ISO13485 as a quality assurance system requirements, the establishment of medical device quality assurance system are based on these standards. To enter the market of different countries in North America, Europe or Asia, medical devices should comply with the corresponding regulatory requirements.