Recently, single-use system plant has successfully obtained the quality management system certifications of ISO15378:2017 and ISO13485:2016, which marks another milestone made by Morimatsu's single-use system plant in terms of quality management.
ISO15378:2017, an application standard for the design, manufacture and supply of primary packaging materials for medicinal products, aims to ensure the quality of medicinal packages during the supply process and help organizations engaged in design, manufacture and supply of medicinal packages manage the risk, traceability and safety of their products.
ISO13485:2016, with a full name of Regulatory Requirements for Medical Device Quality Management System, puts forward specialized requirements for the quality management system of medical device manufacturers and plays a good role in driving medical devices to be safe and effective in use.
Following the ISO9001:2015 system certification obtained in March this year, Morimatsu's single-use system plant has obtained a total of three quality management system certificates, namely ISO9001, ISO15378 and ISO13485.
The additional two quality system certifications gained this time shows that Morimatsu's single-use system plant has been brought in line with international standards when it comes to the R & D, design, production, quality management, etc. across the whole life cycle. It marks a new step forward taken by Morimatsu in terms of standardization and normalization and also lays a solid foundation for the company to moving towards the global market. In the future, Morimatsu will strictly implement the requirements of the quality management system standards, and contribute more to the development of the industry, as well as the global medical and healthcare cause.
About Morimatsu LifeSciences
Morimatsu LifeSciences, one of the key business segments of Morimatsu International Holding Co., Ltd. (Morimatsu International, stock code: 2155.HK), mainly consists of Shanghai Morimatsu Pharmaceutical Equipment Engineering Co., LTD., Morimatsu (Suzhou) LifeSciences Co., LTD., Shanghai Morimatsu Biotechnology Co., LTD., Shanghai Mori-Biounion Technology Co.,Ltd., and Pharmadule Morimatsu AB and its subsidiaries, which serves the pharmaceuticals, bio-pharmaceutical, cosmetic medicine, FMCG (cosmetics, baby, women & home Care, health care, fabric & home care, food, beverage, nutraceuticals) and other industries, providing customers with "core equipment+value-added services+digital intelligent overall factory solutions and services" ("MVP Solutions&Services"), focusing on core equipment, stainless steel process systems, disposable process systems, consumables, laboratory solutions, digital and modular factory solutions and services.
As a diversified multinational company, Morimatsu has opened subsidiaries or advanced manufacture plants in China, Japan, Sweden, United States, India, Italy, Singapore, and has delivered different forms of products and services to more than 40 countries and regions so far, by its global footprint of an efficient and professional team.
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