VIE
📌 Quick Summary ISO 13485:2016 is an international standard for quality management systems for organizations operating in the medical device sector. Medical devices may be used directly for diagnosis, monitoring, prevention, or treatment, so errors in design, manufacturing, or quality control can directly affect users. The standard helps organizations control processes that affect the quality, […]
Author Archives: Quỳnh Trang
📌 Quick Summary ISO 45001 is an international standard for occupational health and safety (OH&S) management systems, helping organizations identify hazards, assess risks, and implement appropriate controls in the workplace. The standard applies to organizations of all types and sizes, with its requirements integrated into management processes according to each organization’s actual operations. To effectively […]
📌 Summary ISO 15378:2017 is a quality management system standard for organizations that manufacture primary packaging materials used for medicinal products. It incorporates the requirements of ISO 9001:2015 together with relevant GMP requirements. The standard focuses on controlling factors that may affect the quality of primary packaging materials, including raw materials, suppliers, production, hygiene, contamination, […]
📌 Summary ISO 9001 is an international standard that specifies requirements for a Quality Management System (QMS) and is applicable to various types of organizations. ISO 9001:2015 is the current edition, while ISO 9001:2026 is the next revised edition, expected to be published in September 2026. The standard is based on seven quality management principles […]
📌 Key Takeaways FSSC 22000 is a Food Safety Management System Certification Scheme developed and managed by the Foundation FSSC. Recognized by the Global Food Safety Initiative (GFSI) since 2010, FSSC 22000 has become one of the most widely adopted food safety certification schemes across the global food supply chain. FSSC 22000 Version 7 is […]
📌 Key Takeaways ISO 22000 is an international standard for Food Safety Management Systems (FSMS), applicable to all organizations in the food chain, from production and processing to distribution and supporting services. ISO 22000:2018 is the current version of the standard. It is based on the High-Level Structure (HLS) comprising 10 clauses and was supplemented […]
