ISO 13485: Quality Management System for Medical Devices Introduction to ISO 13485ISO 13485:2016 is an international standard that specifies technical requirements for quality management systems (QMS) in the medical device industry. Designed to ensure safety, efficacy, and regulatory compliance, this standard applies to every stage

Step 1: Establish the HACCP Team Team members must be trained and have sufficient understanding of issues related to developing and implementing the HACCP program. Step 2: Describe in detail the products involved Provide a full description of important details of the product(s) under study,

Product Certification Conforming to Vietnamese Standards (TCVN) What is conformity certification or product certification conforming to Vietnamese Standards (TCVN)? Conformity certification, also known as product certification conforming to Vietnamese Standards (TCVN), is the process of evaluating products and quality assurance systems against relevant standards to

OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEM (International Standard: ISO 45001:2018) According to incomplete reports from 63 Departments of Labor, Invalids and Social Affairs in 2015, there were 629 fatal occupational accidents in labor-related sectors across the country. Therefore, ensuring occupational safety for workers and minimizing

ISO 50001 – ENERGY MANAGEMENT SYSTEM The purpose of this standard is to help organizations establish the systems and processes necessary for continual improvement in energy performance, including energy efficiency, energy use, and energy consumption. It sets out the requirements for an Energy Management System

What is ISO/IEC 27001? ISO/IEC 27001 is the world’s best-known standard for information security management systems (ISMS). It helps businesses identify risks to critical information and implement appropriate controls to reduce information security risks. What are the benefits of Information Security Management? Identify risks and

ISO 22000 – Food Safety Management Unsafe food can lead to serious consequences for human health and life. Therefore, a management standard is essential to help businesses identify and control food safety risks. In today’s world, where food is frequently imported from multiple countries, its

ISO 14001:2015 Environmental Management Standard   1. Development History of the ISO 14000 Standards ISO 14001:1996: The first release of the international environmental management system standard. ISO 14001:2004: The second edition. ISO 14001:2015: The third and most recent edition. Issued by: International Organization for Standardization

WHAT IS ISO 9001? WHY DO BUSINESSES NEED ISO 9001 CERTIFICATION? Nowadays, the concept of ISO 9001 has become familiar and widespread in society. However, if asked what ISO 9001 actually is, many people may still struggle to give a clear answer. ISO 9001 is