ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices
What is ISO 14971:2019? ISO 14971:2019 is the international standard that outlines a comprehensive framework for the risk management of medical devices throughout their lifecycle. It provides manufacturers with a systematic approach to identifying hazards, estimating and evaluating risks, controlling those risks, and monitoring the effectiveness of those controls. This standard is essential for meeting regulatory requirements in global […]
ISO 14698 Cleanrooms and Associated Controlled Environments: Biocontamination Control
Introduction to ISO 14698 ISO 14698 is an essential international standard that addresses the control of biocontamination within cleanrooms and other associated controlled environments. While ISO 14644 primarily addresses particulate contamination, ISO 14698 focuses on microbiological contamination, ensuring cleanrooms meet rigorous biological safety and hygiene standards crucial for industries such as pharmaceuticals, biotechnology, healthcare, and […]
ISO/IEC 11801-1:2017 – Information Technology — Generic Cabling for Customer Premises
What is ISO/IEC 11801? ISO/IEC 11801 sets the international baseline for structured cabling systems used in customer premises. It defines cabling configurations and interface standards for a range of applications including from voice to residential environments. The standard ensures that different communication systems can function over a unified infrastructure. It supports a wide array of […]
ISO 11064-1
ISO 11064-1:2000 Ergonomic design of control centres Human factors and ergonomics (HF&E), also known as comfort design, functional design, and systems, is the practice of designing products, systems, and work environments to take into account the human body and its cognitive abilities. The goal of HF&E is to reduce human error, increase productivity, and improve […]
ISO 10664– Hexalobular Internal Driving Feature for Bolts and Screws
What is ISO 10664? ISO 10664:2014 defines the geometry and dimensions of the hexalobular internal drive used in bolts screws and other externally threaded fasteners. Many know it as the Torx drive. It increases torque transfer and lowers the risk of stripping during tightening. Manufacturers use it in automotive assembly aerospace hardware electronics and industrial […]
15 Best HACCP Tips You Need To Know
This article is a simple breakdown of the processes involved in HACCP and its importance in food safety. It will also walk you through some of the tactics used to keep your operations safe and productive. HACCP is a food safety system that can help reduce the risk of contamination and prevent foodborne illness outbreaks. […]
Sedex: Sustainable Supply Chain Solutions
What is SEDEX: Sustainable Supply Chain Solutions? SEDEX stands for Supplier Ethical Data Exchange, is a membership organization and online platform that provides sustainable supply chain solutions. It was founded in 2004 and is based in London, United Kingdom. Furthermore, primary goal of Sedex is to promote responsible and ethical business practices throughout global supply […]
EN 149 – Respiratory Protective Devices for Filtering Half Masks
EN 149 – Respiratory protective devices
HALAL Certification Guide for Food Products and Businesses
What is HALAL Certification? HALAL Certification is a document issued by a certifying body or authority that confirms that a product, service, or establishment complies with Islamic dietary and ethical guidelines. The term “HALAL” in Arabic means “permissible” or “lawful” according to Islamic law (Sharia). HALAL certification ensures that the products or services have been […]
FDA Registration
What is FDA Registration? FDA Registration is the process of registering certain types of businesses with the U.S. Food and Drug Administration (FDA) to ensure compliance with federal regulations. This process is required for companies that manufacture, distribute or import food, drugs, medical devices, cosmetics, dietary supplements and certain other products that are regulated by […]
