What is ISO 13485? ISO 13485 is a quality management system standard that is specific to the medical device industry. It helps manufacturers create products that are safe and effective for patients. To receive ISO 13485 certification, a company must demonstrate that it has a comprehensive quality management system in place. This system includes processes for the design, development, production,...

What is ISO Lead Auditor Training? ISO Lead Auditor Training is a program that provides participants with the skills and knowledge necessary to conduct ISO lead audits. The program covers topics such as auditing principles, auditing techniques, and auditing standards. It also teaches participants how to prepare and conduct an audit, and how to write an audit report. Importance  ISO Lead...

What is the FDA? The Food and Drug Administration (FDA) is a government agency that oversees and regulates the safety of foods, drugs, cosmetics, medical devices, and other products that impact public health. One of the FDA's responsibilities is to certify certain products as safe and effective for use. This certification is known as FDA approval or FDA clearance. Importance If a product has...

Defining HACCP HACCP Certification is a food safety system certification that helps businesses identify and prevent food safety hazards. The HACCP Certification process involves identifying potential food safety hazards and then putting steps in place to reduce or eliminate those hazards. Businesses that have obtained this Certification demonstrate a commitment to food safety and are able to...

Defining RoHS Certification The Restriction of Hazardous Substances Directive (RoHS) Certification is a certification that declares that a product or material meets the requirements of the RoHS Directive. The RoHS Directive limits the use of certain hazardous materials in electrical and electronic equipment. To be certified as RoHS compliant, products must meet specific requirements for the...