Courtesy: Internal Auditor ISO 13485 Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organization’s operations. It helps an organization to accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes. Internal auditing might achieve this goal by providing insight and recommendations based on analyses and assessments of […]
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Courtesy: Internal Auditor ISO 13485 This standard adopted by CEN as EN ISO 13485:2012 is harmonized with respect to the European Medical Devices Directive 93/42/EEC. Mexico published on October 11, 2012, a national standard as a Norma Oficial Mexicana (NOM) to control manufacture of medical devices inside the country. NOM-241-SSA1-2012, Buenas Practicas de Fabricación para Establecimientos dedicados […]
Courtesy: Internal auditor 13485 ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 […]
Courtesy: Inspection specialist An inspection is, most generally, an organized examination or formal evaluation exercise. In engineering activities inspection involves the measurements, tests, and gauges applied to certain characteristics in regard to an object or activity. The results are usually compared to specified requirements and standards for determining whether the item or activity is in line with these targets, often with a Standard Inspection Procedure in place […]
Courtesy: Inspection and certification service Most fire equipment needs to be inspected to make sure in the event of a fire, every effort has been taken to make sure it doesn’t get out of control. Extinguishers are to be inspected every month by law and inspected by a servicing company at least once a year. […]
Courtesy: Information technology ISO 20000 certification If your organization wishes to be formally you will need to be assessed by a Registered Certification Body (RCB). If you are able to demonstrate compliance with the requirements of ISO 20000-1 (part 1 of the standard, containing the mandatory requirements), the RCB will issue a certificate of conformance. According to […]
Courtesy : Information technology ISO 20000 certification [Withdrawn] ISO/IEC 20000-9: Guidance on the application of ISO/IEC 20000-1 to cloud services ISO/IEC TR 20000-9:2015 provided guidance on the use of ISO/IEC 20000‑1:2011 for service providers delivering cloud services. ISO/IEC 20000-10: Concepts and vocabulary ISO/IEC TR 20000-10:2018 describes the core concepts of ISO/IEC 20000, identifying how the […]
Although work provides many economic and other benefits, a wide array of workplace hazards (also known as unsafe working conditions) also present risks to the health and safety of people at work. These include but are not limited to, “chemicals, biological agents, physical factors, adverse ergonomic conditions, allergens, a complex network of safety risks,” and […]
Emergency management, also called emergency response or disaster management, is the organization and management of the resources and responsibilities for dealing with all humanitarian aspects of emergencies (prevention, preparedness, response, mitigation, and recovery). The aim is to prevent and reduce the harmful effects of all hazards, including disasters. The World Health Organization defines an emergency as the state in which normal procedures are interrupted, and […]
The Testing, Inspection and Certification (TIC) sector consists of conformity assessment bodies who provide services ranging from auditing and inspection, to testing, verification, quality assurance and certification. The sector consists of both in-house and outsourced services. Definition of Testing, Inspection and Certification services The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), international standard-setting bodies composed of representatives from various national standards organizations, define the different testing, inspection and […]