Courtesy: Internal Auditor ISO 13485 Internal auditing activity is primarily directed at evaluating internal control. Under the COSO Framework, internal control is broadly defined as a process, effected by an entity’s board of directors, management, and other personnel, designed to provide reasonable assurance regarding the achievement of the following core objectives for which all businesses strive: Effectiveness and […]
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Courtesy: Internal Auditor ISO 13485 The internal auditing profession evolved steadily with the progress of management science after World War II. It is conceptually similar in many ways to financial auditing by public accounting firms, quality assurance and banking compliance activities. While some of the audit technique underlying internal auditing is derived from management consulting and public accounting professions, the theory of internal auditing was […]
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 […]
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 A home inspection is a limited, non-invasive examination of the condition of a home, often in connection with the sale of that home. Home inspections are usually conducted by a home inspector who has the training and certifications to perform such inspections. The inspector prepares and delivers to the client a written report of […]
Courtesy: Inspection specialist In international trade several destination countries require pre-shipment inspection. The importer instructs the shipper which inspection company should be used. The inspector makes pictures and a report to certify that the goods that are being shipped and produced are in accordance with the accompanying documents. Commodity inspection is other term that is used between buyers […]
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: Inspection and certification services 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 […]