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The focus of that ISO 9001 is customer satisfaction and continual improvement. For medical devices, the applicable international Standard is ISO 13485:2003. This Standard is based upon the ISO 9001 standard, but clauses were added for the specific needs of medical device regulations. Also, the focus of the Standard was changed:
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Certificarea reprezintă acțiunea unei terțe părți (organism de certificare) ce demonstrează că organizația furnizează servicii și/sau produse în conformitate cu un anumit standard referențial. Procesul de certificare ISO 9001 presupune parcurgerea mai multor etape. Avem, pe de o parte etapele de obținere a certificării propriu ...
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ISO 9001 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries ...
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ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard ...
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CE Marking – Does it apply to your product, or not? Even after a quarter of a century in the quality and standards business, I occasionally get caught out.. So Far, So Good. I wrote a Quality Management System for someone recently against ISO 9001, 2015. The senior management team knew their business, market and customers well, and had that mature, no …
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ISO 9001, ISO 14001, ISO 18001, ISO 22000, ISO 27001, HACCP, CE MARKING. Home; About Us; Services; Validate Cert; Contact; Delivering Confidence. Our world-leading certification services enable you to demonstrate that your products, processes, systems or services are compliant with national and international regulations and standards.
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Marcado CE. Para poder venderse en la UE, muchos productos deben llevar obligatoriamente el marcado CE, que demuestra que el fabricante ha evaluado el producto y se considera que este cumple los requisitos de seguridad, sanidad y protección del medio ambiente exigidos por la UE.El marcado CE es obligatorio para los productos fabricados en cualquier …
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