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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] 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.
ISO 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 ...
ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to ...
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
"You're pregnant," Shriver says to the person behind the camera, most likely Patrick S chwarzenegger's fiancée, Abby Champion, who shouts, "No!" "I'm just really not supposed to tell people ...
Top-ranked Jannik Sinner accepting a three-month doping ban deal was slammed by his fellow tennis professionals on Saturday. Sinner and the World Anti-Doping Agency settled on the suspension that ...
Edwin Arroyave is letting fans of his estranged wife, Teddi Mellencamp, know how she is doing following her brain tumor surgery. In a statement posted to his Instagram Stories and main feed on ...
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