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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 does not necessarily mean compliance with ISO 9001 (and vice versa).
The International Organization for Standardization (ISO / ˈ aɪ s oʊ /; [3] French: Organisation internationale de normalisation; Russian: Международная организация по стандартизации) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member ...
Management determines the scope of the ISMS for certification purposes and may limit it to, say, a single business unit or location. The ISO/IEC 27001 certificate does not necessarily mean the remainder of the organization, outside the scoped area, has an adequate approach to information security management.
product certifications (many nations) Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications (sometimes called "certification schemes" in the product certification industry).
The history of testing, inspection and certification services spans back several centuries. In the late 19th century, following the advent of the Industrial Revolution and the considerable risks involved with high-pressure steam boilers, specialized institutions emerged across Europe which carried out periodical inspections of such vessels to assess their overall condition as a precautionary ...
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.
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