BSI, together with its Group Companies, also offers a broad portfolio of business solutions other than NSB activity that help businesses worldwide to improve results through Standards-based best practice (such as certification, self-assessment tool, software, product testing, information products and training). The British Standards Institution (BSI, a company incorporated by Royal Charter), performs the National Standards Body (NSB) activity in the UK. Likewise, we do not offer consultancy to clients when they also seek certification to the same management system. It means decisions are made free from any engagements of influences which could affect the objectivity of decision making.Īs an accredited certification body, BSI Assurance cannot offer certification to clients where they have also received consultancy from another part of the BSI Group for the same management system. In summary, there are basically five sections in the standard of the ISO.
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Impartiality means acting fairly and equitably in its dealings with people and in all business operations. ISO 13485:2016 (ISO/TC 210) The new ISO 13485:2016 (Published February 25. Impartiality is the governing principle of how BSI provides its services. Cybersecurity and information resilience Medical Device Regulation, the ASR Division Equipment and Technology Group are implementing a Quality Management System (QMS) compliant with ISO 13485.General Requirements EU Declaration of Conformity This is a formal document that officially certifies that your product fulfils the essential requirements needed to meet the applicable CE directives. Employees need to review all changes and document approaches, testing, and similar.
This is particularly important in the change and release management system, to ensure that any risks, issues, defects or feedback are properly addressed and resolved.
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