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Products and services used in Orthopaedic, Trauma and Spine procedures, including medical devices (including Orthopaedic specific equipment such as power tools), equipment management services and orthopaedic specific services. Note: For future tenders the following requirements will apply: • ISO Certification: Tenderers must have ISO 9001: 2015 or BS EN ISO 13485:2016 or Medical Device Single Audit Program (MDAP) accredited by the United Kingdom Accreditation Service (or international equivalent) to cover all segments of the Tenderer’s and the product’s supply chain. This should include, but not be limited to, sales, manufacturing, storage and distribution ('ISO Certification'). Link for acceptable alternatives https://iaf.nu/en/accreditation-bodies/ (‘Notified Bodies’). • CE Certification and Declaration of Conformity certificates are required where applicable to be presented at submission stage of the tender. • Modern Slavery for Tenderers that have an annual turnover of at least £36 million must have a link to their modern slavery statement on their website. • Modern Slavery Assessment Tool (MSAT) Tenderers must have a score of 41% or above within 12months of the Tender Publ
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