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<section id="main"><div id="title-container"><div class="center clear" style="display:none;"><ul class="vb breadcrumb"><li><a href="/">Home</a><span class="divider">/</span></li><li><a href="/global-supply-chain">Global Supply Chain</a><span class="divider">/</span></li><li><a href="/global-supply-chain/onboarding-process">Onboarding Process</a><span class="divider">/</span></li></ul><h1 class="vb">Documentation Requirements - Quality</h1></div><hr style="display:none;" ><div style="height:35px;background-color:white;"></div></div><div id="alerts-container" class="vb center"><noscript><div class="alert"><h4>JavaScript is currently not supported or is disabled by this browser.  Please enable JavaScript for full functionality.</h4></div></noscript></div><div class="clearfix" style="-webkit-font-smoothing: antialiased;"><a href="#sideNav"></a><div class="center"><section id="outlier" class="two-column clearfix vb"><section id="sideNav"><h5>Global Supply Chain</h5><nav><ul><li><a class="" href="/global-supply-chain">Global Supply Chain</a><ul><li><a class="" href="/global-supply-chain/german-supply-chain-act">German Supply Chain Act</a></li><li><a class="" href="/global-supply-chain/types-of-suppliers">Types of Suppliers</a></li><li><a class="" href="/global-supply-chain/onboarding-process">Onboarding Process</a><ul><li><a class="selected" href="/global-supply-chain/onboarding-process/documentation-requirements-quality">Documentation Requirements - Quality</a></li><li><a class="" href="/global-supply-chain/onboarding-process/documentation-requirements-accounting">Documentation Requirements - Accounting</a></li><li><a class="" href="/global-supply-chain/onboarding-process/audit-types-and-frequency">Audit Types and Frequency</a></li><li><a class="" href="/global-supply-chain/onboarding-process/special-process-evaluation">Special Process Evaluation</a></li><li><a class="" href="/global-supply-chain/onboarding-process/certificate-of-compliance">Certificate of Compliance</a></li><li><a class="" href="/global-supply-chain/onboarding-process/production-part-approval-process">Production Part Approval Process (PPAP)</a></li></ul></li><li><a class="" href="/global-supply-chain/request-for-quotes">Request For Quotes (RFQ)</a></li><li><a class="" href="/global-supply-chain/arthrex-sba-supplier-base-program">Arthrex SBA Supplier Base Program</a></li><li><a class="" href="/global-supply-chain/arthrex-global-trade-compliance">Arthrex Global Trade Compliance</a></li><li><a class="" href="/global-supply-chain/supplier-performance-management">Supplier Performance Management</a></li><li><a class="" href="/global-supply-chain/sustaining-business-relationships">Sustaining Business Relationships</a></li><li><a class="" href="/global-supply-chain/supplier-sustainability">Sustainability</a></li><li><a class="" href="/global-supply-chain/arthrex-supplier-applications">Arthrex Applications</a></li><li><a class="" href="/global-supply-chain/supplier-contact-page">Become a Prospective Supplier</a></li><li></li></ul></li></ul></nav></section><section><article><div class="contributor-content"><p><strong>Category A Supplier Documentation</strong></p><table style="width: 886px; height: 271px;" border="1" width="654"><tbody><tr style="height: 45px;"><td style="width: 153.525px; height: 45px;"><p style="text-align: center;"><strong>Supplier Category</strong></p></td><td style="width: 162.556px; text-align: center; height: 45px;"><p><strong>Arthrex-Designed Devices (ADD)</strong></p></td><td style="width: 125.431px; text-align: center; height: 45px;"><p><strong>OEM</strong></p></td><td style="width: 177.606px; text-align: center; height: 45px;"><p><strong>Private Label</strong></p></td><td style="width: 250.881px; text-align: center; height: 45px;" colspan="2"><p><strong>Services</strong></p></td></tr><tr style="height: 27px;"><td style="width: 153.525px; text-align: center; height: 216px;" rowspan="3"><p>A</p></td><td style="width: 162.556px; text-align: center; height: 216px;" rowspan="3"><p>ISO 13485</p></td><td style="width: 125.431px; text-align: center; height: 216px;" rowspan="3"><p>ISO 13485 or ISO 9001 if certified</p></td><td style="width: 177.606px; text-align: center; height: 216px;" rowspan="3"><p>ISO 13485 or ISO 9001 if certified</p></td><td style="width: 113.394px; height: 27px; text-align: center;"><p><strong>Sterilization</strong></p></td><td style="width: 134.488px; height: 27px; text-align: center;"><p>ISO 13485</p></td></tr><tr style="height: 81px;"><td style="width: 113.394px; height: 81px; text-align: center;"><p><strong>Analytical testing/laboratory services</strong></p></td><td style="width: 134.488px; height: 81px; text-align: center;"><p>ISO 13485 and/or ISO 17025</p></td></tr><tr style="height: 45px;"><td style="width: 113.394px; height: 45px; text-align: center;"><p><strong>Other</strong></p></td><td style="width: 134.488px; height: 45px; text-align: center;"><p>ISO certificate if supplier is certified</p></td></tr></tbody></table><ul><li>Supplier Evaluation and Selection Form</li><li>Arthrex Supplier Quality Agreement</li></ul><p>&nbsp;</p><p><strong>Category B Supplier Documentation</strong></p><table style="width: 887px; height: 221px;" border="1" width="654"><tbody><tr><td style="width: 129.294px; text-align: center;"><p><strong>Supplier Category</strong></p></td><td style="width: 188.431px; text-align: center;"><p><strong>Arthrex-Designed Devices (ADD)</strong></p></td><td style="width: 125.287px; text-align: center;"><p><strong>OEM</strong></p></td><td style="width: 175.4px; text-align: center;"><p><strong>Private Label</strong></p></td><td style="width: 252.587px; text-align: center;" colspan="2"><p><strong>Services</strong></p></td></tr><tr><td style="width: 129.294px; text-align: center;" rowspan="3"><p>B</p></td><td style="width: 188.431px; text-align: center;" rowspan="3"><p>ISO 13485 or ISO 9001 if certified</p></td><td style="width: 125.287px; text-align: center;" rowspan="3"><p>ISO 13485 or ISO 9001 if certified</p></td><td style="width: 175.4px; text-align: center;" rowspan="3"><p>ISO 13485 or ISO 9001 if certified</p></td><td style="width: 116.269px; text-align: center;"><p><strong>Calibration</strong></p></td><td style="width: 133.319px; text-align: center;"><p>ISO 17025 or OEM</p></td></tr><tr><td style="width: 116.269px; text-align: center;"><p><strong>Analytical testing/laboratory services services</strong></p></td><td style="width: 133.319px; text-align: center;"><p>ISO 13485 and/or ISO 17025</p></td></tr><tr><td style="width: 116.269px; text-align: center;"><p><strong>Special processes</strong></p></td><td style="width: 133.319px; text-align: center;"><p>ISO 9001</p></td></tr></tbody></table><ul><li>Supplier Evaluation and Selection Form</li><li>Arthrex Supplier Quality Agreement</li></ul><p>&nbsp;</p><p><strong>Category C Supplier Documentation</strong></p><table style="width: 885px; height: 72px;" border="1" width="624"><tbody><tr><td style="width: 322.362px; text-align: center;"><p><strong>Supplier Category</strong></p></td><td style="width: 555.638px; text-align: center;"><p><strong>All Category C Suppliers</strong></p></td></tr><tr><td style="width: 322.362px; text-align: center;"><p>C</p></td><td style="width: 555.638px; text-align: center;"><p>ISO certificate if supplier is certified</p></td></tr></tbody></table><ul><li>Vet/Distributors/Importers Quality Agreement for veterinary, translation, and literature printing companies</li><li>Supplier Evaluation and Selection Form</li><li>Curriculum vitae, professional resume, and/or other acceptable documents for consultants and other private personal entities demonstrating ability to successfully fulfill criteria established by Arthrex for the product or service requested</li></ul></div></article></section></section></div></div></section>