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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>/</li><li><a href="/global-supply-chain">Global Supply Chain</a>/</li><li><a href="/global-supply-chain/onboarding-process">Onboarding Process</a>/</li></ul><h1 class="vb">Audit Types and Frequency</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="" 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="selected" 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">As part of the Arthrex supplier monitoring program, Arthrex suppliers may be subject to routine quality system audits. In addition, Arthrex may conduct for-cause audits in circumstances that warrant additional activity. See the information below for which supplier types and categories correspond to audit types and frequencies. Supplier types not listed below do not require routine quality system audits.&nbsp;<table style="height: 870px;" border="1"><tbody><tr style="height: 26px;"><td style="width: 426.918px; height: 26px;" colspan="3">Supplier Classification</td><td style="width: 427.088px; height: 26px;" colspan="3">Audit Information</td></tr><tr style="height: 26px;"><td style="width: 97.7699px; height: 26px;">Type</td><td style="width: 225.469px; height: 26px;">Description</td><td style="width: 97.7131px; height: 26px;">Category</td><td style="width: 144.616px; height: 26px;">ISO Certification</td><td style="width: 133.324px; height: 26px;">Audit Type</td><td style="width: 143.182px; height: 26px;">Audit Frequency</td></tr><tr style="height: 44px;"><td style="width: 97.7699px; height: 238px;" rowspan="5">&nbsp;&nbsp;Arthrex-Designed Device (ADD)</td><td style="width: 225.469px; height: 44px;">Contract manufacturer (High risk)</td><td style="width: 97.7131px; height: 44px;">A</td><td style="width: 144.616px; height: 44px;">ISO 13485</td><td style="width: 133.324px; height: 44px;">On-site audit</td><td style="width: 143.182px; height: 44px;">3 years</td></tr><tr style="height: 44px;"><td style="width: 225.469px; height: 44px;">Contract manufacturer (Moderate risk)</td><td style="width: 97.7131px; height: 44px;">B</td><td style="width: 144.616px; height: 44px;">ISO 13485 or ISO 9001</td><td style="width: 133.324px; height: 44px;">On-site or desktop audit</td><td style="width: 143.182px; height: 44px;">4 years</td></tr><tr style="height: 62px;"><td style="width: 225.469px; height: 62px;">Contract manufacturer (Low risk)</td><td style="width: 97.7131px; height: 62px;">C</td><td style="width: 144.616px; height: 62px;">ISO certificate if Supplier is certified</td><td style="width: 133.324px; height: 62px;">Desktop audit and/or ISO certificate</td><td style="width: 143.182px; height: 62px;">5 years</td></tr><tr style="height: 26px;"><td style="width: 225.469px; height: 26px;">Packaging (Sterile barrier)</td><td style="width: 97.7131px; height: 26px;">A</td><td style="width: 144.616px; height: 26px;">ISO 13485</td><td style="width: 133.324px; height: 26px;">On-site audit</td><td style="width: 143.182px; height: 26px;">3 years</td></tr><tr style="height: 62px;"><td style="width: 225.469px; height: 62px;">Veterinary</td><td style="width: 97.7131px; height: 62px;">C</td><td style="width: 144.616px; height: 62px;">ISO certificate if Supplier is certified</td><td style="width: 133.324px; height: 62px;">Desktop audit and/or ISO certificate</td><td style="width: 143.182px; height: 62px;">5 years</td></tr><tr style="height: 80px;"><td style="width: 97.7699px; height: 80px;">&nbsp;&nbsp;OEM</td><td style="width: 225.469px; height: 80px;">Externally manufactured devices</td><td style="width: 97.7131px; height: 80px;">A</td><td style="width: 144.616px; height: 80px;">ISO 13485 or ISO 9001if certified</td><td style="width: 133.324px; height: 80px;">Desktop audit</td><td style="width: 143.182px; height: 80px;">3 years</td></tr><tr style="height: 80px;"><td style="width: 97.7699px; height: 80px;">&nbsp;&nbsp;OEM</td><td style="width: 225.469px; height: 80px;">Externally manufactured devices</td><td style="width: 97.7131px; height: 80px;">B</td><td style="width: 144.616px; height: 80px;">ISO 13485 or ISO 9001if certified</td><td style="width: 133.324px; height: 80px;">Desktop audit</td><td style="width: 143.182px; height: 80px;">4 years</td></tr><tr style="height: 44px;"><td style="width: 97.7699px; height: 88px;" rowspan="2">&nbsp;Private Label</td><td style="width: 225.469px; height: 44px;">Externally manufactured devices</td><td style="width: 97.7131px; height: 44px;">A</td><td style="width: 144.616px; height: 44px;">ISO 13485 or ISO 9001 if certified</td><td style="width: 133.324px; height: 44px;">Desktop audit</td><td style="width: 143.182px; height: 44px;">3 years</td></tr><tr style="height: 44px;"><td style="width: 225.469px; height: 44px;">Externally manufactured devices</td><td style="width: 97.7131px; height: 44px;">B</td><td style="width: 144.616px; height: 44px;">ISO 13485 or ISO 9001 if certified</td><td style="width: 133.324px; height: 44px;">Desktop audit</td><td style="width: 143.182px; height: 44px;">4 years</td></tr><tr style="height: 26px;"><td style="width: 97.7699px; height: 167px;" rowspan="3">&nbsp;&nbsp;Services</td><td style="width: 225.469px; height: 26px;">Sterilization</td><td style="width: 97.7131px; height: 26px;">A</td><td style="width: 144.616px; height: 26px;">ISO 13485</td><td style="width: 133.324px; height: 26px;">On-site audit</td><td style="width: 143.182px; height: 26px;">3 years</td></tr><tr style="height: 47px;"><td style="width: 225.469px; height: 47px;">Analytical testing/Laboratory services &ndash; Product release</td><td style="width: 97.7131px; height: 47px;">A</td><td style="width: 144.616px; height: 47px;">ISO 13485 and/or ISO 17025</td><td style="width: 133.324px; height: 47px;">On-site audit</td><td style="width: 143.182px; height: 47px;">3 years</td></tr><tr style="height: 50px;"><td style="width: 225.469px; height: 50px;">Analytical testing/Laboratory services &ndash; Non-product release</td><td style="width: 97.7131px; height: 50px;">B</td><td style="width: 144.616px; height: 50px;">ISO 13485 and/or ISO 17025</td><td style="width: 133.324px; height: 50px;">On-site audit or certificate</td><td style="width: 143.182px; height: 50px;">4 years</td></tr><tr style="height: 44px;"><td style="width: 97.7699px; height: 88px;" rowspan="2">&nbsp;&nbsp;Services</td><td style="width: 225.469px; height: 44px;">Device design</td><td style="width: 97.7131px; height: 44px;">A</td><td style="width: 144.616px; height: 44px;">ISO certificate if Supplier is certified</td><td style="width: 133.324px; height: 44px;">On-site audit or desktop</td><td style="width: 143.182px; height: 44px;">3 years</td></tr><tr style="height: 44px;"><td style="width: 225.469px; height: 44px;">Calibration</td><td style="width: 97.7131px; height: 44px;">B</td><td style="width: 144.616px; height: 44px;">ISO 17025 or OEM</td><td style="width: 133.324px; height: 44px;">On-site audit or certificate/OEM</td><td style="width: 143.182px; height: 44px;">4 years</td></tr></tbody></table>&nbsp;Packaging = sterile barrier material, pouches, trays, lids, etc.Externally Manufactured Devices includes suppliers that are manufacturers of OEM/private label products distributed by Arthrex and/or off-the-shelf components that may be included in an assembly or kit.</div></article></section></section></div></div></section>