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Oliver Medical is committed to meeting the high levels of quality required by the medical device and pharmaceutical industries. Our dedication to quality includes operating to ISO and FDA standards.
Oliver currently holds the following quality certifications:
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ISO 13485:2003 certified,
Grand Rapids facility
Oliver Medical's Grand Rapids headquarters is ISO 13485:2003 certified, ensuring the consistent delivery of products and services that meet customer and regulatory requirements and facilitating compliance with global regulations. Oliver Products Company, Medical Business Unit is registered by BSI, certification number FM 535308.
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ISO 13485:2003 certificate
(348 K) Adobe PDF
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ISO 9001:2000 certified
Oliver is ISO 9001:2000 certified, ensuring the consistent delivery of products and services that meet customer requirements and achieve customer satisfaction while pursuing continuous improvement. Oliver Products Company, Medical Business Unit is registered by BSI, certification number FM 75008.
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ISO 9001:2000 certificate
(484 K) Adobe PDF
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FDA registered contract manufacturer
Oliver Products Company is an FDA registered contract manufacturer, #1000396174.
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ISO 14644-1 certified class 8 cleanroom, Grand Rapids facility
Oliver Medical's gowning and manufacturing areas for zone-coat lids are certified class 8 in compliance with ISO 14644-1.
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Grand Rapids class 8 cleanroom certificate
(832 K) Adobe PDF
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ISO 14644-1 certified class 8 cleanroom, Venray facility
The Oliver Medical facility in Venray, the Netherlands, features printing, materials, and gowning areas that are certified class 8 in compliance with ISO 14644-1.
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Venray class 8 cleanroom certificate
(96 K) Adobe PDF
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Quality assurance overview
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Quality certifications
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