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Quality certifications

Oliver-Tolas Healthcare Packaging 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 standards and FDA regulations.

Oliver-Tolas currently holds the following quality certifications:

ISO 13485:2003 certified
Oliver-Tolas Healthcare Packaging's Grand Rapids, Michigan, USA and Venray, the Netherlands facilities are 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-Tolas Healthcare Packaging, LLC and Oliver-Tolas Healthcare Packaging BV are registered by BSI, certification number FM 535308.

ISO 13485:2003 certificate
 
ISO 13485:2003 certificate
(504 K) Adobe PDF

ISO 9001:2008 certified
Oliver-Tolas Healthcare Packaging's facility in Feasterville (Philadelphia), PA is ISO 9001:2008 certified, ensuring the consistent delivery of products and services that meet customer requirements and achieve customer satisfaction while pursuing continuous improvement. Oliver-Tolas Healthcare Packaging is registered by BSI, certification number FM 41360.

ISO 9001:2008 certificate
 
ISO 9001:2008 certificate
(296 K) Adobe PDF

ISO 9001:2008 certified
Oliver-Tolas Healthcare Packaging's facility in Hamilton (Cincinnati), Ohio is ISO 9001:2008 certified, ensuring the consistent delivery of products and services that meet customer requirements and achieve customer satisfaction while pursuing continuous improvement. Oliver-Tolas Healthcare Packaging is registered by BSI, certification number 523229.

ISO 9001:2000 certificate
 
ISO 9001:2008 certificate
(232 K) Adobe PDF

FDA registered contract manufacturer
Oliver Products Company is an FDA registered contract manufacturer, #1000396174.

ISO 14644-1 certified class 8 cleanroom, Grand Rapids facility
Oliver-Tolas' work, inspection, and changing areas for zone-coat lids are certified class 8 in compliance with ISO 14644-1.


Cleanroom 8 certificate
 
Grand Rapids class 8 cleanroom certificate
(1.2 MB) Adobe PDF

ISO 14644-1 certified class 7 cleanroom, Feasterville facility
Oliver-Tolas' work, inspection, and changing areas for hand assembled products are certified class 7 in compliance with ISO 14644-1.


Cleanroom 7 certificate
 
Feasterville class 7 cleanroom certificate
(1.2 MB) Adobe PDF

ISO 14644-1 certified class 8 cleanroom, Venray facility
The Oliver-Tolas facility in Venray, the Netherlands, features printing, materials, and gowning areas that are certified class 8 in compliance with ISO 14644-1.


Cleanroom 8 Venray certificate
 
Venray class 8 cleanroom certificate
(360 K) Adobe PDF

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VisiSeal™ | LogoTint™ | Micro text | WaterMark™

Pocket pouch | Chevron header bag | Ostasis™ reinforced pouch

Dispos-a-vent™ pouches | Isotech® bags | Puncture resistant pouches

Ovantex® sterile-grade material | Osurance® zone coated lids | Roll stock | Lids | Pouches

Xhale® hot melt adhesives | SealScience® water based adhesives

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© 2004–2010 Oliver-Tolas™ Healthcare Packaging  |  info@oliver-tolas.com

Grand Rapids, MI USA   877.283.3431   616.456.7711  |   Feasterville, PA USA   888.398.6527   215.322.7900  |   Hamilton, OH USA

Venray, the Netherlands   +31.478.517.560  |   Suzhou, P.R. China   +86.512.6917.1258