Achieving ISO 9001:2008 and ISO 13485:2003, certification process requires a considerable amount of time and preparation, which concludes with a meticulous review by an independent agency; this is a outstanding milestone for HR Pharmaceuticals, Inc.
York, PA (Vocus) November 12, 2010
HR Pharmaceuticals, Inc. announced today that it has achieved the International Organization for Standardization's (ISO) 9001:2008 and ISO 13485:2003 certifications for its design and manufacturing of HR Lubricating Jelly. This accomplishment reaffirms the company’s adherence to these widely recognized requirements and enables HR Pharmaceuticals, Inc. to better serve the medical market.
“Achieving ISO 9001:2008 and ISO 13485:2003, certification process requires a considerable amount of time and preparation, which concludes with a meticulous review by an independent agency; this is a outstanding milestone for HR Pharmaceuticals, Inc.” said Colby Wiesman, Quality System Management Representative.
ISO certification, which evaluates organizations according to the stringent standards upheld by the world’s most respected companies, serves as a measure of the organizations’ management and operational controls. The voluntary certification assures customers of HR Pharmaceuticals, Inc. compliance to documented processes and procedures that ensure continued and ongoing improvements in delivering superb customer support.
"HR Pharmaceuticals, Inc. is proud to have earned the two ISO certifications, an achievement that demonstrates our commitment to maintaining the highest standards of manufacturing and quality control. These certifications are important attributes that further distinguish HR Pharmaceuticals, Inc. from other companies in our industry,” said David Wilson, Director of International Operations.
"HR Pharmaceuticals, Inc.’s ISO and audit team has successfully implemented an effective quality management system based on the requirements of the ISO 9001:2000 and ISO 13485:2003 standard and will directly benefit our customers and distributors into the future" said Jon P. Wiesman, President & CEO.
HR® Lubricating Jelly is available for purchase & distribution as of October 1, 2010; for more information please visit http://www.hrpharma.com
About HR® Pharmaceuticals, Inc.
Headquartered in York, PA, HR® Pharmaceuticals Inc. manufactures and distributes HR® Lubricating Jelly and HR® Clini-CleanTM Hand Sanitizer.
Since 1925, HR® Lubricating Jelly has been used in a variety of medical applications from surgical & reproductive therapies to the development of the transcutaneous electrical nerve stimulator in the 1950’s. HR® Lubricating Jelly provides a superior echogenic medium for imaging soft tissues such as muscles and/or tendons achieving exceptional results. HR® Clini-Clean Hand Sanitizer is an alcohol free, dye free, hypo-allergenic and non-toxic hand sanitizer making it more effective and less harmful than alcohol based sanitizers. The active ingredient benzalkonium chloride (BAC) is an alcohol-free antimicrobial compound that has been widely used in hospitals for more that 60 years. BAC offers a broad-spectrum kill against bacteria, viruses and fungi. Laboratory studies have proven that BAC antimicrobial intensity is superior while leaving natural skin oils and micro-flora intact.All HR® branded products are manufactured in the USA under the scrutiny of the FDA; we are an ISO9001:2008 and ISO 13485:2003, certified company, dedicated to meeting the most stringent of quality assurance. HR® Lubricating Jelly & HR® Clini-CleanTM are Kosher Certified- Orthodox Union Approved. We source the best pharmaceutical grade ingredients followed by a production profile in accordance with the requirements of 21 CFR Part 820, Good Manufacturing Practices - cGMP & Quality Systems Requirements (QRS) for Medical Devices.