BUSINESS STANDARDS
is the quarterly magazine of BSI Group, highlighting the vital role that standards play in today's business environment. Regular features include interviews with leading business figures, as well as news on the latest developments in management systems and standards.
Medical matters
17 Mar 2008
Topics: Medical devices, ISO 13485, Healthcare, Quality management, ISO 9001, USA
Reglera, a regulatory and quality consulting company, has achieved certification to ISO 13485:2003 Medical Devices and ISO 9001:2000 Quality Management Systems by BSI.
Reglera specializes in quality and regulatory consulting and process outsourcing, focusing on two primary industries: medical devices and human cellular and tissue products. Since 1994, the company has been working with tissue and medical device companies, and helping them cope with the various regulatory and quality systems in place.
"Reglera's customer base is made up exclusively of regulated companies. As a result, we decided to pursue a quality system model that would be understood and accepted by the vast majority of our clients," explains Clay Anselmo, president of Reglera. "The combination of ISO 13485 and ISO 9001 certification, through an internationally recognized Notified Body, was the obvious choice. Being audited and certified by a well respected third party brings a level of credibility to our quality system that internal audits cannot.
"In addition to the credibility it brings to our services, it provides us with a clear competitive advantage over other consulting/outsourcing companies. It is extremely powerful to be able to say that we hold ourselves to the same quality management systems (QMS) requirements as our clients and it demonstrates that we know how to implement quality systems that are compliant with recognized QMS standards."
While ISO 13485:2003 is normally reserved for manufacturers and suppliers of medical devices, Reglera's outsourced products (eg its Document Control and Training programme, and a Donor Eligibility Determination System) include some aspects of the medical device manufacturing process. As such, it is one of the first companies of its type to qualify for this certification.
"For us, the most difficult part of the process was understanding how to map QMS elements that typically apply to traditional manufacturing to a services based environment. Items like non-conforming material and identification and traceability were certainly challenging," Anselmo adds. "We would suggest that other services-based business considering certification to ISO 13485, spend time early on in the process developing a strategy for mapping the requirements to their business, then use the pre-assessment as a tool to evaluate the implementation.
"The standards set a common expectation level for everyone that wants to participate in the industry and provide a roadmap for building a strong quality system. As such, they are extremely valuable. The ISO 13485 standard has gone a long way to educate industry participants worldwide and is providing a mechanism for QMS standardization," he concludes.
For more information:www.bsiamericas.com/MedicalDevices
Business Standards © 2008. Editorial produced by Caspian Publishing in association with the British Standards Institution. Editorial opinions expressed on are not necessarily those of BSI Group or Caspian Publishing. Neither Caspian Publishing nor BSI Group accept responsibility for advertising or editorial content, nor for that appearing on linked third-party websites. Reproduction in whole or in part is forbidden without written permission from BSI Group or Caspian Publishing.
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