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“Achieving certification just eleven months after starting is a remarkable accomplishment. We are now very well positioned to accelerate growth and effectively compete with the major players in our industry.”

James C.D. Hengst, PhD, President and CEO

Tricia Hoover performs Coxsackie virus purification inside a Biological Safety Level-3 laboratory at ZeptoMetrix’s Buffalo facility.

Firm Benefits

Obtained certifications for ISO 9001:2000 and ISO 13485:2003 within 11 months providing the opportunity to:
Access numerous new accounts
Increase sales by 20%
Increase employment by 20%
Improved internal documentation and structure
Customers no longer need to perform quality audits

ZeptoMetrix Corporation is a life sciences company that develops, manufacturers and sells products for scientists. The company's primary focus is on products used in the research of infectious diseases and oxidative stress including HIV, hepatitis, SARS, various cancers, Avian influenza, West Nile virus and numerous primate viruses. In addition, many of these products are packaged into test kits used for disease control and sold to major pharmaceutical and diagnostic companies.

ZeptoMetrix was founded in 1982 and has been under its present ownership since 1999. Its employment has grown to 35 people, including five PhD educated professionals. Company headquarters are located within the burgeoning medical research complex in downtown Buffalo, NY where ZeptoMetrix has maintained active collaboration with several renowned area institutions including Roswell Park Cancer Institute, SUNY at Buffalo and Hauptman-Woodward Medical Research Institute. In recent years ZeptoMetrix's sales have grown significantly as its products are marketed globally (about 30% of its sales volume is exported) to many diagnostic companies as well as numerous universities, hospitals, research centers and government agencies. Its major customers include such high-profile accounts as the National Institute of Health, the Center for Disease Control and the New York State Department of Health. In addition, because of its level 3 safety laboratory, ZeptoMetrix has received a "select agent permit" from Homeland Security to work with bio-terrorism agents.

Situation
Despite being both GMP and FDA compliant, one of ZeptoMetrix's customers, a major diagnostic company, insisted that future business was incumbent upon ZeptoMetrix becoming ISO 9001: 2000 registered. The company's senior management determined that it would not only pursue this registration, but also become certified in the ISO 13485:2003 medical standard as well. This certification is an enhanced version of the world-wide ISO standard with specific provisions uniquely applicable to the life sciences industry. It was believed that this certification was both closely related to the company's primary business and could provide a competitive advantage as few other manufacturers were registered to this extent. Unfortunately, due to business demands, limited internal resources and an unfamiliarity with the specifics of the standard, ZeptoMetrix management did not feel prepared to achieve registration within a reasonable time frame.

Solution
The company subsequently engaged the services of Insyte Consulting to support the upgrade of the quality system to the above standards. ZeptoMetrix's management believed that Insyte Consulting's trained staff could work effectively with their employees to develop and implement the enhanced quality processes. Insyte Consulting's intent was to clearly link the quality system, including the manual, processes and procedures, to the company's business structure and operations. A joint ZeptoMetrix/ Insyte Consulting team was formed to implement the elements of both these ISO standards. An initial review of existing procedures and documentation was conducted at the outset in order to develop a realistic project plan. An overview of the ISO 9000 standard was presented to all employees. This overview set a strong, common foundation of understanding across the organization, and validated the importance of the ISO implementation to the company's future.

The management team developed a quality manual, along with a quality policy and quality objectives to provide the structure for a quality system that was aligned with the company's vision. Personnel were trained in process mapping to assist in development of internal procedures. Teams were assigned to develop area and process specific procedures, while Insyte reviewed the created documentation and coached the team to ensure compliance to the ISO standard.

Internal auditor training was subsequently completed. The internal audit schedule was created and one complete audit cycle implemented. Review of the quality system was done through weekly meetings with the project management team. Management reviews were initiated and conducted at specified intervals. This aided in the system implementation while developing the practice of management reviews required by the standard.

Additionally Insyte Consulting worked with ZeptoMetrix's internal team to address specific nuances of the ISO 13485:2003 standard including risk management, advisory notices, traceability requirements, cleanliness of product and contamination control, and status identification.

Finally, an ISO registrar was selected and scheduled for the formal audits. Of particular importance, at this time the company personnel assumed ownership of the quality system and have been effectively maintaining it after formal registration (and subsequent surveillance audits) and completion of Insyte Consulting's involvement.

ZeptoMetrix achieved both ISO 9001:2000 and ISO 13485:2003 registration in June, 2005, just eleven months after project initiation. Since then the company has gained access to numerous new accounts because of the ISO certifications. This has helped support a 20% increase in sales during that period along with the opportunity to significantly accelerate growth over the next several years. Due to recent business growth, employment has increased proportionately by 20% as well. From an operational perspective the quality processes have supported improved internal documentation and structure, both of which were good before, but now meet or exceed prevailing industry standards. In addition many customers no longer need to perform quality audits at ZeptoMetrix, as the ISO registrations sufficiently attest to product quality and the adherence to a formal quality process with documented corrective action procedures in place.

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