Bio-Chem Valve Inc. Receives ISO 9001
Bio-Chem Valve, Inc., located in Boonton, NJ is a leading manufacturer of miniature solenoid valves and pumps. Bio-Chem Valve Inc. manufactures a complete line of miniature isolation valves, pinch valves and pumps used in chromatography, auto-sampling, blood diagnostics, medical instrumentation, bio-technology, pharmaceutical equipment, environmental analysis and other applications. The company was founded in 1983 and became a part of Halma Group plc in 1995. They have grown rapidly in the last few years and currently have 50 employees. Bio-Chem Valve provides product development engineers and equipment manufacturers a unique partnership that meets both performance and price point objectives.
Two factors prompted Adam Meyers, president of Bio-Chem Valve, to pursue ISO 9001 certification. The first involved their primarily US-based customers, who were not pressuring the company for certification, but were going through certification themselves. As a result, Bio-Chem Valve was required to provide detailed information on their quality system and design controls to meet the needs of their customers. Secondly, internal pressures as a result of rapid growth fueled the desire to have procedures and programs that would facilitate and manage current and future growth. Pursuing ISO 9001 certification would enable Bio-Chem Valve to better serve their customers needs and requirements and provide them with more control over production and design functions.
Bio-Chem Valve discussed their interest in ISO 9001 with the Morris Area Development Group who called in the New Jersey Manufacturing Extension Program, Inc. (NJMEP), a NIST MEP network affiliate, to work with Adam and his team. An NJMEP Field Agent told Adam about an ISO consortia that was being held in cooperation with the County College of Morris and implemented by Alamo Learning Systems. NJMEP also helped Bio-Chem Valve receive funding for the program from the New Jersey Department of Labor Office of Customized Training.
The consortia activities commenced in March of 1999. These activities consisted of group activities in conjunction with company specific on-site activities. Bio Chem Valve implemented their own company-wide training for all employees and mock audits. An internal audit was conducted and in February 2000 an external auditor conducted a pre-assessment. The final audit was completed on April 24th. Due to their thorough preparation, Bio-Chem was spared the usual step of the auditors issuing corrective actions that need to be addressed before certification. Bio-Chem received their certification on May 15th. The certification was without comment and without finding – an exemplary result!
Adam credits this success to the commitment to the process from the top down. Bio-Chem’s Certification Team consisted of five senior managers, including Adam. Scott Reider, Quality Assurance Manager, worked on the certification full time for three months. The other team members included: Benny Wilcox, Vice President of Finance; Curt Eliason, Production Manager; and James Motta, Engineering Manager. Everyone in the company was trained and involved. Adam is also quick to point out that his company had a thorough quality program in place before they started the certification process started.
According to Adam, “We have grown dramatically in all aspects of our business over the past few years, including the doubling of our facility this past December. Without these processes and documentation, we would have imploded. The process served us well and our customers well.” Before the ISO certification, individual projects were documented in an ad-hoc manner and information shared only among the people directly involved. Now Bio-Chem Valve has centralized project management and design and development. Every project is tracked and maintained in a central place and documented in a uniform fashion. Information is archived, indexed and retrievable. Adam says that now “anyone can learn any job.” The company has been able to grow smoothly.
Adam credits NJMEP with helping Bio-Chem Valve towards ISO 9001 certification. “They were able to jump on it and get the ball rolling. NJMEP has the right set of programs combined with a good understanding of what is needed by small, local manufacturers."
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