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Theresa Phillips
Theresa's Biotech / Biomedical Blog

By Theresa Phillips, About.com Guide to Biotech / Biomedical

ISO Certification

Monday February 12, 2007

Starting a new company always involves a certain amount of mandatory paperwork such as registrations and licensing. In the biotech industry, or any field with laboratories and release of chemical or biological products and waste, there is even more to worry about than your standard company. As a result, it might be tempting to rationalize that ISO certification is too much unnecessary effort and paperwork (or bureaucratic hoop-jumping) for a small company to bother with.

However, it seems that smaller companies come up short in terms of organization and communication for precisely that reason. Often the prevailing attitude is that the company is too small to need formal means of communication and record-keeping, and as a result, confusion arises when the chain of command is blurry or requests, work orders or research plans and results are relayed by word of mouth. Taking the time to work out formal protocols for planning, orchestrating, reviewing and revising a company’s R&D program, production, marketing and sales, all part of the process of obtaining certification in ISO 9001:2000 Quality Management Systems (QMS), has been demonstrated to improve efficiency and increase revenues, while also enhancing staff morale and productivity.

The requirements of ISO QMS certification involve a little extra paperwork and attention to detail, but the documentation that is required is not a whole lot more than what you should already have in place anyway. Also, as your company grows, following the QMS standard will ensure that internal lines of communication are open and clear, and that all of your company processes run as smoothly as possible, and that’s what everyone wants for their company, isn’t it?

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