The processes followed by most small- and medium-sized companies to prepare for or maintain an ISO 9001 registration have been largely manual rather than computerized. Employees are expected to key in or type the required quality documents, physically draw process diagrams, and spend hours creating and crossfooting reports and validating data to show ISO auditors that the business has actually followed the documented processes.

Likewise, internal and external ISO 9001 auditors can spend many days looking for paperwork, and manually assessing the reasonableness of data compared to company specifics.

This is particularly ironic, because most of the systems being certified are computer-based, and computers were designed to reduce the errors and inefficiencies of highly manual operations. The facts are that ISO 9001 registrations in manual environments still cost most small companies more than $100,000, and take an average of one year of preparation. There is evidence that up to 50 percent of these registrations fail at the time of recertification, due to the inability of a company to maintain and scale manual processes.

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