We at QPS have extensive experience completing ISO 9001 in manufacturing organizations. Recently however we were asked to create a 9001 QMS for a major healthcare organization encompassing design and development of software systems used in major hospitals around the globe.
Our mission was accomplished in only three months. Our first task was to perform an assessment audit to see what was needed to build the QMS. During that process, we discovered that different parts of the organization were at different stages of compliance and that many issues were not documented well. The QPS team worked hard to correct documentation, improve processes, and organize communication amongst different parts of the organization. Performance and evaluation of process metrics are now communicated and evaluated by the management team and issues are resolved in a timely manner. At the end of our project, we successfully built a complete 9001:2015 system, and implemented all processes needed to support a 9001 QMS. In addition, we trained everyone on the system, went through a stage 1 audit at which time we corrected some nonconformances, and passed a stage 2 audit with zero nonconformances.
In order to achieve efficiencies that today’s world demands, it is critical that healthcare organizations implement ISO 9001:2015, the new ISO 9001 standard. The main structure of the new ISO standard is business improvement – integrating the QMS and the business into one management system. For many years, healthcare organizations have operated with limited management systems resulting in delays and errors that increase costs. Without good manageable control systems, healthcare costs will continue to increase with companies that lower their costs capturing more market share.
An effective 9001:2015 QMS can create improvement that addresses some of these issues, including reduction in the time to process claims, efficiencies in administrative processes, etc. The QMS drives quality improvement, which then translates to a business’s bottom line. The 9001:2015 QMS standard touches every part of the business and requires the management team and every employee to be involved in executing and improving the system. In addition, the standard ensures that every employee is focused on customer satisfaction, voice of the customer and cost reduction. Business improvement is much more than just improving quality, it is about improving everything the organization does as a business, one process at a time.