With ISO9001 Certification Korber Breaks Barriers to Entry to New Customers
Körber Pharma, Inc.
Körber Pharma, Inc. is part of Körber, a German-based company and a worldwide leader in manufacturing of packaging equipment to pharmaceutical and medical companies. Such packaging equipment, for instance syringe handling machines, is designed and built specifically to customer’s specifications. In addition Körber Pharma, Inc. offers advanced integration services, which provide a complete packaging line with all of the mechanical components and controls tied together seamlessly. Körber Pharma, Inc. Fargo facility employs 137 people.
Körber Pharma, Inc. team was aware of significant opportunities to secure relationships and revenue with key clients that required ISO9001 certification. COO, David Brown, committed to a key client that their team would achieve their ISO9001 certification before end of the year to meet that client’s needs.
Deploying a project manager, Jeremy Wentz, and Technical Writer, Kelli Russillo, to lead the project team. Jeremy contacted Impact Dakota for support knowing their expertise serving manufacturers in North Dakota. A meeting was set up on site at Körber Pharma, Inc. to perform a no cost ISO9001 assessment and to share implementation plan. The Körber Pharma leadership team collaborated with Jodie Mjoen of Impact Dakota sharing the mature processes they had in place and identified the areas additional support would be needed in order to meet the ISO9001 Standard requirements.
Seeing alignment to meet their needs, Körber Pharma, Inc. moved forward with an ISO9001 Implementation agreement with Impact Dakota.
An ISO9001 Implementation Project kickoff meeting was held on June 20, 2021 with all the Körber Pharma's leadership team to share the updated implementation plan and assign areas of responsibility. Based on the process a project timetable was established. Break-out sessions were scheduled over the next several weeks with the various departments to perform a full gap assessment to the ISO9001 Standard. The team determined where they were compliant, where the gaps existed, and what actions they could take to make their current processes more robust to meet the Standard. The team executed on their actions in the gap closure plan, trained their entire organization to the revised processes.
The collaborative team put their new Quality Management System into motion to collect objective evidence of compliance. They completed an internal audit to the full standard, identified their own internal corrective action and closed them. The team then notified their RAB accredited third party registrar informing the company was ready for certification and completed their ISO9001 Stage 1 Audit with the registrar beginning of November and closed all corrective actions from that.
They positioned themselves for the full ISO9001 Stage 2 Registration Audit that was completed on December 20th 2021, just 6 months after the team kicked off this ISO9001 implementation project, and passed with a few minor corrective actions to close and got their ISO9001 QMS Certification!!
Award: Körber has received ISO9001 Certification from RAB certified Registrar.
Team initial investment (time and money): $150,000 including a) 1,280 hours to train employees and implement compliance, b) fees for using Impact Dakota services and Registrar costs, c) calibration of tools and d) internal ISO auditor training.
Training: 137 employees were trained for ISO9001 QMS
Culture: The team enhanced their culture of being process performance driven by formalizing processes to drive actions in any areas they were trending or not meeting their targets. Increased Productivity by standardizing and documenting processes to adopt best practices across their teams. People are more in tuned to what needs to be done for their jobs.
Increased Market: Körber has secured one new customer who requires ISO9001 Certification. It is expected that this certification will attract more customers.
“Impact Dakota provided a step by step process of preparing and guiding our company through the unknown to achieve our final goal of attaining ISO 9001 certification. Great resource to have in your corner no matter what your business needs.”
Jeremy Wentz, Senior Project Manager – Team Lead