Global manufacturer’s ISO compliance simplified with BPM.
After 18 months of continuous effort, Medifab successfully achieved ISO-13485 compliance.
We caught up with Stuart Clook, Quality and Regulatory Affairs Manager at Medifab, to hear about their compliance journey, and what their major learnings were.
Nintex Promapp: Why is it important for Medifab to be ISO compliant?
Medifab: At Medifab we have our sights set on growing in our export markets, namely Europe and the Americas, where compliance requirements are very demanding for manufacturers and marketers of medical appliances.
Compliance with ISO 13485 is critical for us, because it’s a quality management system (QMS) that specifies requirements for medical device manufacturers to meet both customer requirements and regulatory requirements. Compliance with ISO 13485 demonstrates a commitment and excellence in producing medical devices that meet rigorous safety, quality and efficacy standards: a certificate that most major markets require from medical device manufacturers who want to sell products in their country.
The ISO 13485 standard will provide us with a solid foundation on which to build additional processes, required to meet the regulatory requirements for each of our export destinations. These requirements can be particularly challenging when we deal with certain parties, like the US Food and Drug Administration (FDA) and the European Union.
Compliance with the ISO 13485 standard sets Medifab apart because our solid processes and business systems give customers and our distributors around the world confidence in the systems and processes that Medifab uses to design, manufacture and distribute our products.
Medifab is also certified to ISO 9001, a QMS used by many manufacturing and services industries to help ensure that customers get consistent, good quality products and services, and with ISO 14001, an environmental standard that Medifab follows to improve and manage its effect on the environment.
Nintex Promapp: How did you go about achieving ISO 13485?
Medifab: One of my major focuses at Medifab has been to help the company achieve ISO 13485. Our certification is a huge milestone for Medifab and now that we have set the bar, the challenge will be to keep improving.
The certification process initially involved a two-day audit in June 2017, where Medifab was assessed to see whether we had the right systems and processes in place.
We then spent the next four to five months preparing for the second audit which recently took place over six days, to assess whether we had followed our processes correctly. The quality records generated during this time provided evidence for the auditors to determine if we were compliant to the requirements in the standard.
Risk management is a new focus for both ISO 9001 and ISO 13485 since the revision of all quality standards over the last two years. This has placed increased emphasis on the business understanding and managing its risks, and has become a lot more integrated into the business than it used to be.
We learned some key lessons during this process:
- You can’t do it alone. You need the whole business to engage and support the project.
- Teams need to follow a standard process to increase accountability and encourage process improvement. This starts with staff – and not the quality manager - identifying and documenting their own processes.
- Make sure you implement an effective audit trail, together with a robust change process.
- Integrate the newly documented processes with risk management to meet the revised risk requirements in the quality standards.
Nintex Promapp: How did Nintex Promapp help Medifab become ISO compliant?
Medifab: As quality manager, I need to make the QMS work for Medifab, and not the other way around. Nintex Promapp helped us do this.
There were 4 ways Nintex Promapp impacted our ISO compliance journey:
Processes are managed efficiently and are continuously improving.
Nintex Promapp’s process management and process approval workflow capability empowers the Medifab team by giving them visibility and access to everything within one system. As a quality manager, I can ensure changes are managed and approved correctly before publishing. Processes are also continuously being improved through integration with the improvement modules we have created for managing customer feedback, non-conformances, improvement opportunities, and engineering changes.
Risk management is simpler and easily integrated with our processes and improvement modules.
Our risk management has been a lot easier with the creation of risk portfolios in Nintex Promapp for the different areas of the business. It’s straightforward to link a risk to the process that manages it. The risk heatmaps and dashboard provide a simple way to view and manage these risks, to ensure that the treatments (controls) have been completed and that further risk reduction is prioritized in the right areas.
Workflow accountability facilitates the audit trail.
Electronic signatures are a big part of our compliance because they create an audit trail that records who has published, reviewed and changed a process, and what the change was for.
The improvement module workflow - established for customer feedback, non-conformances, improvement opportunities, and engineering changes - helps ensure root cause, corrective and preventive actions are identified and actioned. The notification system and dashboard facility make this easy for me to manage and oversee.
The auditor had confidence in Medifab’s ability.
The audit was remarkably painless, because the auditor could find everything in one system. Within that one platform we house all our processes and our records, as well as audit trails detailing why things were changed. It was a lot more straightforward than diving into different locations, looking for files.
The dashboards and heat maps were also helpful, and the headline dashboards for each of the Improvement modules provided a great overview in just one glance.
Nintex Promapp: How has the implementation of Nintex Promapp impacted people and culture at Medifab?
Medifab: Our ISO 13485 certification has meant big changes for the teams at Medifab. We have a non-negotiable requirement to document what we do, to keep records, and to ensure that any changes are approved and signed off.
By providing a platform for our teams to register ideas for process improvement, Nintex Promapp encourages our people to contribute to Medifab’s change culture.
With a straight-forward system like Nintex Promapp this is easy to do and provides a level of transparency that we have not had before - everyone can see and understand why our processes have changed.
About Stuart Clook.
Stuart has been championing business and process improvement for over 25 years. With a degree in Polymer Science and Engineering, and postgraduate studies in Manufacturing Systems Engineering, Stuart’s previous roles have seen him deploy quality management systems, and Lean principles and methodologies across global companies. Today, he leads and manages Medifab’s strategy for quality assurance and regulatory affairs.