By Mike Powers
ChristianaCare’s Clinical Engineering Department is certified and registered as ISO 9001:2015. The journey we took to achieve this was unique, and the experience helped us to understand the benefits of each quality management system (QMS) – and which would support our commitment to excellence. Through courageous self-evaluation and empathy, we became aware of our strengths and weaknesses and the need for a more formal QMS.
As a clinical engineering department, our responsibility is to always provide proper working equipment so that our employees, whom we refer to as caregivers, can leverage that equipment to treat or diagnose our patients. This responsibility is underscored by our organization’s core value to be exceptional today and even better tomorrow.
We decided to embark on this journey in 2016, after attending a Food & Drug Administration (FDA) workshop titled, “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices.” At the time, the industry was seemingly moving toward a formal QMS as a best practice. Since then, ChristianaCare has helped participate or drive several projects, including the 2018 FDA workshop “Medical Device Servicing and Remanufacturing Activities” and the development of Medical Imaging & Technology Alliance’s QMS standard for imaging devices.
Our budget for 2019 was approved with a line item for ISO certification. Calendar 2018 ended, and we made 2019 goals, one of which was to complete our certification process. I attended an American Society for Quality (ASQ) class on biomedical auditing, attempted to write our quality manual and generally found the whole endeavor daunting. It was hard to know where to begin, what to measure and how to convert our concepts into actionable items. In the end, we hired a facilitator who helped guide us through the implementation of and certification to ISO 9001:2015. Our decision to go with ISO 9001:2015 may be surprising, given the penchant in the industry for the ISO 13485:2016 Medical Devices Standard. However, when mapping the requirements for our compliance with the laws and regulations of federal, regional and state authorities – as well as our environment of care tasks from our Joint Commission accreditation – we discovered a few things that shaped our goal to be the adoption of ISO 9001:2015. Being an accre
dited Healthcare Delivery Organization (HDO) meant that we had 90% of the requirements for a formal ISO 9001 QMS already established and in place as processes and habits. For that reason, we would be able to use our resources wisely and effectively for certification of our well-run in-house program.
The first thing we found was that The Joint Commission requirement for continuous improvement aligned more elegantly with the ISO 9001:2015 framework around continuous improvement of customer service. This was due to several reasons, such as The Joint Commissions’ polling mechanisms, solicitation of feedback, and corrective and preventative actions (CAPA) language. As we worked through the process of certification, we discovered other variables by having to define our core processes, instead of a focus on core products and reproducibility of each product. Based on our understanding, ISO 13485:2016 is more concentrated on reproducibility and regulatory compliance around post-market surveillance instead of the formalization of growing benefits to patient care.
In our journey to certification, we stopped and formalized our management processes, which had been in place but less rigorous in implementation. Our key processes were identified to be in four areas:
For those processes, we established metrics for “what excellence looks like” and implemented key performance indicators (KPIs). Furthermore, we found that our great ideas needed a home. We took the initiative to vet proposals and establish a cost/benefit analysis and a reporting feedback loop.
In our management reporting weekly meetings, we document ideas, task a colleague with the research and, if appropriate, the item’s implementation. We establish a timeline for completion and follow up to make sure the project is completed. We analyze whether the expected benefits matched the actual results. The process of documentation to maintain compliance with our QMS has been a blessing that has allowed and provided a framework for advances such as:
Digital project management in lieu of paper copies that get damaged and misplaced.
Changing the wording of some of our work order close codes, to facilitate what is occurring and improve accuracy in reporting.
Re-evaluation of our approved vendor list and establishing requirements for how vendors are added and managed as well as periodical re-evaluation to ensure that our clinical engineers are providing the materials and services expected while minimizing risks.
Reports delivered to internal stakeholders that document the value of our cost center, and our timely delivery on quality and safety metrics that enable caregivers to deliver world-class care.
Having completed our certification journey, and now progressing through the regular day-to-day work of performing tasks in compliance with our QMS, we highly recommend the implementation of a formal QMS for any organization that strives for excellence.
Mike Powers, MBA, CHTM, CDP, CBA, is the Clinical Engineering Quality Manager at ChristianaCare.
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