In 2020 NeoGenomics decided to launch an accreditation program for its international sites in Switzerland and Singapore.
Clarity on the need to be ISO 15189 accredited
Why? The regulation (EU) IVDR (2017) states: "the health institution's laboratory is compliant with standard EN ISO 15189. It shall apply from May 2022. The Swiss site needed to be compliant with ISO 15189 before May 2022 to be used by CDx/IVD manufacturing companies. Moreover, ISO standards are more prevalent in Europe and ASIA PAC than CAP.
So, what? ISO standards are international standards bringing a visible hierarchy to the Quality Management System (QMS), thus creating clarity and a big picture.
What is next? Once the European site is accredited, other sites may be ready to make the shift. Anticipating the time needed for all the steps of the accreditation process is crucial, including an internal gap analysis and potential changes to documents.
Conclusion on the need to be ISO 15189 accredited
Evidence of the gaps: An internal gap analysis between NeoGenomics QMS and the ISO 15189:2012 requirements allowed organization and planning of the accreditation process. The project created an improvement of the QMS.
Persuasion of the need: Another essential part of the project's effectiveness was influencing, persuading, and communicating the necessity of the goal, which allowed alignment of the multi-functional teams.
Change mentalities: An essential part of the project was helping people accept the change by giving them enough time and involving them. The accreditation process with the notified body (NB) CAP (called CAP15189 program) with approximately one year, so including the team from the start and communicating clear timelines helped.
Decision on the need to be ISO 15189 accredited
Collaboration: This crucial project involved all departments, creating an interdepartmental collaboration “by getting everyone aligned behind an initiative.” For example, feedback from the Compliance team, EHS, Quality, Regulatory, Operations, Facilities, and operational excellence from NeoGenomics was needed.
Planning: A checklist of actions needed for the application and accreditation was created. An evaluation of the time required for each activity with set timelines was conducted, having in mind as a goal to reach accreditation in May 2022. Different strategic steps were to be followed by the team (see summary key dates).
Risk: The risk was for NeoGenomics not to obtain accreditation on time. A solution was to use the approach and approximate timeline from CAP15189 by gaining their knowledge and experience to reduce the risk. In their one-year program, they have a desk review, a Gap assessment, etc., before the actual accreditation assessment, in addition to numerous very well-made training courses on the standard (see below).
Summary of ISO 15189 accreditation process
Obtaining ISO 15189 accreditation before May 2022 was feasible with a thorough internal Gap analysis, organization, planning, and involvement of every department and international sites, in addition to a fundamental Quality culture shift by using the CAP15189 tools such as a root cause analysis tool, Quality culture questionnaires, and starting a pFMEA Risk analysis of all our processes. Accreditation through the previously known notified body CAP15189 program reduced the risk by using their educational best practice tools (see below).
Accreditation of Rolle and Singapore sites was achieved six months ahead of schedule, on the April 1st, 2021 for the Rolle site and the July 1st, 2021 for the Singapore site. The Gap assessment was turned into the accreditation assessment for the Rolle site. It was the first time in the history of CAP15189 that such a result was obtained remotely, and only the 4th time in 12 years of the CAP15189 program. It has been a fantastic journey for the Swiss and Singapore sites and such a great team-building effort. The help of the CAP15189 auditors Amy Pennock, Lead auditor and Deborah Miller, the technical auditor, was crucial in the process.
Summary of key dates:
The accreditation is non-defined, often a multiyear process: which turned into 6 months for the Rolle site!
CAP15189 quality management education tools:
Risk Management: Learn how the different elements of the quality management system—e.g. internal audit, data analysis—play a role in identifying and controlling risk.
Quality Culture: This course provides an adaptable program for proactively shaping the culture of your organization. It includes video commentary by CAP member pathologists.
Root Cause Analysis: Learn real-world methodology to conduct a root cause analysis, along with the tools necessary to implement it.
Mistake Proofing: Increase your ability to design new processes, modify existing processes, minimize mistakes, and manage your risks.
Internal Auditing: Increase your capabilities for internal auditing with a proven methodology for process audits, tracer audits, and laser audits.
Management Review: This course interprets the ISO 15189 requirements for management review.
Quality Manual Development: This course provides guidance on how to go beyond a quality plan to develop a manual that organizes and communicates your laboratory’s quality management system.
Document Control: This “how-to” course on document control systems details how to control documents in a way that meets ISO 15189 requirements.
QMS Implementation Roadmap: This course outlines the practical steps necessary to build, implement, and maintain a quality management system that meets the ISO 15189 standard.
15189 Walkthrough: This course summarizes each of the main clauses of the ISO standard, clarifying the intent of the clause and the key requirements.
References
- CAP15189 accreditation program, https://www.cap.org/laboratory-improvement/accreditation/cap-15189-accreditation-program, https://www.cap.org/laboratory-improvement/accreditation/cap-15189-accreditation-program/cap-15189-accreditation-process
Accessed on 13/07/20. - International standard (2012). ISO 15189 Medical laboratories— Requirements for quality and competence ISO15189. (ii-53). ISO
- Kallet, M. (2014). Think smarter: Critical thinking to improve problem-solving and decision-making skills. Hoboken, NJ: Wiley Sons.
- The European Parliament and the Council of the European Union (2017). IVDR: Regulation (EU) 2017/746 of the European Parliament and of the council of 5 April 2017 on in vitro diagnostic devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. (L 117/176-117/323) Official Journal of the European Union.
