Clinical and pathological laboratories in the Netherlands are undergoing major changes. A growing number of them are applying for Dutch ‘Raad voor Accreditatie’ (RvA) accreditation in accordance with the ISO 15189 norm. Laboratories previously needed CCKL accreditation, but the mandatory transition from CCKL to the international ISO 15189 as guideline for laboratories is now well under way. ISO 15189 means laboratory customers, regulatory authorities and accreditation bodies can confirm the medical laboratories’ competence. The aim of the RvA is to replace all Dutch laboratory CCKL accreditations with ISO 15189 before January 1st 2018.

Making the mandatory transition from one standard to another needs significant preparation. Laboratories must have the ability and tools to adjust their quality systems to the new norm. As a software vendor in quality management, Neomatics has a wealth of experience in optimising quality management systems for new standards. Below are a few things to bear in mind when considering ISO 15189.

ISO 15189 and CCKL overlap – but aren’t the same

Although CCKL accreditation laid the foundation for ISO 15189, the RvA concluded that CCKL doesn’t cover every aspect of the ISO norm. In any case, the new norm stipulates different quality management processes. While the CCKL approach is driven by the industry, the ISO norm is more process-based. It focuses on a continuous circle of improvement, with reports on quality issues throughout the entire organisation, annual management reports and consistent feedback. This means management is far more involved than it is with CCKL accreditation, and that ISO affects not just the quality department, but the entire company. Everyone is involved in the quality process, from management to every single employee.

ISO 15189 is the perfect moment for digitisation

Laboratories need to change their quality management systems in the transition from one standard to another. Since some laboratories are still not operating digitally, this is the right moment to ‘go digital’ with your quality management system. A digitised quality management system offers many benefits, including making data more measurable and controllable, and reducing the risk of human error. Switching to a digital system? Make sure you choose a solution based on the PDCA circle: Plan-Do-Check-Act – for example by including reporting possibilities, not only for quality issues but also preventive actions. And don’t forget to implement all the quality aspects that came to light during previous internal and RvA audits. This ensures that your management is far more involved, and receives better reporting.

ISO 15189 stipulates a risk-based approach

A CCKL audit is an annual one in which the complete accreditation checklist is checked. But the ISO 15189 certification process assumes a risk-based approach. This means that while the RvA checks everything, it focuses on activities, situations and equipment entailing the highest risks. Companies should make use of this efficient approach. They need to capitalise on the RvA advice and other audits, and should create a risk roadmap with anticipated issues and possible solutions. Organisations will be fully prepared with thorough risk analysis policies and tools, and audits can occur with more accuracy and focus.

ISO 15189 requires better validation

At Neomatics, not only do we deliver software for quality management systems, but we also offer validation services. And that’s a must for laboratories. Unlike CCKL, ISO 15189 imposes stricter and more thorough validation. There are more validation requirements, like documentation proving that equipment or software actually does what’s needed. Although it may be difficult to optimise your validation processes, in the end they will offer you greater control and insight. You’ll increase the success rate of your projects and software, while ensuring that management has faith in the business processes.
To me it’s perfectly clear. Although the transition from CCKL to ISO 15189 takes some preparation, it also offers companies plenty of opportunities. Organisations switching to a digital system, a risk-based approach and better validation processes can easily handle the transition. And companies dealing with this correctly will also benefit from major improvements to their business processes.

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