Accreditation certificate for Medical Laboratory AM 007, confirming compliance with the requirements of the standard: PN-EN ISO 15189 Medical laboratories. Requirements for quality and competence
All medical laboratories must meet legal requirements and operate in accordance with good laboratory practice, but not every laboratory takes on the challenge of achieving accreditation in accordance with the PN-EN ISO 15189 standard, which confirms compliance with additional requirements regarding quality and technical competence.
What are the benefits of accreditation?
Undergoing accreditation introduces quality management into a medical laboratory as a systematic process, encompassing the supervision of all processes, procedures, staff qualifications and competences, and the working environment. During their audits, independent auditors from the Polish Centre for Accreditation confirm that the laboratory operates in accordance with best practice and provides medical laboratory diagnostic services of the highest standard.
There are nearly 2,700 medical laboratories operating in Poland, of which only 14 are currently accredited; since 2013, INVICTA Medical Diagnostic Laboratories have been among the accredited laboratories. Worldwide, there are 8,700 accredited medical laboratories – as one of them, we confirm the world-class quality of our tests (as at 14 February 2022).
In 2020, our scope of accreditation changed to a flexible one. This allows our laboratory to incorporate additional analyses and modify methods within the scope of accredited tests without having to notify the PCA. Obtaining this flexible scope is therefore a sign of the PCA’s utmost confidence in the operations of INVICTA Medical Diagnostic Laboratories.
Our laboratories are accredited. What exactly does this mean for patients?
- We listen to our clients, striving to meet their needs and expectations
- We provide accurate information, ensuring the highest quality of our services and, above all, the reliability of test results
- We operate on the basis of risk analysis with regard to patient safety
- We monitor our work using quality indicators
- We collect and analyse data from various sources to continuously improve our work
Certificates and attestations confirming participation in interlaboratory quality control programmes
In addition to our daily in-house quality control system, INVICTA Medical Diagnostic Laboratories participate in mandatory quality control schemes organised by Polish organisations:
- the Central Centre for Quality Assessment in Laboratory Diagnostics in Łódź
- Central Centre for Quality Assessment in Microbiology (Polmicro) in Warsaw
INVICTA Medical Diagnostic Laboratories also participate in 50 additional international programmes run by, amongst others:
- Randox – RIQAS programmes, England
- Labquality, Finland
- Instand, Germany
- CFNetwork – Cystic Fibrosis European Network, Belgium
- EMQN – European Molecular Genetics Quality Network, England
- Cytogenetic European Quality Assessment, England