Information and documents regarding our quality management standards.
ISO 9001
It is a standard that defines the conditions to be applied during the establishment of Quality Management Systems. This Standard is subject to a certification audit. To maintain accreditation, follow-up audits are carried out by authorized institutions every year.
ISO 15189
Quality and qualification requirements are an international standard that specifies quality management system requirements specific to medical laboratories. Its main purpose is to accredit medical laboratories and to ensure that test results are assured based on patients and healthcare personnel. In 2020, we received our accreditation certificate by being audited by TURKAK. To maintain the accreditation, a follow-up audit is carried out by TURKAK every year.
ISO 27001
ISO 27001 is a set of standards that specify the requirements for a robust information security system with international validity. The ISO 27001 standard is an information security management system that helps organizations secure and manage their and their customer's confidential information.
Work on the harmonization process of the standard started in 2021. Our center was entitled to certification in 2022.
ISO 13485
ISO 13485 is a quality management standard that can be applied to medical device manufacturers with the title of requirements for regulatory purposes, published by the ISO Institute. ISO 13485:2003 Standard is a parallel standard with ISO 9001:2000-8 Standard and has been prepared based on ISO 9001:2000-8 Standard. The standard, which brings some requirements in addition to the ISO 9001:2008 standard, is accepted and implemented in many countries around the world. It is the version of ISO 9001:2000-8 Standard adapted to medical devices and developed in this field. It is an international standard that contains special requirements for medical devices. ISO 13485 is one of the most important arguments that medical device manufacturers can use when going for CE Marking. It has been published to put medical devices on the market effectively and safely without harming human health.
Our center has been certified in 2021 within the scope of 'Design, Storage, Marketing of Diagnostic Kits and Reagents Used Outside the Body, and Production, Delivery, Installation and Technical Services of Devices.
GENQA
From 1 January 2018, GenQA was formed from the merger of the Cytogenetic External Quality Assessment Service for Molecular Genetics (CEQAS) and the UK National External Quality Assessment Service (UK NEQAS). GenQA is the only genomics External Quality Assessment provider that covers the entire clinical genomics service, from patient consultation, sample preparation, testing processes, results interpretation, and reporting. At GenQA, labs and individual clinicians have access to over 100 unique EQAs; available for several rare and inherited disorders and acquired diseases. Objective information and advice are provided to diagnostic laboratories and clinical genetics centers that determine preimplantation genetic testing (PGT), non-invasive prenatal testing (NIPT), newborn screening, as well as germline and somatic variant classification and interpretation.
GenQA facilitates optimal patient care by advising on the quality of analytical and interpretive laboratory performance. Clinical Genetics Education case scenarios allow clinicians to review their practice and demonstrate continuing professional development.
EMQN
The European Molecular Genetic Quality Network (EMQN) is a provider of External Quality Assessment services essential for any laboratory wishing to provide and maintain a quality service. It helps ensure that diagnostic molecular genetics laboratory test results are accurate, reliable, and comparable wherever they are produced. EMQN collaborates with many organizations including EuroGentest, CF Network, UK NEQAS, RCPA QAP, RfB, and EAA.
EQA
External quality assessment is the challenge of the effectiveness of a laboratory's quality management system. It refers to the analysis of quality controls made with blind samples sent by international organizations.
The audits performed by International independent audit organizations:
International independent auditing organizations expect worldwide centers and companies to have certain quality standards, as required by their policies. Since our center has been in cooperation with many international centers and companies for many years, it is audited every year by independent auditors determined by independent external audit institutions upon the request of this center and companies, and nonconformities and suggestions observed as a result of these audits are reported to the relevant pharmaceutical company. To maintain cooperation, these determinations are made compatible with the quality management system, and the process is completed successfully. Therefore, as required by our quality management policy, the continuous improvement process continues at our center.