WHY ACCREDITATIONS MATTER
At Medicover Genetics, we understand the significance of delivering accurate and reliable genetic test results. Therefore, we are proud to have achieved accreditation from leading organizations, such as the College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA). This recognition is a testament to our commitment to quality and a guarantee to our customers that we meet the highest standards for testing procedures, personnel qualifications, and laboratory facilities.
When you choose Medicover Genetics for your genetic testing needs, you can have confidence in the results you receive. Our accreditation means that we are dedicated to staying up-to-date with industry developments and regulations, ensuring that you receive the most current and accurate information available.
Please note that not all accreditations apply to all products, contact us for further information or if you have any questions.
CAP is the world’s largest organization of board-certified pathologists and the leading provider of laboratory accreditation and proficiency testing programs. CAP, the first in the industry to offer an accreditation program for biorepositories, based the program on the principles of its Laboratory Accreditation Program. The accreditation process, a three-year accreditation cycle, includes on-site inspection, desk review, and optional education modules and gap assessment – designed to ensure the highest standard of patient care and application of best practice. Learn more here.
This certification verifies that a device meets all regulatory requirements for in-vitro diagnostic medical devices to be freely sold in the European Economic Area. Learn more here.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) statute is an amendment to the US Public Health Services Act in which Congress revised the federal program for certification and oversight of clinical laboratory testing. In general terms, the CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. Learn more here.
The European Federation for Immunogenetics (EFI) awards the EFI certificate to laboratories that meet the quality requirements set by EFI (Standards). EFI is a European organization focusing on immunogenetics, tissue typing, and transplantation. The EFI certificate is required by several organizations operating in the field of stem cell and solid organ transplantation including JACIE, NMDP, and the Eurotransplant foundation. The EFI Accreditation Programme provides an internationally recognized accreditation scheme for laboratories providing Histocompatibility & Immunogenetics (H&I) testing services in support of solid organ and hematopoietic stem cell transplantation, blood transfusion, disease diagnosis, and drug hypersensitivity reactions. Learn more here.
GLP and Quality Assurance
Good Laboratory Practices (GLP) and Quality Assurance are crucial components of a well-functioning laboratory. GLP outlines guidelines for the management, personnel, facilities, equipment, and protocols involved in conducting non-clinical health and environmental safety studies to ensure quality, integrity, and reliability of study data. Quality Assurance is a systematic and ongoing process that guarantees that laboratory activities are performed following established procedures and guidelines. By combining GLP and Quality Assurance, a laboratory can ensure the accuracy and consistency of its results, which are critical for making informed decisions about the safety and efficacy of products. Accreditation by a reputable organization, such as the Fetal Medicine Foundation, provides external validation that a laboratory is operating in compliance with GLP and Quality Assurance standards. Learn more here.
Good manufacturing practices (GMP) define the minimum requirements that must be fulfilled by pharmaceutical manufacturers in their production processes. Compliance with these standards is essential for any company that wishes to offer its medicines for sale in the European market, regardless of location. GMP mandates that all medicines must be consistently high-quality, appropriate for their intended use, and meet the regulatory requirements outlined in marketing or clinical trial authorizations. These guidelines help to ensure that the end product is safe, effective, and of a consistently high standard. Learn more here.
ISO (International Organization for Standardization) is an independent, non-governmental international organization that develops and publishes standards to ensure the quality, safety, and efficiency of products, services, and systems.
ISO 13485 | 10477037
ISO 13485 provides a comprehensive framework for medical device manufacturers to ensure product quality and regulatory compliance. The primary objective of the ISO 13485 certification process is to ensure medical devices consistently meet customer needs and applicable regulatory requirements. Learn more here.
ISO 15189 | L124
ISO 15189 specifies requirements for quality and competence in medical laboratories. It is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. Learn more here.
ISO 9001 | QS.22.035
ISO 9001 specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of ISO 9001 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. Learn more here.
DIN EN ISO 15189 | D-ML-21356-01-00
DIN EN ISO 15189 is an international standard for medical laboratories. It specifies the requirements for quality and competence in medical laboratory services and outlines the processes that are necessary to ensure that patient test results are reliable and accurate. The standard covers areas such as laboratory management, personnel training and qualifications, test performance, and the reporting of results. Adherence to DIN EN ISO 15189 helps to ensure that medical laboratories provide high-quality services that meet the needs of patients, healthcare providers, and regulatory agencies. The standard is regularly reviewed and updated to reflect the latest developments in medical laboratory technology and practices. Learn more here.