Quality Management

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1. Quality policy and quality management system

Our diagnostic laboratories provide analytical services to physicians, clinicians and individuals in the field of human genetics. Tests are accredited by DAkkS according to DIN ISO 15189. The accreditation applies to the testing techniques specified in the accreditation certificate and the associated annex. In accordance with the requirements of the European Accreditation fields with flexible scope of accreditation, we refer to the list of accredited testing techniques, which is updated regularly and may therefore differ from the Annex.

Our diagnostic laboratories perform these examinations in accordance with the respective state of the art in science and technology as defined in the guidelines and recommendations of the national and international professional societies. At the same time, our Institute strives to achieve the highest level of satisfaction among affected patients and referring physicians through accurate and on-time order fulfilment.

To achieve this, our diagnostic laboratories have implemented a quality management system which is continuously updated. We have formulated the following quality policy, in which our laboratories commit to compliance with DIN EN ISO 15189. We regularly train and inform all our employees in the respective work areas about the principles and objectives of the quality management system and assure that the regulations are strictly adhered to.

Our laboratories are equipped in such a way that we are able to provide services according to the current state of science and technology.  Our well-trained staff ensures that all requests in the areas of preanalytics, analytics, reporting and documentation are processed on time.

2. Laboratory quality assurance

Besides the work processes defined in detail by work and process instructions, our quality policy includes the following overarding aspects:

• Top priority of our diagnostic laboratories is to provide correct, precise and comprehensible analytical results that are comparable in their interpretation with the results of other laboratories.
• The tests are to be made available as promptly as possible and the results should be forwarded to the patient/physician without delay. This requires continuous optimization of all steps.
• Our laboratory personnell receive regular training according to an annual schedule. Additionally, they receive special in-house training.
• Quality management is carried out by highly qualified staff members, who regularly report directly to the General and Medical Director of the Institute of Human Genetics.
• Test procedures and equipment are always kept up to date with the latest scientific and technical developments. Maintenance and functional testing of the equipment is carried out according to their specifications.
• Internal and external quality controls (e.g. participation in interlaboratory tests) are carried out on a regular basis.
• To optimize satisfaction, we strive for close cooperation with our clients. To communicate results in a comprehensible manner, the following measures are taken:
  • Detailed, constantly updated service descriptions,
  • Immediate processing of inquiries and follow-up orders,
  • Consistent recording, processing and rectification of complaints
  • Optimization and, if necessary, modification of procedures that did not meet the needs of the client

• All employees receive regular training and our internal and external quality assurance measures are reviewed on a regular basis.
• Each employee shares responsibility for implementing the quality policy in his or her area of responsibility. The overall responsibility lies with the Director of the Institute of Human Genetics