TS EN ISO 15189 Medical Laboratory Accreditation
Customers of medical laboratories; Patients are institutions and businesses that request analysis reports, public hospital unions, private hospitals, doctors who own a doctor's office.
TS EN ISO / IEC 17025 Laboratory Accreditation
Experimental laboratories are used in food, environment, OHS, medicine, paint, textile, veterinary etc. Chemical, physical, mechanical, biological, genetic, etc. in many different fields. they serve many types of tests
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TS EN ISO / IEC 17025 Test Laboratories Accreditation Consultancy
Experimental laboratories are used in food, environment, OHS, medicine, paint, textile, veterinary etc. Chemical, physical, mechanical, biological, genetic, etc. in many different fields. They serve many types of tests. While the customers of the laboratories can be public or private sector, the tests and results they make affect the whole society. The common expectation of all these customers is to get accurate, reliable and quality results.
There are important differences between the reports given by the experimental laboratories after they have obtained an internationally recognized laboratory accreditation and the reliability, respectability and recognition of the reports they give before being accredited.
Accreditation by legal authorities or customers is set as a prerequisite for the standardization of the quality management systems of the experimental laboratories all over the world and the harmonization of the quality of the results.
In our country, it has been decided by legal authorities in many fields that test laboratories cannot be granted work permits in some areas without accreditation. These areas are; Food Analysis (toxin, pesticide, etc.), Occupational Hygiene and Environment Measurement analysis (noise, vibration, VOC measurements, etc.), Environmental (wastewater, emission, imission, etc.) analysis, Drinking and potable water analysis, Dosimeter Measurements, Textile Analysis, etc. . fields can be given as an example.
One of the most important instruments that will ensure the quality of analysis results is accreditation. The TS EN ISO / IEC 17025 Standard sets out the general requirements for the competence of medical laboratories, and addresses the technical competence and ability of a laboratory to produce technically accurate and reliable results.
The TS EN ISO / IEC 17025 standard sets out the managerial and technical requirements that should be included in an experimental laboratory with the quality management system requirements it offers. The standard consists of 5 main parts. Article 4, which includes basic managerial competence requirements, consists of 15 sub-items, and Article 5, which includes technical competence requirements, consists of 10 sub-items. Laboratory quality management system conditions are discussed in detail in these articles.
By starting to use a single international standard as an indicator of competence in laboratories, it is aimed that the experimental laboratory operating anywhere in the world will compete with each other at the same level. Therefore, the analysis report prepared by a laboratory working in accordance with these standards can be recognized abroad. A laboratory accredited according to the TS EN ISO / IEC 17025 standard provides a wider market, in other words a wider customer base, due to the international validity of its reports.
The test reports issued by a laboratory with TS EN ISO / IEC 17025 standard accreditation will be recognized all over the world within the scope of ILAC (International Laboratory Accreditation Association) MRA (mutual recognition agreement).
What will TS EN ISO / IEC 17025 Experiment Laboratory Accreditation add to your laboratory?
Analysis Result reports have international acceptance,
It inspires confidence in the customer,
Increases the reputation of the laboratory,
Increases market share and competition,
Increases Business Volume,
Increases business and personnel awareness,
Provides more reliable and quality results,
It helps you to minimize the errors that occur in the laboratory,
By measuring your processes, it contributes to your continuous improvement,
Provides reputation and prestige to the laboratory,
Stabilizes sample and test management methodology,
The laboratory saves you from the hassle of work,
Improves result verification and traceability capability,
Provides effective solutions to customer complaints,
Provides a disciplined Laboratory management,
Takes measures to prevent corrective actions in advance,
Helps prevent mistakes with risk management,
It helps the development of the laboratory information management system,
Provides accurate results with the validation and verification of analysis methods,
Guarantees the quality assurance of internal and external quality control studies and laboratory results,
By calculating the measurement uncertainty, the confidence interval of the measurements is determined,
Laboratory information management systems are provided to work correctly and effectively,
After the necessary interviews with the laboratory that requires TS EN ISO / IEC 17025 Medical Laboratory Accreditation, the laboratory that wants to enter the accreditation process is visited on-site and the working method, the scope of analysis, the laboratory processes and the situation are evaluated.
In case of contract approval;
Providing the laboratory with TS EN ISO / IEC 17025 Trainings (basic standard training, documentation training, measurement uncertainty, method validation / verification training, Internal Audit Training, risk analysis training),
Creation / creation of the documentation required by the TS EN ISO / IEC 17025 Standard,
Performing all applications required by the standard; Creating records, Risk Analysis, Quality indicators, Software verification, Internal audit, YGG, etc.,
Ensuring the application for accreditation,
Before the accreditation audit, the preparation of the laboratory for the audit is pre-audited by the experts of our company.
Closing possible nonconformities after accreditation audit,
Our company has helped many laboratories to be accredited with its competent experts. We are committed to being a solution partner in a reliable system that you can easily accredit.
TS EN ISO 15189 Medical Laboratory Accreditation Consultancy
Customers of medical laboratories; Patients, institutions and enterprises requesting analysis reports, public hospital unions, private hospitals, doctors who own a doctor's office. The common expectation of all these customers is to get accurate, reliable and quality results. In fact, medical laboratories provide important services concerning society and health. The most important output of the service they provide is the analysis reports.
Biochemistry, Microbiology, Pathology, Genetics, IVF, MR, etc. There are important differences between the reports issued by the medical laboratories serving on the subjects after they have obtained an internationally recognized laboratory accreditation and the reliability and dignity of the reports they give before they become accredited.
Having accreditation by legal authorities or customers is set as a prerequisite for the standardization of the quality management systems of medical laboratories all over the world and for the harmonization of the quality of their results.
One of the most important instruments that will ensure the quality of analysis results is accreditation. The TS EN ISO 15189 Standard sets out the general requirements for the competence of medical laboratories, and addresses the technical competence and ability of a laboratory to produce technically accurate and reliable results.
TS EN ISO 15189 standard sets out the managerial and technical requirements that should be included in a medical laboratory with the quality management system requirements it offers. The standard consists of 5 main parts. Article 4, which includes basic managerial competence requirements, consists of 15 sub-items, and Article 5, which includes technical competence requirements, consists of 10 sub-items. Laboratory quality management system conditions are discussed in detail in these articles.
By using a single international standard as an indicator of competence in laboratories, it is aimed that medical laboratories operating anywhere in the world will compete with each other at the same level. Therefore, the analysis report prepared by a laboratory working in accordance with these standards can be recognized abroad. A laboratory accredited according to the TS EN ISO 15189 standard provides a wider market, in other words a wider customer base, due to the international validity of its reports.
Many private and public hospitals receiving service in our country have started to determine TS EN ISO 15189 accreditation as a prerequisite in their tender specifications.
Medical analysis reports issued by a laboratory with TS EN ISO 15189 standard accreditation will be recognized all over the world within the scope of ILAC (International Laboratory Accreditation Association) MRA (mutual recognition agreement).
What will TS EN ISO 15819 Medical Laboratory Accreditation add to your laboratory?
Analysis Result reports have international acceptance,
It inspires confidence in the customer,
Increases the reputation of the laboratory,
Increases market share and competition,
Increases Business Volume,
Increases business and personnel awareness,
Provides more reliable and quality results,
It helps you to minimize the errors that occur in the laboratory,
By measuring your processes, it contributes to your continuous improvement,
Provides reputation and prestige to the laboratory,
Stabilizes sample and test management methodology,
The laboratory saves you from the hassle of work,
Improves result verification and traceability capability,
Provides effective solutions to customer complaints,
Provides a disciplined Laboratory management,
Takes measures to prevent corrective actions in advance,
Helps prevent mistakes with risk management,
It helps the development of the laboratory information management system,
Provides accurate results with the validation and verification of analysis methods,
Guarantees the quality assurance of internal and external quality control studies and laboratory results,
By calculating the measurement uncertainty, the confidence interval of the measurements is determined,
Laboratory information management systems are provided to work correctly and effectively,
After the necessary interviews with the laboratory in need of ISO 15189 Medical Laboratory Accreditation, the laboratory that wants to enter the accreditation process is visited on-site and the working method, the scope of analysis, laboratory processes and situation are evaluated.
In case of contract approval;
Providing the laboratory with TS EN ISO 15189 Trainings (basic standard training, documentation training, measurement uncertainty, method validation / verification training, risk analysis training),
Creation / creation of the documentation required by the TS EN ISO 15189 Standard,
Performing all applications required by the standard; Creating records, Risk Analysis, Quality indicators, Software verification, Internal audit, YGG, etc.,
Ensuring the application for accreditation,
Before the accreditation audit, the preparation of the laboratory for the audit is pre-audited by the experts of our company.
Closing possible nonconformities after accreditation audit,
Our company has helped many laboratories to be accredited with its competent experts. We undertake and guarantee to be your solution partner in a reliable system that you can easily accredit.