DIN EN ISO/IEC 17025:2018-03
DIN EN ISO/IEC 17025:2018-03: Requirements and Significance for Laboratories
DIN EN ISO/IEC 17025:2018-03 is an international standard that specifies the requirements for the competence of testing and calibration laboratories. The standard specifies that laboratories must comply with certain procedures to ensure that their measurement results are reliable and comparable. Compliance with the standard is confirmed by accreditation, which is awarded by independent accreditation bodies.
This glossary entry takes a closer look at the requirements of DIN EN ISO/IEC 17025:2018-03 and explains the significance of the standard for laboratories.
Quality Laboratory Accreditation According to DIN EN ISO/IEC 17025:2018-03 at Carl Zeiss GOM Metrology GmbH
As a leading supplier of optical metrology, Carl Zeiss GOM Metrology GmbH is committed to providing its customers with the highest quality and reliability. The implementation of the DIN EN ISO/IEC 17025:2018-03 standard in our DAkkS accredited laboratory is an important part of these efforts.
By implementing the requirements of DIN EN ISO/IEC 17025:2018-03, we ensure that our measurements are traceable and comparable, and that measurement uncertainty is adequately taken into account. This helps to ensure that our customers can trust in the reliability and quality of our work.
Carl Zeiss GOM Metrology GmbH continuously pursues the goal of optimizing its processes and procedures and improving the quality of its work. The implementation of the DIN EN ISO/IEC 17025:2018-03 standard is an important step in this direction and underlines our commitment to highest quality and reliability.
What Is DIN EN ISO/IEC 17025:2018-03 and What Is the Significance of the Standard for Laboratories?
DIN EN ISO/IEC 17025:2018-03 is an international standard that defines the requirements for the competence and quality assurance of testing and calibration laboratories. The standard contains specific requirements that laboratories must meet in order to demonstrate their competence in performing tests and calibrations and to ensure the reliability and comparability of their measurement results.
The significance of DIN EN ISO/IEC 17025:2018-03 for laboratories is that it enables laboratories to demonstrate their competence and reliability in performing tests and calibrations. Accreditation to DIN EN ISO/IEC 17025:2018-03 confirms that these requirements have been met by the accreditation body, thus strengthening the confidence of customers and partners in the laboratory's work.
In addition, the application of the standard can help laboratories to improve their internal processes and thus achieve a higher quality of their work. Overall, the application of DIN EN ISO/IEC 17025:2018-03 is therefore of great importance for quality assurance and the competence of testing and calibration laboratories.
What Are the Requirements of DIN EN ISO/IEC 17025:2018-03?
The requirements of DIN EN ISO/IEC 17025:2018-03 are divided into two categories:
- Requirements for the management system of the laboratory
- Requirements for the technical competence of the laboratory
Requirements for the Management System of the Laboratory
The management system requirements include the need to implement and maintain a quality management system that ensures continuous improvement of the laboratory's work. This includes, among other things, document management, process control, planning and implementation of internal audits, and good resource planning.
Requirements for the Technical Competence of the Laboratory
The requirements for the technical competence of the laboratory include, among others, the validation of test methods, ensuring the traceability of measurement results to national or international standards, performing calibrations and monitoring environmental conditions. The technical competence of the laboratory is also determined by the qualifications and skills of the personnel and by the equipment of the laboratory.
Compliance with these requirements ensures that the laboratory performs reliable and accurate work when performing tests and calibrations. Only by fully implementing these requirements can the laboratory achieve accreditation according to DIN EN ISO/IEC 17025:2018-03.
How Is Accreditation According to DIN EN ISO/IEC 17025:2018-03 Achieved?
Accreditation according to DIN EN ISO/IEC 17025:2018-03 is awarded by an independent accreditation body. To obtain accreditation, the laboratory must apply for accreditation and demonstrate during the accreditation process that it meets all the requirements of DIN EN ISO/IEC 17025:2018-03.
The accreditation procedure includes the following essential steps:
- First, the laboratory must submit an accreditation application form informing the accreditation body about the type of tests and calibrations performed by the laboratory. The laboratory must provide information on its competencies and experience.
- The accreditation body shall subsequently examine the documents submitted by the laboratory. The laboratory shall provide meaningful documentation for all requirements according to DIN EN ISO/IEC 17025:2018-03.
- In the following, an audit of the laboratory is carried out on behalf of the accreditation body to ensure that all requirements of DIN EN ISO/IEC 17025:2018-03 are met. The assessment is carried out by experienced professionals who evaluate the laboratory's compliance with the management system requirements and technical competence.
- If the laboratory meets all the requirements of DIN EN ISO/IEC 17025:2018-03, the accreditation body will issue an accreditation which is normally valid for a period of several years. The laboratory must periodically demonstrate that it continues to meet all requirements of DIN EN ISO/IEC 17025:2018-03 to maintain accreditation.
Accreditation to DIN EN ISO/IEC 17025:2018-03 is an important demonstration of laboratory competence and quality assurance and helps to increase the confidence of customers and partners in the laboratory's work.
What Are the Benefits of DIN EN ISO/IEC 17025:2018-03 Accreditation for a Laboratory?
DIN EN ISO/IEC 17025:2018-03 accreditation offers laboratories various advantages. First of all, accreditation is proof of the laboratory's competence and quality assurance. This can help to strengthen the confidence of customers and partners in the work of the laboratory.
In addition, DIN EN ISO/IEC 17025:2018-03 accreditation can help to improve the efficiency and effectiveness of the laboratory. By implementing the requirements of DIN EN ISO/IEC 17025:2018-03, the laboratory faces the challenge of optimizing and continuously improving its processes and procedures. This can help to reduce costs, shorten turnaround times and increase the quality of the laboratory's work.
DIN EN ISO/IEC 17025:2018-03 accreditation can also help a laboratory tap into new business opportunities. Many customers and partners specifically look for laboratories that have DIN EN ISO/IEC 17025:2018-03 accreditation, as this is important evidence of the laboratory's quality assurance and competence. DIN EN ISO/IEC 17025:2018-03 accreditation can therefore help a laboratory win new customers and projects.
What Role Does DIN EN ISO/IEC 17025:2018-03 Play in the Quality Management of Laboratories?
DIN EN ISO/IEC 17025:2018-03 plays a central role in the quality management of laboratories, as it is an international standard that defines the requirements for the competence of testing and calibration laboratories. The standard contains specific requirements for the management system of the laboratory as well as for the technical competence of the laboratory.
The requirements of DIN EN ISO/IEC 17025:2018-03 help laboratories to carry out their work systematically and effectively and to improve it continuously. By implementing the requirements of DIN EN ISO/IEC 17025:2018-03, a laboratory can optimize its internal processes and procedures, reduce costs, and achieve higher quality in its work.
DIN EN ISO/IEC 17025:2018-03 also plays an important role in ensuring the reliability and comparability of measurement results. By applying the standard, laboratories can ensure that their measurements are traceable and comparable, and that measurement uncertainty is adequately taken into account.
Overall, the application of DIN EN ISO/IEC 17025:2018-03 helps to increase the effectiveness and efficiency of laboratories and to ensure the quality and reliability of tests and calibrations. Thus, DIN EN ISO/IEC 17025:2018-03 plays an important role in the quality management of laboratories.
What Is the Significance of DIN EN ISO/IEC 17025:2018-03 for the Comparability of Measurement Results?
DIN EN ISO/IEC 17025:2018-03 is of great importance for the comparability of measurement results, as it defines the requirements for the competence of testing and calibration laboratories. By implementing the requirements of DIN EN ISO/IEC 17025:2018-03, laboratories can ensure that their measurements are traceable and comparable, and that the measurement uncertainty is correctly estimated.
Traceability of measurement results means that a measurement result can be traced back to national or international standards. By complying with the DIN EN ISO/IEC 17025:2018-03 requirements, laboratories can ensure that their measurements are traceable and thus that there is comparability between different measurement results.
Consideration of measurement uncertainty is another important aspect in the comparability of measurement results. By implementing the requirements of DIN EN ISO/IEC 17025:2018-03, laboratories must ensure that they adequately assess and document the measurement uncertainty of their measurements. This ensures that the results of different laboratories are comparable, and that the uncertainty is taken into account when interpreting the results.
Overall, DIN EN ISO/IEC 17025:2018-03 is of great importance for the comparability of measurement results and helps to ensure that customers and partners can trust the reliability and quality of laboratories' work.
How Is the Monitoring of Compliance with the DIN EN ISO/IEC 17025:2018-03 Standards Performed?
Compliance with the DIN EN ISO/IEC 17025:2018-03 standards is monitored by an independent accreditation body, which carries out regular audits of the accredited laboratories. The audits are carried out by experienced experts who assess compliance with the management system requirements and the technical competence of the laboratory.
During the assessment, various aspects of the laboratory are examined, including documentation of processes, qualification of personnel, validation of calibration procedures, traceability of measurement results, and monitoring of environmental conditions. The laboratory must demonstrate that it meets all the requirements of DIN EN ISO/IEC 17025:2018-03 and performs its work at a high level of quality.
If the laboratory meets all requirements, it receives accreditation. The laboratory must periodically demonstrate that it continues to meet all requirements of DIN EN ISO/IEC 17025:2018-03 to maintain accreditation.
Monitoring compliance with DIN EN ISO/IEC 17025:2018-03 standards by independent accreditation bodies ensures that the quality and competence of testing and calibration laboratories is maintained at a high level. It helps ensure that customers and partners can trust the reliability and quality of laboratories' work.
Which Other Standards Are Relevant for Laboratories That Apply DIN EN ISO/IEC 17025:2018-03?
Laboratories that apply DIN EN ISO/IEC 17025:2018-03 often also consider other standards that are relevant for their specific applications. One example is ISO 9001, which defines the requirements for a quality management system. Many laboratories also implement the requirements of ISO 9001 to ensure that their processes and procedures are carried out effectively and efficiently and that high quality work is maintained.
Other examples of standards that may be relevant to laboratories include Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP), depending on the type of testing or calibration the laboratory performs. GLP is an international standard that defines the requirements for the quality and integrity of laboratory studies, while GMP defines the requirements for the manufacture of drugs, medical devices or food.
There are also industry-specific standards that may be relevant to laboratories, such as the Automotive Quality Management System (IATF 16949) for laboratories working for the automotive industry, or the Medical Device Quality Management System (ISO 13485) for laboratories working for the medical device industry.
Overall, laboratories that apply DIN EN ISO/IEC 17025:2018-03 often need to consider other standards that are relevant to their specific applications. It is important that laboratories ensure that they implement and maintain all relevant standards to ensure high quality and reliability of their work.