If you need advice on the implementation of the ISO15189:2022 standard, please contact our experts at Modirfa.
02188764867 – 02188761795
ISO 15189 standard
ISO 15189 standard is an international standard in the field of accreditation of medical and human medicine laboratories. In this article, we introduce this standard and how to obtain ISO 15189 certificate.
In general, laboratories can be divided into two categories: industrial laboratories and medical laboratories. The standard for industrial laboratories is ISO 17025 and the standard for medical laboratories is ISO 15189. ISO 15189 standard states the requirements related to the quality and competence of medical laboratories. ISO 15189 standard states the requirements of medical laboratories in the development of quality management systems and qualification evaluation. This standard can also be used to confirm or recognize the competence of medical laboratories by laboratory customers, regulatory bodies and accreditation bodies.
Obtaining the ISO 15189 standard
Obtaining the ISO 15189 standard certificate with our group is not a difficult or complicated issue. Obtaining the ISO 15189 certificate has two stages, and if we are honored to cooperate with you, these two stages will be carried out from 0 to 100 by the modirfa team. These two steps include the following: 1. Registration and submission of documents required by the accreditation body approved by international assemblies and necessary coordination regarding evaluation. 2. Implementing standard requirements and preparing the laboratory for evaluation. In addition to registering you in the system of the relevant accreditation center and making the necessary arrangements until the evaluation day and following up on the relevant administrative matters, the modirfa team also prepares the documents required by the accreditation body and personnel training. Since the first stage is time-consuming and has a high time uncertainty, the modirfa team advances both stages at the same time in order to save the time and cost of the laboratory.
ISO 15189 standard certificate
Obtaining the certificate of this standard for laboratories gives the assurance to the relevant stakeholders that the results provided have international validity. In this way, everywhere in the world, you can trust the results published by the institution that has the ISO 15189 standard. Relevant stakeholders can be institutions such as customers, government bodies such as justice, insurance, etc. and include private institutions.
Obtaining the ISO 15189 standard certificate must be done from an accreditation body that has the authority to grant accreditation, as only two centers have the authority to grant such accreditation in Iran.
Accreditation of a laboratory shows its qualification and technical ability for tests that require skill in performing them and presenting reports, as well as ISO15189 certification. The determinant of this is that the laboratory performs its work correctly and according to the standards and methods of the relevant tests. Good laboratories provide defensible results, having validation means that the results are defensible based on a known standard that does not change with personnel or environmental conditions.
Some advantages of getting 15189 standard certificate
- Creating a systematic approach to control all the activities and define appropriate procedures and documents.
- The possibility of participating in relevant government tenders
- Gaining international recognition of technical competence and gaining the trust of customers and stakeholders.
- Also, opening the doors of domestic and international markets.
- Saving time and money due to the reduction or elimination of the need to perform repeated tests.
- Increasing the quality of employees’ knowledge and reducing defects and defects and improving services.
- Better control of laboratory operations
- Increasing self-confidence of employees in completing work and exams
- Ensuring validation and appropriateness of test methods
- Traceability of measurement and calibration with international standards
- calibration ratio and repair and maintenance of laboratory equipment and environment
- Guaranteeing the quality of sampling, carrying, transporting and moving test items and related data.
- Taking feedback from customers, in order to develop the management system.
- Be sure to use the latest valid version of the standard in question.
According to the aforementioned cases, the implementation of the ISO15189-based laboratory qualification standard It has numerous advantages for the laboratory. If you want to implement the standard and obtain the certificate, the management team with experience since 2017 in the field of consulting and implementing all kinds of standards will help you. If you need advice, you can call 021-88764867-88761795 Please get in touch.
The cost of obtaining the ISO 15189 standard
Obtaining the ISO15189 standard includes two main parts. The first part is related to evaluation costs and the second part is related to consulting costs. The evaluation costs depend on the type of accreditation body chosen to receive the certificate and the scope of application including the number of tests.
You can implement the standard requirements internally and using your knowledge and experience in the laboratory. You can also use the advice of the ISO 15189 standard from the modirfa team to speed up the implementation of the requirements and also use the experiences of the modirfa team. do it You can contact us to get more information about ISO 15189 standard consulting fee.
If you have any questions about choosing an accreditation company in the field of ISO 15189 standard, you can contact the experts of the modirfa team.
Contact our experts at Modirfa to get free advice on obtaining ISO 15189 certification.
02188761795
02188764867