PROSPERITY Ltd., having a 15-years experience in medical laboratories accreditation, undertakes the development and implementation of Quality Management Systems and the preparation of medical laboratories for accreditation according to ISO 15189:2022 standard.
It must be emphasized that PROSPERITY Ltd. does not simply carry out studies, but provides its clients with the know-how to design, implement and maintain the Quality Management System. This means in simple words that PROSPERITY Ltd provides training to laboratory personnel in order to fully understand the requirements of the accreditation standards and to learn how to use the tools it will provide them (Manuals, procedures, forms, Instructions, software, applications, etc.).
THE IMPORTANCE OF ACCREDITATION
The practice of official recognition of the competence of laboratories by a nationally recognized authority is known as Accreditation.
Since the European Union began implementing the Single European Market, it has been recognized that trade barriers between countries can only be removed if a country trusts the quality of the tests and certification of the other country. Thus, in 1999, the use of the International Standard ISO 17025 was established for the assessment by independent National Bodies of the Quality Management Systems of the tests provided by laboratories. Since 2003, with the publication of the ISO 15189 standard, accreditation has been extended to Medical laboratories.
Accreditation is essential for laboratories to be able to demonstrate their independence and technical competence and to ensure transparency, trust in the results issued, and competition based on quality among them. Reliable results from a medical laboratory contribute decisively to the prognosis, diagnosis, monitoring and treatment of patients.
It is essential for Doctors and hospitals who need reliable testing results from accredited laboratories in order to decide on the appropriate treatment and management of diseases.
It is essential for public services in order to have the desired level of confidence in the testing results issued throughout the European area and therefore to control infectious diseases more effectively.
It is essential for insurance companies in order to ensure the validity and reliability of the results issued by medical laboratories for their customers.
It is essential for all patients who want to be certain that the examinations are correct and that the results they receive are accurate and reliable.
OBJECTIVES AND RESULTS OF ACCREDITATION
Through accreditation, a laboratory achieves:
- Equal recognition with other laboratories in the European Union and around the world.
- Increasing the prestige of the laboratory at the National and European level.
- Upgrading the services it offers and the certainty that the results it issues are reliable.
- Recognition of the competence of the staff.
- Better organization, addressing and resolving chronic problems and improving working conditions.
- Integrating the staff into a Quality Management System environment, which requires interest, responsibility and consistency from
the staff.
- Strong support for its results in case of disputes.
- To offer accredited tests where required by customers and the European Union.
GENERAL INFORMATION ON THE PREPARATION OF A LABORATORY FOR ACCREDITATION
The aim is to implement and operate a Quality Management System (QMS) that meets the requirements of the International Standard ISO 15189 and at the same time improve the operation and reliability of the laboratory. Although the desired result is accreditation, the real benefit of the laboratory results from the correct implementation of the QMS and the continuous improvement of the services provided that this entails.
We should point out that accreditation is not a guarantee that a laboratory will always deliver a specified level of service quality, but it gives assurance that it is capable of doing so. This simply means that if the QMS is not effective, then mistakes, errors and indifference will lead to a degradation of the services provided, regardless of the initial ability of the laboratory to provide quality services.
Bureaucratic and complex Management Systems do not add any value to the laboratory, because sooner or later they will be abandoned by the personnel. At this point it should be noted that any attempt to transfer a Management System from a 100-person industry certified to ISO 9001 to a 5-person laboratory will impose unnecessary bureaucracy, will bring confusion and discomfort to the staff and will remove the flexibility of the laboratory. The Laboratory Management System must be simple and functional.
It is very important to initially assess the scope of accreditation, i.e. to assess which tests the laboratory needs to accredit in the beginning in order to successfully perform its tasks. An excessively large scope of accreditation is likely to be a waste of time and money.
If the laboratory is not used to working in a documented Management System environment, it would be better to initially accredit a limited number of examinations, to the extent that the main customer requirements are met and compliance is demonstrated. More examinations can be added to the scope of accreditation during the annual assessment visits of the Accreditation Body. If a small number of examinations are added in each category at each assessment visit, the scope of accreditation will increase rapidly.
The most difficult examination for accreditation is the first one. Although different equipment is often used in examinations, the accreditation of the first examination of a category (e.g. chemical, microbiological) shows what the requirements really are and so the next series of examinations can be approached with greater confidence.
Participation in External Quality Assessment (Proficiency Testing Schemes, interlaboratory comparisons) will indicate the areas of the laboratory with high competence and confidence and will help in the selection of examinations for the first accreditation. The results of these comparisons play a great role in securing accreditation, as they show the essential capability for quality. They also identify areas where further training and improvement are required.
Equipment calibration requirements are an important, difficult and often expensive part of accreditation. They may include not only calibration in the usual sense (e.g. balances), but also compliance checks and internal verifications. In general, the cost of calibration is often high and is what often directs the laboratory to which examinations it will accredit. Thus, the issue of the need for laboratory equipment and calibration should be raised early, so that it can be resolved before the start of documentation.
SERVICES PROVIDED BY PROSPERITY LTD TO THE MEDICAL LABORATORIES
The services and tools provided by the Consultant to the laboratories, in order to ensure the smooth execution and completion of the projects with the receipt of the accreditation certificate, are the following:
- Recording the current situation and identifying deficiencies based on the requirements of the ISO/IEC 15189 standard,
- Introductory briefing - training of the laboratory staff on general issues of quality management systems and accreditation
requirements,
- Drafting of operating procedures,
- Drafting of the quality manual,
- Drafting of the necessary work instructions,
- Drafting of work forms,
- Proposals for participation in External Quality Assurance schemes and proficiency testing,
- Evaluation of the results from participation to External Quality Assurance schemes and proposals for the elimination of any
deviations,
- Evaluation of the needs of the laboratory in calibrations.
- Evaluation and selection of calibration laboratories.
- Checking the adequacy of calibration certificates,
- Drafting procedures for the control of examination methods and for the control of management system documents,
- Training on how to validate and verify examination methods,
- Monitoring the validation or verification of the examination methods,
- Application (software) for the implementation of Internal Quality Control,
- Where necessary, creating initial control charts for each of the examinations to be accredited,
- Monitoring the development and implementation of Internal Quality Control and evaluating the results,
- Estimation of the measurement uncertainties of the examination methods,
- Application (Software) for the calculation of the uncertainties of the examination methods,
- Performing an internal audit of the Management System and the tests,
- Training personnel on how to conduct internal audits,
- Training certificate for each training provided,
- Preparation of personnel files,
- Delivery of relevant bibliography, regarding accreditation such as EA, ILAC guidelines and relevant standards,
- Conducting the Management System Reviews in collaboration with the laboratory Management.