Who should implement ISO 15189 standard?
The ISO 15189 standard should be implemented by medical laboratories that conduct research on human material in order to provide information for diagnostics in medical processes or preventive measures in the area of patient health assessment.
The advantage of obtaining accreditation for compliance with the ISO 15189 standard is the fact that the laboratory, thanks to the ISO 15189 accreditation certificate, increases its credibility among potential clients by joining the mutual recognition system. The test results presented by the laboratory are recognized all over the world. It can be concluded that the results of a laboratory accredited for compliance with ISO 15189 are unquestionable. The laboratory with the accreditation certificate is perceived as the institution with the highest quality of the research service provided.
How much does the laboratory accreditation ISO 15189 cost?
The implementation of the company quality management system that match the requirements of ISO 15189, tailored to the company builds a foundation on which you can safely develop laboratory.
The total costs of obtaining accreditation include:
- The costs of implementing the quality management system in the laboratory including: organization and management, supervision of documents, review of contracts, subcontracting of research, acquisition of services and supplies, advisory services, handling complaints, identification and monitoring of non-compliance, corrective actions, preventive actions, continuous improvement, quality records and technical records, internal audits and management reviews.
- The costs of the accreditation audit.
The benefits of having ISO 15189 accreditation:
- A clear and transparent definition of the tasks and powers of the staff
- Establishing uniform communication channels in our company
- Maintaining a constant level of quality of our research services
- Unambiguous identification of the client’s needs, those explicit and hidden
- Increasing the level of customer service quality
- Shortening the time of adaptation of new employees to the tasks entrusted to them
- Rationalization of costs incurred due to the activity