ISO 15189 is a universal standard is designed for the accreditation of medical laboratories. The quality management system and technical procedures of laboratories are evaluated by the ISO 15189 standard. Officials and end users can both use ISO 15189 since it assures them that labs are qualified to perform medical tests and examinations, that their staff is dedicated to the lab’s quality, and that their service uses the most recent technologies and practices that comply with best practices.
What are the benefits of ISO 15189 accreditation?
The implementation of the ISO 15189 standard has numerous advantages. Here are a few benefits that medical laboratories can make use of.
- Risk reduction: Systems will be more rigorous if the organization develops its operations on best practices. Particularly in laboratories that deal with sensitive information, complex technology, and issues involving people’s health, planning for, and detecting any potential hazards will significantly lessen them.
- Cost-saving: The laboratory will save costs by ensuring results are technically valid and avoiding the need for retesting. As the efficiency rises, other cost-cutting methods will be applied across the standard.
- Improved team morale: The standard helps in reducing staff errors and other unnecessary mistakes. It shows higher performance, also the staff’s motivation will increase if their technical proficiency is acknowledged and promoted.
- Legally compliant: By applying regulation and industry standards to the medical laboratory, ISO 15189 guarantees that the clinical services are secure, dependable, and cost-effective. This inspires confidence in decision-makers and stakeholders who understand and value the commitment. Laws and regulations will be less likely to occur, and if they do, the framework will be able to support the organization.
- Continual improvement: By integrating the framework into the basis of what the business does, the organization will gradually establish additional programs. Best practices will not end with the ISO 15189 certification. The framework serves as an important tool for evaluating developments in quality and constantly improving consistency.
- Globally recognized: Being a universally accepted standard offers advantages beyond just reputation. Global recognition is especially important for ISO 15189. The International Laboratory Accreditation Cooperation (ILAC) has a series of Multilateral Mutual Recognition Arrangements that guarantee that laboratories accredited to ISO 15189 will have their certificates and test results recognized in more than 80 nations worldwide. In this approach, the work can improve global as well as domestic medical health.
After understanding the benefits, here are the several processes that must be implemented to get all the benefits. So, a list of actions that should be properly considered is as follows:
Key processes
- Handling, storage, and disposal of samples
- Reception, storage, acceptance testing
- Collection and handling of primary samples
- Evaluation of customer requirements and handling customer agreements
- Safe handling, transport, storage, and use tools to prevent their contamination or deterioration
- transportation of samples
- Sample receipt
Supporting activities
- Control of ISO 15189 documents and ISO 15189 records
- Selecting and assessing external providers and Purchasing
- Management of complaints and other feedback from clinicians, patients, laboratory staff, and other parties
- Personnel auditor training
- Corrective and preventive actions
- Internal Audits Criteria and the management reviews
- Facility and work environment maintenance and improvement
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