Friday, June 19, 2020

Overview and Training Requirements for ISO 15189

ISO 15189 Accreditation is a guarantee that the laboratory has been tested by internationally recognized standards aimed at proving the availability of the program, the technical capacity, and that the staff actually has the ability to produce appropriate technical results and specific details for the purposes for which each test is used.

In order to comply with the requirements of ISO 15189, strong involvement of laboratory staff is required to understand the best process for satisfying the requirements according to the latest technology and methodology, scientific documents, but also time and cost. A growing number of voluntary medical are taking the path to approval, so ensure practice and technical competence in accordance with the Laboratories Best Practice policy, as well as boost confidence in laboratory tests by all participants, thus including patients and physicians.

The ISO 15189 Standard requires, in part, a document, to agree on the purpose for which each test is intended. For example, it instructs laboratory staff to evaluate the validity of the performance indicators of the test procedures and whether the limitations can be controlled by the lab, so that the adverse impact on patients' outcomes can be avoided.

Another important factor related to choosing the size of ISO 15189 is accreditation. Each test, independently of the environment or technology, can vary widely the patient's health and safety outcome. Therefore, accreditation of clinical laboratories should include the largest number of laboratory tests performed.

Proper training of laboratory staff is the first step in introducing accreditation. This clearly includes acknowledging the importance of laboratory medicine in health care and ensuring that the right results are given to doctors. However, continuous monitoring and monitoring of the entire process is needed to ensure consistency of the methods and procedures that should ensure the effective contribution of the test results to patient care.

The ISO 15189 Auditor Training, in which can understand the requirements for Quality and Competence in Medical Laboratories and to learn everything that an ISO 15189 certified auditor needs to aware about auditing a laboratory. First, all the ISO 15189 requirements are discussed in order to understand and accept the basis under approval. Treated as a workplace training exercise, is where all employees are involved in a professional forum by saying the following:
  1. Read and interpret all requirements and concurrent negotiations of procedures, ensure compliance of requirements and in accordance with revised and approved guidelines;
  2. Collection of proposals for improving the level of compliance and assessment accordingly and feasible;
  3. Exploring new approaches and / or processes, and introducing alternatives.

The Accreditation Body plays an important role in teaching and training the auditors correctly. Training needs to focus on the processes and procedures of the audit but, first of all, how to emphasize the quality of the lab, not only in terms of requirements, but also in relation to improvement programs and projects, which should be clearly recognized as an additional value. For getting ISO 15189 Accreditation Consultancy services please visit: http://www.accreditationconsultancy.com/iso-15189-accreditation-consultancy.htm

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