What Are The Key Documentation Requirements For Iso 15189 Accreditation?

By Author: Emma
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ISO 15189 is an international standard that specifies requirements for quality and competence in medical laboratories. To be accredited with ISO 15189, laboratories need to prove that they can produce accurate and reliable results while following the proper procedures and ensuring continuous improvement. One of the most critical components of this process is documentation. Below are the key documentation requirements that laboratories must meet for ISO 15189 accreditation.

1. Quality Manual: The Quality Manual is the central document explaining the laboratory's QMS. It defines policies, processes, and procedures through which the laboratory ensures high standards of operation. This manual guides staff on how to proceed and allows the ISO 15189 accreditation body to understand how the laboratory meets required standards. It also ensures consistent practices by all employees.

2. Documented Procedures: Laboratories should have written procedures for all relevant activities. These would include activities such as sample collection, testing, analysis, and result reporting. Therefore, procedures should be lucid and easy ...
... to follow so that the process may be standardized and repetitions can be made to ensure the reliability and credibility of the report issued after testing.

3. Work Instructions: Work instructions give step-by-step guidance for the performance of a specific task. Although ISO 15189 documents procedure tells the general guidelines, work instructions ensure that employees can continue to perform a particular task properly and repeatedly. For instance, they may provide instructions on how to calibrate certain equipment or handle certain types of samples. These helps minimize errors and increase efficiency.

4. Personnel training and competence records: ISO 15189 requires that staff members in a laboratory be properly trained and competent. Laboratories must retain records showing the qualifications, training, and competencies of each staff member. This is to ensure all employees have the necessary skills to conduct their work, which will correspond to the established standards for accreditation.

5. Equipment Maintenance Records: Maintenance, calibration, and validation records for the equipment should be kept accurately. These records include the calibration status, maintenance history, and repairs done on the equipment. Proper documentation ensures that everything remains in the best condition for operation since results will always be reliable.

6. Internal Audits and Management Reviews: The quality management system shall be periodically reviewed and audited by laboratories to ensure effectiveness. The records of these audits should be kept, and where necessary, actions to correct the identified non-conformities shall be taken. Such records reflect the laboratory's commitment to continual improvement.

7. Corrective and Preventive Action CAPA Records: Non-conformities found in laboratories shall have a control system. Issues that arise from the process require investigation of cause and corrective action so that preventive actions can be initiated to avoid repeating the same error. Detailed records of these, including analysis and solutions, should be maintained.

8. Patient and Sample Records: Documentation of patient and sample information is a way to maintain traceability and accountability. Laboratories are advised to keep track of records that document receipt, processing, and analyses of samples, as well as patient information and test results. Proper documentation ensures confidentiality and obedience to law and regulation.

9. Standard Operating Procedures: SOPs are detailed instructions that document routine laboratory processes. They ensure that tasks are performed consistently and safely, following best practices. They cover a wide range of activities such as specimen collection, handling, testing, and reporting of results.

ISO 15189 accreditation demands that laboratories document every area of the laboratory in great detail, including procedures, training, equipment, audits, and sample records. Such documentation ensures that laboratories meet the highest standards of quality and competence which in turn brings confidence to patients and regulatory bodies.