Understand The Control Of Iso 15189 Documents And Records In Medical Laboratories

By Author: John
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A global quality standard for clinical and medical laboratories is ISO 15189. This standard, in effect from 2007, and up to its most recent revision in 2022, establishes the standards for quality management, technical procedures, and competency in medical laboratories. Therefore, the ISO 15189:2022 standard encourages trust and excellent quality in the analysis and result-creation processes used in medical laboratories.

The ISO 15189 standard for quality and process requirements is based on both the ISO 9001 and 17025 standards. While the ISO 17025 standard specifies criteria for testing and calibration laboratories, the ISO 9001 standard refers to requirements for quality management. The ISO 15189:2022 standard, on the other hand, is intended for medical laboratories, outlining the examination procedures and equipment needs to adhere to the standard and to deliver high-quality and dependable results. Documents and records that comply with ISO 15189 are a crucial part of the standard. The laboratory must establish, record, implement, and maintain a management system to support and demonstrate that the criteria of the ...
... document are consistently met. The laboratory's management system must comprise at the very least the following:
• Documented information
• Responsibilities
• Objectives and policies
• Actions to address risks and opportunities for improvement
• Continual improvement
• Corrective actions
• Evaluations and internal audits
• Management reviews

The laboratory is responsible for maintaining control over all documents (internal and external) related to the implementation of the policy statements. This includes flowcharts, specifications, manufacturer's instructions, flow charts, instructions for usage, and many more documents. The laboratory must make sure that:

• ISO 15189 documents are uniquely identified
• The documents are approved for adequacy before issue by authorized personnel who have the expertise and competence to determine the adequacy
• documents are intermittently reviewed and updated as necessary
• relevant versions of applicable documents are available at points of use and, where required, their distribution is controlled
• variations and the current revision status of documents are identified
• documents are protected from unofficial changes and any deletion or removal
• documents are protected from unauthorized access
• the unintended use of obsolete documents is prohibited, and suitable identification is applied to them if they are retained for any purpose
• at least one paper or electronic copy of each obsolete controlled document is retained for a specified period or by applicable specified requirements

To prove that all requirements of the document have been met, the laboratory must create and maintain readable records. Every action that has an impact on the quality of an examination must be recorded at the time that it is performed.

The lab must make sure that any record updates may be linked back to the original observations or earlier iterations. Original and adjusted data and files must both be retained, along with information about the date and, if applicable, the time of the alteration, the aspects that were changed, and the people who made the changes.

Retention of records

• The lab must put the necessary processes in place for the identification, storage, protection from unauthorized access and alterations, backup, archive, retrieval, retention period, and disposal of its documents
• Records must be retained for a specific amount of time
• Results of reported exams must be accessible for as long as necessary or as requested
• All records must be available for review by laboratory management, accessible for the duration of their retention period, and legible on whichever medium they are kept on