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ISO 15189


ISO 15189 specifies particular requirements for quality and competence in medical laboratories. It can be used by medical laboratories as a guideline in developing their quality management systems and assessing their own competence. While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care. It outlines the controls required to manage risks that may have an impact on the validity of examination results, and tools to help the laboratory to improve its operations and customer satisfaction.

The standards includes provision of advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab's role in the education and training of their staff.

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The implementation of ISO 15189 standards and its accreditation benefits medical laboratories by:

  • Allowing them to organize their operational procedures efficiently, meet the expectations of their clients and improve their service;
  • Confirming and recognizing their competence by laboratory customers, regulating authorities and accreditation bodies to gain an edge with reputation and user confidence;
  • Assuring the quality of their examination procedures;
  • Setting standards for the requisition of the analysis, patient identification and preparation, collection, transportation, storage, processing and examination of patient samples;
  • Setting standards for validation and interpretation of patient test results;
  • Aiding them to determine whether they are performing their work correctly and to appropriate standards providing them with a benchmark for maintaining that competence.

The Challenge

All medical laboratories are not alike and do not offer the same combinations of testing in the same facility configuration and staff organization. The main challenges faced by medical laboratories accredited by ISO 15189 are:

  • Keeping operating an effective Management System (MS) that has strong elements of Quality Assurance, Quality Control and Quality Improvement;
  • Assuring their Management system addresses and conforms to all elements of ISO 15189, is documented in accordance with those requirements and is fully operational;
  • Ensuring the competence of their staff and the reliability of their services;
  • Having continuous assurance that they are meeting their customers’ needs and expectations for consistent, accurate and timely test results.

The Solution

Clause ISO 15189 - Summarized SoftExpert Compliance Evidence
Management requirements
Organization and Management

Introduces requirements and responsibilities of the laboratory management like compliance to legal requirements, definition of responsibilities and authorities of all personnel, definition and implementation of policies and organizational structure.

The medical laboratory creates the responsibilities and authorities matrix of all personnel, and with the definition and implementation of policies and an organizational structure these documents are published and maintained in SE Document.

The quality manual, SOPs and other documentation required by ISO 15189:2012 or any other regulatory authority are published and maintained in SE Document.

Quality Management System

Indicates the need for the implementation of a Quality System that includes Quality Assurance, Quality Control, Proficiency Testing procedures, Calibration and Maintenance, described in a Quality Manual. Policies and objectives of a Quality System should be defined. People shall be educated about Quality Management System principles. This topic also presents a summary of issues to be addressed in a Quality Manual.

Documentation is often the most important part of an effective quality management system. SE Document allows Medical and Clinical Laboratories to create documents that will be automatically tracked, distributed (electronic or hard copies) and controlled (as they are being revised) in a secure and centralized system to ensure compliance with the standards. SE Document allows medical and clinical laboratories to create any type of file and secure them in the system. SE Document has search capabilities to allow any authorized system user to quickly search and retrieve documents and records such as SOPs, work instructions, and etc. SE Document has configurable workflows for approvals and automated routing and storage capabilities to comply with ISO 15189 quality standards. SE Document combines training and documentation management features to meet ISO 15189 training requirements. For example, SE Document can be set to automate the release of training tasks or full-scale training units to employees every time an SOP is revised within the system. SE Document includes change control management capabilities to connect internal and external system users with data and processes. SE Document improves efficiency through automatic task assignment, routing, scheduling, notification, and escalation of incomplete tasks.

Document Control

Requirements for documentation control including elaboration, approval and updating of documents, in paper – or not.

SE Document automates document management processes, such as document change requests and document review and approval processes, to ensure that they are carried out accurately and efficiently.

Review of contracts

Analysis of the capability to meet the requirements of the customers and the need of communication of further amendments.

SE Document allows medical laboratories to automate and manage at configurable intervals the revision and publication of all contracts for services delivered by the laboratory to clients.

Examination by referral laboratories

Evaluation, selection and monitoring of referral laboratories, including the need for a clear definition of the interpretation of the examination results.

SE Document will maintain the procedures and records used for the evaluation and selection of referral laboratories and consultants. The system will also maintain the documentation regarding the interpretation of the examination results provided by the medical laboratory.

External services and supply

Selection and use of purchased external services, equipment and consumable supplies, including criteria for inspection, acceptance, rejection and storage of these materials according to pre-defined standards.

SE Inspection is a central repository for all supplier performance evaluation, material status and quality information providing an easily maintainable and up to date Approved Supplier List. SE Inspection integrates with SE Document, SE Audit and SE Problem allowing authorized users to access documentation, audit and nonconformance records related to each supplier. SE Inspection automatically tracks and stores all supplier information derived from audits, non-conformance reports, supplier deviations, and CAPAs. This information allows SE Inspection to automatically generate supplier qualification and quality ratings as required by ISO 15189 standards.

Advisory services

Advising and assistance on examinations Appropriate laboratory staff shall give advice on the choice of examinations and services and procedures defining the regular meetings between professional and clinical staff should be documented / arranged.

SE Document allows medical laboratories to publish and maintain policies, procedures, and any other documentation required by ISO 15189 and regulatory authorities in regards to advisory services.

Resolution of complaints

Procedures and records of customer complaints resolutions. Causes of complaints must be investigated and corrective actions taken in order to solve them.

SE Problem keeps records of any complaints or feedback and of investigations or corrective action taken by the laboratory. SE Problem manages the entire process by reviewing real and potential nonconformities, including customer complaints and evaluating the need for action to ensure that nonconformities do not reoccur.

Identification and control of nonconformities

Documentation and analysis of process deviations. Causes must be investigated and corrective actions taken. Sources of deviations include complaints, QC results, calibration procedures, audit results, etc.

SE Problem connects all responsible personnel to manage identified CAPAs and improvement opportunities. The integration with SE Action Plan allows authorized users to create effectively and timely disposition actions as well as corrective, preventive and improvement actions. SE Problem has embedded tools such as 5Why’s and the Fish-bone for a best-practice root cause analysis. SE Problem automates data collection, routing, follow-up, and escalation of any records created (i.e. CAPAs, nonconformances, complaints, and etc.). SE Problem allows access to real-time data providing tools for staying on top of things. The system tracks all routing information and records created allowing the record owner or the responsible personnel to identify bottlenecks and understand the sequence of events during the whole process. SE Problem includes powerful tools for reporting and statistics.

Corrective action

Establishment of corrective actions to avoid recurrence of problems. Results must be evaluated in order to check if the actions taken were effective.

Preventive action

Identification of preventive actions to avoid occurrence of problems. Results must be evaluated in order to check if the actions taken were effective.

Continual Improvement

Revision of procedures to improve their performance - by using indicators, for instance. The main idea is to identify opportunities for improvement.

Quality and technical records

Maintenance, safe disposal and retrieval of quality records. A list of potential records should be provided.

SE Document allows medical laboratories to publish and maintain their procedures for the identification, collection, indexing, access, maintenance and safe disposal of quality and technical records.

Internal audits

Planning, organization and conduction of audits to check compliance of processes to the ISO 15189 standard and also to the internal procedures.

SE Audit automates the scheduling of all audit-related activities. The system connects the audit process with the rest of the quality system for a holistic approach to quality management. It allows the planning and scheduling of tasks and provides powerful analytics and reporting capabilities, including customizable reports and online charting. Through the reports and charts authorized users can get a real-time view of the audit process and can be more proactive about improving the quality system. SE Audit integrates with SE Document and SE Problem allowing auditors to record nonconformances directly from an audit finding form.

Management review

Evaluation of the effectiveness of the system implemented and the need for resources. Indicators, nonconformities and audits results are some issues to be addressed in a management review meeting.

Management review is an essential element of any quality management system. SE Document automates review reminders as well as the release of related documentation in compliance with ISO 15189 quality standards requirements.

Technical Requirements
Technical Requirements

Definition of responsibilities, evaluation of personnel competences * and training requirements. Records – job descriptions, personnel files, training records, competence evaluation results - shall be maintained. Personnel must be able to develop their functions. Responsibilities of the laboratory director and designees are listed in this topic.

SE Competence and SE Training allow medical laboratories to manage employees’ competence and training processes effectively as this is one of the main items of ISO 15189. SE Competence offers different management indicators to measure training effectiveness in terms of human resource qualification. SE Training automates the routing, tracking, follow-up of training tasks and employee evaluation. Users are automatically notified about new training tasks, training validity that will expire and a lot more. SE Competence and SE Training integrate the training process with the rest of the quality system providing full compliance with ISO 15189 requirements. For example, if a document or process (SOP, policy, and etc.) linked to a required course/training is changed or revised then all affected users (trainees and personnel responsible for the training) will immediately receive email notifications with the new training tasks to be completed. SE Training allows access to real-time data including advanced analytics and reports as well as gap analysis tools for all training tasks.

Accommodation and environmental conditions

Adequacy of space and work environment in order not to compromise the quality of the work performed and reduce the risks of injuries and occupational illness. Areas for dangerous materials storage and safe waste disposal must be provided. Environmental conditions must be controlled when they can affect the quality of the analytical process. Good housekeeping shall be ensured. Provisions must be made when the space is found not adequate.

SE Waste allows medical laboratories to manage the entire process of identification and planning of operations related to waste, including the storage, transportation and disposal of generated waste. SE Waste manages the complete lifecycle of waste by-products, starting with the generation, on to processing and the final disposal.

Laboratory Equipment

Selection and monitoring of equipment, reference materials, consumables, reagents, instruments and analytical systems. This topic includes monitoring of the performance of equipment, calibration and maintenance procedures and also requirements for computer software and automated equipment.

SE Calibration allows medical laboratories to schedule, document, plan, analyze, and manage calibrations of all their instruments, test equipment, devices, and etc. SE Maintenance allows medical laboratories to monitor and manage corrective and preventive maintenance associated to all their equipment and computer software. SE Document will allow medical laboratories to manage all calibration and maintenance procedures making these documents available to all authorized users.

Pre-examination procedures

Implementation of a process that includes definition of criteria for request forms, collection, identification, handling, transportation and receipt of primary samples. Criteria for accepting and rejecting samples must be defined. Samples collection procedures must be described in a manual.

SE Document and SE Process allow medical laboratories to implement actions and maintain the effectiveness of processes and policies defined by their QMS.

Examination procedures

Control of the analytical process: validation, reference and critical intervals and documented procedures. This item addresses a set of information to be included, when applicable, in the documented procedures.

SE Document allows medical laboratories to publish and maintain their documentation and procedures for the control of their analytical processes as required by ISO 15189.

Assuring quality of examination procedures

Quality Control procedures: use of internal quality control systems and definition of the uncertainty of results, application of methods to calibrate measuring systems, participation in inter-laboratory comparison programs or alternative mechanisms that can assure the quality of analytical procedures.

SE Document allows medical laboratories to publish and maintain their SOPs related to the assurance and quality of their examination procedures.

Post-examination procedures

Definition of criteria for storage and safe disposal of primary samples, review and release of results.

SE Document allows medical laboratories to publish and maintain their documentation related to post examination procedures, reporting results, release of results, laboratory information management and etc.

Reporting of results

Description of requirements for reports formatting, transmitting and alteration. Definition of criteria for communication of delays and critical values, retention period of results, etc. The laboratory must achieve compliance to national legal requirements, when applicable.

Release of results

The laboratory shall establish documented procedures for the release of examination results, including details of who may release results and to whom. The procedures shall ensure that the following conditions are met.

Laboratory information management

The laboratory shall have access to the data and information needed to provide a service which meets the needs and requirements of the user. The laboratory shall have a documented procedure to ensure that the confidentiality of patient information is maintained at all times.

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