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ISO 15189:2012
Medical Laboratories
Requirements for Quality & Competence

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Medical Laboratories Requirements for Quality & Competence | ISO 15189:2012

Medical Laboratories Requirements for Quality & Competence

ISO 15189: 2012 Standard is a global initiative that aims at creating a standard measure of quality in medical laboratories. The standard has developed initiatives to promote competence and responsibility in medical laboratory processes, equipment and outcomes. ISO 15189: 2012 Standard was developed by the International Standards Organizations Technical Committee and has been implemented in over 200 countries. The process involves testing of the effectiveness of laboratory equipment and the impact those particular equipment have on the processes in the labs and their outcomes.  This International Standard is also applicable for those working in other services and disciplines such as clinical physiology, medical imaging and medical physics could also find it useful and appropriate. This standard is used as bench mark by those who inspect and permit the inclusion of the laboratories as the outsource provider for laboratory services.

It is an initiative that presents a global concerted approach in creating a standardized measure for management practices in medical laboratories. An ISO 15189:2012 certification has been seen as a critical initiative towards harmonizing global practices in medical laboratories towards a common measure of quality assurance and safety. The approach considers many perspectives, including the interpretation of test results, the method patient samples are collected as well as the time required for the tests to be carried Out.

A reputed ISO 15189 consultant provides effective ISO 15189 training, to meet all requirements of ISO 15189 standard initially through a gap analysis using ISO 15189 checklist and fully prepare organizations to ISO 15189 certification. ISO 15189 requirements emphasize total patient satisfaction related to laboratory testing, results accuracy using competent laboratory technicians. ISO 15189 standard requires medical laboratory technicians use appropriate checklists to record medical test results with accuracy and correctness. It is essential to conduct internal audits using ISO 15189 Audit checklists to judge the effectiveness of the entire ISO 15189 standard quality management system in maintaining and retaining patient satisfaction related to medical laboratory testing

ISO 15189 Certification is not mandatory but any laboratory who wishes to get certified must approach accredited bodies as per ISO/IEC 17011:2017 Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies

Among the basic and fundamental requirements, the following are the most significant ones:

  • A well-documented procedure analysis by the laboratories.
  • ISO 15189 Standard ‘s Training manual provided by the laboratories.
  • ISO 15189: 2012 standard requires an effective detailed analysis of medical laboratory procedures in a bid to make sure that all weaknesses have been identified.
  • Detailed evaluation reports of the existing ISO 15189 Standard quality management system as well as other monitoring and evaluation reports.
  • A detail ISO 15189 audit of management reviews

The ISO 15189: 2012 certification has a set of unique benefits and the main objective of certification is quality assurance.

Process for Getting ISO 15189 Certification

  • Process of ISO certification starts with preparation of a Quality Management System (QMS)
  • ISO Consultants assist in developing a comprehensive, QMS to meet all requirements of ISO 15189 and third- Party Certification Body stage 1 audit checklist requirements. The stage 1 audit from Certification Bodies vary depending on the selected Certification Bodies which verifies the documented system meeting all ISO 15189 requirements or not
  • An ISO 15189 consulting firm provides the techniques for implementation, and trains organization’s internal auditors to become competent to perform internal audits using ISO 15189 audit checklists or provides ISO Internal Auditing Services to audit all processes, all ISO 15189 Standard requirements and effective implementation of ISO 15189 Standard
  • Facilities using ISO 15189 Standard need to initiate corrective actions and continual improvement is realized through control of nonconforming products/services.
  • Facilities need to implement the prepared QMS for a minimum of 3 months and gather adequate data and record to show as evidence of conformity to ISO 15189 Standard
  • Managements of the facilities need to conduct one full scale review of the entire QMS and ensure its adequacy for their organization. Management Team needs to identify Action items to make corrections to any ISO 15189 requirement not being fulfilled
  • Once a QMS is ready, Internal audit is performed using ISO15189 audit checklists and one full set of Management review on implementation of ISO 15189 standard, takes place, the facility needs to contact a certification Body for certification audit
  • Certification Bodies conduct Audit in 2 stages. During Stage 1, ISO 15189 audit evaluates the documentation system and basic requirements of meeting ISO 15189 Requirements
  • Certification Body returns for final audit where all ISO 15189 Requirements are thoroughly audited to ensure that ISO15189 requirements are met and documentary evidence exists to demonstrate compliance
  • Once certification Body is satisfied, recommendation is sent to accrediting agencies to issue ISO 15189 certification

ISO 15189 Consulting, Auditing, & Training Services from QSE

  • QSE’s ISO 15189 Consulting is the practice of assisting small, medium and large organizations in developing, training, implementing, and maintaining a documented Quality Management System (QMS) for achieving ISO 15189 certification for Medical Laboratories
  • QSE’s ISO 15189 Consultants can prepare your facilities to have a Quality Management System for medical laboratories(QMS) and associated documents/records to show as evidence of having implemented the system
  • QSE always follows a tried and tested 10 step disciplined path in preparing facilities for ISO 15189 certification, which is insensitive to failure
  • QSE’s ISO 15189 Consultants assist facilities to prepare a comprehensive simplified documentation system to show as evidence of having a streamlined process that ensures quality product or service every time without fail
  • QSE’s ISO 15189 consultants help in identifying issues and concerns of all stake holders and take them in to account in preparing a QMS for ISO 15189 certification
  • QSE’s ISO 15189 consultants assist facilities in matching competence of personnel assigned to tasks, methods to select providers who supply quality products and services
  • QSE’s ISO 15189 Consultants assist to build a robust system which compels task performers to have defined roles, responsibilities and controls to ensure quality
  • QSE’s ISO 15189 Consultants assist organizations to identify all manufacturing and nonmanufacturing processes and facilitate in establishing process performance metrics or process performance indicators (Key Process Indicators = KPIs) to effectively monitor and measure organizations intended Goals and Objectives
  • QSE’s ISO 15189 Consulting services are required to assist organizations in building a comprehensive QMS to identify risks at every process and have steps to mitigate risk
  • Internal Quality Audits conducted by QSE consultants, help the facilities to find all deficiencies in their implementation which are not normally found during organizations first party audits
  • QSE’s ISO 15189 Consultants assist in meeting “Annex SL, a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written.” which in turn meets ISO 15189 requirements
  • QSE’s ISO 15189 Consultants provide training to top management in promoting Risk-Based Thinking, Process Approach, and Continual Improvement
  • QSE’s ISO15189 consultants assist organizations to effectively control document information (Documents and Records) related to changes, conducting ISO management review meetings covering all management review inputs (as per ISO 15189 requirements)
    Including the trends to be monitored, internal audit results are fully addressed, risk related activities identified/assessed/mitigated, root-cause, identified and analysis is fully applied.
  • QSE’s ISO 15189 consultants ensure that certification is achieved with no or minimum nonconformities first time around
  • QSE has over 27 Years of standing in the field of Consulting, Auditing and Training for any ISO Standard, Sector Specific Standard, AISC standard or Food Safety Standard
  • QSE has helped over 700 facilities to earn their ISO certifications and other certifications
  • All QSE customers passed ISO 15189 certification audits with no or minimum nonconformities
  • Over 98 % of QSE customers passed ISO 15189 certification audits with nil nonconformity first time around. QSE has a 100 % success rate in obtaining certifications for its customers
  • Unlike our competitors, QSE has a unique, comprehensive, evidence based, simplified single level, documentation system which is easy to implement and provides evidence for implementation to earn ISO 15189 certification
  • QSE’s designed ISO 15189 templates are tried and tested for accuracy and correctness and provide objective evidence during internal audits and ISO 15189 certification audits
  • QSE’s ISO 15189 standard documentation is simplified system is evidence based, and it is easy to implement, easy to use and easy to audit
  • QSE ‘s ISO 15189 standard documentation is an evidence based system with proven lists, forms and tables results in ISO 15189 certification with minimum or no nonconformities
  • QSE engages all competent ISO 15189 auditors to conduct ISO 15189 internal audits or supplier audits
  • President QSE, Baskar Kotte is an original and an active member of ISO/US TAG/TC 176, the Technical Committee that originally developed the ISO 9000 family of standards, ISO/US TAG/TC 207 which developed the ISO 14000 family of standards, ISO/US TAG/ TC 301 (TC 242) which developed ISO 50001 and   ISO 19011 the Guiding standards for Auditing. Mr. Kotte also participated and provided input to the development of the current ISO 9001:2015, ISO 140001:2015, ISO 50001:2018 family of Standards and ISO 19011:2018 revised standards.
    corrective actions are initiated and continual improvement is realized

The benefits of implementing ISO 15189:2012 management systems are diverse and are seen in all departments of your company. The following are some of the benefits that you should take into consideration:

  • An ISO 15189: 2012 certification promotes development of an international reputable image for your organization through Quality Assurance and Management Systems.
  • Promotes a strong degree of consistency in compliance to medical laboratory laws and legislation both from an international and national perspective.
  • ISO 15189:2012 certification helps Improvement in Productivity and Quality
  • ISO 15189;2012 certification is a powerful marketing tool that brings to your organization long-term Global Recognition
  • ISO 15189:2012 certification helps Improvement in Business Opportunities
  • ISO 15189:2012 certification enhances consumer confidence through Problem Solving and Continual Improvement
  • Through ISO Internal Audit using ISO 15189 audit checklists provides an effective management tool to run any business considering from “Quote to Cash” processes for enhancing consumer confidence
  • ISO 15189:2012 certification is fundamentally critical in promoting laboratory efficiency and responsibility for better results and service delivery.
  • The ISO 15189:2012 certification program also has been very critical in promoting modern laboratory practices that include professionalism and expertise in conduction of medical activities in the labs.
  • ISO 15189:2012 certification ultimately promoted the growth of customer satisfaction in organizations involved in medical laboratory testing

QSE has assisted over 700 organization in obtaining ISO and other certifications, contact details can be furnished on demand for any certification

  1. Supplier selection and performance, and changes to the approved supplier list
  2. Staff qualifications, training and competency records
  3. Request for examination
  4. Records of receipt of samples in the laboratory
  5. Information on reagents and materials used for examinations (e.g. Lot documentation, certificates of supplies, package inserts)
  6. Laboratory work books or work sheets
  7. Instrument printouts and retained data and information
  8. Examination results and reports
  9. Instrument maintenance records, including internal and external calibration records;
  10. Calibration functions and conversion factors
  11. Quality control records
  12. Incident records and action taken
  13. Accident records and action taken
  14. Risk management records
  15. Nonconformities identified and immediate or corrective action taken
  16. Preventive action taken
  17. Complaints and action taken
  18. Records of internal and external audits
  19. Interlaboratory comparisons of examination results
  20. Records of quality improvement activities
  21. Minutes of meetings that record decisions made about the laboratory’s quality management activities;
  22. records of management reviews.

Ensure that all above referred quality and technical records are made available for laboratory management review

FAQ

Frequently Asked Questions​

ISO Audits are unbiased, structured and documented evaluation of any given international standards such as ISO 9001, ISO 10993-1, ISO 14001, ISO 45001, ISO 50001, ISO 55001, ISO 22000, ISO 27001, IATF 16949, AS 9100, AS 9110, AS 9120, BRC, FSSC 22000, SQF, TL 9000, and recording the results.

  • First-Party Audit: Audits performed by a team within the facility is called First-Party Audit
  • Second-Party Audit: Audits performed by organizations on their suppliers is called Second-Party Audit
  • Third-Party Audit: Audits performed by Certification Bodies is known as a Third-Party Audit

Third-Party audit Certification Bodies (Accredited by International Accreditation Forum =IAF) perform the audits on the organizations to grant ISO15189 Certifications with demonstrated evidence of conformity to all the requirements of ISO 15189:2012.

Typically, it takes anywhere between 7 to 8 months for certification when you start from scratch. QSE has well developed systems and ISO 15189 templates which are easily understood for implementation. Therefore, it is possible to get certification within about 5 months through QSE.

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Bhaskar Kotte

Baskar Kotte

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