ISO 15190 | Medical Laboratories Requirements for Safety

ISO 15190:2020 Medical Laboratories – Requirements for Safety, the newly updated version of previous the ISO 15190:2013 Standard was revised by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. This new publication supersedes the ISO 15190:2003 Standard with changes to improve risk assessment, preparation for emergencies, and the safety management program and multiple other additions / changes.

ISO 15190:2020 Standard refers to the requirements of all types of laboratories to demonstrate their ability to provide accurate and consistent results on the tests and measurements performed by them.

The ISO 15190 Standard is applicable to all currently recognized medical laboratory service disciplines desiring to maintain a safe laboratory work environment. Implementation of ISO 15190:2020 Medical Laboratories – Requirements for Safety includes establishment of requirements and guidelines to provide safety for all interested persons that may be affected. The ISO 15190 Standard enables medical laboratories to demonstrate their ability to provide competent, accurate, and consistent results of testing for assurance to medical Laboratory and patients. The ISO 15190:2020 Standard includes requirements for identifying risks in clinical testing results and the need for taking preventive actions to mitigate the risk and provide reliable services.

In some cases, examination of patients be performed by the laboratory service in consultation cases for prevention. Due to the personal nature of this ISO 15190 Standard in addressing related to patients and clinicians, specific services may need to be available. Examples include:

  • Examination requests / arrangements
  • Patient identification / preparation, HIPPA(Health Insurance Portability and Accountability Act)
  • Sample collection and storage processes
  • Sample / material / patient transportation (when required)
  • Sample / material storage
  • Processing instructions
  • Clinical sample analysis and Interpretation of results
  • Report function

Laboratories requiring level 3 and/or 4 containment for human pathogen handling have additional requirements beyond those in ISO 15190.

ISO 15189 Medical Laboratories – Requirements for Quality and Competence is advised for use in laboratories applying for ISO 15190:2020. This is beneficial in meeting requirements in providing suitable training, educational / scientific opportunities for staff.

An experienced / reputable ISO 15190 consulting company is beneficial in successful ISO 15190 certification achievement. Quality System Enhancement has over 27 years of experience as a premier consulting company providing effective ISO training. The QSE process meets all requirements of the ISO 15190 Standard through gap analysis, creation of simplified documentation, implementation assistance, initial internal audit of system, corrective action assistance, and preparation for the ISO 15190 Certification Audit.

To prepare organizations for ISO 15190 Certification, QSE auditors provide extensive / comprehensive ISO 15190 internal audit reports and submits them to top management for appropriate and timely corrective actions.

ISO 15190 emphasizes total customer satisfaction related to laboratory safety, through accurate results using competent laboratory clinicians / technicians. The ISO 15190 standard requires clinicians / technicians use appropriate ISO 15190 audit checklists to record test results with for comprehensive coverage of requirements. It is essential to conduct internal audits using ISO 15190 audit checklists to judge the effectiveness of the entire ISO 15190 system in maintaining and retaining customer satisfaction related to laboratory testing.

  • All Laboratories engaged in Laboratory testing of need a TestingQuality Management System (TQMS)
  • TQMS can assure customers / government that the facility has a robust system and can produce valid results on test services, saving and conserving Quality.
  • ISO 15190:2020 Standard is an international standard dedicated to supporting safety ensuring TQMS for Laboratory Safety. The medical laboratories requiring to have a comprehensive TQMS and satisfying their customers/interested parties need ISO 15190 certification to maintain safety.
  • A good ISO 15190 consulting firm can provide a detailed explanation of the intent of the standard and build a safe laboratory system. The medical laboratories requiring to build a safe laboratory system needs ISO 15190 certification.
  • A comprehensive laboratory safety system creates confidence in end users, government, statutory and regulatory agencies and Laboratories seeking to provide answers to all questions from agencies must get ISO 15190 Certification.
  • An ISO 15190 consulting firm provides the techniques for implementing the system. Hence any facility seeking comprehensive system must get certified.
  • Consulting firm can provide auditing services to help the facility to verify the accuracy and adequacy of implementation. Companies hoping to have world class service and accuracy in their work must get ISO 15190 Certification.
  • Internal Quality Audit is conducted by ISO 15190 consultants help the Laboratory find deficiencies in their implementation, make correction and take corrective actions. ISO 15190 Certification streamlines these processes. Laboratories desirous of having processes streamlined must get ISO 15190 Certification.
  • An annual surveillance audit is conducted to ensure maintenance of an ISO 15190 Accreditation laboratory.
  • Consulting firms provide distinction in documentation between repeatability and reproducibility of test results.
  • ISO 15190:2020 Certification is renewable every three years.

  • Process of ISO Certificationstarts with preparation of a Quality Management System. (QMS) and the process of ISO 15190 certification starts with developing ISO 15190 Laboratory System.
  • ISO Consultants assist in developing a comprehensive QMS to meet all requirements of ISO 15190 and 3rdParty Certification Body stage 1 audit requirements. The stage 1 audit from ISO 15190 Certification Bodies vary depending on the selected Certification Bodies which verifies the documented system meeting all ISO 15190 requirements or not.
  • An ISO 15190 consulting firm provides the techniques for implementation, and trains the organization’s internal auditors to become competent to perform internal audits or provides ISO Internal AuditingServices to audit all processes, all ISO 15190 Standard requirements and effective implementation of ISO 15190 Standard.
  • Laboratories need to initiate corrective actions and continual improvement is realized through control of nonconforming products / services.
  • Laboratories need to implement the prepared QMS for a minimum of 3 months and gather adequate data and record to show as evidence.
  • Management of Laboratories need to conduct one comprehensive management review of the entire Laboratory System and ensure its adequacy for their organization. Management Team needs to identify Action items to make corrections to any ISO 15190 standard requirements not being fulfilled.
  • Once the medical laboratory system is ready, one full cycle of Internal audits  is performed and one Management review is conducted prior to inviting a Certification Body to perform ISO 15190 Certification Audit.
  • Certification Bodies conduct Audit in 2 stages. During Stage 1, ISO audit evaluates the documentation system and basic requirements of meeting ISO 15190 Requirements.
  • Certification Body returns for final audit where all ISO 15190 standard requirements are thoroughly audited to ensure that requirements are met and documentary evidence exists to demonstrate compliance.
  • Once Certification Body is satisfied for compliance, the recommendation is sent to accrediting agencies to issue ISO 15190 certification.

  • QSE Consulting practice focuses on assisting small, medium and large organizations in developing, training, implementing, and maintaining a documented Laboratory Management System (LMS) for achieving ISO 15190 Certification for Laboratories.
  • QSE Consultants Laboratories to have a Laboratory Management System 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 Laboratories for ISO 15190 Certification, which is insensitive to failure.
  • QSE 15190 consultants assist Laboratories to prepare a comprehensive simplified documentationsystem to show as evidence of having a streamlined process that ensures quality product or service every time without fail.
  • QSE ISO 15190 consultants help in identifying issues and concerns of all stake holders and take them in to account in preparing a QMS for ISO 15190 Certification.
  • QSE’s ISO 15190 consultants provide training to assist Laboratories in matching competence of personnel assigned to tasks, methods to select providers who supply quality products and services.
  • QSE’s ISO 15190 consultants assist to build a robust system which compels task performers to have defined roles, responsibilities and controls to ensure quality.
  • QSE’s ISO 15190 consultants assist organizations to identify all 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 15190 Consulting services are required to assist organizations in building a comprehensive LMS to identify risks at every process and have steps to mitigate risk.
  • Internal Quality Audits conducted by QSE’s ISO 15190 auditors and consultants, help the Laboratory to find all deficienciesin their implementation which are not normalcy found during organizations first party audits.
  • QSE’s 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 15190 requirements.
  • QSE’s ISO 15190 consultants provide ISO 15190 training to top management in promoting Risk-Based Thinking, Process Approach, and Continual Improvement.
  • QSE’s ISO 15190 consultants assist organizations to effectively control documented information (Documents and Records) related to changes, conducting ISO management review meetings covering all management review inputs. (as per ISO 15190 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 15190 consultants ensure that certification is achieved with no or minimum nonconformities first time around.
  • 1stParty Audit: Audits performed by a team within the facility is called 1st Party Audit.
  • 2ndParty Audit: Audits performed by organizations on their suppliers is called 2nd Party Audit.
  • 3rdParty Audit: Audits performed by Certification Bodies is known as a 3rd party audit.

3rd Party audit Certification Bodies (Accredited by International Accreditation Forum =IAF) perform the audits on the organizations to grant ISO 15190 Certifications with demonstrated evidence of conformity to all the requirements of ISO 15190:2017.

3rd Party audit is conducted by Accredited Certifying Bodies accredited by ISO and are signatories to IAF and MLA.

  • 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
  • QSE has helped over 800 Laboratories to earn their ISO 15190 Certifications and other certifications.
  • All QSE’s ISO15190 laboratories pass ISO 15190 Accreditation Audits with no or minimum nonconformities.
  • Over 98 % of QSE customers pass ISO 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 15190 Certification.
  • QSE’s designed templates are tried and tested for accuracy and correctness and provide objective evidence during internal audits and ISO Certification audits
  • QSE’s ISO 15190 simplified system is evidence based, and it is easy to implement, easy to use and easy to audit.
  • QSE ‘s evidence-based system with proven lists, forms and tables results in ISO 15190 Certification with minimum or no nonconformities.
  • QSE only engages competent ISO 15190 auditors to conduct internal audits or supplier audits.

The benefits of implementing ISO 15190:2020 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 15190:2020 Accreditation or 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 laboratory laws and legislation both from an international and national perspective.
  • ISO 15190:2020 Certification helps Improvement in Safety and Quality.
  • ISO 15190:2020 Certification is a powerful marketing tool that brings your organization long-term Global Recognition.
  • ISO 15190:22020 Certification helps Improvement in Business Opportunities
  • ISO 15190:2020 Certification enhances consumer confidence through Problem Solving and Continual Improvement.
  • Through ISO 15190 Internal Auditing provides an effective management tool to run any business considering from “Quote to Cash” processes for enhancing consumer confidence.
  • ISO 15190:2020 Certification is fundamentally critical in promoting laboratory efficiency and responsibility for better results and service delivery.
  • TheISO 15190:2020 Certification program also has been very critical in promoting modern laboratory practices that include professionalism and expertise in conduction of activities in the labs.

ISO 15190:2020 Certification ultimately promoted the growth of customer satisfaction in organizations involved in laboratory testing to ensure safety

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

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