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ISO 15189 | Medical Laboratories Requirements for Quality and Competence

Why is Consulting Required for Quality Practices?

US TAG 212 ISO/TC 212 (Technical Advisory Group) is currently in process of revising ISO 15189:2012. The following information will be updated upon final revision in 2020.

Those having medical laboratory applications should take into consideration implementation of special Disaster Recovery processes in the event of any possible emergency situation such as the recent Covid 19 virus. It is essential to follow cGMP requirements without any violation. To be ahead of standard requirements, the Disaster Recovery Plan should include social distancing, increased sanitation, and use of Personal Protective Equipment (PPE). This Disaster Recovery Plan must cover the initial handling of incoming raw materials and all processes up to and including dispatch.

Other standards to consider for integration include ISO 15378:2017 for addressing those with packaging processes; ISO 17025, Quality Management Systems for Laboratories to address emergency situations; and ISO 15189:2017, Medical Laboratories requirements for quality and competence support of ISO 15189

The following Bullets reference information for the 2012 revision and will be updated soon.

  • ISO Consulting services are required to assist organizations in building a comprehensive quality management system to meet all requirements of ISO 15189
  • ISO Consulting services can build a QMS that can prepare organizations with a robust system to produce quality products and services
  • ISO 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
  • A good ISO consulting firm provides training to top management in promoting Risk-Based Thinking, Process Approach, and Continual Improvement
  • ISO Consultants assist in developing a comprehensive, simplified QMS to meet all requirements of ISO 15189 and 3rd Party Certification Body stage 1 audit requirements. The stage 1 audit from Certification Bodies vary depending on the selected Certification Bodies which verifies the documented system meeting all the requirements of ISO 15189 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 or provides ISO Internal Auditing Services to audit all processes, all ISO 15189 Standard requirements and effective implementation of ISO 15189 Standard
  • Internal Quality Audits conducted by ISO consultants, help the facilities to find all deficiencies in their implementation which are not normally found during organizations first party audits
  • ISO consulting companies 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, analysis is fully applied, corrective actions are initiated and continual improvement is realized

ISO 15189 Quality Audits

Quality Management System Consulting is the practice of assisting small, medium and large organizations in developing, training, implementing, and maintaining a documented quality management system for achieving ISO 15189 certification.

Quality Management Consultants can prepare your facilities to have a Quality Management System (QMS) and associated documents/records to show as evidence of having implemented the system.

Quality Management System Consultants assist facilities to prepare documentation to show as evidence of having a streamlined process that ensure quality product or service every time without fail.

Quality Management System Consultants assist to build a robust system which compels task performers to have defined roles, responsibilities and controls to ensure quality.

Quality Management System 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.

Quality management consultants provide clarifications on which standard is to be followed for medical laboratories and avoid confusion between ISO 13485 and ISO 15189

Audits are unbiased, structured and documented evaluation of any given international standards such as ISO 15189, ISO 10993-1, ISO 14001, ISO 15189, 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.

  • 1st Party Audit: Audits performed by a team within the facility is called 1st Party Audit
  • 2nd Party Audit: Audits performed by organizations on their suppliers is called 2nd Party Audit
  • 3rd Party 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 15189 Certifications with demonstrated evidence of conformity to all the requirements of ISO 15189:2012

The benefits of implementing ISO 15189:2012 management systems are diverse and will be 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 will bring 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 Auditing 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 Difference in Training, Auditing & Consulting Services:

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 certification audits with no or minimum nonconformities
  • Over 98 % of QSE customers passed 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 15189 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 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 15189 certification with minimum or no nonconformities
  • QSE engages all competent auditors to conduct internal audits or supplier audits

ISO 15189: 2012 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 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 actually collected as well as the time required for the tests to be carried out

Certification to this standard 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.
  • Training manual provided by the laboratories.
  • ISO 15189: 2012 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 quality management system as well as other monitoring and evaluation reports.
  • A detail audit of management reviews

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

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