5. ISO 15189-2022 INTRODUCTION FINAL.ppt
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5. ISO 15189-2022 INTRODUCTION FINAL.ppt
- 1. LABORATORY QMS MENTORS TRAINING ISO 15189:2022 STANDARD Introduction
- 2. Training Objectives Broad Objective. To provide participants with general overview and understanding of new ISO 15189:2022 from the old version of ISO 15189; 2012. Specific Objectives. 1.To discuss each requirement of the standard and the required evidences/records for implementation 2.To understand the structure and scope of the new ISO 15189:2022. 3.To describe main changes of the ISO 15189:2022. 4.To understand the implications of the new version of standard in QMS implementation.
- 3. INTRODUCTION ISO from “isos,” Greek for “equal” “If two objects meet the same standard, then they are equal.” “Standardis essentially an internationally recognized way of doing something.” ISO It is basically advising and guiding everyone to follow the same set of requirements no matter where they are based, and it ensures safer practice to produce more consistent end result.
- 4. ISO STANDARDS Key ISO Standards •• ISO 9001 – Quality management systems •• ISO 17025 – Testing and calibration laboratories •• ISO 15189 – Medical laboratories •• ISO 22367 – Risk management •• ISO 15190 – Laboratory safety •• ISO 20658 – Sample collection and transport •• ISO 22870 – Point-of-care testing (POCT) •• ISO 17043 – Proficiency testing / External quality assessment •• ISO 19011 – Internal audit •• ISO 17011 – For accrediting bodies
- 5. Purpose & Scope of ISO 15189 Standard Promote welfare of patients and satisfaction of laboratory users through confidence in quality and competence in medical Laboratories Requirements for medical laboratory to plan and implement actions to address risks and opportunities for improvement Applicable to: ― Medical laboratories - developing management systems and assessing competence o Applicable to users, regulatory authorities and accreditation bodies - confirming / recognizing competence of medical laboratories ― POCT ― Other healthcare services (e.g., blood banks/transfusion, diagnostic imaging, respiratory therapy, physiological sciences)
- 6. Key Reasons for change. o The parent standard – ISO/IEC 17025:2017 – had been updated to comply with the structure of the normative ISO 9001:2015. o As ISO/IEC 17025:2017 is a normative reference of ISO 15189 there was a requirement for the document to be aligned. o ISO 15189:2012 had reached its periodic review date. A vote was taken by the international community, and it was agreed that the standard required review and update to reflect the changing demands of the medical laboratory community. o A decision was made very early in the revision that the updated version needed to be patient-focused and risk based as this is the clinical standard for a service that is key to the patient pathway. o There was an understanding that, as effective as the current version is, there is a high degree of prescription and over-reliance on interpretation of the standard in terms of perceived accreditation requirements.
- 7. Content Overview of ISO 15189:2022 Standard • • The standard is divided into 8 major sections plus annexes (A-C) • 1. Scope • 2. Normative references • 3. Terms and definitions • 4. General requirements • 5. Structural and governance requirements • 6. Resource requirements • 7. Process requirements • 8. Management system requirements • • Sections 1, 2 and 3 are for guidance only and are not auditable • • The ‘meat’ of ISO 15189 resides in the requirements sections (5 total) Laboratories must effectively satisfy these requirements to be accredited
- 8. ISO 15189:2022 Standard Highlights • 4th edition = 2022 version (Previous ISO 15189 Versions – 2003, 2007, 2012.) •• Replaces 3rd edition (ISO 15189:2012), which has been technically revised •• Incorporates POCT requirements and supersedes ISO 22870:2016, which is now withdrawn •• Formatting based in ISO 17025:2017
- 10. 1. LESS PRESCRIPTIVE Gives more flexibility to the laboratory management on how to meet the requirements and how to create the required evidence.
- 11. 2. RISK BASED Increased emphasis on risk management within 2022 version Risk is now covering all aspects of laboratory activities and not just the examination processes as before. Risk is now central to patient care. Risk requirements seems to replace the requirement for Preventive Action.
- 12. 3. PATIENT FOCUSED A clause on requirements regarding patients has been added that demands that patients’ well being, safety and rights be the key primary considerations.
- 13. 4. POCT IS INCORPORATED Point of Care Testing (ISO 22870:2016) has now been fully incorporated into ISO 15189:2022 and will be withdrawn. This is a new inclusion within the scope of the 2022 version POCT to be part of the management system.
- 14. 5. REQUIREMENTS ESSENTIALLY THE SAME Most of the requirements from the old version have remained the same albeit with more clarifications.
- 15. 6. REFERENCES TO OTHER STANDARDS It cites companion standards that have more information on implementing the certain requirements. i.e.; i. ISO 15190:2020 – Medical Laboratories Requirements for Safety. ii. ISO/TS 20658 :2017 - Medical Laboratories Requirements for Collection, Transportation, Receipt and Handling of Specimens/Samples. iii. ISO 22367:2020 - Medical Laboratories Application for Risk Management. iv. ISO 35001:2019 – Biorisk Management for Medical Laboratories and other related organization. v. ISO 19011:2018 – Guidelines for auditing management systems. vi. ISO/TS 20914:2019 – Medical Laboratories practical guidance for the estimation of measurement uncertainty. vii. ISO/TS 22583:2019 – Guidance for supervisors for operators of point of care testing (POCT) devices.
- 16. NB; • Alignment with ISO/IEC 17025:2017 resulted in general management requirements now appearing at the end of the 2022 version. • The use of ISO 15189:2022 facilitates cooperation between medical laboratories and other healthcare services, assists in the exchange of information, and in the harmonization of methods and procedures.
- 17. NB; • ISO 15189 Auditable Requirements Comparison; • Alignment with ISO/IEC 17025:2017
- 18. New Terms and Definitions in 2022 Version There are15 New Terms & Definitions for Review i.Bias / Measurement Bias ii.Clinical Decision Limit Examination iii.Commutability of a Reference Material / Commutability iv.Complaint v.Consultant vi.Examination Procedure vii.External Quality Assessment viii.Impartiality ix.In Vitro Diagnostic Medical Device (IVD) x.Laboratory User xi.Management System xii.Measurement Accuracy / Accuracy of Measurement / Accuracy xiii.Measurement Uncertainty (MU) xiv.Patient xv.Trueness / Measurement Trueness
- 20. Thank you!!