ISO 15189:2022 vs ISO 15189:2012 – What’s New for Diagnostic Labs?

The new ISO 15189:2022 standard has introduced many important changes, but here I’m highlighting the main updates to help you easily understand how to implement the new version in your diagnostic laboratory.

1. Revised Clause Structure
   The new standard now organizes requirements into five main clauses, whereas the previous version had only two.
• Clause 4: General Requirements – This includes two key elements: Impartiality and Confidentiality. It explains how labs must ensure fairness and data protection in all their operations.
• Clause 5: Structural and Governance Requirements – This clause defines the Laboratory Director’s responsibilities, Quality Objectives, Policies, and overall governance, helping to establish a strong lab structure.
• Clause 6: Resource Requirements – It elaborates on manpower, equipment, reagents, and facilities - ensuring every resource is sufficient and well-maintained for accurate testing.
• Clause 7: Process Requirements – This focuses on all three phases of lab testing: Pre-Examination, Examination, and Post-Examination, clearly defining their quality and control procedures.
• Clause 8: Management Requirements – This section covers documentation, record keeping, internal audits, and management review meetings (MRM) - all core parts of the Quality Management System (QMS).
2. Impartiality – A New Core Concept
   Earlier, the standard included a similar concept under Ethics. However, the new version defines Impartiality more broadly. Labs must now identify, manage, and maintain records of any risks to impartiality to ensure unbiased results.
3. Laboratory Director’s New Responsibilities
   The role of the Lab Director has been expanded. In addition to earlier duties, the director is now responsible for conducting Risk Assessments to identify potential issues that may affect test quality or safety.
4. Staff Competency – Everyone’s Responsibility
   While competency was part of the previous version, ISO 15189:2022 redefines it more clearly.
   The role of Quality Manager is no longer mandatory, as the standard emphasizes that quality is everyone’s responsibility. Every staff member must be competent in their designated tasks. To ensure this, labs must conduct regular training sessions and perform annual competency assessments for all personnel.
5. Management Review Meeting (MRM) – Updated Approach
   Two major updates have been added to the MRM process:
• The Review Input must include all topics specified in the new standard, along with discussions of problems and related records.
• The Review Output should now document three key points -
1. The conclusion or solution to each discussed issue,
2. The person responsible for resolving it, and
3. The timeline for resolution.

These are the major changes in the ISO 15189:2022 standard.

If you want to understand these updates in detail and learn how to implement them practically, I highly recommend joining Qualityveda’s 4-Day ISO 15189:2022 Training Program - it covers everything you need to know about the new standard in depth.

Link for Registration: https://qualityveda.co/checkout-live/6678f5add64288c76c335391