ISO 15189:2022 Compliance—How to Meet Section 7 Requirements in the Pre-Analytical Phase

Laboratories must comply with this newest version by December 5, 2025. Two critical additions—section 7.2.4.2 (Sample pre-collection activities) and 7.2.4.4 (Sample collection activities)—emphasize traceability, documentation, and standardization right from the start of the laboratory workflow.

What’s New in Section 7?

Amongst others, ISO 15189:2022 recognizes the pre-analytical phase as being just as important as the analytical and post-analytical phases. The clear focus in 7.2.4.2 and 7.2.4.4 is on:

• Documenting every step before and during sample collection
• Ensuring sample traceability and identification
• Minimizing errors through standard operating procedures (SOPs)
• Training and competency checks for personnel involved in pre-analytical activities

7.2.4.2 — Sample Pre-Collection Activities
Laboratories are now required to trace and record all pre-collection activities, including patient preparation, correct identification, and verification of sample requirements. This means:

• Providing clear pre-collection instructions to healthcare personnel
• Ensuring documentation of patient preparation (e.g., fasting state, medication use)
• Verifying patient identification and cross-checks before sample draw

7.2.4.4 — Sample Collection Activities

During the collection itself, labs must implement mechanisms to:

• Confirm patient identity again at the point of draw
• Record collection time, personnel, and any deviation from SOPs
• Ensure proper labeling and secure chain-of-custody

Options for Compliance—Manual vs. Digital
Many labs still rely on manual checklists and paper forms. While this meets the bare minimum, it is vulnerable to human error, incomplete data capture, and audits that are time- and resource-intensive.

Digital solutions streamline compliance

• Structured electronic forms ensure completeness
• Real-time validation reduces mistakes
• Automated audit trails make inspection and reporting straightforward

S4DX offers a purpose-built, digital pre-analytics platform that directly addresses ISO 15189:2022’s new requirements:

• End-to-end Documentation: Every step, from pre-collection preparation to sample pick-up and delivery, is digitally recorded and traceable—fulfilling the traceability demands of 7.2.4.2 and 7.2.4.4.
• Real-time phlebotomy data: The platform offers an easy way for phlebotomists to record collection-relevant information (patient data such as fasting, pregnancy), and simple cross-checks around tube types, order status, and any phlebotomy-relevant topic.
• Error Reduction: Built-in checks, barcode-based patient/sample matching, and live alerts shrink the risk of mislabeling and mix-up.
• Audit-Ready Records: Instant access to digital logs simplifies regulatory inspections and compliance reviews.
• Improved Quality and Efficiency: With streamlined processes and reduced manual handling, laboratories can deliver more reliable results while saving staff time.
  Conclusion

ISO 15189:2022 raises the bar for laboratory quality—especially in the crucial, but often overlooked, pre-analytical phase. Digital solutions like S4DX not only help labs achieve and document compliance but also boost quality, efficiency, and patient safety. Investing today in the right technology ensures your lab is audit-ready and future-proof.