How ISO 9001:2025 Could Influence ISO/IEC 17025 — What Labs Should Know

ISO 9001:2025 is on its way, and while most of the attention is focused on how it will reshape general quality management systems, laboratories working under ISO/IEC 17025 should also take notice.

Both standards share a common foundation — the Annex SL structure — which means when ISO 9001 evolves, other standards often follow. That includes ISO 17025, the cornerstone for competence in testing and calibration labs.

Even though 17025 hasn’t been officially slated for revision yet, the 9001:2025 draft offers an early preview of what could be coming next for laboratories.

1. Why ISO 9001 and ISO/IEC 17025 Move in Tandem

ISO designed its management system standards to be interoperable. By using the Annex SL high-level structure, organizations can integrate multiple standards without duplicating processes.

For labs accredited to ISO/IEC 17025, that integration is already clear: documentation control, leadership, risk-based thinking, and continual improvement are all shared with ISO 9001.

When ISO 9001 updates — as it now has — it’s not just a terminology refresh. These shifts can redefine how labs interpret competence, impartiality, and risk. Understanding these changes early helps labs future-proof their quality management systems and avoid expensive rework later.

2. Key ISO 9001:2025 Updates That Could Affect 17025

Climate and Sustainability Enter the Equation

Clause 4 of ISO 9001:2025 introduces the consideration of climate change and sustainability within the context of the organization.

For labs, this could influence how environmental conditions and resource dependencies are evaluated. Think of supply chain stability for reagents, environmental controls for calibration, or the carbon footprint of equipment procurement. Even if these aren’t direct requirements in 17025 yet, labs that begin documenting these factors now will be one step ahead.

Leadership and Ethical Accountability

ISO 9001:2025 strengthens the leadership clause (Clause 5), emphasizing the need for ethical behavior, transparency, and quality culture.

17025 already requires impartiality, but the revised 9001 language suggests broader accountability — from management conduct to communication culture. Expect future revisions to 17025 to reflect stronger expectations around ethical decision-making and conflict-of-interest management.

Risk and Opportunity: Separate, Not Synonymous

The 2025 draft separates risks and opportunities as distinct concepts within planning.

For labs, this could shape risk registers and method validation reviews. Rather than treating every deviation as a “risk,” the standard encourages identifying where improvement or innovation creates opportunity — such as adopting digital calibration tracking or expanding accredited scopes.

Digital Infrastructure and Data Reliability

ISO 9001:2025’s expanded references to hardware and software systems in the Support clause acknowledge how much of quality now depends on digital tools.

Labs managing LIMS, calibration databases, or automated instruments will likely see greater emphasis on software validation and cybersecurity resilience in the next iteration of 17025.

3. What Labs Can Do Right Now

Even if no immediate updates to ISO/IEC 17025 are announced, labs can take proactive steps to align with the direction ISO 9001:2025 is heading.

• Map overlaps between 9001 and 17025: Identify shared clauses and note where 9001 updates could create gaps in documentation or risk analysis.

• Enhance management review agendas: Include ethics, sustainability, and data security as discussion topics.

• Validate your infrastructure: Ensure software systems used for measurement, traceability, and records are properly controlled and validated.

• Document “context of the organization”: Even if 17025 doesn’t yet ask for climate consideration, start recording external factors that affect lab operations.

4. Why Early Awareness Matters

Waiting for the official revision announcement means falling behind the trend. By preparing now, labs can:

• Reduce transition costs once updates arrive.

• Minimize disruption during re-accreditation cycles.

• Strengthen alignment between ISO 9001, 17025, and other standards like ISO 14001 or ISO 45001.

Final Takeaway

ISO 9001:2025 is more than an update — it’s a signal of where quality management is heading globally. For laboratories, it’s a chance to build a more ethical, resilient, and digitally capable foundation for the future.