Last Updated on November 5, 2025 by Melissa Lazaro

Why Resources Define the Quality of Your Reference Materials

When I work with reference-material producers, Clause 6 is often the quiet troublemaker. On paper, it looks simple — hire competent people, use the right equipment, maintain good facilities. But in practice, it’s the clause that reveals whether your system is actually under control.

Here’s what I’ve noticed: when resources aren’t planned, documented, or reviewed, small issues—like an expired calibration or untrained technician—turn into accreditation findings. Clause 6 ensures every element behind your reference materials is reliable: the people, the environment, the tools, and even the software.

If you get this clause right, you won’t just pass audits; you’ll run a smoother, more predictable operation that builds trust with clients and assessors alike.

Understanding ISO 17034 Clause 6: What ‘Resources’ Really Cover

Clause 6 isn’t just about equipment. It covers everything that affects the validity of your reference materials:

• People (competent, trained, and authorized).
• Facilities (controlled, clean, and suitable).
• Equipment and standards (calibrated and traceable).
• External services (evaluated and monitored).
• Information systems (secure and validated).

Every activity in your RM production process depends on these. The goal is consistency — to make sure every batch, measurement, or certification rests on dependable resources.

Pro Tip: Map resources to processes. For every step in RM production, identify who’s responsible, what equipment they use, and under what conditions they operate. It turns compliance into a working system, not paperwork.

Common pitfall: Treating resource control like a yearly checklist. Resource management should be active and continuous—just like risk management.

Personnel Competence and Authorization – The Core of Clause 6

Competence is where everything starts. ISO 17034 expects you to prove that your people are qualified to perform their assigned work—and authorized to make key decisions.

Here’s what works:

• Keep a competence matrix that lists each task (e.g., preparation, homogeneity testing, stability evaluation) and who’s trained for it.
• Record training and supervision—not just attendance, but evidence of understanding.
• Use authorization records to show who can approve RM certificates or release materials.

One small RMP I worked with simplified this brilliantly. They replaced long résumés with a single chart: tasks down one side, staff across the top, checkmarks for competence, signatures for authorization. Auditors loved it because it was clear and current.

Pro Tip: Don’t confuse job titles with competence. A “technical manager” isn’t automatically qualified for all technical work—show task-based proof.

Pitfall: Skipping reassessment after process changes. When new techniques or instruments are introduced, competence must be updated.

Facilities and Environmental Conditions – Controlling the Working Environment

Your environment plays a bigger role than many realize. Temperature, humidity, air cleanliness—all can influence the stability and accuracy of reference materials.

Clause 6.2 asks you to control these factors and show evidence that they’re fit for purpose.

Here’s how to do it well:

• Define environmental limits for each area (e.g., 20 °C ± 2 °C, < 50 % RH).
• Keep monitoring logs or automatic records.
• Store RMs in segregated, labeled, and secure areas.
• Include environmental readings in your production or stability records.

One client avoided a major finding by installing simple humidity alarms near their RM storage. It cost almost nothing but showed the assessor they were proactive.

Pro Tip: Document what you do when conditions go out of range—this corrective action plan is often overlooked.

Pitfall: Forgetting to monitor temporary areas, like packaging or transport zones. These count too.

Equipment, Reference Standards, and Metrological Traceability

If competence is your foundation, traceability is your backbone. Clause 6.3 demands that all measuring equipment used for characterization or testing is calibrated, maintained, and traceable to recognized standards.

Your assessor will look for:

• A complete equipment register with calibration dates and status.
• Calibration certificates that trace to SI units or recognized national standards.
• Clear linkage between equipment and RM batches.

Pro Tip: Before every production run, do a quick “equipment readiness check.” Confirm calibration is valid, maintenance is current, and instruments are performing within limits.

Example: One RMP tied each calibration certificate to the specific RM batch file—so the assessor could trace results directly from equipment to certificate. It built instant confidence.

Pitfall: Using “in-house verified” instruments without documented traceability. That’s one of the most common nonconformities.

External Services and Subcontractors – Keeping Control Beyond Your Walls

Even if you subcontract testing or calibration, Clause 6 keeps the responsibility with you. The RMP must evaluate, approve, and monitor any external provider that affects the quality of RMs.

Here’s how to show control:

• Maintain a supplier-approval list with competence evidence (like ISO/IEC 17025 accreditation).
• Review performance annually.
• Keep evaluation records—communication, audits, or scorecards.

One producer I helped created a simple scoring system: competence, reliability, and turnaround time. They used it to rank subcontractors and decide renewals. Auditors found it logical and risk-based.

Pro Tip: Even accredited suppliers need review. Accreditation doesn’t replace your responsibility to ensure suitability for your specific RMs.

Pitfall: Letting expired accreditation certificates linger in your files—update them regularly.

Information Systems and Data Integrity – The Hidden Resource

Clause 6 doesn’t say “IT,” but it’s implied. Any system that stores or processes RM data is a resource. That includes spreadsheets, LIMS, databases, and calculation software.

Key controls:

• Limit access—only authorized staff should modify data.
• Validate software used in calculations or reporting.
• Keep version-control and backup procedures documented.

I once helped a client validate a simple Excel tool for uncertainty calculations. It took two screenshots and one signed test record—and it satisfied the assessor. You don’t need fancy systems; you need controlled ones.

Pro Tip: Treat software like equipment—plan, validate, maintain, and record its status.

Pitfall: Forgetting that spreadsheets evolve. Revalidate when formulas or macros change.

Resource Planning and Continuous Improvement

Clause 6 connects closely to planning and management review. Your resources should always match your workload and future needs.

During each management review, ask:

• Do we have enough trained staff for our current scope?
• Are our facilities adequate for new product types?
• Is our equipment downtime affecting production?

Example: One RMP integrated resource planning into its production schedule. Before each new RM batch, they reviewed competence, equipment readiness, and space availability. It cut delays by 30 %.

Pro Tip: Show assessors how you forecast needs—not just react to shortages. That’s maturity in resource management.

FAQs – ISO 17034 Clause 6 Simplified

Q1: Do we need separate competence files for each staff member?
No. A single matrix works fine if it links names, tasks, training, and authorization clearly.

Q2: Can subcontracted calibration replace internal verification?
Yes—if the provider is accredited and their scope covers your equipment type. Keep copies of valid accreditation certificates.

Q3: Does software validation really fall under resources?
Definitely. Any software that influences RM results or reporting is a controlled resource under ISO 17034.

Conclusion – Resource Control as Proof of Technical Credibility

Clause 6 isn’t just about having enough people or equipment. It’s about demonstrating control, competence, and consistency across every step of RM production.

In my experience, RMPs that invest in resource management have fewer audit findings and smoother operations. They plan ahead, document wisely, and treat every tool—from balances to software—as part of their quality chain.

If you haven’t reviewed your resources lately, now’s the time. Check your competence matrix, calibration log, and supplier list. Those small updates today could be what keeps your next accreditation report clean.