Last Updated on November 5, 2025 by Melissa Lazaro

Why Clause 7 Is the Core of Reference-Material Production

Whenever I help a new Reference Material Producer (RMP) prepare for ISO 17034 accreditation, we spend most of our time on Clause 7. This clause isn’t just another list of requirements—it’s the engine room of your entire operation. It defines how you plan, produce, test, and release your materials so every unit leaving your facility is reliable and traceable.

Here’s what I’ve noticed: labs that rush through Clause 7 end up firefighting non-conformities later—missing stability data, unclear batch records, or uncertainty budgets that can’t be justified. But when you treat Clause 7 as a process map rather than a checklist, everything flows: production runs smoothly, data make sense, and audits feel less painful.

Let’s walk through it step-by-step, just like I do when training new RMP teams.

Step 1: Plan the Production Process (Clause 7.2 – Planning)

Every good reference material starts with a clear plan. ISO 17034 expects you to decide what you’re producing, why, how, and under what controls—before you start mixing anything.

A solid production plan should include:

• Purpose and intended use of the RM.
• Target property values and required uncertainty.
• Materials, methods, and environmental conditions.
• Assigned personnel and equipment.
• Acceptance criteria and documentation.

One RMP I supported used a single “Production Plan Form” for each batch—covering risks, methods, and approval signatures. It became their most valuable audit document.

Pro Tip: Always define acceptance criteria before starting. It proves control.

Common pitfall: Skipping planning because “we’ve done this material before.” Conditions change—document the rationale every time.

Step 2: Prepare and Identify Materials (Clause 7.4 – Material Preparation)

Once planning is approved, the focus shifts to preparation and identification. The goal here is control—keeping your material traceable and uncontaminated from start to finish.

Here’s what you need to do:

• Assign batch codes or unique identifiers immediately.
• Record all preparation steps (weighing, blending, drying, bottling).
• Control environmental conditions during processing.
• Label samples clearly and consistently.

Example: One producer I worked with introduced barcode tracking for every unit. During audit, they scanned a random bottle, and the full preparation record appeared on screen. Zero findings.

Pro Tip: Label first, handle second. Never process unlabeled material—it’s a risk magnet.

Pitfall: Mismatched labels between documents and containers. Auditors catch this instantly.

Step 3: Establish Homogeneity (Clause 7.5)

Homogeneity testing proves that each unit of your RM performs the same way. Without it, certification means little.

To comply, you must:

• Select representative units from the batch.
• Use validated, statistically sound methods.
• Analyze data to confirm uniformity across units.

Pro Tip: Integrate your homogeneity test data into the batch file, not in a separate folder. Auditors should see the full trace from production to evaluation in one place.

Example: A client of mine once failed this section because they only tested two samples “as a quick check.” After redoing the test properly—with ten randomly selected bottles—they passed with no comments.

Pitfall: Using convenience sampling (“top row bottles only”) instead of random selection.

Step 4: Assess Stability (Clause 7.6 – Short-Term and Long-Term)

Even the most homogeneous material is useless if it doesn’t stay stable. Clause 7.6 requires you to demonstrate both short-term stability (during shipping) and long-term stability (over shelf life).

Here’s what works:

• Define storage conditions and test intervals.
• Keep temperature and humidity logs.
• Perform trend analysis on stability data.
• Update shelf life when new data emerge.

Example: One RMP I advised used a rolling stability program—testing a subset of materials every quarter instead of all at once. It kept data fresh and manageable.

Pro Tip: Plot data trends visually. Assessors love seeing graphs that tell the stability story clearly.

Pitfall: Assuming stability without data because “we’ve never had complaints.” That’s not evidence.

Step 5: Characterize and Assign Values (Clause 7.7 – Characterization & Value Assignment)

This is the technical heart of the process—the step that determines the certified value or assigned property.

You must:

• Use validated or verified analytical methods.
• Ensure traceability to SI units or recognized reference standards.
• Calculate uncertainty using sound statistical approaches.
• Document every step—from raw data to final result.

Example: A producer I worked with built an “Uncertainty Budget Template” in Excel that linked each source of uncertainty to its data file. The assessor said, “This is what transparency looks like.”

Pro Tip: Involve a statistician early in the process. It’s easier to design traceable calculations than to justify them later.

Pitfall: Copying uncertainty values from previous projects—each batch must have its own data-based calculation.

Step 6: Approve and Release the RM (Clauses 7.8 & 7.9 – Review and Certification)

Before your material goes out the door, ISO 17034 expects a structured review. It’s your final defense against errors.

You’ll need to:

• Review all production and test records for completeness.
• Verify that acceptance criteria were met.
• Approve release through authorized personnel (technical and quality).
• Issue an RM certificate or accompanying documentation.

Pro Tip: Use a dual-signature release—one for technical accuracy, one for impartiality. It shows separation of duties.

Example: One RMP used an electronic approval workflow with digital signatures. Their audit finding count dropped by half.

Pitfall: Issuing certificates before management approval or document-control verification.

Step 7: Store, Handle, and Distribute (Clause 7.10)

Your responsibility doesn’t end after certification. Clause 7.10 requires you to preserve the integrity of RMs during storage and shipment.

Key actions:

• Keep controlled storage conditions (temperature, humidity, security).
• Use protective packaging and tamper-evident seals.
• Provide users with storage and handling instructions.
• Record shipment details—date, batch number, destination.

Example: A client added storage temperature to each RM label and delivery note. Auditors called it “simple but smart.”

Pro Tip: Keep copies of shipping temperature logs—especially for sensitive materials.

Pitfall: Relying on courier conditions without proof. Responsibility remains with you until the RM reaches the customer.

Step 8: Review and Improve (Clause 7.11 – Technical Process Review)

Clause 7 ends with a crucial step: continual improvement. You must review your production and testing processes periodically to make sure they remain effective.

Focus on:

• Evaluating data from stability studies and customer feedback.
• Reviewing methods, equipment, and statistical tools.
• Implementing corrective or preventive actions.

Example: One RMP discovered recurring moisture issues during review. They improved their drying process—and eliminated that finding entirely in the next audit.

Pro Tip: Add a “technical review” summary to every management-review meeting. It’s evidence that you learn from your data.

Pitfall: Treating review as paperwork. It’s your chance to evolve the process, not just maintain it.

FAQs – ISO 17034 Clause 7 Production Steps Simplified

Q1: Do all reference materials require both homogeneity and stability testing?
Yes, unless you can scientifically justify an exemption—and that justification must be documented and approved.

Q2: Can subcontracted labs perform characterization?
Yes, but you’re still responsible for their data integrity, traceability, and accreditation. Always evaluate their competence.

Q3: When should stability be re-evaluated?
Whenever packaging, formulation, or storage conditions change—or when periodic data suggest a trend.

Conclusion – Turning Clause 7 into a Repeatable, Controlled Process

Clause 7 transforms technical work into a structured, defendable system. When each step—from planning to shipment—is documented and reviewed, your RMs gain something priceless: credibility.

In my experience, RMPs that treat Clause 7 as a process map, not paperwork, build smoother operations and stronger reputations. They can trace every decision, defend every number, and pass audits with confidence.

If it’s been a while since you reviewed your production workflow, start today. Walk through these steps with your team and tighten the weak spots. Every improvement here strengthens your foundation for ISO 17034 success.