Last Updated on November 5, 2025 by Melissa Lazaro

Why Clause 8 Is the Backbone of ISO 17034 Compliance

When I help reference-material producers prepare for ISO 17034 accreditation, Clause 8 is where most questions begin. It’s the part that glues everything together — linking technical work with management oversight, documentation, and continual improvement.

Here’s what I’ve noticed: labs often do the hard scientific work flawlessly but get tripped up by management-system details. They either over-document with endless procedures or under-document and miss key controls. Clause 8 fixes that by offering two clear routes — Option A or Option B.

If you understand the difference and build your system around your organization’s reality, not theory, you’ll save time, reduce audit stress, and keep your quality system lean but effective.

Understanding Clause 8 – The Purpose Behind the Management System

Clause 8 is there to make sure your reference-material production isn’t just technically correct, but consistently managed and improved. It’s the “operating system” that holds everything else — impartiality, resources, and production — in place.

ISO 17034 gives you two options:

• Option A – a stand-alone management system built entirely under ISO 17034.
• Option B – an integrated system based on ISO 9001 (or equivalent).

Both achieve the same goal: control, consistency, and continual improvement. The path you choose simply depends on what you already have.

Pro Tip: Treat Clause 8 as your system’s spine — every document, record, and meeting connects back to it.

Pitfall: Treating the management system like a separate project. It should support your daily operations, not sit in a binder collecting dust.

Option A – Building a Stand-Alone ISO 17034 Management System

Option A is for organizations that don’t already have ISO 9001 certification. You’ll build your quality system directly around the requirements of ISO 17034 Clause 8.

That means covering everything from document control to continual improvement. Specifically:

• Procedures and forms for document and record control.
• A defined process for nonconforming work and corrective actions.
• Scheduled internal audits and management reviews.
• A system for customer feedback, complaints, and preventive actions.
• Evidence of continual improvement activities.

Example: I worked with a small chemical RMP that had no existing QMS. We built Option A using just ten core procedures — simple, direct, and fully aligned with their workflow. They passed their first accreditation with zero major findings.

Pro Tip: Keep Option A tight and functional. Focus on the processes that truly affect your RM quality — not endless forms.

Pitfall: Ignoring risk and communication controls. Even under Option A, you still need to show how you identify and manage risks to impartiality and competence.

Option B – Integrating ISO 17034 with an Existing ISO 9001 System

If your organization is already certified to ISO 9001, Option B is your friend. Instead of maintaining two systems, you integrate ISO 17034 requirements into your existing quality-management framework.

But there’s a catch: you can’t assume ISO 9001 automatically covers everything. You must demonstrate that your ISO 9001 system also addresses the unique elements of ISO 17034 — impartiality, technical competence, RM traceability, and control of reference-material data.

Here’s how to do it:

• Create a cross-reference matrix mapping ISO 9001 clauses to ISO 17034 requirements.
• Add or revise procedures where technical elements are missing (e.g., value assignment, traceability, or control of nonconforming RMs).
• Include RMP activities in your existing internal-audit and management-review schedules.

Example: One client, a testing company already certified to ISO 9001, integrated 17034 into its system by adding just three new procedures — RM Production, Technical Review, and Value Assignment. Assessors commended the simplicity and coherence.

Pro Tip: Build a “Clause 8 Crosswalk Table.” It’s a simple document, but it proves to assessors that you’ve covered every ISO 17034 requirement.

Pitfall: Thinking ISO 9001 is a free pass. It’s not — assessors still expect full evidence of technical control, impartiality, and record management for RM activities.

Option A vs Option B – Which Path Fits You Best?

Here’s a quick side-by-side comparison I often share during training sessions:

Feature	Option A – Standalone System	Option B – Integrated ISO 9001 System
Certification required	None	ISO 9001 certification
Framework	Built solely on ISO 17034 Clause 8	Built on ISO 9001 + 17034 mapping
Documentation	Custom to RMP scope	Follows ISO 9001 structure
Flexibility	High – tailor-made for small RMPs	Moderate – must align with ISO 9001 terms
Ideal for	New or small RMPs	Larger or multi-standard organizations

Pro Tip: Choose the option that fits your workflow — not just what “sounds easier.” A simple Option A done right beats a messy Option B every time.

Pitfall: Mixing both options halfway. You’ll confuse assessors and double your workload. Pick one and commit.

Core Elements Common to Both Options

No matter which option you choose, these foundations never change:

• Document and record control — controlled templates, version history, and access management.
• Internal audits — covering both technical and management processes.
• Management review — top management evaluating impartiality, performance, and resource adequacy.
• Nonconforming work — clearly defined steps for containment, evaluation, and corrective action.
• Customer feedback and complaint handling.
• Continual improvement — tracking lessons learned and system enhancements.

Example: A producer I supported used one improvement register to capture internal-audit findings, customer feedback, and risk actions in one place. Assessors loved the efficiency.

Pro Tip: Keep your management-system records together in one folder or dashboard — it shows integration and control.

Pitfall: Thinking Option B means you can skip internal audits. ISO 17034 still expects you to audit RM-specific activities.

Choosing the Right Option for Your RMP

Here’s how I guide clients through the choice:

• Go with Option A if you’re small, agile, and not ISO 9001 certified. It gives you total control and simplicity.
• Go with Option B if your organization already runs a solid ISO 9001 system and RMP activities are part of that ecosystem.

If you’re unsure, talk to your accreditation body. They’ll confirm which path aligns with your structure and expectations.

Pro Tip: Review your current documentation — if it already meets ISO 9001 principles, Option B will save you time.

Pitfall: Copy-pasting someone else’s system. Build yours around your own processes, not a template from another lab.

Auditor Expectations and Common Findings

Assessors don’t expect perfection, but they do expect structure and consistency.

What they’ll look for:

• Documented procedures aligned with Clause 8 requirements.
• Evidence of internal audits covering RM production.
• Management-review minutes discussing impartiality and performance.
• Corrective actions with clear root-cause analysis.

Frequent findings include:

• Outdated document-control systems (no revision log).
• No cross-reference between ISO 9001 and ISO 17034.
• Weak follow-up on corrective actions.

Pro Tip: Before your audit, prepare a quick-access binder or digital folder with your crosswalk table, management-review records, and last audit reports. It shows readiness.

FAQs – ISO 17034 Clause 8 Simplified

Q1: Can we switch from Option A to Option B later?
Absolutely. Many RMPs start with Option A, then migrate to Option B once they gain ISO 9001 certification. Just update your documentation mapping.

Q2: Do internal audits look different under each option?
Slightly. Under Option B, your ISO 9001 audit cycle can include RM processes. Under Option A, you’ll define your own audit frequency and scope — but both require full coverage of production and management processes.

Q3: Which option is better for small organizations?
Option A. It’s flexible, easy to maintain, and focuses entirely on your RM operations.

Conclusion – Build a Management System That Works for You

Clause 8 gives you freedom — two different paths to the same goal: a consistent, transparent, and continually improving management system. Whether you build your own under Option A or integrate under Option B, the key is making it work for your daily operations.

In my experience, RMPs that simplify and personalize their management systems get the best results. They spend less time explaining documents and more time proving competence.

Take a moment to review your current setup. Map what you already do to Clause 8, identify what’s missing, and choose your path. The right option isn’t the one that looks good on paper — it’s the one your team can actually live with.