Every ISO 17034 project I’ve worked on has one common thread: structure makes or breaks the system. You can have brilliant technical staff and the best instruments in the world, but if roles, responsibilities, and authority lines aren’t clear, impartiality and quality start to crumble.
Clause 5 is all about that structure. It defines how your organization should be set up—who makes the decisions, who’s accountable, and how independence is maintained.
Here’s what I’ve noticed: most reference-material producers (RMPs) underestimate this clause because it seems “administrative.” But when auditors start asking who approves certificates, who verifies data, and who ensures impartiality, this is where the cracks show.
If you understand Clause 5 properly, you’ll build a foundation that not only satisfies auditors but strengthens trust with your clients.
Understanding ISO 17034 Clause 5: The Foundation of Organizational Control
Clause 5 sets the structure that supports every activity you do as an RMP. It ensures your production, testing, and certification functions are managed by people who have both authority and accountability.
Think of it as your organization’s “wiring diagram.” Each connection—each reporting line—must make sense, and it must prevent conflicts of interest.
The clause links directly with Clause 4 (Impartiality) and Clause 8 (Management System). Together, they make sure your decisions are independent, competent, and traceable.
Pro Tip: Create an organizational chart that shows functions, not just job titles. Auditors care more about what is done and who’s responsible than about fancy position names.
Common pitfall: Letting authority overlap—like having the same person handle both production and quality decisions. That’s a red flag for assessors.
Top-Management Responsibilities – Setting Direction and Accountability
Top management carries the biggest responsibility in Clause 5. They don’t just sign the quality policy; they shape how impartiality and structure work in practice.
Their duties include:
Assigning competent staff to key functions.
Establishing and maintaining the management system.
Demonstrating commitment to impartiality and customer confidence.
In one client case, the CEO personally joined quarterly management reviews where impartiality risks were discussed. That simple act impressed auditors—it showed leadership wasn’t distant from compliance.
Pro Tip: Document every top-management decision related to structure or competence. Meeting minutes, approval memos, and training authorizations are solid evidence.
Common pitfall: Relying solely on the quality manager to “own” compliance. ISO 17034 expects leadership involvement, not delegation of accountability.
Organizational Independence – Ensuring Objectivity and Avoiding Conflicts
Clause 5 demands structural independence. Your organization must be designed so that decisions about reference-material production remain objective—free from financial or commercial influence.
In plain terms: whoever verifies results or approves certificates should not be pressured by sales, clients, or management incentives.
Here’s what works:
Separate technical and commercial reporting lines.
Keep decision-making independent of revenue targets.
Regularly review risks to impartiality as part of management review.
One RMP I worked with nearly failed accreditation because the production head also led the sales department. Once they split those responsibilities and clarified reporting lines, the issue disappeared.
Pro Tip: Map all possible influences—financial, personal, and contractual. Then record how your structure mitigates each.
Common mistake: Thinking independence means isolation. You can collaborate internally—just ensure final decisions remain free from undue influence.
Defining Roles, Responsibilities & Authorities in ISO 17034
Everyone in your RMP should know what they’re responsible for—and where their authority begins and ends. Clause 5 wants clarity.
That means:
Each role has a written job description.
Decision authority is documented (for example, who can issue reference-material certificates).
Competence is proven through records, not assumptions.
Pro Tip: Keep an “authority matrix” that matches each process with who approves it. It’s a simple tool, but auditors love it.
Example: A mid-sized producer I supported added an authorization column to their organizational chart—it showed at a glance who could release RMs, review data, and sign reports. The assessor called it “the cleanest structure I’ve seen this year.”
Pitfall: Verbal delegation. Auditors will not accept “everyone knows their job.” You need written proof.
Your organizational chart isn’t just decoration. It’s a live document that shows how your RMP is structured for impartiality and efficiency.
Here’s what it should show:
All functional areas (production, testing, quality, admin).
Key roles and reporting lines.
Dotted lines for functional relationships (e.g., technical advice).
Pro Tip: Update your chart every time there’s a personnel or structural change—and keep old versions for traceability.
Common pitfall: Forgetting to align the chart with your actual QMS documents. If your SOP names one person but your chart lists another, auditors will question your control.
Example: One RMP was cited for a major nonconformity simply because their org chart listed an employee who had left six months earlier.
Delegation and Outsourcing Under Clause 5
Clause 5 allows delegation—but only with control. If you outsource any activity (like calibration or subcontracted testing), you still hold full responsibility for the result.
The same goes for internal delegation: assigning authority doesn’t remove your accountability.
Best practices:
Keep a delegation record showing what was delegated, to whom, and under what conditions.
Use a subcontractor-approval log with competence and performance evaluations.
Review all outsourced work annually to confirm compliance.
Example: A reference-material producer I worked with kept a simple Excel log for all subcontracted activities—it listed service type, provider, last evaluation, and approval date. It passed every audit with zero comments.
Pro Tip: Never delegate approval of reference-material certificates to external parties. That decision must stay internal.
Integrating Structural Requirements with the Management System
Clause 5 isn’t a standalone exercise—it fits naturally into your management system (Clause 8). The structure you define must support competence, impartiality, and consistent operations.
One smart approach is to include a “structure review” in your annual management-review agenda. Check if roles still make sense, if reporting lines are effective, and if workload balance supports impartiality.
Pro Tip: When you combine ISO 17034 with ISO 9001 or 17025, use shared structures—but make sure responsibilities unique to RMP activities are clearly identified.
Example: A laboratory I supported held dual accreditation under ISO 17025 and ISO 17034. By merging the management structure but keeping separate impartiality records for RM production, they simplified their system without losing compliance.
Pitfall: Using a lab-based structure for RMP work without adjusting for product-based responsibilities. RMPs certify products, not results—the accountability chain is different.
FAQs – ISO 17034 Clause 5 Simplified
Q1: Can small RMPs combine roles like Quality and Technical Manager? Yes—if you can prove competence and impartiality. Keep a written justification explaining how objectivity is maintained and who reviews that person’s decisions.
Q2: Do we need a specific “RMP Manager” position? No title is required, but you must designate who holds overall authority for reference-material production and certification decisions.
Q3: How often should the organizational structure be reviewed? At least once a year, or when there’s any significant change in staffing, ownership, or scope.
Conclusion – Structure as a Strategic Advantage
Clause 5 isn’t bureaucracy—it’s your blueprint for control, competence, and confidence. When everyone knows their role and decisions flow through clear, independent lines, your RMP operates smoothly and earns genuine credibility.
From what I’ve seen across dozens of accreditation projects, strong structure equals fewer non-conformities and faster assessments.
Take time this week to review your organization chart, delegation records, and authority matrix. Small updates there can make a big difference in your next audit—and in how your clients perceive your professionalism.
Melissa Lavaro is a seasoned ISO consultant and an enthusiastic advocate for quality management standards. With a rich experience in conducting audits and providing consultancy services, Melissa specializes in helping organizations implement and adapt to ISO standards. Her passion for quality management is evident in her hands-on approach and deep understanding of the regulatory frameworks. Melissa’s expertise and energetic commitment make her a sought-after consultant, dedicated to elevating organizational compliance and performance through practical, insightful guidance.
