Why Competence Is the Cornerstone of ISO 17034 Compliance

When I help Reference Material Producers (RMPs) prepare for ISO 17034 accreditation, one thing becomes obvious fast — your technical system is only as strong as the people running it.

You can have the best procedures and equipment in the world, but if your key personnel don’t fully understand their roles or lack documented proof of competence, auditors will notice immediately.

ISO 17034 doesn’t just ask who does the job. It asks, can they prove they’re competent to do it?

In this article, I’ll walk you through how to build a practical and auditable competence assessment system for your key staff — from defining roles to maintaining training records.

Understanding Competence Under ISO 17034

ISO 17034 defines “competence” as a combination of knowledge, skills, training, and experience necessary to perform assigned tasks effectively. In plain terms, it means your people can actually do what their job descriptions say — consistently and accurately.

Clause 5 of ISO 17034 puts heavy emphasis on this. It applies to everyone who influences the quality of reference materials — your quality manager, technical manager, analysts, and authorized signatories.

Pro tip: Keep your competence criteria role-specific. Don’t just say “experienced in testing.” Instead, define exactly what competence means for each position — e.g., “can demonstrate correct homogeneity testing procedures using Method X.”

Common pitfall: Listing qualifications but not verifying actual performance. A diploma proves education, not day-to-day competence.

Identifying Key Personnel and Their Responsibilities

Not everyone in your organization needs formal evaluation, but the key players do — those whose decisions directly affect reference-material quality.

Here’s who accreditation bodies focus on:

• Quality Manager – ensures your QMS is implemented, documented, and effective.
• Technical Manager – oversees production, testing, and metrological traceability.
• Authorized Signatories – review and approve certificates and RM documentation.
• Analysts and Technicians – carry out production, homogeneity, and stability studies.

Pro tip: Create an organization chart that links each role to its ISO 17034 clause responsibility. It’s simple, visual, and auditors love it.

Example: One RMP I worked with attached a “Competence Matrix” to their Quality Manual — each row listed staff names, assigned functions, and corresponding clause references. During the audit, the assessor called it “the cleanest personnel overview” they’d seen.

Pitfall: Assuming seniority equals competence. A long tenure doesn’t replace structured evaluation.

Building a Competency Assessment Framework

A good framework ensures every assessment is consistent, measurable, and auditable. Think of it as your internal standard for evaluating people.

Here’s how to set it up:

1. Define competence criteria for each role (education, training, experience, and observed performance).
2. Select evaluation methods — observation, document review, interviews, or practical tests.
3. Establish frequency — at least annually or whenever there’s a new role, method, or process.
4. Document results in a controlled record or form.

Pro tip: Include both technical and behavioral indicators. Accuracy and precision matter, but so do teamwork, responsibility, and communication.

Example: A lab I supported introduced peer-observation sessions for homogeneity testing. It not only validated staff competence but also built team trust and shared learning.

Pitfall: Relying solely on training certificates. Real competence is demonstrated on the job, not just in a classroom.

Conducting Competence Evaluations Step-by-Step

Competence evaluation doesn’t need to feel like an exam. Done right, it’s collaborative and confidence-building.

Here’s a step-by-step approach that works in practice:

1. Prepare — define the scope, review previous records, and select an impartial assessor.
2. Observe — watch staff perform their actual work: weighing samples, labeling, preparing standards, etc.
3. Ask and listen — encourage staff to explain why they’re doing things a certain way.
4. Provide feedback — reinforce good practices, clarify misunderstandings immediately.
5. Record results — use a standardized evaluation form that ties results to competence criteria.

Pro tip: Rotate assessors occasionally. A fresh set of eyes can catch things familiarity might overlook.

Example: One RMP holds semi-annual cross-department assessments where team leads observe each other’s processes. It keeps evaluations objective and encourages open improvement.

Pitfall: Treating assessments as a box-ticking exercise. The goal isn’t just compliance — it’s confidence.

Maintaining and Updating Competence Records

Competence means nothing if it’s not documented — and controlled.

Auditors will expect to see:

• Training records and certificates.
• Signed competence assessments or witnessed demonstrations.
• Links between job descriptions, SOPs, and assigned tasks.

Pro tip: Use a Competence Register — one sheet per employee showing qualifications, completed training, dates of assessment, and next review date. Keep it version-controlled under your QMS.

Example: One RMP created a digital register synced with their document-control system. During audits, they could pull up any employee’s full competence record in seconds — no paper chase.

Pitfall: Storing records across different folders or departments. Centralize them so nothing gets lost or outdated.

Linking Competence to Training and Continual Improvement

Competence assessment shouldn’t stop at evaluation. It should feed your training and improvement plans.

Here’s how to connect the dots:

• Review assessment results to spot skill gaps.
• Build individual development plans (IDPs) for each key staff member.
• Use these results to design your annual training calendar.
• Include competence trends in your management review discussions.

Pro tip: Track recurring skill gaps as performance indicators — they tell you where to focus resources next year.

Example: A client noticed repeated findings in stability testing due to calculation errors. They introduced refresher training, updated the SOP, and added a second-review step. The next audit? Zero findings in that area.

Pitfall: Treating training as a one-time event. Competence fades without reinforcement.

FAQs

Q1: Which personnel must undergo formal competence assessment under ISO 17034?
Everyone whose work affects reference-material quality — management, analysts, signatories, and support staff involved in production or testing.

Q2: How often should competence be reassessed?
At least annually, or whenever responsibilities, equipment, or methods change.

Q3: Can we reuse ISO/IEC 17025 competence records for ISO 17034?
Yes, but review them carefully. ISO 17034 requires added focus on metrological traceability, production consistency, and homogeneity/stability tasks.

Conclusion — Competence Builds Confidence

Competence is more than a compliance requirement — it’s what gives clients and auditors confidence in your reference materials.

When every key person in your organization can demonstrate their skills, explain their process, and show proof of training, your system becomes unshakable.

That’s what ISO 17034 is really about — trust through demonstrated capability.

If you’re ready to make your next audit easier, download the ISO 17034 Competence Assessment Template and start evaluating your team systematically.
The right people, with the right proof, make accreditation feel effortless.