Hi, I'm HarmJan, your hands-on partner for quality and regulatory compliance.
For more than 25 years I've worked inside the quality and regulatory function. That started in civil and electrical engineering, continued in oil & gas, and for the last 17 years has been in MedTech, where I took personal legal accountability as Responsible Person and PRRC.
Through H2QR I help companies in any regulated industry navigate ISO standards and regulation. I do this through consultancy, interim leadership, training and tools. My approach combines hands-on experience with the latest industry knowledge, without heavy jargon or binders nobody reads. The aim is quality systems that work in daily practice and keep running after I've left.
Based in Breda, working across Europe, and always happy to start with a coffee.
H2QR: the formula for compliance in a pragmatic way.
Practical, hands-on support for turning quality and regulatory requirements into systems that work in day-to-day operations — gap assessments, quality management-system design, audit preparation and remediation against ISO 9001, ISO 13485, ISO 14001, and sector regulations such as EU MDR/IVDR and GDP. Built on 25+ years across MedTech, oil & gas, and civil and electrical engineering, bringing proven practices between regulated industries, backed by one accountable expert and documentation your organization can keep running after the engagement ends.
Contact meHands-on quality and compliance leadership for organizations navigating growth, transition, certification, or vacancies — including Responsible Person and PRRC coverage across multi-site, international distribution networks. Backed by 25+ years operating inside the quality function itself, not just advising from outside, including personal legal accountability in MedTech — one accountable expert who keeps the function running and leaves your team stronger than before.
Contact mePractical, on-demand courses to gain or refresh knowledge on ISO standards and regulations.
A practical, module-by-module guide to the ISO 9001:2015 to ISO 9001:2026 transition. Covers what's actually changing in the revised standard, how to interpret the updated clause structure, and a step-by-step plan for updating your existing quality management system without disrupting certification. This course guides you through every clause: what the requirement actually says, a realistic implementation example, where audits commonly find gaps, ten certification-body audit questions with guidance on a strong answer, and a dedicated differences slide showing exactly what changed from 2015. At the end of the course you can take a knowledge quiz.
Also includes a gap-assessment checklist.
A practical course on the core quality metrics used in manufacturing and quality engineering — DPPM, DPMO, Cp, and Cpk — and how to apply them. Explains how each metric is calculated, when to use it, and the common misinterpretations that lead to bad decisions on the shop floor. Includes worked examples using real production data, guidance on setting realistic targets, and tips for presenting quality metrics to leadership in a way that drives action rather than confusion.
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A practical guide for quality & regulatory professionals, working module by module through ISO 13485:2016. Breaks down every clause in plain language, with worked examples drawn from real medical device quality management systems — document control, management responsibility, resource management, product realization, and measurement, analysis & improvement — plus the audit findings that come up most often and how to avoid them. Built for QA/RA professionals who need a working understanding of the standard, not just a summary.
A practical transition guide for environmental & sustainability professionals working with ISO 14001:2026. Mapping what changed compared to the 2015 revision, the 2024 amendment and the newly published 2026 revision of ISO 14001. Works through the environmental management system requirements clause by clause, with a focus on practical implementation rather than theory — environmental aspects and impacts, legal and compliance obligations, operational controls, and continual improvement. Includes templates and worked examples for building or upgrading an EMS that holds up under third-party certification audits.
Reference apps and tools to get and keep you compliant.
Whether it's hands-on consultancy, interim QA/RA leadership, or a question about training or tools — reach out and I'll get back to you personally.