Quality systems

built for scale.

We help deeptech companies move from prototype to repeatable production by building product assurance, manufacturing quality, supplier quality and compliance into the way the business operates.

Services

What we help you build.

01 / MANAGEMENT SYSTEMS

ISO, AQAP and integrated management systems, from implementation and certification readiness to systems that connect risk, processes, compliance and day-to-day operations.

02 / SCALE & QUALITY READINESS

Assess product, production, supplier and quality-system readiness before increasing production volume.

03 / MANUFACTURING & SUPPLIER QUALITY
Production readiness, process controls, supplier capability, traceability and quality planning for increasing volume.

04/ PRODUCT ASSURANCE & COMPLIANCE

Product risk, DFMEA, verification and validation, CE and UL compliance, certification and market release.

05 / FRACTIONAL QUALITY LEADERSHIP
Senior Quality ownership and leadership without the need to build a full-time senior function.

Our APPROACH


We build quality around how the business actually operates, connecting product development, production, suppliers, compliance, risk and management systems rather than treating them as separate activities.

The objective is not more Quality administration. It is stronger ownership, better visibility and controls that can scale with the business.

Build quality into the business.

Better visibility. Clearer ownership. Faster decisions. Less manual work.

EXPERIENCE


Quality from product development to production, compliance and scale.

Our experience spans the full product and Quality lifecycle, from product risk, FMEA and validation to manufacturing, supplier development, CE and UL compliance, ISO and AQAP management systems and senior Quality leadership.

This means we don't look at Quality as a standalone function. We understand how decisions in engineering, production, procurement, suppliers and management affect each other as the business scales.

PRODUCT
Product risk · DFMEA · Verification · Validation · CE · UL

PRODUCTION
Manufacturing readiness · PFMEA · Control Plans · Traceability

SUPPLIERS
Qualification · Capability · APQP · PPAP · VDA

SYSTEMS & LEADERSHIP
ISO · AQAP · Risk · Governance · Fractional Quality Leadership

What if Quality could create value instead of constantly controlling and administering it?

My approach is simple: every function in a business should create value, and Quality is no exception.

Quality creates value when it builds systems that embed quality management into the way the business actually works. Product risks become part of engineering decisions, supplier quality becomes part of supplier management, and production controls become part of operations.

The role of Quality is not to control everything. It is to build the system that allows the business to stay in control as it grows.

+18 years of Quality management and consultancy experience

Karina Bärg
Fractional Head of Quality · Principal Advisor
Founder of Quality Agency

Scale the quality system.

Not the function.

As companies grow, Quality shouldn't simply grow by adding more people, procedures and administration.

Product risks should flow into engineering decisions, supplier controls, production processes and verification. Significant issues should have clear ownership and escalation. Management should have visibility without Quality manually collecting and reporting information.

We design quality systems so that responsibility sits where the work happens and the Quality function can focus on assurance, risk and improvement rather than chasing actions.

LET'S TALK

What needs to work better before you scale?

Whether you're preparing for certification, increasing production, strengthening suppliers or building the Quality capability around a growing business, let's start with the problem you need to solve.