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Quality Management
that delivers

Practical QM Consulting and Training for SMEs – compliant, efficient and sustainable.

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Explore Services
Situation

Do you recognize this scenario
in your company?

Quality management for SMEs is often challenging – without in-house expertise and with limited resources.

Regulatory Compliance without Specialized Personnel

ISO 9001 and ISO 13485 require a functioning QMS – yet many SMEs often lack an in-house QM department or appropriately qualified specialized personnel familiar with these requirements.

Growth Without QM Scaling

Your company is growing, but your quality management system isn’t keeping pace. New locations, suppliers, and markets increase complexity – without structured support.

Certification Pressure & Audit Anxiety

An audit is looming, yet documented processes, structured workflows, and the necessary know-how to pass with confidence are missing. The consequences can be existential.

Regulatory Requirements (MedTech)

As MedTech SME you face unique challenges: MDR compliance, post-market surveillance, and rigorous audits overwhelm teams lacking specialized expertise.

ABOUT US

Experience, that makes
the difference

Qknows stands for sound expertise – tested in practice, not in the classroom.

Qknows is a specialized quality management consultancy focusing on small and medium-sized enterprises (SMEs), start-ups, as well as companies in the medical technology sector and other regulated industries.

We support you in the establishment, further development, and sustainable implementation of effective quality management systems in accordance with ISO 9001 and ISO 13485. Our focus lies on practical solutions that are not only compliant with standards but also applicable to your daily business operations.

Our range of services includes, among other things, audit readiness, document management, supplier management, training, workshops, and the optimization of quality processes.

In doing so, Qknows does not rely on rigid standard programs, but rather on a modular consulting offering that is individually tailored to the client’s initial situation, maturity level, and objectives. This results in robust, auditable, and sustainably effective structures for Quality Compliance.

1
+

Years

Quality Management

1
+

Years

MedTech

1
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Years

Electrical Engineering

carsten busch

Founder & Principal Consultant

Carsten Busch

I founded Qknows in 2026 to share my extensive and long-standing experience in quality management. After spending over 15 years at Medtronic – one of the world’s leading medical technology companies – and holding various other interesting positions within the industrial sector, I decided to make this knowledge directly accessible to SMEs.

• Education / Qualification:

Industrial master of electrical engineering; Manager Regulatory Affairs Medical Devices International; REFA Quality Manager; REFA Quality Representative; REFA Process Organizer; Lead Auditor ISO 13485:2016; Internal Auditor

• Experiences:

  • Worldwide Lead Auditor assignments (internal audits, supplier and distributor audits) at one of the world's leading medical technology companies.
  • Establishing and leading global projects and workstreams for standardization and further development of QM systems.
  • Coaching and mentoring of country-specific QM teams in the EMEA region – from Benelux to the Nordics, DACH, and Greece.
  • Active AI Competence Development in AI Integration, AI Governance, and GenAI Applications for Regulated Industries
nela

Feel Good Manager

Nela

Ensures a good mood and a good working atmosphere and pays attention to the important little breaks in between.

Services

Practical Solutions for
Your Quality Management

Tailored consulting, training, and audits – to ensure your QMS is efficient, compliant, and future-proof.

QMS Setup & Consulting

We develop or optimize your QMS – compliant with standards, practical, and tailored to your company.

  • Gap Analysis and Current State Assessment
  • Documentation & Process Design
  • Certification Preparation
  • On-site Rollout Support

QM Trainings & Customized Workshops

Practical training for your team – from QM fundamentals to advanced auditing.

  • ISO Fundamentals Training
  • Document Management
  • 1-on-1 Coaching for QM Managers
  • Online or On-site

Internal Audits & Audit Programs

We help you improve your internal audits and support you in preparing for external certification audits.

  • Internal Audits (ISO 9001 / ISO 13485)
  • Supplier and Distributor Audits
  • Audit Program Management
  • CAPA Support

Digitalization in Quality Management

We help you digitize your QM processes – efficiently, compliantly, and for the future.

  • AI-powered Process Optimization
  • GenAI for QM Documentation
  • eQMS integration
  • Digital QM Workflows

Regulatory Affairs Consulting

Spezialized support for medical technology companies regarding regulatory requirements and MDR compliance.

  • Adverse Event & Product Complaint Reporting
  • Field Corrective Safetey Actions
  • Post-Market Surveillance
  • Communication with Competent Authorities

Supplier Management

Targeted monitoring and control of your suppliers through risk-based supplier management.

  • Risk-based supplier segmentation
  • Documented justifications for control levels
  • KPI dashboards for monitoring
  • Audit-ready supplier qualification files

We prepare you to be Audit-ready. Always.

Themed Packages

Structured packages for clear results

01 dashboard

QM-Gap-Check

“Uncovers what your QM system is still missing”

Structured assessment of your quality management system

More details

Typical scope: approx. 4 days

02 tacho

ISO 9001 Quick Check

“The quick reality check for your existing ISO 9001 system”

Compact practical assessment for existing management systems

More details

Typical scope: approx. 4 days

03 lupe

Audit-Readiness Check

“Know how audit-ready you really are – before it counts”

Concerted preparation for internal and external audits and inspections

More details

Typical scope: approx. 4-7 days

04 schild

Supplier QM Check

”Greater security in your supply chain – before weaknesses become risks”

Risk-based assessment of your suppliers from a quality management perspective

More details

Typical scope: approx. 4 days

★ = The stated total scope is based on standard values. Deviations – whether higher or lower – depend in individual cases on factors such as company size, complexity, the scope of processes, etc.

Workshops & Training

We offer a variety of workshops and training courses covering key topics within the context of ISO 9001 and ISO 13485.
Below, you will find a selection of examples illustrating some of these potential topic areas.

ISO 9001

Topic areas

  • Preparation for ISO 9001 Certification
  • ISO 9001:2026 Revision (NEW)
  • QM-System & Document Control
  • CAPA & Nonconformities
  • Risks & Opportunities
  • Change Management
  • Complaint Handling
  • Customer Feedback
  • Supplier Management
  • Internal Audits & Management Review
  • etc.

ISO 13485

Topic areas

  • QM-System & Document Control
  • CAPA & Nonconformities
  • Risk Management & Product Safety
  • Change Management & Configuration Control
  • Design & Development – Controlling Development
  • Complaint Handling & Vigilance
  • Traceability
  • Supplier Management
  • Post-Market-Surveillance (PMS) & PMCF
  • Production, Validation & Process Control
  • Internal Audits & Management Review
  • etc.

Should you be interested in specific individual topics, this is generally feasible as well.
Simply get in touch with us!

FAQs

Frequently Asked Questions

We answer the most important questions regarding our service.

Qknows is specifically tailored to SMEs – particularly companies without their own QM department or appropriately qualified specialist personnel. However, we also collaborate with larger companies and individuals seeking targeted expert knowledge.

Yes – we offer solutions, particularly for urgent audit preparations or individual projects. Contact us, and we will find a quick way to assist you.
The initial consultation (approx. 45 − 60 minutes) is completely free of charge and without obligation. We get to know your situation and provide you with initial concrete recommendations − without any hidden costs or commitments.
Three things set us apart:
(1) Genuine practical background – many years of professional experience in international companies.
(2) Focus on SMEs – we understand your specific requirements and work with them.
(3) Future orientation – digitalization within QM systems (integration of digital tools, use of AI, etc.).
We begin with a free initial consultation to assess the current situation. This is followed by a structured gap analysis, based on which we develop a tailored project plan. Implementation takes place in close collaboration – remotely or on-site, depending on your needs.

Absolutely. All training sessions are available both online (via live webinar) and on-site at your company. For groups of five or more, we recommend in-person workshops to ensure maximum interaction and practical exercises.

Yes, definitely. We guide you from the gap analysis and the establishment of the QMS through to full certification preparation – and, optionally, during the certification audit itself.

QM-Gap-Check

“Uncovers what your QM system is still missing”

Structured assessment of your quality management system

With the QM Gap Check, you gain a clear and structured overview of how robust your current quality management system already is – and where further action is required.

Qknows evaluates your existing system with regard to relevant requirements, processes, responsibilities, and documentation. The result is a transparent assessment of existing gaps and vulnerabilities, as well as prioritized recommendations for the next steps.

This package is particularly suitable if you wish to build a new quality management system, develop your existing one in a targeted manner, or thoroughly prepare for certification.

Typical scope: approx. 4 days

  • Preparation and document review
  • Approx. 1-2 days of consulting at the client's site – on-site or remote.
  • Structured compilation of results and final presentation of key findings and recommendations

★ The stated total scope is based on standard values. Deviations – whether higher or lower – depend in individual cases on factors such as company size, complexity, the scope of processes, etc.

ISO 9001 Quick Check

“The quick reality check for your existing ISO 9001 system”

Compact practical assessment for existing management systems

The ISO 9001 Quick Check offers you a compact, practical assessment of the current status of your existing quality management system.

Qknows evaluates the core elements of your ISO 9001 system for currency, plausibility, and practical effectiveness. This quickly reveals whether your system is still soundly structured or if there is a need for targeted adjustments.

This package is particularly suitable if you wish to obtain an objective external assessment with manageable effort and derive clear priorities for short-term improvements.

Typical scope: approx. 4 days

  • Preparation and document review (of selected QM documents)
  • Approx. 2 days of consulting at the client's site – on-site or remote.
  • Structured compilation of results and final presentation of key findings and recommendations

★ The stated total scope is based on standard values. Deviations – whether higher or lower – depend in individual cases on factors such as company size, complexity, the scope of processes, etc.

Audit-Readiness Check

“Know how audit-ready you really are − before it counts”

Concerted preparation for internal and external audits and inspections

The audit readiness check provides you with a realistic assessment of how well your quality management system is prepared for an upcoming audit. Qknows simulates an audit-like assessment situation in a compact format and evaluates whether processes, documentation, responsibilities, and evidence hold up under audit conditions. In the process, potential weaknesses, risks, and uncertainties are identified at an early stage.

This package is particularly suitable if you wish to gain clarity prior to a customer audit, surveillance audit, or certification audit and specifically prioritize the final preparatory steps.

Typical scope: approx. 4-7 days

  • Preparation and document review
  • Approx. 2-3 consulting days for audit-style interviews, process reviews, and sample-based testing. The actual total effort depends on the scope of the audit, the number of processes, the state of documentation, and the desired scope and level of detail of the report.
  • Structured compilation of results and final presentation of key findings and recommendations

★ The stated total scope is based on standard values. Deviations – whether higher or lower – depend in individual cases on factors such as company size, complexity, the scope of processes, etc.

Supplier QM Check

”Greater security in your supply chain − before weaknesses become risks”

Risk-based assessment of your suppliers from a quality management perspective

Your suppliers’ performance directly impacts quality, delivery capability, and compliance. The Supplier QM Check provides a structured assessment of how robustly an existing or potential supplier is positioned from a quality management perspective – or how effectively your internal supplier management process is actually implemented.

In doing so, Qknows examines key QM aspects such as documented processes, responsibilities, evidence, CAPA, change management, risk-based assessment criteria, and relevant quality and risk indicators.

This reveals whether a supplier can reliably meet requirements, whether a critical supplier has any weaknesses, and whether your internal supplier management is implemented in a sufficiently structured, effective, and transparent manner.

The check is particularly suitable if you wish to approve new suppliers on a sound basis, review existing supplier relationships using a risk-based approach, specifically evaluate critical suppliers, or further develop your internal supplier management.

Depending on the initial situation, the supplier QM check can focus on one of two key areas:

Option A: Supplier Evaluation

A structured assessment of the robustness of an existing or potential supplier’s operations from a quality management perspective. Suitable, for example, for the initial evaluation of a new supplier, the re-evaluation of an existing supplier, or the analysis of a critical supplier.

Option B: Supplier Management Process Check

An analysis and structured assessment of the effectiveness of your internal supplier management process implementation. Key areas of focus include supplier selection, qualification, risk classification, monitoring, escalation, CAPA, change management, and documented evidence.

You receive a clear, practical assessment identifying strengths, weaknesses, and risks, along with concrete recommendations for action. This establishes a solid foundation for approval decisions, supplier development, process improvements, or audit preparation.

Typical scope: approx. 4 days

  • Preparation and document review
  • Approx. 2 consulting days to conduct the supplier QM check – on-site or remote.
  • Structured preparation of results and final presentation of key findings and recommendations.

★ The stated total scope is based on standard values. Deviations – whether higher or lower – depend in individual cases on factors such as company size, complexity, the scope of processes, etc.