Certification-ready QMS solutions for SMEs
Seamlessly obtain your
ISO-9001 and
ISO-13485 certification
With a customized QMS that takes the pressure off you at the company - and impresses auditors and customers
- We develop your customized, legally compliant and audit-compliant quality management system
- You gain valuable time for your day-to-day business
- Your QMS is certified at the first attempt
Why is the establishment of a QMS
a stress test for many companies?
Fact 1
The requirements of ISO 9001 and ISO 13485 are usually clear - but QM and specialist departments are too involved in day-to-day business and do not have the capacity for a complete QMS project.
Fact 2
Many processes already exist, but they are not properly documented or implemented in a verifiable manner. The audit-compliant common thread is missing.
Fact 3
The responsibilities are unclear. Nobody feels fully responsible - and the project gets bogged down between the specialist department, QM and management.
What a QMS must really satisfy
to pass an audit successfully:
- Processes must be interlinked and documented in a traceable manner, not merely exist.
- Responsibilities and competencies must be clearly defined - not just on paper, but in everyday practice.
- The applicable standards must be internalized and practiced across the team without getting lost in paragraphs.
- Technology, organization and management must work together seamlessly - otherwise there are problems at the interfaces.
- The entire system structure must match the audit logic - otherwise you will not receive approval despite good approaches.
Our observation
Many companies start out motivated, get lost in the details and are left with more questions than answers shortly before the audit. This is exactly where we come in.
Certification certainty
You receive an auditable QMS with a clear structure - and, thanks to our certification guarantee, the certainty that you will achieve your goal.
Technology, Law & Organization from one source
We combine specialist knowledge from quality management, norm practices and operational organization - so that processes are interlinked and auditable.
Project progress instead of coordination chaos
We bring together operational departments, QM managers and management - and create sustainable decisions between standards, reality and customer requirements.
Practical systems
You benefit from a lean, modular QMS which can be seamlessly integrated into your day-to-day work - without any theoretical overhead.
Predictability & Control
You maintain visibility at all times: With a binding plan, concrete deadlines and clear responsibilities.
Guidance up to the finish line
We don't just deliver concepts, we’ll go all the way with you until you’re holding your certificate in your hands.
We build your
Quality Management System in such a way that ...
... your individual requirements can be integrated with ease - whether customer specifications, industry-specific features or existing process structures.
... existing preparatory work is systematically integrated - so that there is no duplication of work and you start exactly where you are right now.
... everything runs reliably even without an internal project team - because we take over the management, coordination and implementation completely, right through to successful certification.
The bottom line
You don't have to become a QMS professional,
just make the right decisions.
With a structured, audit-capable quality management system, you not only secure the longed-for certification - but also the trust of your customers, your positioning as a reliable partner in your industry and access to lucrative contracts
How your
certified QMS solution takes shape:
Step 1
Analysis
We record your initial situation in the initial consultation, clarify requirements and identify what really matters for your planned certification (ISO 9001, ISO 13485).
Step 2
Concept
Based on the analysis, we develop a clear strategy including an implementation plan: Precisely tailored to your industry, process landscape and customer requirements - including all key metrics, certificates and QM-relevant specifications.
Step 3
Introduction & Integration
We create the relevant documents, carry out training and anchor the QMS where it belongs: In the minds, processes and systems of your organization.
Step 4
Secure operation
Together we ensure that your ISMS not only works on paper, but also day to day - with simple tools, clear responsibilities and lean processes.
Step 5
Certification
We prepare you specifically for the audit and accompany you through the entire audit process. Meaning: we make sure that you pass the test and at the same time impress from A to Z.
About MEMEX Consulting
Over 20 years of experience
6-member team of
compliance experts
100+ satisfied customers
Legal expertise
Certified consulting quality
Specialized IT knowledge
Certified.
Unburdened.
Future-proof.
With a functioning QMS, you show customers and partners that you not only promise data protection - but that you demonstrably live it. You gain certainty in the audit, trust from the market and create the basis for sustainable growth.
Book your free initial consultation now and guide your company safely to ISO 9001 and ISO 13485 certification.
Any questions?
You will find answers here:
Because we get your QMS ready for certification in 3-6 months - without unnecessary theory and without overloading your team. Preliminary work already carried out by your team is not discarded but integrated in a targeted manner. Regardless, the system remains practical, lean and auditable. And: We give you a certification guarantee. This means you know what you’re getting into right from the start.
A good quality management system (QMS) is more than just formal documentation. It ensures that quality in the company is not only defined and described, but lived day to day. This requires clearly structured processes, traceable evidence, unambiguous responsibilities - and a system that works in practice. At MEMEX, we develop QMS solutions that are not only ISO 9001-compliant, but also auditable, lean and suitable for everyday use.
A quality management system (QMS) has a modular structure and is of fundamental importance for your quality management: It includes a documentation structure (e.g. manual, procedural instructions, process descriptions), clear allocation of roles, quality targets and metrics as well as defined control loops for control and improvement. ISO 9001 provides the normative framework for this - the specific design must be tailored to the individual organization.
The QMS manual provides an overview of the entire system, while the documentation contains individual processes, work instructions and evidence. The QMS processes form the operational core and must be actively lived in day-to-day business.
A QMS is not mandatory by law, but is a de facto requirement in many industries - for example for customer requirements, audits or certification obligations along the supply chain. ISO 9001 certification is recognized worldwide as proof of an effective quality management system and is often a mandatory requirement in tenders or for OEMs.
As well as achieving a certification-ready QMS (quality management system) - our collaboration also aims to make your team fit for day-to-day work. The training content ranges from process responsibility, understanding roles and audit preparation to the safe application of ISO 9001 in an operational context. We anchor this content directly in the ongoing project - efficiently, practically and tailored to your processes.
