CEISO 9001 CERTIFICATION MADE "EASY"
WITH OUR HELP
You simply apply the CE mark and sign the Declaration of Conformity, worry-free
Willy Lebherz
Director & founder of easyCE GmbH
Your processes analyzed!
We identify your relevant processes and help you make them "ISO 9001 ready"
Your documentation prepared!
We help you document your processes so that you are ready for the ISO 9001 audit
Employees involved!
We train your team and ensure a lived quality awareness throughout the company
Internal audit conducted!
We simulate the audit, address weaknesses, and prepare you for certification
Audit successfully passed!
We support you not only in preparation but also during your ISO 9001 audit
CE First Aid: Your guide to successful importing into the EU
AS MANAGEMENT
AS QUALITY MANAGER
AS EMPLOYEE
You want to implement ISO 9001 because your customers demand it and it is regularly asked about in supplier qualifications.
What often lands on management’s desk:
Too many templates, unclear processes, Excel chaos, uncertainty about what is really necessary—and the feeling that you have to do everything yourself.
What is actually required:
Define quality policy and objectives, provide direction, make decisions, allocate resources.
How easyCE relieves you:
We sort it out for you: What is mandatory, what is useful, what is superfluous?
We structure the documentation, streamline and make processes transparent, and prepare everything so that management can keep an overview—without getting lost in the details.
This way, you can focus on what matters: strategy, leadership, and customer satisfaction—we take care of the rest.
Over 300 CE markings for machines since 2021 and counting every day...
Only with easyCE, CE marking is worry-free
Approach to CE marking
Flexibility and concept of support
Scope & scale of support
Contact during project work
Simplified and pragmatic approach to CE marking to ensure compliance
In line with to your needs, our experts will take you along the CE marking journey
You choose our support model: From "One-stop-shop full service", to partial and modular - whatever you prefer
First things you receive your dedicated, personal CE expert who will support you along the entire process
Other CE service providers
Often without a sense of proportion and unnecessarily complicated
Mostly flexible but often bureaucratic
Mostly flexible in the extent of support
Mostly personal contact
CE software
Follows a standardised process that does not take special features into account
Double burden for you: Software administration + no support for processing
Only according to software scope and purchased modules
No contact
We simplify CE-marking not the opposite
Reference Projects
Preparation for ISO 13485 certification with an existing ISO 9001 structure
For a company with an already implemented ISO 9001 system, we prepared certification according to ISO 13485—specifically for a medical device in the field of eye protection. Existing QMS documents were systematically analyzed, and a GAP analysis identified missing ISO 13485 requirements. We then supported the adjustment of processes, evidence documents, and risk-based procedures up to successful audit preparation. Result: Efficient certification thanks to structured integration into the existing system.
Includes, among others: DIN EN ISO 9001:2015, DIN EN ISO 13485:2021, ISO 14971:2019
GAP Analysis for Risk Management according to ISO 14971
For a company with an existing risk management system, we conducted a comprehensive GAP analysis—with a focus on the requirements of EN ISO 14971, EN ISO 10993-1, EN ISO 13485, and the MDR. The focus was on assessing the risk management process and biological evaluation. Existing processes and documents were compared with current standard requirements, gaps identified, and an optimized target process developed—tailored to the company’s specific structures. Result: Structured, standards-compliant process design as a foundation for regulatory compliance and future audits.
Includes, among others: EN ISO 14971:2022, EN ISO 10993-1:2021, EN ISO 13485:2021, MDR (EU) 2017/745
ISO 13485 Recertification and MDR Initial Certification for a Dental Implant Manufacturer
A dental implant manufacturer was supported in ISO 13485 recertification as well as initial MDR certification. The goal was to adapt the existing QMS to the expanded requirements of the MDR. Relevant processes were analyzed, gaps closed, and a cross-site audit at two production facilities was successfully coordinated. The measures were closely aligned with the client to ensure smooth recognition by the notified body. Result: Successful ISO 13485 recertification and MDR compliance through targeted system adaptation and structured audit preparation.
Includes, among others: EN ISO 13485:2016, ISO 14971:2019, MDR (EU) 2017/745
Learn more about our project references and success stories
Get CE-marking done in 3 simple steps
Step 1
Request expert opinion
Ask for our expert opinion free of charge and find out what is necessary for the CE marking of your product. Be prepared to describe your product in broad terms.
Step 2
Receive our offer
If your product is subject to CE marking, we offer you our support with the CE marking and all accompanying measures. We will be happy to explain necessary steps on the phone.
Step 3
We get it done
When you place an order, you will be assigned your own personal CE expert who will carry out your CE marking and accompany you throughout the entire process. Your expert will also be at your side after the CE marking has been successfully completed.
We support you with CE marking and all accompanying measures
Frequently asked questions
How long does the ISO 9001 certification process take?
Depending on the company size and starting situation, the process usually takes between 2 and 6 months. With our support, it is often significantly faster—structured, efficient, and without unnecessary effort.
Is a quality management manual still mandatory according to ISO 9001?
Under ISO 9001, a QMS manual is no longer required but is often used as a useful guide. In medical technology according to ISO 13485, however, it is mandatory and a central part of the quality management system.
Do I need to get certified for ISO 9001 every year?
No—the ISO 9001 certification is generally valid for three years. However, annual surveillance audits are conducted to ensure the quality management system continues to meet the requirements. After three years, a recertification audit takes place.
How does easyCE support with ISO 9001?
easyCE supports you from start to certification: we analyze your existing processes, create the necessary QMS documents together, conduct internal audits, and prepare you specifically for the external certification. Everything is tailored to your company—practical, efficient, and easy to understand.
What are the key contents of ISO 9001:2015?
The standard focuses on:
- Customer focus
- Leadership responsibility
- Process orientation
- Risk-based thinking
- Continuous improvement
- Measurable results and documented information
In short: a structured system that makes quality measurable and sustainably ensured.
What makes easyCE different from other providers?
We don’t offer off-the-shelf solutions: easyCE stands for individual support, long-standing experience, and lean, practical implementation. Our team knows the challenges from numerous industries—from startups to industrial companies—and supports you with genuine commitment, not just templates.
Is ISO 9001 certification associated with a lot of effort for us?
Not with the right support. We structure the process so you can focus on what matters. Many tasks can be handled internally with minimal time, while we take care of the rest. For most clients, the effort is surprisingly manageable.
What happens after ISO 9001 certification?
Even after certification, we are there for you: we assist with annual surveillance audits, support improvement measures, and are available for questions regarding system maintenance. A good QMS is a living system—and brings real long-term benefits.
Trust the experts of product safety and compliance
Willy Lebherz - Founder and Managing Director of easyCE
- Expert in product safety and compliance, since 1995
- Recipient of the "Medal of the Order of Merit of the Federal Republic of Germany", awarded in 1983 by the then Federal President Carl Carstens
- Master of measurement and control technology
- Captain (ret.), Project Officer for Technical Logistics in the Army Material Office and Chief of the Telecommunications Repair Company
easyCE is a digital, dynamic engineering office with a focus on product safety and product conformity. We support manufacturers, operators and dealers in designing products safely and offering them on the market in compliance. We are a "full-service provider" and can take over the entire conformity assessment process for you if you wish. To do this, we support you in carrying out risk assessments, researching standards, product analyses, developing suitable safety precautions, preparing user-friendly technical documentation, coordinating tests and all other accompanying measures. easyCE was founded in southern Germany, but is now active globally.
We know the special features that you need to take into account when CE marking your product and we are happy to help you.