AUDIT according to ISO 45001
completed! SUPER "EASY" with our help

Are you facing an ISO 45001 audit and unsure whether your in-house built or modified machines comply with CE requirements? easyCE provides targeted support for the CE certification of your internal machines and helps you successfully pass your audit.

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Willy Lebherz

Geschäftsführer easyCE GmbH

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Let's find out what is required for the CE labelling of your products

Request our expert opinion free of charge and find out exactly what is necessary for the CE marking of your product and what accompanying measures are required.

What can we help you with?

How can we reach you and provide answers?

Or simply give us a call: +49 7248 4524700

Conformity Check!

We check your in-house built and modified machines for CE compliance before the audit

Conformity Update!

We bring your existing CE documentation up to date with the latest standards and directives

Gap filling!

We professionally prepare all missing CE documentation for your internal machines

Expert advice!

We answer your critical questions about machine safety in the context of the ISO 45001 audit

Pass the audit!

All done! With your new CE documentation, you will pass the audit without any problems

The ISO 45001 audit process and important aspects

Preparing for the audit: Focus on key areas

Legal compliance as a key test criterion

Auditing of self-built and modified machines

Documentation and evidence management in the audit

An ISO 45001 audit checks the implementation of your occupational health and safety management system. Particular attention is paid to the identification of hazards, risk assessment, and compliance with legal requirements. Self-built or modified machines are critically examined, as they can pose a potential hazard. Audits are usually carried out in two phases: a document review and an on-site inspection, during which machines and equipment are also inspected.

Compliance with legal requirements is a core component of ISO 45001. During the audit, particular attention is paid to the that applies to all machines in your company—including those you have built yourself or significantly modified. Audits check whether valid CE markings, declarations of conformity, and necessary technical documentation are available for all relevant machines. Lack of CE conformity constitutes a serious

This constitutes a deviation and may result in the audit being failed.

easyCE supports you in obtaining the CE mark for all your machines, enabling you to pass the audit without any problems.

Machines constructed in-house, modified series devices, and assembled machines are viewed particularly critically in the audit. These must be treated as “new machines” within the meaning of the Machinery Directive and require complete CE documentation with risk assessment, technical documentation, and declaration of conformity. Audits often reveal gaps in this area, as many companies are unaware that machines developed in-house are also subject to CE requirements.

As part of the audit, complete documentation of your occupational health and safety management system is expected. For machines and systems, this means: operating instructions, risk assessments, maintenance plans, training certificates, and, of course, complete CE documentation. Auditors will view a systematic list of all machines with details of their CE status, year of manufacture, and responsibilities favorably. Missing documentation often leads to complaints that must be resolved before certification can be granted.

We support you with CE marking and all accompanying measures

+49 7248 4524700

Over 300 CE markings for machines since 2021 and more every day...

Mercedes Stego Teka Drexler Böhmler Bürkle CPM Extrusion Hengst IMS Gears Kabe MicroStep MSE Polyrack Reintjes

Options for action: If the audit reveals CE gaps

CE quick check: Determining the need for action

CE-Update

Full CE certification for self-built machines

Our recommendation: Preventive CE strategy

If machines without valid CE documentation were identified during the audit, swift action is required. easyCE offers an efficient CE quick check to determine the actual need for action.

We analyze which of your machines fall under the Machinery Directive and which are subject to other directives. We check machines that have already been labeled for the validity of the existing documentation and identify any necessary additions. This gives you a precise overview of the measures required.

Machines often have CE marking, but the documentation no longer meets current requirements or is incomplete. easyCE offers a specialized CE update service, in which we bring your existing documentation up to date. We supplement missing documents, update risk assessments in accordance with the latest standards, and create compliant declarations of conformity. This approach is cost-effective and faster than completely recreating the documentation, allowing you to complete your audit evidence in a timely manner.

For self-designed machines or significantly modified systems, easyCE offers complete CE certification. Our specialists prepare all necessary documentation in accordance with the Machinery Directive, including:

  • Risk assessment according to EN ISO 12100
  • Operating instructions in accordance with requirements
  • EU Declaration of Conformity
  • Nameplate with CE mark

With our support, you can also ensure full CE conformity for your own designs. This allows you to successfully remedy critical audit findings or avoid them in advance.

To avoid future audit problems, easyCE works with you to develop a long-term CE strategy. We implement processes for the CE-compliant development and modification of machines in your company, train your employees on CE-related topics, and create templates and checklists for internal CE conformity assessment.

This preventive approach makes CE conformity an integral part of your occupational health and safety management system—future audits will not only run more smoothly, but also be significantly faster and more cost-efficient, as time-consuming revisions are avoided. This structured approach is easyCE's clear recommendation for ensuring long-term safety, efficiency, and legal certainty in your company.

+49 7248 4524700

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 complianceg

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

CE marking of laboratory machines developed in-house

CE marking of laboratory machines developed in-house

In the course of an upcoming ISO 45001 occupational health and safety audit, easyCE supported a laboratory technology manufacturer in ensuring CE conformity for its internally used validation machines for medical equipment. Our specialists conducted a comprehensive assessment of occupational health and safety aspects and integrated these into the CE documentation. Particular attention was paid to safe operation by laboratory staff and the documentation of risk assessments that meet both CE and ISO 45001 requirements.

Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU EN ISO 12100, EN 60204-1

CE marking for a laboratory robot

CE marking for a laboratory robot

In the course of an upcoming ISO 45001 occupational health and safety audit, easyCE supported a medical technology manufacturer in achieving CE conformity for its coagulation robot—a specialized laboratory machine for the automated performance of coagulation cycles for testing purposes. Our specialists conducted a comprehensive assessment of occupational health and safety aspects and integrated these into the CE documentation. Particular attention was paid to the safe handling of electrosurgical components and the documentation of risk assessments that meet both CE and ISO 45001 requirements.

Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU, EN ISO 12100, EN 60204-1, etc.

CE marking and consulting for laboratory equipment

CE marking and consulting for laboratory equipment

In the context of an upcoming ISO 45001 certification, easyCE supported a medical technology manufacturer with the CE documentation for a specialized testing and calibration machine for insufflators in the laboratory sector. Our specialists developed integrated documentation that covers both the CE requirements and the occupational health and safety aspects according to ISO 45001. Particular attention was paid to the safety requirements for handling various hose systems and connections, which can vary depending on the insufflator model.

Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU, EN ISO 12100, EN 60204-1 etc.

CE marking for electrical equipment in medical laboratories

CE marking for electrical equipment in medical laboratories

As part of the ISO 45001 certification preparation process, easyCE supported a manufacturer of electrical laboratory equipment in the correct classification and CE conformity of its products. Our experts carried out a precise analysis to distinguish between medical devices and electrical equipment in order to ensure correct classification in terms of occupational health and safety. This clarity was crucial for the ISO 45001 requirements regarding hazard identification and risk assessment in the workplace. Successful documentation and conformity assessment enabled the customer to operate its laboratory equipment in full compliance with occupational health and safety guidelines and to pass the ISO audit without any objections.

Takes into account, among others: EN 55032, EN 55035, EN 60335-1 etc.

CE marking for test station for low-pressure units

CE marking for test station for low-pressure units

In the run-up to an ISO 45001 occupational health and safety audit, easyCE supported an industrial company in compiling CE documentation for an internal test bench for low-pressure units in accordance with occupational health and safety regulations. Our experts first analyzed the regulatory classification of the test bench and were able to prove through precise measurements that the Pressure Equipment Directive was not applicable. This clarification was crucial for the correct risk assessment within the framework of the ISO 45001 management system. The CE documentation subsequently created took particular account of occupational health and safety aspects such as operational safety and emergency procedures. This enabled the customer not only to demonstrate CE conformity, but also to pass its ISO 45001 certification without any deviations in the area of work equipment.

Takes into account, among others: 2006/42/EG, EN ISO 12100, EN 60204-1, EN ISO 4414, EN ISO 13849-1 etc.

Learn more about our project references and success stories

Get CE-marking done in 3 simple steps

Step 1

Request our 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 an offer

If your product is subject to CE marking, we offer you our support with the CE marking and all accompanying measures. We would be happy to explain the necessary steps over 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

+49 7248 4524700

Q&A

Which machines require CE marking in the context of an ISO 45001 audit?

As part of an ISO 45001 audit, the CE conformity of all machines covered by the Machinery Directive 2006/42/EC is checked. These include:

  • Commercially purchased machines after 1995
  • Self-built machines for personal use
  • Significantly modified existing machines
  • Interlinked machines or systems consisting of several individual machines

Interchangeable equipment that changes the basic function of a machine Exceptions may include simple hand tools, very old machines (pre-1995) without significant modifications, or certain laboratory equipment. However, during an audit, documented justification is expected as to why a machine does not bear the CE marking.

What happens if missing CE documentation is identified during the ISO 45001 audit?

If an auditor finds missing CE documentation, this usually leads to a documented nonconformity. Depending on the severity, this can be:

  • Minor non-compliance (e.g., minor documentation deficiencies) that must be corrected by the next audit
  • Serious non-compliance (e.g., complete absence of CE marking on high-risk machines), which must be rectified prior to certification

In both cases, you must submit an action plan that shows how and by when you will remedy the deviations. In the case of serious deficiencies, a follow-up audit is often necessary to verify implementation. easyCE supports you in remedying these deviations quickly and efficiently.

Trust the experts of product safety and compliance

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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.