ISO 45001 AUDIT AHEAD?
GET YOUR MACHINERY READY.
Get your machinery compliance evidence ready for your ISO 45001 audit. easyCE assesses your in-house and modified machines, carries out risk assessments and prepares the agreed technical documentation. Your dedicated expert identifies the CE requirements, prioritises corrective work and brings the evidence together for review. Clear findings. Documented action. Traceable machinery records.
Willy Lebherz
Founder and Managing Director of easyCE GmbH
CE requirements clarified!
We assess your machinery, its history and modifications to establish the applicable CE requirements.
Documentation reviewed!
We check existing documents, identify gaps and define the corrective work your machinery needs.
Missing evidence prepared!
We carry out risk assessments and prepare the agreed technical documentation and instructions.
Your expert, on your side!
Get clear answers on machinery compliance and the evidence needed to address your audit findings.
Ready to show your progress!
Present structured machinery documentation and corrective action evidence at your audit.
Machinery compliance for ISO 45001
Prepare your machinery evidence
Legal compliance and your audit
In-house and modified machines
Clear machinery documentation
Put your machinery evidence in order before the audit.
An ISO 45001 audit assesses your occupational health and safety management system. Machinery safety is part of that wider picture. Auditors consider how your organisation identifies hazards, manages risks and evaluates compliance with its legal obligations.
easyCE focuses on the machinery CE work. We review the equipment and available documents, identify gaps and prepare the agreed evidence. This complements your workplace safety arrangements and your wider ISO 45001 preparation.
We agree a machine list and identify the drawings, instructions and other records needed for the review. This gives your team a clear starting point for gathering evidence and resolving outstanding questions.
Establish what applies to each machine.
An ISO 45001 audit does not create a new CE marking obligation. Whether a machine needs CE marking depends on the applicable product legislation and its history. Workplace use also brings separate safety duties for the employer.
We establish the relevant requirements, review the documentation and explain what needs attention. Your action plan addresses the actual machinery findings, without assuming that every existing machine needs a new declaration or the latest standard applied retrospectively.
The review distinguishes the machine's original supply, later modifications and its current workplace use. We record the basis for each CE decision so your team can explain why a requirement applies or does not apply.
Own-use machinery needs a proper assessment too.
Machinery manufactured for your own use can fall within the Machinery Directive. Modifications and linked machines also need careful assessment, but not every alteration automatically creates a new machine. The nature of the change and the resulting risks matter.
easyCE assesses the project and documents the reasoning. Where a new conformity assessment is required, we carry out the agreed risk assessment and documentation work. Where it is not, we identify the safety and documentation actions that still need to be addressed.
We look at changes to operating limits, controls, protective measures and connections to other equipment. The assessment records which existing evidence remains usable and which parts need further review.
Give your team a clear, usable record of machinery compliance.
A structured equipment register connects each machine with its identification, history, responsibilities and available documents. Depending on the equipment, the evidence may include instructions, declarations, risk assessments, maintenance records and training records.
We organise the machinery CE evidence and prepare missing technical documents within the agreed scope. Product conformity documentation and workplace risk assessments serve different purposes. We keep them connected without treating one as a substitute for the other.
We assign each document to the relevant machine and mark revisions, responsible contacts and unresolved points. This gives your team a clear record to update after repairs, modifications or new evidence.
Close your machinery CE gaps. Get expert support.
Trusted by leading businesses. Chosen for results.
Turn audit findings into action
Find the CE gaps
Complete existing documentation
DoC ready to sign
Compliance processes
Know where you stand and what to do next.
Start with a focused review of the machines and documents involved in your audit finding. We establish the applicable product rules, inspect the evidence and identify the gaps that need action.
You receive clear priorities and an agreed scope of work. Your team knows which documents already provide useful evidence and which assessments or corrective measures are still needed.
We link each audit finding to the affected machine, its identification details and the available evidence. You can then show your auditor which points have been addressed and which actions remain open.
Build on the documentation you already have.
Missing or inconsistent records do not always mean starting again. We review the existing evidence against the requirements relevant to the machine and its history, then complete or revise the documents that need attention.
The work may include a risk assessment, revised instructions or an updated declaration where justified. We explain any physical safety measures that must accompany the paperwork. Documentation alone does not remove a technical hazard.
We check that instructions, drawings and assessment records refer to the same machine configuration. Revised documents have clear version references, so your team can distinguish the current record from superseded material.
Complete conformity assessment for your in-house machinery.
Where your machine requires a full conformity assessment, easyCE carries out the agreed process. We assess risks, research applicable requirements, prepare technical documentation and instructions, and address the required machinery marking information.
We prepare your declaration of conformity ready to sign once the necessary conformity work and safety measures have been completed. Under the Machinery Directive this is an EC declaration of conformity. The manufacturer remains responsible for declaring conformity and affixing the CE marking.
At handover, we explain how the declaration relates to the machine and the supporting technical file. Your team receives a structured document set with clear references for future checks, changes and audit questions.
Make machinery compliance part of the way you work.
easyCE helps you establish a consistent process for developing, purchasing and modifying machinery. We clarify responsibilities, prepare useful templates and checklists, and train your team on the CE decisions they need to make.
That gives future projects a clear starting point and keeps evidence easier to find. Your organisation manages the machinery work systematically, with fewer last-minute documentation gaps before the next audit.
We define review and handover steps for supplier documents, machine modifications and completed CE work. Named responsibilities and consistent document references make it clear who maintains each record and where the evidence is kept.
Your machinery compliance. Expertly handled.
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Approach
How we work
Scope of support
Your point of contact
Hands-on machinery compliance focused on your audit findings
Experts who carry out the work and explain what matters
Complete preparation or individual tasks, agreed around your needs
Your dedicated expert throughout the project
Other CE service providers
Approach depends on the provider and the agreed brief
Advice and implementation support vary by provider
Check which services are included in the proposal
Contact arrangements depend on the provider
CE software
Tools for structuring assessment and documentation
Your team makes the decisions and carries out the work
Functions depend on the product and purchased modules
Technical support depends on the licence and service package
Machinery documentation. Ready for audit review.
Machinery compliance delivered. Proven in practice.
CE documentation for in-house laboratory machinery
Ahead of an ISO 45001 audit, easyCE supported a laboratory technology manufacturer with the CE assessment of internally used validation machines. We assessed machinery risks, prepared the technical documentation and connected the findings with the evidence needed for safe use by laboratory staff. The project brought the machinery compliance work into the wider audit preparation.
CE assessment for a laboratory coagulation robot
easyCE supported a medical technology manufacturer with a laboratory robot used to automate coagulation test cycles. We assessed the machinery risks, including the handling of electrosurgical components, and prepared the CE documentation for the equipment. The work formed part of the customer’s preparation for its occupational health and safety audit.
Technical documentation for insufflator test equipment
For a medical technology manufacturer preparing for ISO 45001 certification, easyCE prepared machinery CE documentation for a laboratory system used to test and calibrate insufflators. We addressed the equipment’s safety requirements, including the different hose systems and connections used with each model. The resulting evidence supported both the machinery project and the customer’s wider audit preparation.
Clarifying the compliance route for electrical laboratory equipment
easyCE reviewed the classification of electrical laboratory equipment during a customer’s ISO 45001 preparation. We distinguished the relevant medical device and electrical equipment requirements and carried out the agreed conformity assessment and documentation work. This gave the customer a clear basis for its product compliance evidence and workplace hazard assessment.
Assessing an internal test bench for low-pressure units
easyCE assessed an internal test bench before an ISO 45001 audit. We reviewed its regulatory classification and used measurements to establish that the Pressure Equipment Directive did not apply to the assessed equipment. We then prepared the machinery CE documentation, including the relevant operational risks and emergency arrangements, to support the customer’s audit evidence.
Close your CE gaps in three simple steps
Step 1
Get free initial advice
Tell us about your machinery, the documents available and any audit findings or deadlines. Your easyCE expert discusses the priorities and next steps, free of charge.
Step 2
Receive your proposal
We define the assessments, documentation and support needed to address your project. Discuss the scope with your expert and choose the work you want us to take on.
Step 3
We get it done
Your dedicated expert carries out the agreed machinery compliance work and prepares the evidence. We support follow-up questions so your team can explain the actions taken at the audit.
Close your machinery CE gaps. Get expert support.
Frequently asked questions
Which machines need CE marking when we prepare for an ISO 45001 audit?
The audit itself does not determine whether a machine needs CE marking. The applicable product legislation, when it was first placed on the market or put into service, and any later modifications are decisive. Machinery made for own use can require CE marking, while not every existing machine or modification requires a new conformity assessment. easyCE reviews the equipment and documents the appropriate route. Workplace safety duties still apply independently of CE marking.
What if the auditor identifies missing machinery CE documentation?
First establish what is missing and which requirements apply to the equipment. The auditor or certification body determines the finding’s classification, the evidence required and the deadline for corrective action. easyCE reviews the machinery, prepares an action plan and carries out the agreed assessment and documentation work. Physical safety defects need corrective measures as well as documentation. Completing CE documents alone does not guarantee certification of the wider ISO 45001 management system.
Trust the experts in 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
- Meister qualification in 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 an engineering consultancy specialising in product safety and conformity. We carry out risk assessments, research applicable legislation and standards, prepare technical documentation and coordinate the tests your project needs. Manufacturers, operators and distributors choose the complete process or individual tasks.
For ISO 45001 audit preparation, our focus is your machinery compliance. Your dedicated expert closes the agreed CE documentation gaps and helps your team present clear evidence. Founded in southern Germany, easyCE works with customers internationally.