Mastering compliance requirements with MYZEL

Jürgen Bukowski, Senior Manager, Consulting &, Services Operations

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How can you implement and comply with statutory requirements for machinery throughout its entire lifecycle? Machinery manufacturers and operators must address this issue now because the EU Machinery Regulation 2023/1230 comes into force on 20 January 2027. This also brings Industrial Security and digitisation to the fore. Both aspects will require a structured approach and full documentation in future. 

The changes and new provisions in the Machinery Regulation affect manufacturers and operators in different ways. For manufacturers, the focus is on developing compliant, safe machinery. They incorporate safety aspects from the outset, both technically and in terms of documentation. Operators, on the other hand, are responsible for safe operation – they must use systems correctly, train employees and comply with processes. The manufacturer lays the foundation; the operator maintains it over the entire machine lifecycle. 

Close cooperation for greater safety 
The legislator requires operators and manufacturers to demonstrate they have control over the lifecycle, from design, operation and maintenance to decommissioning – that includes the handling of software and updates. So the focus is shifting from one-off certification to continuous compliance. Appropriate safety measures are identified and implemented at the start of the lifecycle via a risk assessment. In addition, a Security Assessment now shows the measures required to implement the operator’s Security protection objectives. In future, closer cooperation between machine manufacturers and operators will be required in order to bring technical documentation, Safety and Security mechanisms, update processes and risk assessments up to a level that is MR compliant.   

Maintaining an overview of operations 
Drawing on their many years of expertise in CE marking, Pilz’s safety experts help both manufacturers and operators to implement Safety and Security requirements from the very start. To ensure that all the evidence can be accessed quickly from a central point, this entire conformity process and the associated documentation are recorded in detail. The manufacturer may decide the extent to which they pass technical documentation to the operator. 
But once the system has been successfully commissioned, how can you achieve the continuous compliance that's required? Production managers, safety officers or management – those responsible for production and safety face the daily task of maintaining an overview of machinery and personnel.  

Digital documentation with added value 
There is a growing need to manage documents and permissions in a structured manner. This applies equally to organisation, processes, qualifications and IT Security. Without an integrated asset management that takes statutory and legal aspects into account, it is virtually impossible to put “Secure by Design” and demonstrable safety compliance into practice on a day-to-day basis. Those responsible must document qualifications, inspections, maintenance intervals, revision history, evidence and access rights in full – across all sites and systems. Excel lists and paper files are no longer up to the task; they are error-prone, audit-critical and slow things down in the event of an incident. 

A platform that connects human and machine 
The automation company Pilz is addressing these increased requirements with the MYZEL Lifecycle Platform – a Software-as-a-Service solution for human and machine. MYZEL combines personnel and machine data in a single system and assigns the relevant artifacts (instructions, assessments, validations, declarations of conformity, maintenance schedules, training records). This means you can view the compliance status in real-time. At the heart of the platform is myCore. This is where users set up their machinery and store all relevant information in a central point. Any discrepancies, missing evidence or expiring deadlines relating to assets (machinery, data, people) are immediately visible on a dashboard. As a result the platform provides a clear overview of safety-critical aspects and highlights areas where action is required. An audit log also records every action taken in the system so that it is traceable. 

To comply with the requirements of the Machinery Regulation, manufacturers and operators can use MYZEL as a shared platform: the manufacturer or a consultancy firm such as Pilz can use it to pass the machine documentation to the operator. Pilz offers the right combination of services and complementary software as a complete package, supporting manufacturers and operators on their journey towards continuous compliance. An import function allows you to easily transfer the information into MYZEL, thereby enabling centralised documentation that begins right at the start of the machine lifecycle and can be continued seamlessly.