PDE’s compliance services ensure that your organisation has all the correct paperwork in place before product launch and provide you with the tools to differentiate you from your competition on the basis of product safety and documentation.
CE and UKCA Marking
When placing mechanical products in the marketplace, in both the European Union and the United Kingdom, 2006/42/EC is your bible when it comes to compliance with applicable regulation and ensuring that you consider safety in the right way. Some other territories have their own regulatory framework but, in many places, applying a CE mark through correct use of The Machinery Directive is the path of choice for market entry and acceptance.
Here, at PDE, we can partner with you in all aspects of your compliance journey, helping you with the risk assessments that are the most critical element of your compliance documentation, and ensuring that you pare risk down to the ALARP (As Low As Reasonably Practicable) level that designated authorities hope to see you demonstrate. The most robust way to manage such assessments is to bring them into play early on in your project and use them to drive safety into your design, followed by regular reviews as your project progresses and then, later, as you receive new data and learn more about your product in service, on an ongoing basis.
Equally, we can document how your product complies with the directive’s EHSRs (Essential Health and Safety Requirements), create the declarations (Declaration of Incorporation for partly-completed machinery and Declaration of Conformity for machinery) in the mandated format and, should you wish us to do so, develop and maintain full Technical Construction Files in permanent form.
For more onerous directives that drive the requirements of particular product types, such as EU 2016/46 (GAR) – ‘The Gas Appliance Regulation’, 2014/68/EU – ‘The Pressure Equipment Directive’, etc., we can work with you using the same approach as well as adding novel calculation aspects and other specific requirements.
Finally, for any of the directives arising from the regulatory framework, targeted application of the most appropriate harmonised (EN) standards can often be the most straightforward and cost-effective way of driving the compliance you need and, again, we are here to guide you with such documents and how to use and reference them in the right way.
The quality of instructions, assembly and maintenance information and other technical documents is an area that a lot of businesses, even large and successful ones, do not give as much attention to as they probably could and should. Who hasn’t tried to assemble flat-pack furniture using appallingly described and illustrated instructions, and who hasn’t needed to scramble around for a magnifying glass to try and locate the information in a language that means something to them for a small electrical device?
Customers in all fields benefit from clear, precise information, and this area can present start-ups with an easy route to creating a clear differentiation between them and their competition. There are also legal requirements that mandate the provision of particular types of information: for mechanical products and machinery, our services linked to adherence of directives and regulations can help you here, as well as our CAD services for creating the base models for realistically rendered pictorial information.
EN ISO 13849-1 SRPCS
A sometimes neglected part of safety compliance, especially with regard to organisations and teams that are primarily mechanically biased, is the specification, assessment and evaluation of controls elements of safety systems. Often, an organisation will follow a rigorous process for assessing and then reducing risk but not really know how to robustly incorporate controls elements into their safety case. A not uncommon belief is simply that safety has to be built around designing out dangers, guarding against hazards, and informing users of residual risks using only mechanical approaches and, perhaps, the odd interlock or two.
This is not a good way of working, and it is not the way that regulatory bodies wish organisations to work, either. Best practice is well established: once you have a way forward in which the risk from a particular hazard can be managed, this may or may not involve a controls element. If it does, EN ISO 13849-1 is provided for you to make the right decisions based on a clear, though complex, assessment of danger level, architecture design requirements and control safety system elements’ performance and reliability. It also has a sister standard, EN ISO 13849-2 which helps you validate these systems and maximise the robustness of your assessments and compliance documentation.
For such assessments, we’ll provide you with reports to your specifications, and these will often include documentation created using the industry standard reference software tool:-
SISTEMA: Safety Integrity Software Tool for the Evaluation of Machine Applications.