Risk Assessment
Our team of engineers and legal experts is ready to help you
- Our team of experts can help you implement safety measures according to applicable directives and standards to achieve compliance with the mandatory safety requirements.
- To achieve this, you will have to pass a risk assessment procedure that includes a risk analysis and risk reduction.
- Our team will provide guidance and help to eliminate risks more efficiently and protect your customers and your company. We will supervise the entire process and conduct the full risk analysis.
Trust our team of experts to handle your risk assessment
What is a Risk Assessment?
A Risk Assessment is the process your product goes through to determine the hazards, risks and measures – including its correct implementation – which the manufacturer is ultimately responsible for. Risk Assessment examples include:
- An initial Risk Assessment is carried out after the concept or design phase. This allows certain safety measures to be introduced during the engineering phase, when they can still be processed easily and at little cost.
- After the engineering phase, a second Risk Assessment follows, and risk reduction can take place.
- A final Risk Assessment form follows after the construction phase. This should show that all risks have been minimised. If this is not the case, adjustments will have to be made again.
Carrying out a Risk Assessment requires a lot of documentation and information, including (preliminary) specifications of the machine and the user, information regarding the use of the machine, the relevant and applicable standards and regulations, etc. Getting this in order can be overwhelming, but Certification Experts can support you in collecting all relevant information and in preparing all necessary documentation.
Performing a Risk Assessment
Various methods have been developed to carry out the Risk Assessment, which includes the risk analysis and risk reduction.
All the risk analysis consists mostly of the following steps:
- Determination of the limits of the product
- Identification of hazards
- Risk Assessment
Various methods are available for conducting the appropriate Risk Assessment for different product categories:
- Our experts adhere to EN ISO 12100, which serves as a comprehensive guideline for conducting Risk Analysis of machinery. Although it is primarily designed for Risk Assessments related to machines, it also provides a fundamental framework for evaluating other products. Certification Experts’ specialists utilise Safexpert to conduct these rigorous risk analyses.
- A significant focus is placed on Risk Management for medical devices by the European Medical Device Regulations. Manufacturers of medical devices are obligated to oversee risk mitigation measures from product design through production. It is crucial to emphasise that the assessment of risks is not a one-time task. ISO 14971 compliance necessitates companies to maintain risk management as an ongoing internal process that spans the entire product life cycle of a medical device.
- Risk Assessments required for EU compliance vary by product group and are dictated by specific directives or regulations. These assessments address various types of risks associated with different products, such as mechanical, electrical, chemical, or structural hazards. To ensure compliance with EU compliance, it’s essential to refer to the relevant directives, standards, and regulations applicable to your specific product category.
Risk analysis by Certification Experts
Certification Experts is equipped to provide comprehensive support for Risk Assessment across a wide range of product groups. Our expertise extends to assisting in the development or guiding the process of Risk Assessment. This support is tailored to meet the unique requirements specified by the relevant directives, standards, and regulations that pertain to your specific product category.
The experts of Certification Experts use Safexpert to carry out the risk analysis for machinery and electrical products. Our team will outline the process on the basis of a Risk Analysis Template and conduct it. This will ensure clarity regarding which risks need to be reduced. In addition, our experts will assist you in drawing up and checking the associated documentation and a completed Risk Assessment Template. When the risk assessment, analysis and possible reduction have been carried out correctly and completely, your product is in compliance with safety legislation and you can safely trade or put your product into use within the EU market. This is provided only if nothing changes in the design of your product that could affect the safety of its intended use.
Certification Experts offers Safexpert software to enable manufacturers to carry out their own risk assessments as well. The Safexpert’s software has different risk assessment templates, which ensures an easier process when compiling a risk assessment. With the help of this program you can easily do a Risk Analysis yourself, or, if you find this intimidating, have it performed by our experts. In addition, our experts regularly give webinars about the program where you can ask all your questions.
Our experienced team collaborates closely with you to ensure that the applicable Risk Assessment is conducted meticulously and accurately, taking into account all relevant factors associated with your product’s design, manufacture, use, and potential hazards. We aim to help you navigate the complex landscape of regulatory compliance, enabling you to achieve EU compliance and ensuring the safety and quality of your products within the European market. Whether your product falls under machinery, electronics, medical devices, or any other category, Certification Experts is committed to facilitating a thorough and compliant Risk Assessment process that aligns with the applicable CE marking requirements.
Obtain a Risk Analysis with the help of our team of experts
All the answers you might need!
A risk assessment has a three-part process that includes:
- Risk identification
- Risk analysis
- Risk evaluation
The 4 C’s of online risks of harm are:
- Content
- Contact
- Conduct
- Contract risks
Each risk assessment is specific to each product, however a general process goes as follows: an initial risk assessment is carried out after the concept or design phase. This allows certain safety measures to be introduced during the engineering phase; when they can still be processed easily and at little cost. After the engineering phase, a second risk assessment follows, and risk reduction can take place. A final risk assessment follows after the construction phase. This should show that all risks have been minimised. If this is not the case, adjustments will have to be made again in one of the earlier phases. Certification Experts offers Safexpert software to enable manufacturers to carry out their own risk assessments. The Safexpert software has different risk assessment templates, this ensures an easier process when compiling a risk assessment.
A risk matrix is used during a risk assessment to define the level of risk. This is done by considering the category of probability or likelihood against the category of consequence severity, and is used to increase the visibility or risks and assist management in decision making. When using our Safexperts software, a Risk Assessment Matrix will be included as well.
A risk assessment is the process your product goes through to determine the hazards, risks and measures, which the manufacturer is ultimately responsible for its correct implementation. Herein, you identify hazards and risk factors that have the potential to cause harm (hazard identification) and analyse and evaluate the risk associated with that hazard (risk analysis, and risk evaluation).
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