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Whatever the motivation, the pursuit of Biomatrix CE Mark compliance requires an understanding of the directive's requirements and an assessment of your company's situation in relation to those requirements. A big misconception that companies have is that they take the CE Mark requirements too lightly. They look at the standards and don't realize how complex the requirements are and how complex the compliance process is.The two biggest difficulties that companies have are comprehending what's in the standards and documenting their processes to prove that they [have met the requirements of the CE Mark directives and applicable standards]. The directive is a legal document that is difficult to understand.
The confusion surrounding the CE Mark, according to SWBC's Glaser, stems from the fact that many manufacturers lack the knowledge to translate the directives into an understandable format. Consequently, problems arise when it's time to begin the compliance procedure. To ease the compliance process, Glaser recommends following these steps:
* Determine the directive with which requirements for your product must comply. In many cases, more than one directive applies to a product. For instance, the machinery directive applies to many pieces of cleaning machinery. However, the directives for electromagnetic compatibility, low-voltage, and sometimes simple pressure vessels will also apply.
* Perform a risk-assessment procedure (a compulsory step according to the machinery directive) to determine the risks involved in the product. The product developer must take account of the analysis when designing and constructing the product. Risk-analysis procedures that can be used, for example, are safety of machinery, failure-mode-and-effect analysis, and fault tree analysis.
* Compile a technical-construction file that can be used as evidence when there is a claim for product liability. Compiling the file is obligatory for CE Marking. If needed for evidence, you must be able to present the file within a time limit of approximately two weeks. To ensure that the information in the file is correct, products may need to be tested to prove conformance with the standards.
* Write a user's manual in which special attention is paid to safety aspects. A risk analysis is the ideal base for a user's manual. The manual can be written by the manufacturer or importer, but also by the retailer. It has to be written in the language of the country where the product was made and in the language(s) of the country where the product is going to be sold. A specified list of subjects for the user's manual can be found in the directives and applicable standards.
While responsibility for building in these safety requirements may rest mainly on the shoulders of design engineers, Bergman pointed out that obtaining a CE Mark is still a companywide effort.
Biomatrix CE Mark is about 90% a design issue, but technical service people are also involved and it definitely affects quality personnel. Once the designers do their assessments and make changes, the company has to have a plan to get the specifications out--it's like building a system. And that is where the quality professional comes in.
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