User has to just check the applicability of relevant documents, requirements of relevant directives and then can modify to suit the product under the certification. It is a comprehensive technical file, which can be used by any type of products. Technical File (46 Different processes as required in CE Mark Technical File): Under the main directories, further files are provided in MS Word document as per the details given below.ġ. Retain documented information (Forms / Templates) Maintain documented information (Technical File with individual processes etc.)Ģ. Two types of documented information are provided in this kit, as listed below:ġ. But for making the system better, we have provided many editable templates from which a user can select templates as per their own requirement and make some minor changes in them to make own system. In the Technical File, documented information (processes described in individual file, etc.) are required a few places only. You can make changes as per your organization’s need and within few days your entire Technical File with all necessary controls will be ready. All documents are in MS Word files and you can edit them. Our documentation kit (Technical file) contains sample documents required for CE certification as listed below. Our sample product technical file for CE Mark can be used for the preparation of technical file for any kind of industry after providing necessary details of your company and your products and necessary changes done with the guidelines given in this model technical file.
Test reports from external laboratories.Packaging qualification (Plan & Report).Materials specifications for various products.The procedure of Handling of Non-conformities.Procedure for product classification and conformity root (Only sterile products).Procedure for Failure mode effective control analysis.Process for Handling, storages Packaging, Preservation and Delivery.Procedure for Identification and Traceability.Procedure for equipment operations and maintenance.Procedure for controlled environment conduct (with contamination control.Product Descriptions -Technical Specification.Quality Control and Manufacturing Facilities.Scope of Products under CE Certifications.Note: The sample CE technical file provided by us is a sample and the company needs to make its own technical file after considering its own system, as well as applicable directives and product and necessary samples, are given in the CE technical file for CE certification.
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