Your query seems to contain a typo, but I'll send you information based on what I can gather. Here are some general requirements if you're talking about records and paperwork that need to be kept for a CE (Conformité Européenne) inspection and product certification. Remember that depending on the product type and any relevant guidelines or rules, particular needs could change.
Technicolor Records:
A declaration stating that a product complies with applicable EU rules or regulations is called a Declaration of Conformity (DoC).
Technical Record: a thorough dossier with all the technical details regarding the design, manufacturing process, test results, and product.
Records of Design and Manufacturing:
Design specifications: Comprehensive details on the design, comprising schematics, sketches, and specifications.
A list of all the materials and parts used in the product is called the bill of materials (BOM).
Records and procedures pertaining to the manufacturing process are called manufacturing process documentation.
Evaluation and mitigation of risks:
Documentation for Risk Assessment: Identification and evaluation of possible dangers related to the product, as well as risk-reduction tactics.
Records of Tests and Certifications:
Test Reports: Extracted from testing carried out to show that the product complies with applicable requirements.
Certification from Notified Body: In the event that it is relevant, certification from a Notified Body attesting to adherence to particular guidelines.
Marking & Labeling:
Product Labeling: Details on the necessary labeling for the product, including CE marking specifications.
User Guides & Instructions: Users should receive thorough instructions that include safety information.
Documentation of the Quality Management System (QMS):
Quality Manual: Records detailing the established quality control system.
Records of Inspections and Audits: A record of the inspections and internal audits that are conducted as part of the quality control system.
Details about the supplier:
Supplier Declarations of Conformity (SDoC) are statements from suppliers attesting to the materials or components that they provide you with being compliant with applicable standards.
Reliability Documents:
Traceability Records: Records that show where each product unit came from and how long it has been around.
Records of incidents and corrective actions:
Reports on Incidents: Records any mishaps involving the product.
Records of Corrective and Preventive Action (CAPA): Actions performed to rectify non-conformities or enhance procedures are documented.
The particular needs of the relevant guidelines and regulations must be verified for your product, as the records and documentation may differ depending on the product type, industry, and relevant standards. If necessary, consulting a Notified Body can also offer advice on the paperwork needed to obtain CE certification.
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