Basic procedure of compulsory product certification 1) certification application and acceptance 2) sampling inspection 3) initial factory evaluation 4) evaluation and recognition of certification results 5) supervision after certification The compulsory product certification system can choose one or more of the following certification modes (self-declaration is the development direction, relying on the improvement of laws and the enhancement of consumers' self-protection awareness)-type test-sampling inspection or manufacturing site inspection-market sampling inspection or inspection-enterprise quality assurance system audit. Factory quality assurance capability review 1. Personnel responsibilities 1.2 The key points of resource demand review are: to determine whether the responsibilities of various personnel related to quality activities are established through conversations and consulting documents; ? Determine whether the person in charge of quality has the ability to perform his duties by talking and consulting documents; Whether the conditions and environment for the quality director to perform his duties are available; ? Determine whether the factory has human and material resources through conversation and on-site verification. 1.3 The review of documents and records focuses on: determining the validity, completeness, conformity and applicability of at least the following documents through talking and consulting documents: the quality plan of certified products or similar documents; ? Standards involved in the detailed rules for the implementation of relevant product certification; ? Program files, at least including the following procedures: authentication mark control; ? Document and record control; ? Purchasing and incoming inspection; ? (production) process control (if necessary); ? Routine inspection and confirmation inspection procedures; ? Calibration and verification procedures for instruments and equipment; ? Non-conforming product control procedures; ? Internal review procedures; ? Product change control procedure. ? Quality records shall at least include the following records: records of supplier selection, evaluation and management; ? Inspection or verification records of key components; ? Operation inspection records; ? Routine inspection and confirmation of inspection records; ? Calibration records of instruments and equipment; ? Records of disposal of nonconforming products; ? Internal audit report, corrective and preventive measures formulated after internal audit, and complaint record. 1.4 The key point of the procurement and incoming inspection review is to determine whether all measures can meet the requirements of ensuring that the purchased key parts and materials meet the requirements specified in the certificate through conversation, document review and on-site confirmation. ? Whether the factory has established procedures for selecting, evaluating and managing suppliers of key components of certified products; ? List of suppliers and process records for factory selection and evaluation; ? By consulting the records, we can know how the factory evaluates and selects suppliers and whether the management of suppliers is effective. ? Whether the factory has established inspection and verification procedures for key parts, and regularly confirm the inspection procedures. By consulting the records, check whether the factory has inspected the purchased key components, whether the key components inspected by the supplier have been verified, and whether the key components are confirmed and inspected regularly; ? Whether the technical requirements specified in the inspection/verification procedure can meet the requirements of product certification of the whole machine; ? Check inspection/verification, and confirm the conformity and effectiveness of inspection activities and the consistency control of key components by consulting records; ? If the factory inspects the key components by itself, it should also inspect the inspection resources of the factory, including the experience and technical ability of the inspectors, the equipped instruments and equipment, their calibration status and environmental conditions; ? Whether the factory has kept inspection or verification records, confirmation inspection records, qualification certificates provided by suppliers and relevant inspection data of key components as required; ? On-site designated test; ? Verification of key components. 1.5 the key points of production process control and process inspection review are:? Does the factory identify key processes and ensure the production process is stable and controlled? Pay special attention to those processes that directly or indirectly affect product safety, such as welding power lines, wave soldering, and fastening key screws. ? Are there any work instructions for these key processes? In the absence of work instructions, inspectors should judge whether the operation results of key processes can be stably controlled without affecting the quality of certified products. Work instructions can be words, pictures, photos, etc. ? Through observation and inquiry, check whether the key process operators can operate skillfully and accurately according to the corresponding requirements; ? Does the factory clearly define the process parameters and product characteristics that need to be monitored? If yes, check whether the monitoring measures have been taken according to regulations, and confirm the compliance and effectiveness of their implementation; ? Whether the factory has established the maintenance system of production equipment, and on-site inspection of the operation status and maintenance records of production equipment; ? Whether the production site has special requirements for the environment, if so, check whether these specific environmental requirements are met. 1.6 The key points of routine inspection and review are:? Whether the factory has established routine inspection procedures, and whether the routine inspection items and inspection conditions specified in the procedures conform to the relevant provisions of the certification implementation rules; ? Conformity of actual operation, such as test stress application position, sample condition, test station and layout, etc. ? Calibration and operation inspection of instruments and equipment; ? Routine inspection records (mainly random inspection of past records); ? Disposal of nonconforming products; ? Product certification bodies in different countries have different requirements for routine inspection. Therefore, the conditions of routine inspection stipulated by the manufacturer may also be inconsistent with the requirements of the certification implementation rules. At this point, the examiner should judge whether the coverage of the test pressure and its technical equivalence meet the requirements; ? Routine inspection shall be carried out after the nonconforming products are repaired. 1.7 confirm that the key points of inspection and audit are:? Whether the factory has established a confirmation inspection procedure; ? Whether the specified inspection items, technical contents and methods conform to the provisions of the certification body; ? Check and confirm the inspection report or record; ? If an external organization is entrusted to carry out the confirmation inspection, the organization shall meet the requirements of ISO/IEC 25 guide or ISO/IEC 17025, and its technical capacity shall be able to undertake the confirmation inspection items; ? If it is confirmed that the inspection is carried out by the factory inspection organization, the technical ability, equipment and calibration, test environment, etc. of the inspectors. It should be mainly on-site understanding. ? When the factory arranges confirmation inspection, the selection of sample model should be representative of batch and model. If possible, we should consider covering all product models that apply for certification; ? The standard for confirmation inspection shall be the national certification standard. However, for foreign factories, international standards corresponding to national standards can also be adopted (including converting international standards into domestic national standards), as long as the testing items and testing conditions are technically equivalent; ? Confirmation inspection is a factory quality management measure. Therefore, instead of on-site confirmation inspection, the following work is carried out in the review process: check and confirm the inspection plan; ? Check and confirm the inspection report; ? Check and confirm the inspection items and standards; ? Check and confirm the nonconformities in the inspection? How to correct and take preventive measures; ? Check whether the corrective and preventive measures are effective; ? Confirm whether the qualification of the inspection organization meets the requirements. ? During the initial factory review, the factory may not arrange the confirmation inspection of mandatory product certification requirements. At this time, it is important to check whether the factory has compiled the confirmation inspection procedure and formulated the confirmation inspection plan. 1.8 review of inspection and test instruments and equipment:? Document review, including consulting the calibration plan, reviewing the relevant provisions of self-calibration, spot-checking instruments and equipment files, viewing calibration certificates or calibration records, etc. ? Check the calibration status label on the use site of instruments and equipment to see if there is any situation beyond the calibration validity period. When the phenomenon beyond the validity period of calibration is found, the following measures should be taken according to the situation:? If the calibration record shows that it has been calibrated, it is necessary to remind the factory to pay attention to it because of negligence and forgetting to change the label or clerical error; ? If it is confirmed that the equipment has exceeded the calibration validity period, the use record of the equipment should be consulted to judge the possible impact on the quality of certified products in various ways. And according to the actual situation or consequences, issue the nonconformities; ? If the instrument exceeds the calibration validity period or is completely out of control, the inspector should consider whether the control of this element is effective. If necessary, the sampling can be expanded to determine whether it constitutes a serious nonconformity. We should be cautious in this situation and have enough objective evidence to draw a conclusion. ? Check whether the calibration activities of external calibration laboratories providing calibration services for factories can be traced back to national/international standards, and whether their qualification management meets the relevant regulations of the host country; ? Check whether the verification institutions and records comply with national regulations (in China); ? Check whether the calibration records meet the requirements and whether the factory can use the calibration records to correctly use the inspection and test instruments and equipment. 1.9 The key points of operation inspection and review are:? Whether the equipment used for routine inspection and confirmation inspection is designated for operation inspection and whether the inspection requirements are clear; ? Whether the samples used for operation inspection are effectively controlled; ? Whether the frequency and method of operation inspection are appropriate; ? Understand whether the operation inspection is implemented as required by consulting the operation inspection records and inquiries, and keep the corresponding records; ? By consulting the relevant regulations and asking the equipment operators, we can know whether the operators take measures and how to take measures when they find that the equipment function fails. ? Whether the evaluation methods and corresponding measures adopted by the factory are appropriate when the equipment fails; ? Spot check the operation inspection records and compare them with the field investigation; ? Whether the result evaluation and treatment measures in case of equipment failure are recorded. 1. 10 What are the key points for the control review of nonconforming products? Check the control procedures of nonconforming products to confirm whether their contents meet the requirements; ? In the whole process of on-site review, we should pay attention to whether the control of nonconforming products is implemented according to the specified requirements; ? Whether the found nonconforming products are identified, isolated and disposed of according to regulations; ? Focus on the records of nonconforming products in incoming inspection, process inspection and final inspection, and pay attention to their disposal; ? Spot check the records of reworked and repaired products to confirm whether they are operated according to regulations; ? Whether corresponding effective measures have been taken for the nonconformities that need to be corrected and/or prevented, and what is the effect. 1. 1 1 The key points of internal audit and corrective action audit are:? Whether there is an internal audit plan; ? Whether all elements can be overwritten; ? Whether the audit is conducted by qualified and trained internal auditors; ? Within one year, the internal audit shall cover all elements in the "factory quality assurance capability requirements"; ? Spot check the internal audit records in the last one or two years, focusing on the audit results of certified product consistency and system effectiveness; ? When consulting the internal audit records, pay attention to whether the internal audit input information contains complaint information, especially the complaints that the certified products do not meet the standard requirements, which should be paid special attention to; ? Confirm whether the problems found in internal audit have been effectively corrected and whether the hidden dangers that may affect product quality have been taken corresponding preventive measures by means of spot check records, inquiry investigation and on-site investigation. 1. 12 What are the key points of conformity review of certified products? When producing batch products, confirm whether the certified products produced in batch are consistent with the samples according to the description of the qualified samples in the type test; ? Whether the factory has formulated control procedures for key components, materials and structural changes (including electromagnetic compatibility requirements), and confirmed whether there are any changes through sample description; If there is any change, whether it is approved by the certification body; ? In the daily supervision of the factory, it should be confirmed whether the products with certification marks are consistent with the samples that have passed the type test, and whether the changes are approved by the certification body. 1. 13 packaging, handling and storage review key points:? During the on-site inspection, check the regulations related to packaging, handling and storage, spot check relevant records and on-site observation to confirm whether the regulations are correctly implemented; ? Whether the storage environment is suitable; ? Is the operator aware of the relevant requirements of product packaging, handling and storage, especially the control requirements of special materials? 2. Conformity review of certified products 2. 1 What is the basis for conformity review of certified products? Product description; ? Type test report (if necessary); ? Application; ? Relevant technical standards. ? Change report approved by certification body 2.2 Compliance review of certified products? The nameplate and logo of the certified product shall be consistent with the logo in the type test report; ? The structure of the certified product shall be consistent with the prototype during the type test; ? The key components used in the certified products shall be consistent with those declared in the type test and confirmed by the certification body. ? The main components that have an impact on electromagnetic compatibility shall be consistent with those declared during the type test and confirmed by the certification body. 2.3 On-site witness test? According to the on-site situation, the certified products are extracted from the finished product warehouse or the end of the production line, and the inspectors designate the items, and the factory inspectors start testing and make records. ~