Factory Inspection Introduction

Article 1 the factory is the first responsible person to ensure that the certified products conform to the implementation rules of product certification.

Article 2 the factory shall produce certified products consistent with the qualified samples confirmed by the certification body in accordance with the implementation rules of product certification and the requirements of factory quality assurance capacity.

Article 3 the factory shall timely understand the information and requirements in the online public documents of the certification authority.

Article 4 the factory shall establish and maintain at least the following documented procedures or regulations, and the contents shall be compatible with the factory quality management and product quality control:

（1） Control procedures for the storage and use of certification marks;
（2） Product change control procedure;
（3） Document and data control procedures;
（4） Quality record control procedure;
（5） Supplier selection evaluation and daily management procedures;
（6） Inspection or verification procedures for key components and materials;
（7） Regular verification and inspection procedures for key components and materials;
（8） Production equipment maintenance system;
（9） Routine inspection and confirmation inspection procedures;
（10） Control procedures for nonconforming products;
（11） Internal quality audit procedures;
（12） Responsibilities and relationships of various personnel related to quality activities;

In addition, there should also be necessary process operation instructions, inspection standards, operating procedures of instruments and equipment, management system, etc.

Article 5 the factory shall keep at least the following quality records to prove that the factory has indeed carried out all production inspection and production tests, and the quality records shall be true and effective:

（1） Record the selection, evaluation and daily management of suppliers;
（2） Incoming inspection / verification records of key components and materials and qualification certificates provided by suppliers;
（3） Product routine inspection and confirmation inspection records;
（4） Records of regular calibration or verification of inspection and test equipment;
（5） Record of routine inspection and validation inspection equipment operation inspection;
（6） Disposal records of unqualified products;
（7） Internal audit records;
（8） Records of customer complaints and corrective actions taken;
（9） Regularly confirm the inspection records of parts and components;
（10） Record of the use and implementation of signs;
（11） Corrective records of non conformity in operation inspection;

The storage life of records shall not be less than the time interval between two inspections, i.e. at least 24 months, so as to ensure that all records generated after this inspection can be found in the next inspection.

Article 6 the factory shall cooperate to complete the arrangement of factory inspection activities made by the certification body. For the initial factory inspection, the factory shall carry out the factory inspection according to the planned time agreed with the certification authority; for the supervision and inspection, the factory shall accept the supervision and inspection of the certification authority within the specified period; at the same time, the certification authority can carry out the factory supervision and inspection (such as flight inspection, special supervision and inspection) without prior notice according to international practice, and the factory shall cooperate 。 Otherwise, the certification authority has the right to suspend the certification certificate.

Article 7 the factory shall allow inspectors to enter all areas involved in product certification for sampling or inspection, access to relevant records and visit relevant personnel (if there is any special area that needs to be kept secret, it shall be reported to the certification authority).

Article 8 the factory shall cooperate with the inspection team to carry out the on-site designated test according to the product characteristics and the specific conditions of the factory. The factory shall arrange relevant personnel to carry out the on-site designated test under the witness of the inspection group.

Article 9 the factory shall cooperate with the inspection team to carry out the product consistency inspection. If the disassembly of the whole machine is involved in the inspection process, the factory shall arrange personnel to carry out the inspection.

Article 10 during factory inspection, the factory shall take the initiative to explain to the inspection team if there are changes or inconsistencies in the certified products.

Article 11 when products need to be sampled, the factory shall cooperate with the inspection team to seal the samples on site, and send the samples to the designated testing organization within the specified time.

Article 12 the factory shall provide necessary working convenience for inspectors.

Article 13 the factory shall communicate with the certificate holder and pay the supervision and inspection fee (including the daily fee of supervisor and inspector and the daily fee of passer-by), annuity and product supervision sampling inspection fee (if any).

Article 14 the factory shall not release the following products:
（1） Unqualified products;
（2） Products changed after obtaining the certificate but not confirmed by the certification body;
（3） Products beyond the validity period of certification;
（4） Products listed in the suspended, cancelled or revoked certificates;
（5） When the factory inspection conclusion is judged as on-site verification or failure, the inspector requires the factory to seal up the certified products on site.