The Basic Requirements for Factory Inspection
Public Time：2009-12-11
(CQC/PD021-2005)
Article 1
Factory is the first responsible person that ensures the certification product meets the implementation rules for product certification.
Article 2
Factory shall ensure the production comply with the type-test approved product according to the implementation rules and the product certification requirements for factory’s quality assurance ability.
Article 3
Factory shall get the information and request in public document on the website promptly.
Article 4
Factory shall set up and keep at least the following procedure or regulations which have been noted on document and the content of which shall be according with the factory quality management and product quality control:
1. Procedure for keeping, use and control certification mark;
2. Procedure for product modification control;
3. Procedure for document and material control;
4. Procedure for quality record control;
5. Procedure for audit choosing and routine management of supplier;
6. Procedure for inspection and validation for critical components and material;
7. Procedure for verification for critical components and material;
8. Procedure for production equipment maintenance;
9. Procedure for fixed inspection and affirmation inspection;
10. Procedure for unqualified product control;
11. Procedure for Inner quality auditing;
12. The responsibility and interrelation of kinds of personnel who are relevant with quality activity;
Besides, it should also be included that craftwork instructor, inspection standard, operation rules of instrument and equipment, and management system.
Article 5
Factory shall preserve at least the following quality records; to make sure that the factory has implemented the whole production inspection and test in deed, and the quality records should be true and effective;
1. Audit choosing and routine management record on supplier;
2. Keep inspection record on critical components and material, and the qualification proof provided by supplier;
3. Record on the routine tests and verification tests;
4. Record that the inspection and test equipment are adjusted and checked on schedule time;
5. Record on fixed inspection and affirmation inspection on equipment function;
6. Disposition record of unqualified product;
7. Inner auditing record;
8. Record on complaint of customer and the corrective action;
9. Record on schedule verification inspection on components;
10. Implement record of mark usage;
11. Record on correction measure of function inspection;
The storage life of record shall not less than interval between the inspections, namely at least 24 months, to insure that after this inspection, all the record can be checked next time;
Article 6
Factory shall cooperate with certification body to fulfill the activity arrangement of factory inspection. As to initial factory inspection, the factory shall be carried on the inspection according to the schedule time; as to supervision inspection, the factory shall accept it within the set time, simultaneously, the certification body may carry on the supervision inspection (e.g. flight inspection, specific supervision inspection) without any notice according to international tradition, and the factory shall cooperate. Otherwise, certification body is entitled to suspend the certificate.
Article 7
Factory shall allow the inspector to examine all the areas that involved in the certification, read the related record and interview related people (it should declare to the certification body if has area need to be keep in secret especially).
Article 8
Factory shall cooperate with inspection group to carry on the locale appointed test, which is implemented by factory personnel and witnessed by inspection group, according to product peculiarity and concrete condition request of the factory.
Article 9
Factory shall cooperate with inspection group to carry on the consistency inspection of the product, and arrange workers to dismantle the whole machine if it is needed in inspection course.
Article 10
During the inspection, if the certification product changes or in variance, factory shall make out it to inspection group initiatively.
Article 11
If the product needs sample, factory shall cooperate with the inspection to envelop the sample at the locale, and send the sample to the appointed testing labs in set time.
Article 12
Factory shall provide necessary working convenience for inspectors.
Article 13
Factory shall keep in touch with certificate holder and pay the supervision expense (contains man-day fee of supervision and the road), annuity and expense of sample test (if there is).
Article 14
Factory can not give green light to the following product:
1. Non-conforming product;
2. The products which have been modified after getting certificate but not affirmed by certification body;
3. Products which have exceeded its term of validity;
4. Product listed on the certificate that has been suspended, abolished and cancelled.
5. The certification product need to be sealed up for keeping when the conclusion of factory inspection is locale inspection or unqualified.
Article 15
Factory shall inform the certification body of the modification of contact manner.
return