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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II APPLICATION FOR EXEMPTION CHAPTER III EXAMINATION FOR INSPECTION EXEMPTION CHAPTER IV SUPERVISION AND ADMINISTRATION CHAPTER V SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. In order to guarantee the quality of import and export commodities, to encourage the import and export of high-quality commodities and to promote the development of foreign economic and trade relations, these Measures have been formulated in accordance with the relevant provisions of the Law of the People's Republic of China on Inspection of Import and Export Commodities and the detailed rules for implementation thereof. Article 2. With respect to any import and export commodities included in the catalog of import and export commodities that must be subject to inspection (excluding the commodities provided for in Article 6 of these Measures), the consignee, consigner or the manufacturing enterprise of the commodity (hereinafter referred to the applicant) shall file the application with the State General Administration for Quality Supervision, Inspection and Quarantine (hereinafter referred to AQSIQ), which shall examine the application, and if the approval is granted, the commodity may be exempted from the inspection (hereinafter referred to exemption). Article 3. The AQSIQ shall administer the exemption of import and export commodities of the whole country uniformly, and be in charge of the check, examination and approval, and supervision and administration of the manufacturing enterprises applying for exemption. The agencies of entry and exit inspection and quarantine stationed at the localities by the AQSIQ (hereinafter referred to the inspection and quarantine agencies) shall be in charge of the preliminary examination and the supervision and administration of the manufacturing enterprise applying for exemption under their respective jurisdiction. Article 4. The application, examination, approval, supervision and administration of the exemption of import and export commodities shall be carried out pursuant to these Measures. CHAPTER II APPLICATION FOR EXEMPTION Article 5. To apply for exemption of import and export commodities, one shall meet the following conditions: (1) The quality of the import and export commodity applying for exemption shall be stable for a long period and have a good reputation in the international market, there shall be no dispute, claim or return of product arising due to the manufacturing enterprise's responsibilities, and the commodity shall have an acceptance rate of 100% in the inspections conducted by the inspection and quarantine agency for successive 3 years; (2) The commodity applying for exemption shall have its own brand, and the product grade and quality shall be at a leading position comparing with those of the same industry of the relative countries or regions; (3) With respect to the import and export commodity applying for exemption, its manufacturing enterprise shall have a quality management system that meets the ISO9000 quality management system standard or the management system standard corresponding to the characteristics of the commodity, and the quality management system shall have been certified by the authoritative certification agency; (4) To meet the work needs and to guarantee the product quality, the manufacturing enterprise of the import and export commodity applying for exemption shall have considerable testing capacity; and (5) The manufacturing enterprise of the import and export commodity applying for exemption shall meet the requirements provided for in the Examination Conditions for Inspection Exemption of Import and Export Commodities. Article 6. Applications for exemption of any of the following import and export commodities shall not be accepted: (1) Food, animals and plants and the products thereof; (2) Dangerous goods and the packages thereof; (3) Commodities of which the quality fluctuates severely or which are transported in bulks; or (4) Commodities for which the certificates of inspection and quarantine are required or for which the foreign exchange is settled on the basis of the weight, quantity, or quality, listed in the certificates of inspection and quarantine. Article 7. An applicant shall file the application for exemption pursuant to the following provisions: (1) In case of applying for exemption of import commodity, the applicant shall file the application with the AQSIQ. In case of applying for exemption of export commodity, the applicant shall file the application first with the inspection and quarantine agency directly under the AQSIQ of the place where it is located, and only after passing the preliminary examination conducted by that agency pursuant to the relevant provisions of these Measures, may it file the formal application with the AQSIQ; and (2) The applicant shall fill out and submit the application form for inspection exemption of import and export commodity in triplicates to the AQSIQ, and shall at the same time submit the certificate of ISO9000 quality management system certification or the certificate of management system certification corresponding to the characteristics of the commodity applying for exemption, the quality management system documents, the quality standard, the certification of acceptance rate and the opinions on preliminary examination produced by the inspection and quarantine agency, and the opinions of the users and other documents of the manufacturing enterprise of the commodity applying for exemption. Article 8. The AQSIQ shall examine the documents submitted by the applicant, and give the following written replies within 1 month: (1) Where the documents submitted by the applicant are in conformity with these Measures, they shall be accepted; those not in conformity with these Measures shall be rejected, and the applicants shall be notified in written form; (2) Where the documents submitted are incomplete, the applicant shall be notified to supplement the lacking part, if the applicant fails to do so within the specific time limit and the documents supplemented are still incomplete, it shall be deemed that the application is cancelled. CHAPTER III EXAMINATION FOR INSPECTION EXEMPTION Article 9. The AQSIQ shall, after accepting an application, form an examination group of exemption experts (hereinafter referred to the examination group), and finish the assessment and examination within 3 months. The examination group shall be composed of the personnel of the inspection and quarantine agency of a place other than the place where the applicant is located, and the group leader shall be in charge of the examination. The group members shall be familiar with the inspection technology and management of the commodity applying for exemption. Article 10. If the applicant believes that any member of the examination group has interest relations with the exemption examination and may make an unfair assessment, it may apply for withdrawal of that member. The withdrawal of a member of the examination group shall be decided by the AQSIQ. Article 11. An examination group shall work pursuant to the following procedures: (1) Examining the exemption application form and the relevant materials submitted by the applicant; (2) Examining the preliminary examination form and the relevant materials provided by the inspection and quarantine agency; (3) Studying and working out the specific scheme on exemption examination and announce the scheme to the applicant; (4) Checking and testing the commodity applying for exemption and presenting the check and testing report; (5) Assessing the manufacturing enterprise pursuant to the scheme on exemption examination and the Examination Conditions for Inspection Exemption of Import and Export Commodities; and (6) According to the situation of spot assessment, submitting the exemption examination report to the AQSIQ and giving clear opinions on whether the exemption shall be allowed, and filling out the Report on Exemption Examination of Import and Export Commodities. Article 12. The AQSIQ shall, according to the examination report submitted by the examination group, deal with the exemption application filed by the applicant in the following ways: With respect to that in conformity with these Measures, the AQSIQ shall approve the exemption and issue the Certificate of Exemption of Import and Export Commodity (hereinafter referred to the Exemption Certificate) to the applicant. With respect to that not in conformity with these Measures, the AQSIQ shall not approve the exemption and shall notify the applicant in written form. Article 13. Not until 1 year after the day of receiving the written notification may the applicant, whose application for exemption has not been approved, file the application again with the inspection and quarantine agency. Article 14. The examination group shall keep secret the manufacturing technology, manufacturing techniques, check and testing results and examination results of the applicant. Article 15. For the import and export commodities of which the exemption has been approved, if the certificate of inspection and quarantine is required, the inspection and quarantine agency shall conduct inspection and quarantine over those import and export commodities. CHAPTER IV SUPERVISION AND ADMINISTRATION Article 16. The valid term of a certificate of exemption is 3 years. If the inspection-exempted enterprise requests for extension upon expiration of the certificate, it shall file an application for extension with the AQSIQ 3 months before the expiration, and if the enterprise passes the reexamination carried out by the AQSIQ, a new certificate of exemption shall be issued to it. Article 17. An inspection-exempted enterprise may not change the scope of the inspection-exempted commodity, in case of any change, it shall apply for exemption over again. Article 18. Where the inspection-exempted commodity is imported or exported, the inspection-exempted enterprise may go through the release procedures with the inspection and quarantine agency on the strength of the valid certificate of exemption, contract of foreign trade, letter of credit, and the quality certification and certification of qualified package of that commodity. Article 19. An inspection-exempted enterprise shall, before the end of January of each year, submit to the AQSIQ the report on the import and export of inspection-exempted commodity of the previous year, which shall include the import and export of the previous year, the quality and quality management of that commodity. Article 20. The inspection and quarantine agencies shall be in charge of the daily supervision and administration of the inspection-exempted import and export commodities under their respective jurisdiction. Article 21. If an inspection and quarantine agency finds out in the supervision and administration that the quality management or product quality of any inspection-exempted enterprise fails to meet the requirements of exemption, it shall order that inspection-exempted enterprise to make rectification with a specific period, which shall range from 3 to 6 months. During the rectification, the exemption of import and export commodity of that inspection-exempted enterprise shall be suspended. Article 22. An inspection-exempted enterprise shall, after finishing the rectification within the prescribed period, submit the rectification report to the inspection and quarantine agency directly under the AQSIQ, and the exemption for that enterprise may not be resumed before that report passes the examination by the AQSIQ. Article 23. If, in the supervision and administration, an inspection and quarantine agency directly under the AQSIQ finds out that an inspection-exempted enterprise has any of the following situations, it may cancel the exemption of that inspection-exempted enterprise upon the approval of the AQSIQ: (1) Failing to comply with Article 5 of these Measures; (2) Failing to meet the requirements after rectification within the prescribed period; (3) Committing frauds to import and export counterfeited inspection-exempted commodities; or (4) Other violations of the laws and regulations on inspection and quarantine. Article 24. The enterprise of which the exemption has been written off may no longer enjoy the exemption of import and export commodity from the day of receiving the notification concerning the written-off, and may not file an application for exemption again until 3 years later. CHAPTER V SUPPLEMENTARY PROVISIONS Article 25. The inspection and quarantine agencies may not collect any inspection charges within the exemption period. Where it is needed to produce the certificates of inspection and quarantine or visas, or to make selective inspections over the inspection-exempted import and export commodities, the inspection and quarantine agencies shall do so and collect the charges pursuant to the provisions. Article 26. If any applicant or inspection-exempted enterprise, in violation of these Measures, commits frauds, conceals the facts or conducts deceitful acts, it shall be punished pursuant to the relevant laws and regulations. Article 27. If any working staff of inspection and quarantine, in violation of these measures, abuses his powers, neglects his duties or seeks private benefits by wrongful means in the assessment, examination, approval or daily work, he shall be dealt with pursuant to the relevant laws and regulations. Article 28. The power to interpret these Measures shall remain with the AQSIQ. Article 29. These Measures shall come into force on October 1, 2002. The Examination Conditions for Manufacturing Enterprises of Inspection-exempted Commodities (Trial) promulgated on September 6, 1991, and the Measures for Inspection Exemption of Import and Export Commodities promulgated on August 1, 1994 by the former State Administration of Commodity Inspection shall be abolished at the same time. Attachments: 1. Import & Export Commodities Inspection Exemption Criteria 2. Import & Export Commodities Inspection Exemption Application Form (omitted) 3. Import & Export Commodities Inspection Exemption Review (omitted) ATTACHMENT 1: IMPORT & EXPORT COMMODITIES INSPECTION EXEMPTION CRITERIA I. Inspection Basis: Article 5 and any relevant provisions of Import And Export Of Commodities Inspection Exemption Measures II. Spot Inspection Principles & Methods: Import & Export Commodities Inspection Exemption Form The Examination Form of Exemption Examination of Import and Export Commodities (hereinafter referred to Inspection Form) is formulated in reference with ISO/DIS9000: 2000, which mainly applies to the spot inspection of quality management system of the inspection-exempted manufacturing enterprises of import and export commodities. Inspection opinion in the Inspection Form shall fall within the following categories: qualified, observation needed, unqualified, not applied. Qualified: fulfilling requirements; Observation needed: having problems, which do not constitute disqualified or evidence is not enough to justified disqualified opinion; Disqualified: failing requirements; Not applied: the item does not apply to the actual situation of the enterprise. III. Quality Management System Inspection Result: 1. Those meeting all requirements of the Inspection Form shall be qualified; 2. Where requirements are not met, the total and the seriousness of the requirements that are not met on the overall product quality and the quality management system shall be further analyzed before classifying as "qualified without correcting principles" or "disqualified"; 3. Product inspection is the "must" item of any spot inspection and product quality must fulfill all relevant product inspection requirements. IMPORT & EXPORT COMMODITIES INSPECTION EXEMPTION FORM I. Quality Management System Inspection Content: A. The enterprise shall establish, implement, maintain and continually improve the quality management system of documentation. No. / Inspection Key-points: 1 /Whether the quality management system of documentation has been established, including the quality manuals, procedure documents and quality records that meet the requirements of the standard 2 /Whether the documents are feasible and can be inspected. 3 /Whether the staff members have mastered the requirements for using the operation directions and the relevant record forms for spot work. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks II. Management Responsibilities: Inspection Content: A. The manager with the highest power shall establish the quality guidelines and quality objectives, and implement them among the personnel at all levels. No. / Inspection Key-points: 4 /The quality guidelines and quality objectives approved by the manager with the highest power have been established and promulgated. 5 /Whether the quality objectives are consistent with the overall requirements of the quality guidelines. 6 /Whether the quality guidelines and quality objectives are formulated in light of the actual situations of the enterprise and are easy for understanding, and whether the personnel at various levels have grasped and carried out the guidelines and objectives. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: B. The enterprise shall set up the relevant organizational structure, define their duties, limit of authorities and the relationship between each other. No. / Inspection Key-points: 7/ Whether the relevant organizational structures have been set up, and whether the duties, limit of authorities of the organizational structures and the personnel of quality management, execution and inspection, and the relationship between each other of them have been defined. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: C. The manager with the highest power shall appoint the manager representative, and define his duties and limit of authorities. No. / Inspection Key-points: 8/ Whether the manager with the highest power has appointed the manager representative, and clearly defined his duties and limit of authorities. 9/Whether the manager representative has the adequate experience, capacity and authorization to perform his duties. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: D. The enterprise shall establish the procedures for the formation of documents to clearly provide for the approval, promulgation, distribution, modification, withdrawal, and filing of the documents. No. / Inspection Key-points: 10 /Whether the procedures for the formation of documents have been established to control all the documents required to be controlled 11 /Whether the documents have been approved by the authorizer before promulgation, and whether the scope of distribution of the documents has been provided for and whether there are records of distribution. 12 /Whether the enterprise can ensure that all the documents used at the distribution places are the valid version. 13 /Whether the modification of documents have been examined and approved by the competent department. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: E. The enterprise shall clearly provide for the control of quality records. No. / Inspection Key-points: 14/ Whether the enterprise has formulated provisions on the mark, collection, catalog, borrowing, filing, storing, searching, keeping and handling of quality records and earnestly carried out such provisions. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: F. The quality records shall be clearly written, be formative and complete, and be kept in good conditions. No. / Inspection Key-points: 15 /Whether the quality records are clearly written, are formative and complete, are easy to keep and get, and are kept in good conditions. 16/Whether the duration of the keeping of the records has been provided for. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: G. The enterprise shall establish a management review system. No. / Inspection Key-points: 17/ Whether the management review system has been established. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: H. The manager with the highest power shall make the management review according to the plan. No. / Inspection Key-points: 18/ Whether the manager with the highest power has made the management review according to the plan. 19/ Whether the manager with the highest power has, after the management review, worked out the report of the review and taken effective measures to make improvement. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks III. Resources Management Inspection Content: A. The enterprise shall have the personnel meeting the needs of the production and the quality management system. No. / Inspection Key-points: 20/ Whether there are adequate human resources that meet the requirements for the relevant training and qualification of personnel. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: B. The enterprise shall establish the training procedures to provide for the needs, plan, assessment, determination and records of the training. No. / Inspection Key-points: 21/ Whether the training procedures have been established. 22/ Whether the enterprise has worked out the training plan according to the training needs, and carried out the training pursuant to that plan. 23/ Whether the enterprise has kept the records of training, assessment, and qualifications in good conditions, and made them available for consultation. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: C. The enterprise shall have the equipment and environment needed to produce qualified products. No. / Inspection Key-points: 24/ Whether there are production place and facilities fit for the production of qualified products. 25/ Whether the work environment such as the factories and workshops are under strict management. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks IV. Products Inspection Content: A. The enterprise shall establish the procedures in connection with the manufacturing process of products No. / Inspection Key-points: 26/ Whether the procedures for controlling the product manufacturing process have been established. 27/ Whether the technical requirements or operation directions for the working procedures of the manufacturing process have been formulated. 28/ Whether the operating workers have mastered the technical requirements or operation directions, and operated pursuant to the requirements thereof. 29/ Whether the enterprise has adopted the suitable production equipment, and formulated the systems of repairing and maintenance of production equipment and earnestly carried out such systems. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: B. The enterprise shall determine the departments of service and provide for the duties thereof. No. / Inspection Key-points: 30/ Whether the enterprise has determined the departments of service, provided for the duties thereof, and prescribed that such departments should be in charge of providing necessary information to the customers and finding out the customers' requirement. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: C. The enterprise shall establish a system of review of the product requirements. No. / Inspection Key-points: 31/ Whether the enterprise has established the system of review of product requirements and provided for the duties thereof. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: D. The enterprise shall prescribe the review of contracts and orders. No. / Inspection Key-points: 32/ Whether the contracts or orders have been reviewed and whether there are complete records. 33/ Whether any order is accepted by oral form, and whether there are records and confirmations. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: E. When the product requirements are changed, the enterprise shall modify the relevant documents and take charge of the implementation of the modified documents. No. / Inspection Key-points: 34/ When the product requirements are changed, whether the enterprise has modified the relevant documents pursuant to the provisions, and distributed the modified documents to the relevant departments timely. 35/ Whether the relevant materials of review of the product requirements have been kept in good conditions. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: F. The enterprise shall establish the procedures for product design and development, and shall clearly prescribe the product design and development, review, verification and modification. No. / Inspection Key-points: 36/ Whether the procedures for product design and development have been established. 37/ Whether the enterprise has prescribed the duties and powers of the relevant departments and qualified personnel that take part in the design and development. 38/ Whether the design and development are carried out pursuant to the plan and the development of requirements. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: G. Systematical review and verification shall be made on the design and development. No. / Inspection Key-points: 39/ Whether systematical review and verification have been made on the design and development, and whether there are relevant records. 40/ Whether the change of design and development has been approved by the authorizer, and whether records are taken after alteration and filed as documents under control. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: H. The enterprise shall establish the system of controlling the purchase quality. No. / Inspection Key-points: 41/ Whether the system of controlling the purchase quality has been established. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: I. The purchase documents shall define the requirements of purchase and be approved by the authorizer. No. / Inspection Key-points: 42/ Whether the purchase documents have defined the requirements of purchase and been examined and approved by the authorizer pursuant to the provisions. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: J. The enterprise shall prescribe the evaluation method for selecting the suppliers of purchase. No. / Inspection Key-points: 43/ Whether the evaluation method for selecting the suppliers of purchase has been prescribed, and whether the records of the suppliers have been established. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: K. The enterprise shall prescribe the verification and release of the products purchased. No. / Inspection Key-points: 44/ Whether the methods for purchase verification and release have been set forth, and been carried out earnestly. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: L. The enterprise shall clearly prescribe the marks used in product manufacturing, installation and service. No. / Inspection Key-points: 45/ Whether the enterprise has clearly prescribed the marks used in product manufacturing, installation and service. 46/ Whether the enterprise has prescribed the mark of inspection in the manufacturing process. 47/ Whether the enterprise has strictly executed the provisions on product marks during the manufacturing process, and all the following stages, like delivery and installation, and whether the provisions are retroactive. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: M. The enterprise shall clearly prescribe the transport, package, storage and protection of the products that are processed by it and delivered to the final users. No. / Inspection Key-points: 48/ Whether the enterprise has clearly prescribed the transport, package, storage and protection of the products, and the package shall meet the relevant requirements of entry and exit inspection and quarantine. 49/ Whether the transport methods are in conformity with the provisions and whether such methods can prevent damage. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: N. The enterprise shall clearly provide for the place, warehouse storing the products and the management of storage, thus to prevent the stored products from damage or deterioration. No. / Inspection Key-points: 50/Whether the enterprise has clearly provided for the place, warehouse storing the products and the management of storage. 51/ Whether the enterprise has established the provisions on the products' entry and exit of the warehouse, and actually carried out such provisions. 52/ Whether the package and the materials used thereby are fit for protecting the quality of the products. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: O. The enterprise shall take measures to guarantee the quality of the products delivered. No. / Inspection Key-points: 53/ Whether the final inspection and delivery can guarantee the quality of the products. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: P. The enterprise shall provide for the product inspection and take charge of the implementation. No. / Inspection Key-points: 54/ Whether the enterprise have provided for the product inspection, and whether the inspection process and the final products meet the requirements. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: Q. The purchased goods must pass the inspection before they are put into use. No. / Inspection Key-points: 55/ Whether the inspection of purchased goods has been carried out with records taken pursuant to the provisions. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: R. The enterprise shall provide for the inspection of process, and may not release the goods before the inspection is finished. No. / Inspection Key-points: 56/ Whether the enterprise has carried out the inspection of process and taken records of inspection results pursuant to the provisions, and whether the enterprise has released the products only after they pass the inspection. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: S. The enterprise shall provide for the final inspection No. / Inspection Key-points: 57/ Whether the enterprise has clearly provided for the final inspection, and whether has carried out the final inspection and taken records pursuant to the provisions. 58/ Whether there is evidence that can prove that the delivered products are in conformity with the requirements and the conformity is retroactive. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: T. The enterprise shall provide for the management of the inspection, measuring and equipment. No. / Inspection Key-points: 59/ Whether the enterprise has provided for the management of the inspection, measuring and equipment, and actually carried out such provisions. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: U. The enterprise shall work out the plans on the adjusting and periodical check of the equipment to ensure that the equipment is put into use only after it has been adjusted and has passed the check No. / Inspection Key-points: 60/ Whether the enterprise has worked out the plans on the adjusting and periodical check of the equipment, and actually carried out such plans. 61/ Whether the enterprise has established the archives of the equipment, and whether such archives can show the measurement uncertainty, adjusting, repairing and maintenance. 62/Whether the status of use has been indicated on the existing testing equipment. Inspection Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: V. The testing equipment shall be placed under the prescribed environment and circumstances. No. / Inspection Key-points: 63/ Whether the environment and circumstances under which the testing equipment is place are in conformity with the prescribed requirements. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: W. After repairing or maintenance, the testing equipment shall be adjusted and checked before the next use. No. / Inspection Key-points: 64/ After repairing or maintenance, whether the testing equipment has been adjusted and checked before the next use. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks V. Measuring, Analysis, and Improvement Inspection Content: A. The enterprise shall establish an internal auditing system. No. / Inspection Key-points: 65/ Whether the internal auditing system has been established. 66/ Whether the enterprise has provided for the frequency of internal auditing, and conducted internal auditing pursuant to the requirements of the plan. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: B. The personnel conducting internal auditing shall be trained. No. / Inspection Key-points: 67/ Whether the personnel of internal auditing have been trained and certified, and whether the auditing personnel have no direct relation of responsibility with the auditing. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: B. The personnel conducting internal auditing shall be trained. No. / Inspection Key-points: 67/ Whether the personnel of internal auditing have been trained and certified, and whether the auditing personnel have no direct relation of responsibility with the auditing. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: C. An auditing report shall be produced after internal auditing and effectiveness of the quality management system shall be evaluated No. / Inspection Key-points: 68/ After internal audit, whether an audit report is formed, the effectiveness of the quality management system shall be evaluated and the result shall be passed to the management. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: D. The enterprise shall take prompt measures to correct the errors found out in the auditing and effectively track the correction. No. / Inspection Key-points: 69/ Whether the enterprise has taken prompt measures to correct the errors found out in the auditing, and tracked and supervised the correction. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: E. The enterprise shall establish the verification procedures of the products to be delivered, and the release of the products to be delivered shall be approved by the authorizer. No. / Inspection Key-points: 70/ Whether the enterprise has established the verification procedures of the products to be delivered, and whether there are records, with the signature of the authorizer, of the delivered products that have been released. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: F. The enterprise shall establish the system of control of unqualified products. No. / Inspection Key-points: 71/ Whether the enterprise has established the system of control of unqualified products. 72/ Whether the enterprise has provided for the marking, recording, appraising, separating and treating of the unqualified products. 73/ Whether the marking, storing, recording and treating of the unqualified products are in conformity with the prescribed requirements. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: G. The unqualified products that can be corrected shall be verified over again after the correction. No. / Inspection Key-points: 74/ Whether the unqualified products have any record of being returned for work or repair, and whether the products have been inspected again after the work and repair. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: H. The enterprise shall establish the procedures for corrective measures. No. / Inspection Key-points: 75/ Whether the enterprise has established the procedures for corrective measures. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: I. The enterprise shall analyze the causes for the unqualified products and take effective corrective measures. No. / Inspection Key-points: 76/ Whether the enterprise has, after analysis of the causes for the unqualified products, taken the corrective measures and effectively implemented such measures. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: J. The enterprise shall establish the procedures for preventive measures. No. / Inspection Key-points: 77/ Whether the procedures for preventive measures have been established. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks Inspection Content: K. The enterprise shall identify and analyze the potential causes for unqualified products, and take effective preventive measures. No. / Inspection Key-points: 78/ Whether the enterprise has, after identifying and analyzing the potential causes for unqualified products, taken effective preventive measures. Opinion: Qualified / Disqualified/ Observation needed / Not applied / Remarks VI. Product Inspection Inspection Content: A. The products manufactured by the enterprise must pass the inspections. Inspection Key-points: Product inspections can be divided into: 1. Before the spot examination, the examination group members select some products pursuant to the relevant standards to go through the all-item inspection at the designated laboratory; 2. During the spot examination, the members select some products pursuant to the relevant standards to go through the spot inspection or to the designated laboratory for inspection. Opinion/ Remark: 1. Product inspection must be qualified. Inspection Content: B. The results of laboratory testing of the enterprise shall be accurate. Inspection Key-points: 1.The enterprise's laboratory conducts testing on the blind samples or standard samples provided by the examination group; 2.The enterprise's laboratory presents the certifications of the comparison experiment conducted with the designated laboratory; 3.If necessary, repeated experiments shall be conducted on the sample left from the product inspection. Opinion/ Remark: 2. Enterprise laboratory test result must be accurate. |
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