Standard No.:	TSG Z7003-2004
English Name:	requirements for quality management system of special equipment inspection agencies
Chinese Name:	特种设备检验检测机构质量管理体系要求
Chinese Classification:	J00    Standardization and quality management
Professional Classification:	TSG    Special Equipment Safety Specification
Issued by:	AQSIQ
Issued on:	2004-12-3
Implemented on:	2004-12-3
Status:	valid
Language:	English
File Format:	PDF
Word Count:	8500 words
Price(USD):	170.0
Delivery:	via email in 1 business day

Chapter 1 General Provisions Article 1 This Requirement was formulated based on "Management Regulations of Special Equipment Inspection Agencies" to standardize the establishment and operation of Quality Management System of Special Equipment Inspection Agencies. Article 2 The constitution of the quality management system of inspection agencies shall be compatible to their own inspection activities and operation mode. Article 3 When inspection agencies incorporate the inspection activities beyond the approval project into the quality management system established on the basis of this Requirement, the relevant requirements in the Chapter 6 "Inspection Implementation" of this Requirement may be increased or decreased according to the actual conditions. Chapter 2 Terms and Definitions Article 4 Except the terms and definitions specified in "Quality Management Systems-Fundamentals and Vocabulary" (GB/T 19000), the following terms and definitions are also adopted in this Requirement: (I) Special equipment, which refers to the boilers, pressure vessels (including gas cylinders), pressure pipelines, elevators, lifting equipment, passenger ropeways, large amusement facilities and motor vehicles in site (plant), which are related to the safety of life and property or with high risks. (II) Inspection for special equipment, which refers to such activities as the supervision inspection for the manufacturing process of special equipment products and components, the supervision inspection for the installing, reforming and significant maintenance process of special equipment, the periodic inspection for special equipment in use, the type test for the special equipment product and component as well as the nondestructive examination (NDE) for special equipment. (III) Legal inspection, which refers to the supervision inspection, periodic inspection and type test forcibly conducted for special equipment according to the national regulations and safety technical specifications. (IV) Special equipment inspection agencies, which refers to the agencies (hereinafter referred to as inspection agencies) that are engaged in the inspection for special equipment, including comprehensive inspection agencies, type test agencies, nondestructive examination agencies and gas cylinder inspection agencies. (V) Subcontracting, which refers to entrusting the special inspection items like the nondestructive examination in the inspection for special equipment to other agencies. Chapter 3 Quality Management System Article 5 General requirements for quality management system are as follows: (I) Inspection agencies shall establish, implement, maintain and continually improve the quality management system appropriate to their inspection activities according to this Requirement; (II) Quality management system shall be documented and shall reach the degree required to guarantee inspection quality and process; the system document shall be transmitted to the persons concerned and be obtained, understood and implemented by them; (III) Inspection agencies shall describe the responsibility and affiliation of internal organizations; if the inspection agencies are a part of the parent organization, also shall describe their positions in the parent organization and the relationship with the parent organization in the aspects of quality management, inspection process control as well as support services; (IV) Inspection agencies shall take actions to ensure that their management layer and personnel are free from any pressure and influence, which have bad effects on the inspection service quality and inspection result, from the wrongful business and financial affairs inside and outside as well as from other aspects; (V) Inspection agencies shall keep confidential the business and technical information obtained in the process of inspection so as to protect the ownership of these business and technical information. Article 6 Quality management system document shall include the following contents: (I) The documented quality guideline and quality objective; Note: The overall objective shall be written in the form of document into the quality policy statement which shall be issued by the top management. (II) Quality manual; (III) The procedure document specified in this Requirement; (IV) The document needed by the inspection agencies to guarantee the effective organization, implementation and control of the inspection procedure, such as operating instructions, management system and record form, etc.; Note: The instruction generally includes: inspection rules, inspection scheme, operation specifications for instrument and equipment, check specification for instrument and equipment, self calibration provision of instrument and equipment as well as safety emergency action, etc. (V) External documents related to the inspection, such as laws, regulations and rules, safety technical specifications and standards, documented notice of relevant government departments as well as the drawing and data of customer, etc.. Note: Document may adopt any forms or types of medium. Article 7 Inspection agencies shall compile and maintain the quality manual in which at least the following contents shall be included: (I) The application scope of the quality management system; (II) Summary for the basic situation of inspection agencies; (III) Inspection scope; (IV) The obligation and service commitments made by inspection agencies to the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, the local quality and technical supervision department (hereinafter referred to as governmental quality inspection department) and to the customers; (V) Organization chart; (VI) The responsibility and authority of the technical director, quality director and the relevant personnel who may affect the inspection quality; (VII) The principled description of each quality element in the quality management system and the description of their interrelationship; (VIII) The quoted program file. Article 8 Program file is the specific exposition of each quality element in the quality management system and constitutes the description of the whole quality management system together with the quality manual. The range of the program file shall cover this Requirement and shall meet the requirements for the development and safety of inspection; the quantity and complication of the program file shall be determined according to the property, scale and working range of the inspection agencies. Article 9 The inspection agencies shall control all the documents (internal or external) covered in this Requirement, Such as quality manual, program file, operating instructions, the adopted laws and regulations, technical specifications and standards, the drawing and data provided by customer as well as the used software, etc.. As a special type of document, the record shall be controlled according to the requirements of Article 28. Inspection agencies shall establish the control procedure of the document required for quality management system operating, to ensure to meet the following requirements: (I) Before being issued, the documents shall be examined and approved by the authorized person so as to guarantee that the documents are sufficient and appropriate; (II) If necessary, the document shall be reviewed and updated, and approved again; if feasible, the amended or new content shall be indicated in the document or the corresponding attachment; (III) The updating and revision state of the document shall be identified; the distribution of the internal and external documents shall be controlled; (IV) The invalid or cancelled documents shall be withdrawn from all the operating sites in order to avoid unexpected using them; for the cancelled documents reserved for the purpose of laws and knowledge preservation, they shall be marked and stored properly; (V) For all the operational sites playing an important role in the operation of inspection agencies, the effective versions of relevant documents may be obtained; (VI) For the document formulated internally, the unique label shall be provided; (VII) For the control of the documents stored in computer system, the above requirements also shall be reached. Chapter 4 Management Responsibility Article 10 Top management of inspection agencies shall reflect that their inspection services meet the commitment of this Requirement via the following activities: (I) Deliver the importance of strictly complying with relevant national special equipment laws, regulations and rules as well as safety technical specifications in the inspection agencies, seriously perform the responsibility entrusted by special equipment laws and regulations and meet the requirements of government and customer; (II) Complete each legal inspection task assigned by government quality inspection department, and accept the supervision and management of government quality inspection department consciously; (III) Formulate quality policy and quality objective; (IV) Establish quality management system and ensure its effective operation and continual improvement; (V) Engage in the legal inspection work within the approved range; (VI) Implement the management review as required; (VII) Ensure that the inspection activity obtains the necessary resources (see Article 17). Article 11 Top management shall take the strengthening of the satisfaction of the government and customer as the management objective and take the guaranteeing of the safety of special equipment as the purpose. Inspection agencies shall perform the inspection work according to "Regulations on Safety Supervision over Special Equipment" and relevant laws and regulations as well as safety technical specifications, in addition, shall hold liable to the inspection result and the qualification conclusion. Article 12 The top management shall ensure that the quality policy reaches the following requirements: (I) It shall be compatible to the purpose and property of inspection agencies; (II) It shall promise to meet the requirements of government and customer and to improve the quality management system continuously; (III) It shall be communicated and understood in inspection agencies; (IV) It shall be reviewed in the aspect of continuous suitability. Article 13 Top management shall ensure to establish quality objective and to provide evaluation method on the relevant function and level of inspection agencies, and shall ensure to meet the following requirements: (I) Plan the quality management system to meet the quality objective and the requirements of Article 5; (II) While planning and implementation are performed on the alteration of quality management system, the completeness of quality management system shall be maintained; (III) The quality objective shall be able to check and be consistent with quality policy. Article 14 Top management shall ensure that the responsibility and authority of the each department and personnel in inspection agencies are specified and communicated and meet the following requirements: (I) It shall specify the responsibility, power and interrelationship of all the management personnel, inspection personnel and the personnel in key positions who are influential to the inspection quality; (II) It shall set technical director whose explicit responsibility and power shall be specified to take full charge of the technical operation of inspection agencies; Note: According to the scale of inspection agencies, the technical directors may be set as technical management layer; and different authorized technical directors may be set in several professional technology fields. (III) The quality directors shall be set and their explicit responsibilities and power shall be specified in order to ensure the quality management system to be implemented and maintained; and it is needed to report the performance and any improvement of quality management system to top management by a direct channel; Note: The responsibilities of the quality director may include external contact on affairs about the quality management system; the technical director may be also the quality director. (IV) Quality director shall be set according to profession or project of the inspection, his explicit responsibility and power shall be specified and he shall assist the technical director and quality director to control the inspection technique and quality of this profession or project; (V) If necessary, the agent of the key management staff shall be designated. Article 15 Top management shall establish the effective communication channel among all layers and functions in inspection agencies to ensure that the following items are able to be communicated effectively: the relevant laws, regulations and rules, safety technical specifications, standard information, the information required by government and customer, system operation information and the quality and safety of inspection, etc.. Note: The communication form may be various, such as quality and safety regular meeting, summary report, notice, house journal, network and announcement, etc.. Article 16 Top management shall periodically review the quality management system, inspection activity and inspection safety according to the planned time interval and procedure in order to ensure the continuous suitability, sufficiency and effectiveness. Review shall include the assessment of the improvement opportunity and the alteration demand of the management system as well as quality policy and quality objective; the problem discovered in the management review and the record of the actions taken for that shall be preserved. Note: Generally, the management review shall be conducted once a year. (I) The input of management review shall include the information in the following aspects: 1 The suitability of quality policy and quality objective as well as the applicability of the quality management system document; 2 The opinion and requirements of the government quality inspection department as well as the satisfaction degree of the regulations and safety technical specifications; 3 The results of the recent audit (internal audit and external audit); 4 Feedback, complaint and grumble of customers; 5 Working performance, the quality of inspection service and the safety condition of inspection; 6 Condition of preventive and corrective actions; 7 Follow-up actions for previous management reviews; 8 Alteration that may affect quality management system; 9 Suggestion for improvement; 10 Reports of managers 11 Other relevant information. (II) The output of management review shall include the relevant determination and actions in the following aspect: 1 The effectiveness and its improvement actions of quality management system; 2 The improvement of inspection work related to the requirements of government and customers; 3 Resource demand.

Chapter 1 General Provisions Chapter 2 Terms and Definitions Chapter 3 Quality Management System Chapter 4 Management Responsibility Chapter 5 Resource Allocation, Management and Technical Support Chapter 6 Inspection Implementation Chapter 7 Analysis and Improvement for Quality Management System Chapter 8 Supplementary Provisions