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Manual 1.7 for the quality of internal management and external quality assurance. This manual briefly describes the company's quality management system documents used in the structure of quality management system are the interactions between the process of formulation.
Accreditation period:
a. version for review. b. assessment of major content changes. c. the absence of exceptional circumstances an assessment every two years
Version: ABCD ... ... for the version of times ... ... to amend 0.1.2 No..
For version: After many modifications, can be carried out for four years version, and review and approval.
7.3 design and development and control
7.3.1 Design and Development Planning.
1) Engineering Product Design and Development Department is responsible for the planning, formulation of project objectives, project planning, staffing, a clear organizational structure, responsibilities, authority.
2) Top Management is responsible for providing the necessary resources.
3) With the progress of design and development, technology assessment of the Department responsible for keeping, updating, approval.
7.3.2 Design input
1) Production Department is responsible for providing customer information and similar products.
2) information technology department responsible for receiving and considering the expected use of the Products, and other laws and regulations.
3) the design of the project team responsible for the preparation of the importation of the review report, by the person in charge approved the project.
7.4.3 Design and Development of the output.
Project team responsible for the preparation of design output documents, person in charge of the project examination and approval.
Output:
1) Designed to meet the input requirements.
2) the procurement schedule of the project.
3) the production process and process control.
4) accept the principle of products, the corresponding standards.
5) Products must be characteristics of the normal use of the relevant provisions.
7.3.4 Design and Development Assessment
1) The staff: the chief engineer or engineering manager responsible for technology, and design development phase of the functions of the representatives shall participate in and, if necessary, customers can also participate.
2) The content: the design of the results of the various stages of development to meet the requirements to avoid early failure and defects exist.
3) Evaluation method: different forms, such as: The assessment, expert assessment, the assessment level, assessment and other customers.
4) Record review: the project team responsible for the formation of a written record of integrity.
Design and development verification 7.4.5
1) verify the staff: staff in charge of authentication technology, quality personnel with the Department.
2) to verify the contents: In order to prove that the design outputs meet design input to provide objective evidence, design output documents, drawings, samples.
3) authentication method: different methods, such as: analogy, testing method, method of calculation.
4) Record verification: to verify the project team responsible for the preservation of records and take the necessary measures to record
7.4.6 Design and Development to confirm
1) to confirm that officers: the chief engineer in charge of sales center, the production department, quality department, if necessary, customers can also participate.
2) to confirm the contents of: providing the sample to confirm the purposes to meet the expectations.
3) Confirmation of methods: trial law, simulation, contrast and, if necessary, to conduct clinical evaluation or performance evaluation
4) Confirmation of Record: The responsibility for keeping the project team to confirm the results and take the necessary measures to records.
7.3.7 Design changes
1) to design, develop the scope of change: the design of products has been exported, such as: drawing, design, book design and other tasks.
2) design and development project team to identify changes in the situation, and do a good job to change the logo.
3) change the design and development of the assessment, validation, confirmed by the person in charge by the project specific circumstances of the case; the review are to be included on the product and the impact of the delivery of products.
4) changes in the project team responsible for the preservation of records, changes in assessment records, records of any necessary measures.
7.3.8 Document Design History
Engineering Department is responsible for each type of product design and development to establish and maintain the process of design history documentation.希望可以帮助你呦

This manual applies to 1.7 internal quality management and external quality assurance. This manual briefly describes the quality management system in the document structure is used, the quality management system in the process of interaction between.
Review cycle:
A. when in evaluation. B. significant content change review. C. without special case review once every two years
Version: A.B.C.D... For type, 0.1.2... For modification.
Change: after many years later, after the modification can be changed, and for review and approval.
7.3 design and control
Design and development planning. 7.3.1
1) engineering department is responsible for product design and development planning, project goal, project planning, equipped with personnel, organization, responsibilities and authorities.
2) the top manager is responsible for providing the necessary resources.
3) as the design and development progresses, the department responsible for approval, review and update ceaselessly.
7.3.2 design input
1) production is responsible for providing customer requirements and the similar product information.
2) department is responsible for receiving information, and consider the products intended purpose, laws and regulations, etc.
3) team responsible for design input, the evaluation report project manager for approval.
7.4.3 design output.
Responsible for project design, and the output files by project manager for approval.
Output content:
1) meet design requirements of the input.
2) project sourcing schedule.
3) production process control and process.
4) accept principle, corresponding standard.
5) to the normal use of the product characteristics of relevant provisions.
Sections 7.3.4 design reviews
1) judges: chief engineer or engineering department manager responsible for the design and development stages, and the function of the representative shall be relevant in, when necessary, customers also can attend.
2) evaluation content: the design and development stages of the ability to meet the requirements of existence, avoid early unqualified and defects.
3) review: different forms, such as: a meeting-based evaluation, evaluation expert, customer review, gradually.
4) review: forming a complete team is responsible for the written records.
Design and development validation 7.4.5
1) verification department is responsible for validation: quality related personnel,.
2) proof design for validation content: output satisfies the design input provide objective evidence that the output files, design drawings, samples.
Methods: the methods validation 3), such as: analogy method, test method and calculation method.
4) certification records: project for certification records and take the necessary steps to record
7.4.6 design and development
1) personnel: total engineer is responsible for sales center, with production, quality, when necessary, customers also can attend.
2) to confirm that the contents: provide sample meet anticipated usage.
3) method: try method and simulation method, contrast method, when necessary for clinical evaluation or performance evaluation
4) confirmation record: project for the confirmation, and take the necessary measures.
7.3.7 design change
1) design, development, change the range: output file design products, such as drawing and design, the design plan descriptions, etc.
2) group identification, and design change to change to mark.
3) to design change review, validation, confirmed by project manager according to the specific circumstances, Review of finished product to include and delivery of products.
4) project is responsible for save changes recorded, change review and any necessary measures for the record.
7.3.8 design history documents
Our engineering department is responsible for every type of product design and development process of establishing and maintaining the design history documents.

英语八级翻译：

This manual applies to 1.7 internal quality management and external quality assurance. This manual briefly describes the quality management system in the document structure is used, the quality management system in the process of interaction between.
Review cycle:
A. when in evaluation. B. significant content change review. C. without special case review once every two years
Version: A.B.C.D... For type, 0.1.2... For modification.
Change: after many years later, after the modification can be changed, and for review and approval.
7.3 design and control
Design and development planning. 7.3.1
1) engineering department is responsible for product design and development planning, project goal, project planning, equipped with personnel, organization, responsibilities and authorities.
2) the top manager is responsible for providing the necessary resources.
3) as the design and development progresses, the department responsible for approval, review and update ceaselessly.
7.3.2 design input
1) production is responsible for providing customer requirements and the similar product information.
2) department is responsible for receiving information, and consider the products intended purpose, laws and regulations, etc.
3) team responsible for design input, the evaluation report project manager for approval.
7.4.3 design output.
Responsible for project design, and the output files by project manager for approval.
Output content:
1) meet design requirements of the input.
2) project sourcing schedule.
3) production process control and process.
4) accept principle, corresponding standard.
5) to the normal use of the product characteristics of relevant provisions.
Sections 7.3.4 design reviews
1) judges: chief engineer or engineering department manager responsible for the design and development stages, and the function of the representative shall be relevant in, when necessary, customers also can attend.
2) evaluation content: the design and development stages of the ability to meet the requirements of existence, avoid early unqualified and defects.
3) review: different forms, such as: a meeting-based evaluation, evaluation expert, customer review, gradually.
4) review: forming a complete team is responsible for the written records.
Design and development validation 7.4.5
1) verification department is responsible for validation: quality related personnel,.
2) proof design for validation content: output satisfies the design input provide objective evidence that the output files, design drawings, samples.
Methods: the methods validation 3), such as: analogy method, test method and calculation method.
4) certification records: project for certification records and take the necessary steps to record
7.4.6 design and development
1) personnel: total engineer is responsible for sales center, with production, quality, when necessary, customers also can attend.
2) to confirm that the contents: provide sample meet anticipated usage.
3) method: try method and simulation method, contrast method, when necessary for clinical evaluation or performance evaluation
4) confirmation record: project for the confirmation, and take the necessary measures.
7.3.7 design change
1) design, development, change the range: output file design products, such as drawing and design, the design plan descriptions, etc.
2) group identification, and design change to change to mark.
3) to design change review, validation, confirmed by project manager according to the specific circumstances, Review of finished product to include and delivery of products.
4) project is responsible for save changes recorded, change review and any necessary measures for the record.
7.3.8 design history documents
Our engineering department is responsible for every type of product design and development process of establishing and maintaining the design history documents.