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质量手册英文版

1 Control program of (management) document and data

XLC/QP07.01-02 Page 1 Total: 2 pages 1.1 Aims and applicable scope

In charge of documents and data about quality system and guarantee the related Dept. use the available edition.

1.2 Obligations

1.2.1 Quality Dept. is responsible for the delivering and controlling of quality manual and program file.

1.2.2 Every functional Dept. is in charge of the delivering and controlling of each files and dada.

1.3 Working Procedures

1.3.1 Classification and serial numbers of files and data

1.3.1.1 Controlled and uncontrolled files are divided into. Quality manual and programmed file

the responsible belong to the controlled. “Controlled files checking list” should be proposed by people in related Dept and then checked by the director in that Dept. Finally, representative supervisor approve that. The controlled files should be marked with ID, numbers, whereas, the unrolled files on the contrary.

1.3.1.2 Quality Dept. makes “document number regulation” (without technical files) and that can

be carried out after obtaining the approval of the representative supervisor.

1.3.2 Composing, examining, approving and delivering of documents

1.3.

2.1 The representative supervisors organize the composing of the quality manual and programmed files and the functional departments are responsible of composing each document.

1.3.

2.2 The representative supervisor check the quality manual and the General Manage approve it;

every functional manages make a joint checkup for programmed files and directors approve those

files; the other files should be checked by each functional supervisors according to sufficiency and adaptation.

1.3.

2.3 Quality manual and programmed files will be delivered by Quality Dept. and also

by the data administrators “Borrowing files registration form”. The other files should be delivered

in each functional department in the certain range.

1.3.

2.4 “Inner Notice” as the main form of XLC inner management document will be delivered in certain scope which is approved by examiner and the getters will sign on the original files and then get the copy one.

1.3.3 Altering and cancellation

1.3.3.1 The representative supervisor organizes the altering of quality manual and programmed files. After altering of the documentation, the altering marks and valid time will be given. The original files will be taken back document administrator in Quality Dept and the obvious marks

will be stamped on.

XLC/QP07.01-02 Page 2 Total: 2 pages

1.3.3.2 The other altering files will be carried out by each department and then checked by the

director of each department after altering. Serial numbers and valid time should be marked. Each

document administrator take bake all the files and destroy them completely. Then new files can be

given out. Meanwhile, the altering reasons and contents should be told to representative

supervisors in the form of Inner Notice. “The controlled files checking list” of each Dept. should also be changed when it is necessary.

1.3.4 Files management

1.3.4.1 The document administer in every department is responsible the files management.

1.3.4.2 The document should be easily recognized and referred to.

1.3.4.3 When the user?s files seriously damaged, the document administrator should be informed

immediately for altering and reissuing.

1.3.4.4 The document administrator should check the efficiency of the files regularly and change

“controlled files check list” in time.

1.3.5 Controlling the external files

Direct use the external files should be approved by the director of document management department. Marks should be added and fill in the check list and control delivering.

1.4Relevant Documents

1.4.1 “Quality Manual”

ty Records Controlling Program

1.4.2 “Quali

Processing methods about internal files in Company”

1.4.3 “

1.4 Quality Records

1.4.1 Files Using Registration Form

1.4.2 Inner Notice

1.4.3 Controlling data checking list

2 (technical) documents and data control procedure

XLC/QP07.02-02 Page 1 Total: 2 pages 2.1 Aims and applicable scope

Control the technical files related to quality system and guarantee the valid versions of those documents.

It can be applied to the controlling technical data about quality system.

2.2 Obligations

Document controller is responsible for delivering, controlling and supervising technical files. The

technical department is in charge of making, changing and controlling drawings and part lists (In

the form of Product BOM).

2.3 Working Procedures

2.3.1Files under control (included the electronic document)

Drawings and part lists, technical process sheet, modification notice.

2.3.2examining and approving of documents

2.3.2.1Technical Department make drawings and part lists and enter Product BOM(part list) in to

ERP system.

2.3.2.2Technical director examines and approves drawings and part lists.

2.3.3documents management

2.3.3.1 Document controller provides drawings and part lists according to part list(BOM) and delivery to the relevant departments.

2.3.3.2The technical files under control can be delivered in a certain range made by document maker after the approving of technical manager. For the altered production drawings or part lists,

the document administer delivery files in the approved range which written in the applying list for

changing. At the same time, cancel and destroy the returned drawings.

2.3.4Altering of files

The applicant gives the ID Numbers and changing conditions for the damaged drawings and part

lists. The document administrator changes them according to “Managing Regulations of drawings and part lists”. The drawing only can be printed but no copying.

2.3.5 Altering of files

2.3.5.1 The applicant who wants to change the files should fill in a form (that?s a pplying list for changing) and describe changing reasons, contents and delivering range. The related changing technical data should be enclosed on. It can be changed after the approving of technical manager.

XLC/QP07.02-02 Page 2 Total: 2 pages

2.3.5.2 After modifying the technical documents, the modifying condition marks must be noted.

files modification 2.3.5.3 After modifying documents, the document controller delivery” Technical

in relevant delivering scope.

notice”

2.3.6 Management of technical files

2.3.6.1 In daily time, technical documents are often charged by document administrator. The technical drawings will be recorded in the tapes as copies from working net by technical manager

who is responsible for controlling the technical drawings.

2.3.6.2 The technical department is responsible for entering new data in XLC management system

(ERP) and preserves them. The using rights shall be guaranteed by microcomputer management

system.

2.3.7 The controlling of external technical files

The external technical files such as standard, drawings offered by customers, technical dada supplied by sub-contractor should be kept by technical Dept. Technical Manager?s approval should be obtained when they will be used.

2.4 Relevant Documents

2.4.1“Technical documents serial numbers regulations”

2.4.2“Drawings and part lists managing rules”

2.5 Quality Records

2.5.1 Document modification notice

3 Quality records control program

XLC/QP07.03-02 Page 1 Total: 2 pages 3.1 Aims and applicable scope

Efficiently control and manage the quality records, which can demonstrate the products quality meeting certification and quality system running efficiently.

Quality Systems are suitable for all related records.

3.2 Obligations

Qualities Dept. is responsible for making program document and supervises the controlling condition of every department towards quality records.

Every functional department is in charge of each quality records.

3.3 Working Procedures

3.3.1 Quality records are the true records of forming product quality. They prove that products have reached the quality requirement level and demonstrate the proof of our company quality system running efficiently.

3.3.2 The range of quality records:

Every department work out each quality records checking list and hand in to Quality Dept.

3.3.3 Intermediary form of quality records:

Quality records can be taken down in the forms of tables, reports, documents and E-media.

3.3.4 The filling requirements of quality records:

Fill in the quality records carefully and clearly for easy recognizing and meanwhile guarantee the

correction of whole contents. Faking fillings are not allowed. The signature confirmation by quality recording personnel has to be obtained when necessary.

3.3.5 Collection of quality records, labels and conservation:

Every functional department collect quality records according to the range of quality record checking list and make on each quality records for easy looking for. The quality records have to be

kept well. The suitable environment which can prevent for damp and damage has to be offered by

each functional department for keeping quality records well.

3.3.6 File and sort out the quality records

For easy management controlling, quality recorder should file the quality records. After filing, every functional department sort out and mark the quality records according to certain standard.

XLC/QP07.03-02 Page 2 Total: 2 pages

3.3.7Quality records should be provided to customers for referring to when there is

requirement in contracts.

3.3.8Conservation terms and dealing methods of quality records:

The keeping period of Quality records should not be less than three years (except the products files).When there is a changing on quality records, the quality recorder propose a

applying in the form of inner notice and give it to each department director to approve.

Casual changing is not allowed on quality records. The people who change the records

should sign on the changing place and mark on the exact changing time. When destroy

the quality records, the quality recorder make a checking list and hand in to every functional director for approving.

Products files should be preserved for all the time. The products files which have been

kept more than 3 years will be conserved in the form of E-media.(CD, Disk saving).

3.4Relevant Documents

(Management) documents and data controlling program

3.5 Quality Records

3.5.1 Quality records checking lists

4 Quality management system planned program

XLC/QP07.04-02 Page 1 Total: 3 pages 4.1 Aims and applicable scope

Quality management plan aims for realizing our company?s quality policy and aim.

Identify and plan the processes and resources which are applicable for ensuring realizing quality

policy and process and resource of aims.

4.2 Obligations

4.2.1 General Manager is responsible for approving the quality planned outputs documents which

are made by the related departments according to our company?s quality policy, aims and the necessary resources.

4.2.2 Management representative is responsible for reviewing the related documents which are made for quality management plan.

4.2.3Quality department is responsible for organizing each department to manage and plan and make the corresponding planned documents. Supervising and checking shall be implemented.

4.2.4 The managing people of each department shall be responsible for quality plan of their departments.

4.3Working Procedures

4.3.1 Quality aims

4.3.1.1 In order to realize the quality policy of organizations, the general quality object of organization is:

(1) finished products delivering pass percent is 100℅for one time

(2) Components and parts

(3) customer?s satisfaction rate shall be no less than 90％

(4)the feedback rate of malfunction is less than 5％in early time (3 months)

(5)20％has been increased ( product market expanding rate)

(6) Explore the new products successfully at the first time

4.3.1.2 Each department which related to quality shall divide the whole object of the organization

into several small exact objects. In order to reach the quality goal successfully, the corresponding

quality plan shall be implemented.

4.3.2 The appropriate opportunity for making quality plan

Quality plan shall be carried out when company is in the following situations:

a)Quality management system shall be established and improved according to quality

management standard.

b)Important changes of company?s quality policy, quality aim and company?s organization.

c)Important changes of company?s resource arrangement and market situation.

d)The present document of system can?t cover the special items.

e) 4.3.3 Quality planned contents

The General Manager should identify and plan the necessary resources which ensure realizing the

quality aim. Quality planned contents shall include:

a)Quality aim and corresponding quality management processes; inputs, outputs and activities

of processes and make regulations.

b)Identify the established resources arrangement of processes which are required for realizing

quality aim.

c)Review rules regularly for realizing the whole quality aim and phrase or partial quality aim.

The improvement of processes and activities shall be focused on in review processes.

d)Find the distance of quality aim according to review results and ensure improving

continuously for enhancing the efficiency and effectiveness of quality management system.

e)The planned results shall be filed (includes changing) such as quality manual, programmed

documents and so on.

4.3.4 The principle of making quality planned outputs documents and the following principles

shall be complied with:

a) Complying with company?s aim, the exact practice of product and process shall be made

according to GB/T19001-2000quality management system for satisfying operability.

b) The character and scope shall comply with the requirements of law and rules and the other

related requirements and expectation of customers, and that shall be applicable for company for

satisfying applicability and efficiency.

4.3.5 Making, audition and delivering of quality planned outputs documents

4.3.

5.1 Quality department is responsible for organizing each department to make quality planned

documents according to XLC-QP07.01-02 “Management documents and data control program”．4.3.5.2 Name, serial numbers, organizer, auditor, approval and issuing data shall be written on the

covers of quality planned outputs documents.

4.3.6 Implementation of quality plan, supervising and changing

4.3.6.1 In the process of implementation, each department shall control according to the stipulated

contents, schedule and requirements of quality planned results. The feedback of existed problems

and present situations shall be informed to quality department.

4.3.6.2 Quality department shall inspect and check the present situations of quality plan.

4.3.6.3Quality planned change

a) The changing of quality planned output documents shall be carried out in the controlled

condition and the related department issue “Internal Notice” and finally it shall be implemented according to “Management documents and data control program”

b) Keep the quality management system running completely in changing period, e.g. the

corresponding changing shall be done through organization adjustment

4.3.6.4 The related documents resulted form quality plan shall be turned to quality department and

then file them.

4.4Relevant Documents

4.4.1 “Management documents and data control program”

4.4.2 “Planned control program of realizing process”

4.5 Quality Records

4.5.1 Quality planner of each department output documents

5 Management review procedure

XLC/QP07.05-02 Page 1 Total: 3 pages 5.1 Aims and applicable scope

General Manager assess regularly to the present situation of company?s quality system, adaptability and efficiency, which guarantees that is suitable for company?s policy and aim.

This program is applicable for management review.

5.2 Obligations

5.2.1General manager is in charge of managing review

5.2.2 Management representative is responsible for reporting the quality system running situation

to General Manager and

5.2.3 Director of each department shall be responsible for preparing the demanded and related data

for reviewing and raising corrective and preventative measures for implementation in review.

5.3Working Procedures

5.3.1 Management review shall be carried out per 12 months.

5.3.2 When some important unusual situations about company?s quality system happening, the related personnel shall be called in for management review if General Manager thinks it?s necessary.

5.3.3 Management representative organizes making management review plan and report to General Manager. Then general manager approve for issuing and implementing.

5.3.4 The review plan shall be delivered to company?s leaders and each department director in ten

days before.

5.3.5 Management representative organizes every director of each department to collect and prepare the necessary materials for reviewing according to the review plans.

5.3.6 Review contents include:

a) Review results include internal quality system audition, the third party?s audition of customer?s

review and the results of product quality audition. The quality department provides the related data.

b) Customer?s feedback includes the measuring results of customer?s satisfaction or dissatisfaction

and customer?s complaints. The after-sales department offers the related data.

c) Process outstanding achievement and product conformity, which include the results of process,

product measurement and monitoring results. Each department offers the related data.

d) Improving, preventive and corrective measures. Every department offers the related data.

e) Implementation and efficiency of the tracking measures to management review in the past.

Quality department offers records and the comprehensible report.

f) All various changes include inner and outside environment, law and rules, new technology, new

techniques, new equipment exploration and so on, which perhaps influence quality management

system. Every department offers the related data.

g) The running situation of quality management system, which include the applicability and

efficiency of quality policy and objectives.

5.3.7 There are many forms of management review such as meeting and local reviews can be

adopted. The general manager appoints some special personnel to make the exact review records

in review process.

5.3.8 Management review outputs

approved by General Manager is treated as the review

5.3.8.1 “Management review report”　

outputs. Quality management system improving requirements, product improving requirements,

and resources arrangement requirements shall be included in the report as the corrective and

preventive action for improving continuously.

a) Improvement of quality management system and processes, which include the assessment to

quality policy, quality aim, organization structure, process control and so on.

b) the improvement of products which is required by customers; assessment to present product

conformity include whether product process review is needed or the related contents about review

contents.

c) Resources requirements and so on.

5.3.8.2 Quality department conclude and then make “Management review report”　

according to management review outputs after ending the meeting. The management representative audits the

report and turn to General Manager for approving and then delivery to the related departments for

monitoring and implementing. The outputs of management review in this time can be taken as the

inputs of next management review.

5.3.9 Implementation and verification of improving, corrective and preventative measures.

Quality department tracks and verifies the implementation effects of improving, corrective and preventative measures according to the rules in “Improved control program”．

5.3.10 Management of managing review documents

All the documents and data of management review belong to controlled documents and manage

them according to “Management documents and data control program”. All records and review results shall be controlled according to “Quality record control program”．

5.4Relevant Documents

5.4.1 “Management documents and data control program”

5.4.2 “Quality record control program”

5.4.3 “Internal quality system review program”

5.4.4 “Improved control program”

5.5 Quality Records

5.5.1 Management review plan

5.5.2 Management review notice

5.5.3 Management audition report

5.5.4 Corrective and preventative measures processes list

6 Conscious, ability and training control program

XLC/QP07.07-02 Page 1 Total: 3 pages 6.1 Aims and applicable scope

To make the persons being trained be up to the regulations and requirements of related jobs.

It is applied to educate and train all kinds of persons who work in and are related with quality jobs,

including the supplier if necessary.

6.2 Obligations

6.2.1 Personnel Dept. is a vital ministry in a company to control human resources, and it is responsible to regulate and specify job responsibilities, to plan, identify and control the human resource demand of all departments, to organize, coordinate, implement and evaluate all kinds of

training activities, as well as to make an overall assessment regularly.

6.2.2 Engineering Dept. should cooperate with Personnel Dept. to implement technique training,

safety education and special working procedure training.

6.2.3 Quality Dept. should cooperate with Personnel Dept. to implement the training on workers? consciousness and management knowledge of quality.

6.2.4 All departments should assist Personnel Dept. with their own professional technique training,

to put forward training demand and keep employee training records, as well as to make human

resource plan and employee?s training, demand, assessment and ect on quality.

6.2.5 Personnel Dept. is responsible to make job assessment standard ( including job description, qualification and technique standard ) and work responsibility.

6.3Working Procedures

6.3.1 Identification of ability and consciousness

Identify ability requirements of all workers related with quality activities and make different job responsibilities and training according to different working positions, such as new workers, old workers, all kinds of professional workers, special technique workers, assessor and so on.

6.3.1.1 Workers responsible for quality management system regulation should have capabilities,

which are estimated by education, training, technique and experience.

6.3.1.2 Every department is responsible to compile its own ,position responsibilities?, which is submitted to personnel dept. for collection and carried out with company leaders? approval.

6.3.2 Training

6.3.2.1Training Plan

Personnel department make and carry out training plan which base on the wide suggestions from

related departments and further investigation. From the practical situations of our company, the training contents, aims and checking system should be identified.

6.3.2.2Training forms

Various forms of staff training can be adopted such as off-job-training, day releasing, off-hours and outgoing and short-term temporary arrangement.

6.3.2.3Training contents

Staff training contents can be divided into quality conscience, quality management training; professional knowledge, skills training; safety educational training before work; special processing training

a ) training to leaders

To all directors in company?s departments, the training will be given according to GB/T19001-IS09001 combing with the quality manual and programmed files which made out form the quality system. All the leaders will know more about the quality system and every element in that system. From the training, they can use the methods, technical and efficient evaluation in the quality system.

b) Technical and managing staff training

The technicians and managing staff included designer, technique people, purchasing, and quality

staff should be given training from professional knowledge and quality management. Then they

can know our company?s quality system contents and obtain managing ways, technique, and requirements of their work.

c) Training to production section supervisors and operators

Working skills and quality management basic knowledge training will be given to section supervisors and operators. This can make them know how to use equipment, tools, tolling, apparatus and instrument and testing equipment. Meanwhile, they are able to maintain those equipment well. Through learning our company?s quality manual, related procedure and guidance

books and discussing each quality responsibility, people can record rightly and analyze the quality

situation in production.

d ) Train to new staffs

Safety production training, working skills training should be given to new staffs. Basic concept of

quality management should be mentioned.

e ) Special training

Special training included welder, forklift truck driver, inspector, designer and so on). After special

training, the workers can start their work after obtaining the certificates.

6.3.2.1evaluate the efficiency of offered training

Though theory examining, operation testing, working evaluation, the trainer will be judged whether they are capable of doing the work. In the end, staff training files will be established and preserved.

6.3.3Worker?s daily working performance will be evaluated through personnel department organization. Spot-checking can be carried out to the staff in each department. To the unqualified

people, train, test or change work position which can make the people are suitable for their abilities.

6.4Relevant Documents

6.4.1 “Quality Manual”

6.4.2 “Management files and data control program”

6.4.3 “Quality records controlling program”

6.4.4 “Procedures of controlling program”

6.5Relevant Documents

6.5.1Staff temporary training applying

6.5.2The theory and operation examining records of special workers

6.5.3Yearly training applying form

6.5.4Statistics form of special workers

6.5.5Training attendance book

7 Infrastructure and work environment

XLC/QP07.07-02 Page 1 Total: 2 pages

7.1 Aims and applicable scope

In order to realize meeting standard requirements of products continuously, identify and manage

the factors of people and things in work environment for achieving conformity to product requirements.

This program is applicable for the infrastructure needed to achieve conformity to product requirements. Infrastructure includes workspace, hardware and software, tools and equipment,

supporting service such as communication or control of transporting facility and so on. Control

factors of people and things in work environment.

7.2 Obligations

7.2.1 The maintenance section in Production Dept. is responsible for monitoring the needed

facilities which achieve conformity to product requirements.

7.2.2 Personnel Dept. assists Production Dept. to monitor the needed work environment which

achieve conformity to product requirements.

7.3Working Procedures

7.3.1Identify and manage producing infrastructure.

7.3.1.1 Identify infrastructure

The needed infrastructure which achieve product conformity include: work space (workshop,

offices and so on), equipment and tools (includes working, clamp apparatus, measuring tools),

software (computer net), supporting service (water, electricity, gas supplying), communication

facilities, transporting facilities.

7.3.2Infrastructure management

7.3.2.1Every section director in Production Dept. makes the infrastructure investment plan for

next year in October. The investment plan will be reported to production manager. The Purchasing

Dept. purchases those facilities after obtaining leader?s approval.

7.3.2.2The departments which use apply for self-making infrastructure, and technical department

designs the drawings. After production manager approving, maintenance section organizes implementation.

7.3.2.3For the purchasing and self-making infrastructure, maintenance section in Production Dept.

organizes department which use to fix and adjust. After confirmation, both sides sign for checking

and accepting on “Infrastructure receiving report” and establish the basic information registration of producing equipment. For the working, clamp and measuring tools of low value and easy

damage, the using departments should check by themselves

XLC/QP07.07-02 Page 2 Total: 2 pages

7.3.2.4Maintenance section in Production Dept. establishes the basic information registration of producing equipment. Each December, producing equipment maintaining annual plan will be

made for succeeding year and then the plan shall be reported to Production Manager for confirming and organizing to put it into practice.

7.4Work Environment

For creating comfortable work environment and achieve conformity to product requirements, factory building and offices have the functions of preventing for wind and rain. Heating system

and suitable fire-fighting equipment should also be presented in working places. Keep the moderate temperature and enough space for working; Guarantee the working safety and sanitation.

a. configure applicable factory and comfortable, clean and quite offices;

b. provide ventilation and fire-fighting equipment, and keep moderate temperature and guarantee occupational health and working safety;

c. Production Dept. implements fixed-position approach to management of workshop infrastructure and try to improve working efficiency according to ergonomics;

d. ensure staff?s work according to Labor Law rules.

7.5Relevant Documents

7.5.1“Equipment Management Rules”

7.5.2“Main Equipment Precision Verification Regulations”

7.5.3“Fixture Management Rules”

7.5.4“Shot-blasting Machine Repair and Maintain Rules”

7.5.5“Electric Welder Repair and Maintain Rules”

7.5.6“Crane Repair and Maintain Rules”

7.5.7“Air-compressor Repair and Maintain Rules”

7.5.8“Painting Equipment Repair and Maintain Regulations”

7.5.9“Plasma Machine Repair and Maintain Rules”

7.6Quality Records

7.6.1“Equipment and Fixture Maintenance Recording”

7.6.2“Electric Welder Maintenance Recording”

8 Product realization process planning control procedure

XLC/QP07.08-02 Page 1 Total: 3 pages

8.1 Aims and applicable scope

The specific quality measures, resources and action?s sequence shall be stipulated to products, items or contracts, which guarantee products, achieve objectives and conformity requirements.

This is applicable for control of quality plan related to product, projects and contracts and also corresponding quality plan?s making, implementation and control.

8.2 Obligations

8.2.1 The company?s leaders authorize the quality plan m ade by related departments.

8.2.2 The quality department checks and supervises the implementation of quality plans made by

every department.

8.2.3 Every department?s director is responsible for quality planning and making and also implementation of each corresponding quality plan.

8.2.4 Technical D.P. organizes to make process planning for product realization and then offers it

to leaders for approving.

8.3 Working Procedures

8.3.1 Quality planning shall be made for product realization, projects and contracts. The results of

planning shall be applicable for our company?s running and then documents shall be established

such as quality plan.

8.3.2 Opportunities for quality planning

The quality planning shall be carried out in following situations:

a) Import and test new products

b) Customers? special requirements in sales contract

c) Special items have not been covered in present system documents

8.3.3 Quality planning?s basis

Quality planning inputs is just planning basis.

8.3.4 Quality Planning Contents

8.3.4.1 Quality objective shall be determined aiming at specific products, projects or contracts.

8.3.4.2 For the process and sub-process which are required to establish aiming at specific products,

projects or contracts, identify key process and activity and stipulate ways for process or concerned activities. Documents shall be formed for those ways in review.

XLC/QP07.08-02 Page 2 Total: 3 pages

8.3.4.3 Identify and provide the needed resources arrangement which mentioned above, segregation of operating phrases, personnel?s responsibilities and mutual relationship.

8.3.4.4 Determine verification concerned in processes and validate activities and checking and accepting criteria. Arrange inspection and monitoring activity to important and key characteristics

of process and products. For some special processes? outputs, verification and validation shall be

carried out according to outputs requirements.

8.3.4.5 Determine to provide records of evidence for conformity of processes and products.

8.3.5 Planning process control

8.3.5.1 Identify customer?s requirements

Technical manager determines product quality objectives initially and make planning outline according to requirements of customers or contract. Every department provides contents of planning outline according to orders.

a) Production D.P. provides suppliers? competence for realizing products and application situation

of producing personnel?s competence.

b) Equipment resources competence offered by equipment section.

c) The technical D.P. provides the related national, occupational, enterprise standard and company?s development and design competence (personnel and infrastructure).

8.3.5.2 Draft planning (prepared plan) according to every department?s offer ed inputs data.

a) Technical department draw up the related files about process controlling, each standard for realization products and target value of product quality;

b) Technical department offers producing development scheme and technical process flow plan;

c) Equipment section drafts facilities allocation plan;

d) Quality department drafts product process verification and final verification standard and ways.

8.3.5.3 The technical department director presides the meeting to discuss planning draft, determine modification opinions with Production, Quality, Technical departments and equipment section and specialists. Planning shall be made in the charge of Technical department.

8.3.5.4 The technical manager organizes every department to discuss and review the planning. After passing, the planning shall be put into practice under the direction?s arrangement.

8.3.6 Quality Plan

Describing the processes of quality management system and how to apply to specific products, projects and contract documents is quality plan. The principle of making quality plan:

a) The contents of quality plan shall be determined according to the quality planning contents and

results.

b) Shall refer to the related contents of quality manual and conform to the quality policy and objectives. At that shall coordinate to the contents of the quality system

c) The related contents can be quoted from the present quality document and new contents can be

made according to the special requirements.

XLC/QP07.08-02 Page 3 Total: 3 pages

d) According to the actual conditions, may work out the general quality plans or single plans, such

as the quality plans of designs, quality plans of purchase, or some plans for some special activities,

such as the product exhibitions, users? service week, etc.

e) The quality plan can be regarded as a independent file, and as part of other ones upon requirements.

8.3.7 to work out, check and grant “Quality Plan”

8.3.7.1 The “Quality Plan” shall be worked out by the ones in charge of relevant department, be

checked by managers and then be granted by quality department as a controlled document to the

relevant departments (as well as customers if required).

8.3.7.2 The performance of the “Quality Plan” shall be timely fed back to quality department.

8.3.8To carry out, supervise and amend the Quality Plan

8.3.8.1Each relevant department shall carry out the plan according to the regulated requirements,

and feedback the performance condition to quality department timely.

8.3.8.2Quality department is responsible for the supervision and control of the performance of the

quality plan, coordinate the contacting and resources allocation among relevant departments, and

fill in the “Check Sheet of the Performance of Quality Plan” so as to generally control it and report

to the upper leaders.

8.3.8.3When the quality plan needs amending; the relevant department shall fill in the “Application for Amending Management Files” and then make the amendment according to the “Files Controlling Procedure” after getting the leaders? approval.

8.3.9After finishing the quality plan, the quality department is responsible for saving and recording the relevant files.

8.4Relevant Documents

“Controlling Procedure of Management File and Data”

8.5Quality Records

8.4.1 Special contracts review table

8.4.2 Bid contracts review table

8.4.3 Check sheet of the performance of quality plan”

8.4.4 Quality plans of each department

8.4.5 Application for amending management files

8.4.6 Product quality aim

8.4.7 Planning letter

ISO14001质量手册英文版模板(2008版)

ABC Farms ISO 14001 - Environmental Management System Manual Prepared By: Approved By: Signature: ____________________________ Date: _________ / Revision #: 0 / Revision Date: / Effective Date:

SECTION 0 - TABLE OF CONTENTS MANUAL ISO SECTION SECTION TITLE PAGE SECTION 0TABLE OF CONTENTS x SECTION I INTRODUCTION x SECTION II DISTRIBUTION, REVISION & CONTROL x 4.2 4.2ENVIRONMENTAL POLICY x 4.3 4.3PLANNING x 4.3.1 4.3.1 Environmental Aspects x 4.3.2 4.3.2 Legal and Other Requirements x 4.3.3 4.3.3 Objectives and Targets x 4.3.4 4.3.4 Environmental Management Programs x 4.4 4.4IMPLEMENTATION & OPERATION x 4.4.1 4.4.1 Structure and Responsibility x 4.4.2 4.4.2 Training, Awareness and Competence x 4.4.3 4.4.3 Communication x 4.4.4 4.4.4 Environmental Management System Documentation x 4.4.5 4.4.5 Document Control x 4.4.6 4.4.6 Operational Control x 4.4.7 4.4.7 Emergency Preparedness and Response x 4.5 4.5CHECKING AND CORRECTIVE ACTION x 4.5.1 4.5.1 Monitoring and Measurement x 4.5.2 4.5.2 Non-conformance and Corrective Action x 4.5.3 4.5.3 Records Management x 4.5.4 4.5.4 Environmental Management System Audits x 4.6 4.6MANAGEMENT REVIEW x

ISO9001：2015全套文件英文版(含质量手册及全套程序文件)

Ningbo XXX Material Technology Co.,Ltd ISO9001:2015 Quality Manual Revision [A/0] - [2018/3/1] (c) [Copyright Year Of 2018] [Ningbo XXX Material Technology Co.,Ltd]; all rights reserved. This document may contain proprietary information and may only be released to third parties with approval of management. Document is uncontrolled unless otherwise marked; uncontrolled documents are not subject to update notification.

Revision [A/0] - [2018/3/1] Page 1 of 19 TABLE OF CONTENTS 0.0 Revision History and Approval ...................................................................................................................... 3 1.0 Welcome to Ningbo XXX Material Technology Co.,Ltd ................................................................................ 4 2.0 XXX Material: Who We Are ........................................................................................................................... 4 2.1 Determining Our Strategic Direction ......................................................................................................... 4 2.2 Scope of the Management System ........................................................................................................... 4 2.2.1 Scope Statement ............................................................................................................................... 4 2.2.2 Facilities Within the Scope ................................................................................................................ 4 2.2.3 Permissible Exclusions ..................................................................................................................... 5 2.2.4 Scope of the ISO9001:2015 Quality Manual ..................................................................................... 5 3.0 Quality Policy................................................................................................................................................. 5 4.0 Management System Structure and Controls ............................................................................................... 5 4.1 Process Approach .................................................................................................................................... 5 4.1.1 Process Identification ........................................................................................................................ 5 4.1.2 Process Controls & Objectives .......................................................................................................... 6 4.1.3 Outsourced Processes ...................................................................................................................... 7 4.2 Documentation & Records ....................................................................................................................... 7 4.2.1 General .............................................................................................................................................. 7 4.2.2 Control of Documents ....................................................................................................................... 7 4.2.3 Control of Records ............................................................................................................................ 7 4.3 Change Management ................................................................................................................................ 8 4.4 Risks and Opportunities ............................................................................................................................ 8 5.0 Management & Leadership ........................................................................................................................... 8 5.1 Management Leadership and Commitment .............................................................................................. 8 5.2 Customer Focus ........................................................................................................................................ 9 5.3 Quality Policy ............................................................................................................................................. 9 5.4 Organizational Roles Responsibilities & Authorities ................................................................................. 9 5.5 Internal Communication ............................................................................................................................ 9 5.6 Management Review .............................................................................................................................. 10 6.0 Resources ................................................................................................................................................... 10 6.1 Provision of Resources ........................................................................................................................... 10 6.2 Human Resources .................................................................................................................................. 10 6.3 Infrastructure ........................................................................................................................................... 11 6.4 Work Environment ................................................................................................................................... 11 6.5 Organizational Knowledge ...................................................................................................................... 11 7.0 Operation ..................................................................................................................................................... 11 7.1 Operational Planning and Control ........................................................................................................... 12 7.2 Customer-Related Activities .................................................................................................................... 12 7.2.1 Capture of Customer Requirements ............................................................................................... 12 7.2.2 Review of Customer Requirements ................................................................................................ 12 7.2.3 Customer Communication ............................................................................................................... 12 7.3 Design and Development ........................................................................................................................ 13 7.4 Purchasing .............................................................................................................................................. 13 7.5 Provision of [Production of adhesive tape] .............................................................................................. 13 7.5.1 Control of Provision of [Production of adhesive tape] ..................................................................... 13 7.5.2 Identification and Traceability .......................................................................................................... 14 7.5.3 Property Belonging to Third Parties ................................................................................................ 14 7.5.4 Preservation .................................................................................................................................... 14 7.5.5 Post-Delivery Activities .................................................................................................................... 14 7.5.6 Process Change Control ................................................................................................................. 15 7.5.7 Measurement and Release of [Production of adhesive tape] ......................................................... 15 7.5.8 Control of Nonconforming Outputs .. (15)

质量手册翻译中英文对照解析

质量手册翻译中英文术语表 3.1.1 质量 quality 3.1.2 要求 requirement 3.1.3 等级 grade 3.1.4 顾客满意 customer satisfaction 3.1.5 能力 capability 3.2.1 体系(系统) system 3.2.2 管理体系 management system 3.2.3 质量管理体系 quality management syste m 3.2.4 质量方针 quality policy 3.2.5 质量目标 quality objective 3.2.6 管理 management 3.2.7 最高管理者 top management 3.2.8 质量管理 quality management 3.2.9 质量策划 quality planning 3.2.10 质量控制 quality control 3.2.11 质量保证 quality assurance 3.2.12 质量改进 quality improvement 3.2.13 持续改进 continual improvement 3.2.14 有效性 effectiveness 3.2.15 效率 efficiency 3.3.1 组织 organization 3.3.2 组织结构 organizational structure 3.3.3 基础设施 infrastructure 3.3.4 工作环境 '77ork environment 3.3.5 顾客 customer 3.3.6 供方 supplier 3.3.7 相关方 interested party 3.4.1 过程 process 3.4.2 产品 product 3.4.3 项目 project 3.4.4 设计和开发 design and development 3.4.5 程序 procedure

ISO13485：2016质量手册英文版(修改公司名及程序名就可直接套用)

Table of Contents 1. Purpose & Scope (2) 2. Applicable Standards (2) 3. Business Profile (2) 4. Authority & Responsibility (2) 5. Terms & Definitions (2) 6. Policy & Objectives (3) 7. Application (4) 8. Quality Management System (4) 9. Management Responsibility (6) 10. Resource Management (8) 11. Product Realization (8) 12. Purchasing (11) 13. Production Control / Product Identification & Traceability (12) 14. Control of Inspection, Measuring, and Test Equipment (13) 15. Measurement, Analysis, Improvement (14)

1. Purpose & Scope This manual describes the Quality Management System (QMS) established by and for Dongguan XXX Appliances Limited. The principles and policies on which this manual is based; along with operating procedures, work instruc-tions, and other supporting documents; govern all processes that affect quality throughout the organiza-tion. 2. Applicable Standards 2.1 The QMS is structured and intended to be in compliance with the following standards. ISO 13485:2016 Medical Devices Quality Management Systems Requirements for Regulatory Purposes 21 CFR Part 820 Quality System Regulation (Exclusions and Exceptions noted below.) 2.2 Normative References ISO 9000:2015 Quality Management Systems · Fundamentals and Vocabulary ISO 13485:2016 Medical devices · Quality Management Systems · Guidance on the Application of ISO 13485:2016 3. Business Profile 3.1 Mission Statement To deliver zero defects to our internal and external suppliers and customers. 3.2 XXX, with one facility located at xxx, Dongguan City, Guangdong Province, China. 3.3 The organizational structure is described by Dongguan XXX Appliances Limited Organization Chart. 4. Authority & Responsibility 4.1 This manual is issued under the authority of the President. 4.2 It is the responsibility of the Director of Quality, who is the designated Management Representative, to ensure that the principles of this manual, the Quality Policy, quality objectives, customer requirements, applicable regulatory requirements, and quality management system requirements are promoted, com-municated to and understood by all XXX employees. 5. Terms & Definitions 5.1 Corrective Action A process improvement methodology aimed at identifying and eliminating the causes of known non-conformities to prevent their recurrence. A problem solving process.

ISO9001质量手册英文版(ISO9001QualityManual)

ISO 9001:2000 QUALITY MANUAL WOLSTENHOLME INTERNATIONAL LIMITED CONTENTS 1.0 Scope of the Quality Management System at Wolstenholme International Limited 1.1 Statement of Quality Policy 2.0 Quality Management System Documented Procedures 2.1 Document Control 2.2 Control of Quality Records 2.3 Internal Quality Audits 2.4 Control of Nonconforming Product 2.5 Corrective Action 2.6 Preventative Action 3.0 Quality Management System Processes and Interrelations 3.1 Organisation Charts 3.2 Responsibilities 3.3 Interrelation of Processes 3.4 Processes 1.0 Scope of the Quality Management System at Wolstenholme International Limited

Wolstenholme International Limited is a Company with a long-standing successful history of supplying metal powders, pastes, pellets, varnish, offset ink, flexography ink and other related products for use in a large range of applications, on a worldwide basis. The scope of the Quality Management System encompasses all activities on the Darwen Site. The Metallic Powders Operation at Darwen is responsible for the manufacture and supply of metal powders and pigments mainly in aluminium, copper and brass (bronze) based alloys, for use in printing, inks, plastics and other industrial and engineering applications. The Ink Operation at Darwen is responsible for the manufacture of a wide range and type of printing ink, 'one-pack' gold ink, varnish and related printing products. All production processes at Darwen are validated before leaving the site and as such sub-clause 7.5.2 is excluded. The overall operation at Darwen is controlled by the Ink & Print business unit and the Industrial business unit. Technical Service and Research and Development are vital to the future development of the Company, together with understanding and developing new products and applications for our customers. The manufacturing, technical and administration functions of the Company are based in Darwen, Lancashire, England and employ some 210 staff at that location. Through the application of Quality Management Systems and Company wide training programmes, Wolstenholme International Ltd. is committed to ensuring continuous improvements to both its processes and product technology.

ISO9001：2015质量手册-英文版

Quality Management System Policy Manual ISO 9001:2015 11-8-17 Date Printed: _______________

1. Quality Management System Scope COMPANY NAME establishes this quality policy manual to implement and maintain a quality management system meeting the requirements of ISO 9001:2015, to ensure customer satisfaction in the manufacturing of stamped, formed, machined and fabricated metal parts, weldments, subassemblies and painting of metal parts to customer and COMPANY NAME specifications 1.1. Non-applicable Clauses of ISO 9001: 1.1.1. 8.3 Product Design & Development of Products & Services – COMPANY NAME is a custom manufacturer and designs are provided by our customers. 2. Quality Policy Statement COMPANY NAME is committed to continually improving all products and services to achieve our customer’s expectations. We do this by: 1) Living our values, 2) Providing opportunities for employee involvement, motivation and training, 3) Developing, documenting and following processes. 3. Quality Objectives COMPANY NAME’s quality management system objectives are to enable COMPANY NAME to be our customers’ first choice by: 1) Achieving satisfactory ratings on quality, delivery and other key metrics tracked and reported by our customers through their formal supplier evaluation and performance systems, 2) Achieving a level of 700 ppm as tracked through COMPANY NAME’s RA system for customers without a formal supplier evaluation system for quality, 3) Achieving a 95% on-time delivery to the COMPANY NAME warehouse for customers without a formal supplier evaluation system for delivery. Policy Manual Revisions Log Date 3/22/17 8/7/17 Summary of Revisions Rewrite of Quality Policy Manual to meet ISO 9001:2015. 1. Revised 4.2 to include “employees”, “owners” and “regulators”. Made By JGV JGV 2. Added Figure 2 to support to support the COMPANY NAME QMS Process Flow 11-8-17 Updated to clarify risk, inputs, out puts and KPI’s for Support and Management Process in QMS Process Reference page (page 6) JGV Management Approval Name: Title: Signature: Date: Paul Gintner President

ISO17025：2017质量手册英文版

Quality Manual Reference Standard ISO/IEC 17025:2017 Issue Number 01 Issue Date 01–08–2018 Copy Number Total Pages Issued To Address Prepared By Approved By Issued By Name Designation Quality Manager CEO Quality Manager Prepared By Approved By Issued By Page 1 of 59

Prepared By Approved By Issued By Page 3 of 59 Chapter → 1.0 General Information 1.1 Table of contents Chapter No. Subject Amend ment No. Page No. ISO/IEC 17025 Clause Ref. 1 Cover page, table of contents, amendment record sheet and glossary of terms (abbreviation) 00 1 – 6 ========== 2 Authorization statement and laboratory profile and context of organization 00 7 – 9 ========== 3 Control and distribution 00 10 – 11 ========== 4.0 General requirements 4.1 Impartiality 00 12 – 13 4.0 4.2 Confidentiality 00 14 5.0 Structural requirements 00 15 – 20 5.0 6.0 Resource requirements 6.0 6.1 General 00 21 6.2 Personnel 00 21 – 22 6.3 Facilities and environmental conditions 00 23 6.4 Equipment 00 24 – 26 6.5 Metrological traceability 00 27 6.6 Externally provided products and services 00 28 – 29 7.0 Process requirements 7.0 7.1 Review of requests, tenders and contracts 00 30 – 31 7.2 Selection, verification and validation of methods 00 32 – 34 7.3 Sampling 00 35 7.4 Handling of test or calibration items 00 36 7.5 Technical records 00 37 7.6 Evaluation of measurement uncertainty 00 38 7.7 Ensuring the validity of results 00 39 – 40 7.8 Reporting of results 00 41 – 43 7.9 Complaints 00 44 7.10 Nonconforming work 00 45 7.11 Control of data – Information management 00 46