食品專業(yè)畢業(yè)設(shè)計(jì)外文翻譯1

1、<p><b>　　附錄</b></p><p>　　F1. ISO90012008</p><p>　　ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bod

2、ies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to

3、 be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO c</p><p>　　Introduction</p><p>　　0.1 Gener

4、al</p><p>　　The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by &l

5、t;/p><p>　　a) its organizational environment, change in that environment, and the risks associated with the environment;</p><p>　　b) its varying needs;</p><p>　　c) its particular objec

6、tives;</p><p>　　d) the products provided;</p><p>　　e) the processes it employed;</p><p>　　f) its size and structure of the organization. </p><p>　　It is not the intent

7、of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.</p><p>　　The quality management system requirements specified in this Interna

8、tional Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.</p><p>　　This International Standard can b

9、e used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization

10、9;s own requirements.</p><p>　　The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.</p><p>

11、　　0.2 Process approach</p><p>　　This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhanc

12、e customer satisfaction by meeting customer requirements.</p><p>　　For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activity using

13、 resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.</p><p>　　The appl

14、ication of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired the outcome, can be referred to as the “process a

15、pproach”.</p><p>　　An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combina

16、tion and interaction.</p><p>　　When used within a quality management system, such an approach emphasizes the importance of</p><p>　　a) understanding and meeting requirements,</p><p>

17、;　　b) the need to consider processes in terms of added value,</p><p>　　c) obtaining results of process performance and effectiveness, and</p><p>　　d) continual improvement of processes based on

18、objective measurement.</p><p>　　NOTE  In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows.</p><p>　　Pl

19、an: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.</p><p>　　Do: implement the processes.</p><p>

20、;　　Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.</p><p>　　Act: take actions to continually improve process performance

21、.</p><p>　　0.3 Relationship with ISO 9004</p><p>　　ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independe

22、ntly.</p><p>　　ISO9001 specifies requirements for a quality management system that can be used for internal application by organizations, or not certification, or for contractual purposes. It focuses on the

23、effectiveness of the quality management system in meeting customer requirements. </p><p>　　At the time of publication of this international standard, ISO9004 is under revision. The revised edition of ISO9004

24、 will provide guidance to management for achieving sustained success for any organization in a complex, demanding, and ever changing, environment. ISO9004 provides a wide focus on quality management than ISO9001; it addr

25、esses the needs and expectations of all interested parties and their satisfaction, by the systematic and continual improvement of the organization performance. Howe</p><p>　　0.4 Compatibility with other mana

26、gement systems</p><p>　　During the development this international standard, due consideration was give to the provisions of ISO14001:2004 to enhance the compatibility of the two standards for the benefit of

27、the user community. Annex A shows the correspondence between ISO9001:2008 and ISO14001:2004. </p><p>　　This International Standard does not include requirements specific to other management systems, such as

28、those particular to environmental management, occupational health and safety management, financial management or risk management. However, this International Standard enables an organization to align or integrate its own

29、 quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a qu</p><p>　　INTERNATIONAL STANDAR

30、D</p><p>　　ISO 9001:2008(E)</p><p>　　Quality management systems — Requirements</p><p>　　4 Quality management system</p><p>　　4.1 General requirements</p><p&g

31、t;　　The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.</p>

32、<p>　　The organization shall</p><p>　　a) determine the processes needed for the quality management system and their application throughout the organization (see 1.2),</p><p>　　b) determine

33、the sequence and interaction of these processes,</p><p>　　c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,</p><p>　　d) ens

34、ure the availability of resources and information necessary to support the operation and monitoring of these processes,</p><p>　　e) monitor, measure where applicable, and analyse these processes, and</p&g

35、t;<p>　　f) implement actions necessary to achieve planned results and continual improvement of these processes.</p><p>　　These processes shall be managed by the organization in accordance with the req

36、uirements of this International Standard.</p><p>　　Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such proc

37、esses. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.</p><p>　　NOTE 1 Processes needed for the quality management system ref

38、erred to above should include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.</p><p>　　NOTE 2  An “outsourced process” is a pr

39、ocess that the organization needs for its quality management system and which the organization chooses to have performed by an external party.</p><p>　　NOTE 3  Ensuring control over outsourced processes

40、 does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to outsourced processes can be influenced by fac

41、tors such as</p><p>　　a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements.</p><p>　　b) the degree to which the con

42、trol for the process is shared.</p><p>　　c) the capability of achieving the necessary control through the application of 7.4 </p><p>　　4.2 Documentation requirements</p><p>　　4.2.1

43、General</p><p>　　The quality management system documentation shall include</p><p>　　a) documented statements of a quality policy and quality objectives,</p><p>　　b) a quality manual

44、,</p><p>　　c) documented procedures and records required by this International Standard, and</p><p>　　d) documents, including records, determined by the organization to be necessary to ensure th

45、e effective planning, operation and control of its processes.</p><p>　　NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, d

46、ocumented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.</p><p>　　N

47、OTE 2 The extent of the quality management system documentation can differ from one organization to another due to</p><p>　　a) the size of organization and type of activities,</p><p>　　b) the co

48、mplexity of processes and their interactions, and</p><p>　　c) the competence of personnel.</p><p>　　NOTE 3 The documentation can be in any form or type of medium.</p><p>　　4.2.2 Qua

49、lity manual</p><p>　　The organization shall establish and maintain a quality manual that includes</p><p>　　a) the scope of the quality management system, including details of and justification f

50、or any exclusions (see 1.2),</p><p>　　b) the documented procedures established for the quality management system, or reference to them, and</p><p>　　c) a description of the interaction between t

51、he processes of the quality management system.</p><p>　　4.2.3 Control of documents</p><p>　　Documents required by the quality management system shall be controlled. Records are a special type of

52、 document and shall be controlled according to the requirements given in 4.2.4.</p><p>　　A documented procedure shall be established to define the controls needed</p><p>　　a) to approve document

53、s for adequacy prior to issue,</p><p>　　b) to review and update as necessary and re-approve documents,</p><p>　　c) to ensure that changes and the current revision status of documents are identif

54、ied,</p><p>　　d) to ensure that relevant versions of applicable documents are available at points of use,</p><p>　　e) to ensure that documents remain legible and readily identifiable,</p>

55、<p>　　f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled,

56、and</p><p>　　g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.</p><p>　　4.2.4 Control of records</p>

57、;<p>　　Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be control. </p><p>　　The organization shall establis

58、h a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.</p><p>　　Records shall remain legible, readily identifiabl

59、e and retrievable.</p><p>　　8 Measurement, analysis and improvement</p><p>　　8.1 General</p><p>　　The organization shall plan and implement the monitoring, measurement, analysis and

60、 improvement processes needed</p><p>　　a) to demonstrate conformity to product requirements,</p><p>　　b) to ensure conformity of the quality management system, and</p><p>　　c) to co

61、ntinually improve the effectiveness of the quality management system.</p><p>　　This shall include determination of applicable methods, including statistical techniques, and the extent of their use.</p>

62、<p>　　8.2 Monitoring and measurement</p><p>　　8.2.1 Customer satisfaction</p><p>　　As one of the measurements of the performance of the quality management system, the organization shall m

63、onitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.</p><p>　　NOTE Monito

64、ring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty cla

65、ims and dealer report.</p><p>　　8.2.2 Internal audit</p><p>　　The organization shall conduct internal audits at planned intervals to determine whether the quality management system</p>&l

66、t;p>　　a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and</p><p>　　

67、b) is effectively implemented and maintained.</p><p>　　An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the result

68、s of previous audits. The audit criteria, scope, frequency and methods shall be defined.  The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shal

69、l not audit their own work.</p><p>　　A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results

70、.</p><p>　　Records of the audits and their results shall be maintained (see 4.2.4).</p><p>　　The management responsible for the area being audited shall ensure that any necessary corrections and

71、 corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results

72、 (see 8.5.2).</p><p>　　NOTE See ISO 19011 for guidance.</p><p>　　8.2.3 Monitoring and measurement of processes</p><p>　　The organization shall apply suitable methods for monitoring

73、and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction an

74、d corrective action shall be taken, as appropriate.</p><p>　　NOTE When determining suitable methods, it is advisable that the organization consider the type and extent of monitoring or measurement appropriat

75、e to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.</p><p>　　8.2.4 Monitoring and measurement of produc

76、t</p><p>　　The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product real

77、ization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained.</p><p>　　Records shall indicate the person(s) authorizing relea

78、se of product for delivery to the customer (see 4.2.4).</p><p>　　The release of product and delivery of service to the customer shall not proceed until the planned arrangements (see 7.1) have been satisfacto

79、rily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.</p><p>　　8.3 Control of nonconforming product</p><p>　　The organization shall ensure tha

80、t product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibili

81、ties and authorities for dealing with nonconforming product.</p><p>　　Where applicable, the organization shall deal with nonconforming product by one or more of the following ways:</p><p>　　a) b

82、y taking action to eliminate the detected nonconformity;</p><p>　　b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;</p>

83、<p>　　c) by taking action to preclude its original intended use or application.</p><p>　　d) by take action appropriate to the effects, or potential effects, of the nonconformity when nonconforming produ

84、ct is detected after delivery or use has started.</p><p>　　When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. </p><p>　

85、　Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).</p><p>　　8.4 Analysis of data</p><p>　　The organizati

86、on shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality m

87、anagement system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.</p><p>　　The analysis of data shall provide information relating to&

88、lt;/p><p>　　a) customer satisfaction (see 8.2.1),</p><p>　　b) conformity to product requirements (see 8.2.4),</p><p>　　c) characteristics and trends of processes and products including

89、 opportunities for preventive action (see 8.2.3 and 8.2.4), and</p><p>　　d) suppliers (see 7.4).</p><p>　　8.5 Improvement</p><p>　　8.5.1 Continual improvement</p><p>　　

90、The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions

91、and management review.</p><p>　　8.5.2 Corrective action</p><p>　　The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions

92、shall be appropriate to the effects of the nonconformities encountered.</p><p>　　A documented procedure shall be established to define requirements for</p><p>　　a) reviewing nonconformities (inc

93、luding customer complaints),</p><p>　　b) determining the causes of nonconformities,</p><p>　　c) evaluating the need for action to ensure that nonconformities do not recur,</p><p>　　

94、d) determining and implementing action needed,</p><p>　　e) records of the results of action taken (see 4.2.4), and</p><p>　　f) reviewing the effectiveness of the corrective action taken.</p&g

95、t;<p>　　8.5.3 Preventive action</p><p>　　The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be

96、appropriate to the effects of the potential problems.</p><p>　　A documented procedure shall be established to define requirements for</p><p>　　a) determining potential nonconformities and their

97、causes,</p><p>　　b) evaluating the need for action to prevent occurrence of nonconformities,</p><p>　　c) determining and implementing action needed,</p><p>　　d) records of results o

98、f action taken (see 4.2.4), and</p><p>　　e) reviewing the effectiveness of preventive action taken.</p><p><b>　　參考譯文：</b></p><p>　　國(guó)際標(biāo)準(zhǔn)化組織（ISO）是由各國(guó)標(biāo)準(zhǔn)化團(tuán)體（ISO成員團(tuán)體）組成的世界性的聯(lián)

99、合會(huì)。制定國(guó)際標(biāo)準(zhǔn)工作通常由ISO的技術(shù)委員會(huì)完成。各成員團(tuán)體若對(duì)某技術(shù)委員會(huì)確定的項(xiàng)目感興趣，均有權(quán)參加該委員會(huì)的工作。與ISO保持聯(lián)系的各國(guó)際組織（官方的或非官方的）也可參加有關(guān)工作。ISO與國(guó)際電工委員會(huì)（IEC）在電工技術(shù)標(biāo)準(zhǔn)化方面保持密切合作的關(guān)系。   </p><p><b>　　引言 </b></p><p><b&

100、gt;　　0.1 總則</b></p><p>　　采用質(zhì)量管理體系應(yīng)當(dāng)是組織的一項(xiàng)戰(zhàn)略性決策。一個(gè)組織的質(zhì)量管理體系的設(shè)計(jì)和實(shí)施受以下方面影響：</p><p>　　a)     組織的環(huán)境、環(huán)境的變化和環(huán)境所帶來(lái)的風(fēng)險(xiǎn)；</p><p>　　b)     各種需求<

101、/p><p>　　c)     具體目標(biāo)</p><p>　　d)     所提供的產(chǎn)品</p><p>　　e)     所采用的過(guò)程</p><p>　　f)     組織的規(guī)模和結(jié)構(gòu)

102、</p><p>　　統(tǒng)一質(zhì)量管理體系的結(jié)構(gòu)或文件不是本標(biāo)準(zhǔn)的目的。</p><p>　　本標(biāo)準(zhǔn)所規(guī)定的質(zhì)量管理體系要求是對(duì)產(chǎn)品要求的補(bǔ)充?！白ⅰ笔抢斫夂驼f(shuō)明有關(guān)要求的指南。</p><p>　　本標(biāo)準(zhǔn)能用于內(nèi)部和外部（包括認(rèn)證機(jī)構(gòu)）評(píng)定組織滿足顧客、適用于產(chǎn)品的法律法規(guī)和組織自身要求的能力。</p><p>　　本標(biāo)準(zhǔn)的制定已經(jīng)考慮了ISO

103、19000和ISO19004中所闡明的質(zhì)量管理原則。 </p><p><b>　　0.2 過(guò)程方法 </b></p><p>　　本標(biāo)準(zhǔn)鼓勵(lì)在建立、實(shí)施質(zhì)量管理體系以及改進(jìn)其有效性時(shí)采用過(guò)程方法，通過(guò)滿足顧客要求，增強(qiáng)顧客滿意。</p><p>　　為使組織有效運(yùn)作，必須確定和管理眾多相互關(guān)聯(lián)的活動(dòng)。通過(guò)使用資源和管理，將