8. http://www.5ixue.com (海量营销管理培训资料下载) *4、质量管理体系/4.2 文件要求 4.2.3 文件控制
+文件控制的活动· 批准
a) 确保文件的充分性和适宜性
b) 内行/责任者审批是一个基本
保证方法。正确/可操作的要求和方法
内容完整/要求满足· 评审、更新与再批准
a) 必要时应对文件进行评审
b) 更新
c) 再批准对文件内容和效果的审视/评价
适时/定期
局部/系统适时的修订并标识
适时的换版并标识修订应经过再批准
原批准者批准
可获得背景资料的有把握的人批准Newa) 文件发布前得到批准,以确保文件是充分与适宜的;
b) 必要时对文件进行评审与更新,并再次批准;
9. http://www.5ixue.com (海量营销管理培训资料下载) * 4.2.3 文件控制
+文件控制的活动· 发放
a) 发放的充分性
b) 发放的可追溯性
c) 记录的完整性需要使用处可获得需要追溯时可追回可追溯到每份文件
可追溯到修订时的收回/发放情况
可追溯到丢失/补发情况
可追溯到作废/保留情况4、质量管理体系/4.2 文件要求d) 确保在使用处可获得有关版本的适用文件;New
10. http://www.5ixue.com (海量营销管理培训资料下载) * 4.2.3 文件控制
+ 文件控制的活动· 文件的保持
a) 使用者保持
b) 文管的保持防止丢失
防止破损
防止涂改、受污使用安全的保存形式/包装
丢失补发
破损换发
受污换发4、质量管理体系/4.2 文件要求e) 确保文件保持清晰、易于识别;New
11. http://www.5ixue.com (海量营销管理培训资料下载) * 4.2.3 文件控制
+文件控制的活动· 作废文件的处置
a) 作废文件
b) 防止非预期使用
c) 处置方法作废的整份文件
作废的部分文件(单页)防止继续使用并执行无效文件作废 → 销毁
保留 → 标识4、质量管理体系/4.2 文件要求防止作废文件的非预期使用,若因任何原因而保留作废文件时,对这些文件进行适当的标识。
51. http://www.5ixue.com (海量营销管理培训资料下载) *6.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication).
组织应确定、提供并维护为达到产品符合要求所需的基础设施。适用时, 基础设施包括:
a) 建筑物、工作场所和相关的设施;
b) 过程设备(硬件和软件);
c) 支持性服务(如运输或通讯)。6、资源管理/6.3 基础设施New
55. http://www.5ixue.com (海量营销管理培训资料下载) * F 何时识别和确定补充或更新基础设施质量策划
管理评审
拟定纠正和预防措施
6、资源管理/6.3 基础设施
56. http://www.5ixue.com (海量营销管理培训资料下载) *6、资源管理/6.4 工作环境 F工作环境管理要点· 工作环境· 所需的工作环境心理环境工作时所处的一组条件知识、技能的获得、心情、参与物理环境湿度、电磁、安全、卫生、清洁度、噪声、震动、污染、光线人的工作环境心理、安全、工效设施的工作环境作业空间、工作环境条件· 所需的工作环境识别
保证
维持
测量
调整
改进6.4 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.New
60. http://www.5ixue.com (海量营销管理培训资料下载) *7.2.1 Determination of requirements related to the product
The organization shall determine
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for specified or intended use, where known,
c) statutory and regulatory requirements related to the product, and
d) any additional requirements determined by the organization.
7.2.1 与产品有关的要求的确定
组织应确定:
a)顾客规定的要求,包括对交付及交付后活动的要求;
b)顾客虽然没有明示,但规定的用途或已知的预期用途所必需的要求;
c)与产品有关的法律法规要求;
d) 组织确定的任何附加要求。7、产品实现/7.2 与顾客有关的过程
62. http://www.5ixue.com (海量营销管理培训资料下载) *7.2.2 Review of requirements related to the product
The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) the organization has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.7、产品实现/7.2 与顾客有关的过程
65. http://www.5ixue.com (海量营销管理培训资料下载) *7、产品实现/7.4 采购7.4.1 Purchasing process
The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.
组织应确保采购的产品符合规定的采购要求。对供方及采购的产品控制的类型和程度应取决于采购的产品对随后的产品实现或最终产品的影响。
组织应根据供方按组织的要求提供产品的能力评价和选择供方。应制定选择、评价和重新评价的准则。评价结果及评价所引起的任何必要措施的记录应予以保持。
69. http://www.5ixue.com (海量营销管理培训资料下载) *7.4.2 Purchasing information
Purchasing information shall describe the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
采购信息应表述采购的产品,适当时包括:
a) 产品、程序、过程、和设备的批准要求;
b) 人员资格的要求;
c) 质量管理体系的要求。
在与供方沟通前,组织应确保规定的采购要求是充分与适宜的。7、产品实现/7.4 采购
71. http://www.5ixue.com (海量营销管理培训资料下载) *7.4.3 Verification of purchased product
The organization shall establish and implement the inspection or other activities necessary for ensuring that
purchased product meets specified purchase requirements.
Where the organization or its customer intends to perform verification at the supplier‘s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
组织应确定并实施检验或其他必要的活动,以确保采购的产品满足规定的采购要求。
当组织或其顾客拟在供方的现场实施验证时,组织应在采购信息中对拟验证的安排产品放行的方法作出规定。7、产品实现/7.4 采购
73. http://www.5ixue.com (海量营销管理培训资料下载) *7、产品实现/7.5 生产和服务提供7.5.1 Control of production and service provision
The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable
a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement, and
f) the implementation of release, delivery and post-delivery activities.
77. http://www.5ixue.com (海量营销管理培训资料下载) *7、产品实现/7.5 生产和服务提供7.5.2 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results.
The organization shall establish arrangements for these processes including, as applicable
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.
80. http://www.5ixue.com (海量营销管理培训资料下载) *7、产品实现/7.5 生产和服务提供7.5.3 Identification and traceability
Where appropriate, the organization shall identify the product by suitable means throughout product realization.
The organization shall identify the product status with respect to monitoring and measurement requirements.
Where traceability is a requirement, the organization shall control and record the unique identification of the product.
NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.
适当时,组织应在产品实现的全过程中使用适宜的方法识别产品。
组织应针对监视和测量要求识别产品的状态。
在有可追溯性要求的场合,组织应控制和记录产品唯一性标识(见4.2.4)。
注:在某些行业,技术状态管理是保持标识和可追溯性的一种方法。
83. http://www.5ixue.com (海量营销管理培训资料下载) *7、产品实现/7.5 生产和服务提供7.5.4 Customer property
The organization shall exercise care with customer property while it is under the organization's control or being used
by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use
or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for
use, this shall be reported to the customer and records maintained (see 4.2.4).
NOTE Customer property can include intellectual property.
组织应爱护在组织控制下或组织使用的顾客财产。组织应识别、验证、保护和维护供其使用或构成产品一部分的顾客财产。若顾客提供的财产发生丢失、损坏或发现不适用的情况时,应报告顾客,并保持记录(见4.2.4)。
注:顾客财产可包括知识产权。
85. http://www.5ixue.com (海量营销管理培训资料下载) *7、产品实现/7.5 生产和服务提供7.5.5 Preservation of product
The organization shall preserve the conformity of product during internal processing and delivery to the intended
destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation
shall also apply to the constituent parts of a product.
7.5.5产品防护
在内部处理和交付到预定的地点期间,组织应针对产品的符合性提供防护。这种防护应包括标识、搬运、包装、贮存和保护。防护也应适用于产品的组成部分。
91. http://www.5ixue.com (海量营销管理培训资料下载) *7.6 Control of monitoring and measuring devices
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
b) be adjusted or re-adjusted as necessary;7、产品实现/7.6 监视和测量装置的控制
92. http://www.5ixue.com (海量营销管理培训资料下载) *c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.
In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4).
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
NOTE See ISO 10012-1 and ISO 10012-2 for guidance.7、产品实现/7.6 监视和测量装置的控制
99. http://www.5ixue.com (海量营销管理培训资料下载) *8、测量、分析和改进/8.1 总则8 Measurement, analysis and improvement
8.1 General
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
a) to demonstrate conformity of the product,
b) to ensure conformity of the quality management system, and
c) to continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
组织应策划并实施以下方面所需的监视、测量、分析和改进过程;
a) 证实产品的符合性;
b)确保质量管理体系的符合性;
c)持续改进质量管理体系的有效性。
这应包括对统计技术在内的适用方法及其应用程度的确定。
102. http://www.5ixue.com (海量营销管理培训资料下载) *8、测量、分析和改进/8.2 监视和测量8.2.1 Customer satisfaction
As one of the measurements of the performance of the quality management system, the organization shall monitor
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.
8.2.1顾客满意
作为对质量管理体系业绩的一种测量,组织应监视顾客关于组织是否满足其要求的感受的相关信息。并确定获取和利用这种信息的方法。
111. http://www.5ixue.com (海量营销管理培训资料下载) *8、测量、分析和改进/8.2 监视和测量8.2.3 Monitoring and measurement of processes
The organization shall apply suitable methods for monitoring 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 and corrective action shall be taken, as appropriate, to ensure conformity of the product.
8.2.3 过程的监视和测量
组织应采用适宜的方法对质量管理体系过程进行监视,并在适用时进行测量。这些方法应证实过程实现所策划结果的能力。当未能达到所策划的结果时,应采取适当的纠正和纠正措施,以确保产品的符合性。
113. http://www.5ixue.com (海量营销管理培训资料下载) *8.2.4 Monitoring and measurement of product
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 realization process in accordance with the planned arrangements (see 7.1).
Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product (see 4.2.4).
Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.8、测量、分析和改进/8.2 监视和测量
118. http://www.5ixue.com (海量营销管理培训资料下载) *8.3 Control of nonconforming product
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
The organization shall deal with nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, bythe customer;
c) by taking action to preclude its original intended use or application.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).8、测量、分析和改进/8.3 不合格品控制
121. http://www.5ixue.com (海量营销管理培训资料下载) *8.4 Analysis of data
The organization shall determine, collect and analyses 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 management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to
a) customer satisfaction (see 8.2.1),
b) conformity to product requirements (see 7.2.1),
c) characteristics and trends of processes and products including opportunities for preventive action, and
d) suppliers.8、测量、分析和改进/8.4 数据分析
127. http://www.5ixue.com (海量营销管理培训资料下载) *8.5.1 Continual improvement
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 and
management review.
8.5.1 持续改进
组织应利用质量方针、质量目标、审核结果、数据分析、纠正和预防措施以及管理评审,持续改进质量管理体系的有效性。
8、测量、分析和改进/8.5 改进