GB/T19001: 2016-6.3变更的策划

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“当组织确定需要对质量管理体系进行变更时，变更应按所策划的方式实施(见4.4》”。

变更的策划应符合“4.4质量管理体系及其过程”的要求，以确保在变更期间保持质量管理体系的完整性以及组织继续提供符合要求的产品和服务的能力

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When the organization determines that changes need to be made to the quality management system, the changes should be implemented in the planned manner (see 4.4).
The planning of the changes should comply with the requirements of 4.4 Quality Management System and Its Processes to ensure the integrity of the quality management system is maintained during the change period and the organization's ability to continue providing products and services that meet the requirements

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质量管理体系变更的需求可以通过很多不同的方式来确定，例如，作为管理评审的一部分，考虑审核结果、不合格的评审、抱怨分析、过程绩效的分析、环境的变化，或考虑顾客和其他有关利益方的需求变化。

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The need for changes to the quality management system can be determined in many different ways, for example, as part of a management review, considering audit results, non-conforming reviews, complaint analysis, process performance analysis, environmental changes, or considering changes in customer and other relevant stakeholders' needs.

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组织应考虑可能减少变更的负面影响的可能性的措施，比如，在全面实施变更前首先进行变更的试验，确定当变更没有成功实施时应采取的措施。

基于风险的思维的应用可能有助于确定策划质量管理体系变更所需的措施

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Organizations should consider measures that may reduce the likelihood of negative impacts of changes, such as conducting change testing before fully implementing changes to determine the measures to be taken when changes are not successfully implemented.



The application of risk based thinking may help determine the measures required for planning changes to the quality management system

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质量管理体系的完整性”。策划变更的目的是在变更期间保持质量管理体系的完整性以及组织继续提供符合要求的产品和服务的能力。质量管理体系是过程存在相互作用的一个完整体系，在策划和实施某一要素的变更时，应考虑与此要素相关的其它要素变更的必要性。

“资源的可获得性”。组织应为任何变更考虑资源的可获得性。比如延迟变更直到可以获得合适的资源。

“职责和权限的分配或再分配”。组织应为任何变更考虑职责和权限的必要的分配或再分配。比如指派人员到管理变更的团队

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Integrity of the quality management system. The purpose of planning changes is to maintain the integrity of the quality management system and the organization's ability to continue providing products and services that meet requirements during the change period.

The quality management system is a complete system in which processes interact. When planning and implementing changes to a certain element, the necessity of other element changes related to that element should be considered.



The availability of resources. The organization should consider the availability of resources for any changes. For example, delaying changes until suitable resources are available.



Allocation or redistribution of responsibilities and authorities. The organization should consider the necessary allocation or redistribution of responsibilities and authorities for any changes. For example, assigning personnel to a team that manages changes