为什么您应该从文档、培训和变更管理入手作为 QMS 的基础（三）

携手小灰灰

在采用企业质量管理系统（EQMS）之前，为什么要使用电子文档管理系统（EDMS）？

Companies, as part of their digital transformation, embrace Enterprise Quality Management Systems to help migrate from paper based, be-spoke/non-integrated systems to a unified platform providing capabilities to automate key QMS processes across the organization. As such, the question often asked is, which solution(s) should I start with? The typical consultant response would be, “Start with where you believe the maximum pain for the organization is and evolve from there”. This approach makes perfect sense if the focus was to solve a specific problem that the organization faces. However, to effectively implement a new Quality Management system, it is important for an organization to identify and build the right foundation first and then build the rest of the QMS on it. This approach will not only solve the problems that the company faces in the right model but also provide an approach to roll-out a strategy that is sustaining, well adopted and is longer lasting.

作为数字化转型的一部分，公司采用企业质量管理系统来帮助从基于纸张的、非集成的系统迁移到统一平台，提供自动化关键质量管理流程的能力。因此，经常会问到应该从哪个解决方案开始。典型的顾问回答通常是“从你认为对组织造成最大痛苦的地方开始，并从那里发展”。如果重点是解决组织面临的特定问题，这种方法是完全合理的。然而，为了有效地实施新的质量管理系统，组织需要首先确定并建立正确的基础，然后在此基础上建立其余的质量管理体系。这种方法不仅可以在正确的模式下解决公司面临的问题，还可以提供一种可持续、广泛接受和更持久的策略实施方法。

ComplianceQuest strongly recommends the roll-out of Enterprise Document Management System (EDMS) consisting of Document Control, Training and Change Management processes as the foundational capabilities first. The following provides the salient points to consider:

ComplianceQuest强烈推荐首先推出由文档控制、培训和变更管理流程组成的企业文档管理系统（EDMS）作为基本能力。以下是需要考虑的要点：

11. Operational excellence and compliance are dependent upon accurate data and real-time document management.Although the change from paper-based or hybrid systems to a fully automated system is a challenging one, recent regulations and scrutiny on product safety is making the transition necessary. Companies that use automated systems report quick return on investment through expedited and effective document control that drives overall enhanced conformance and harmonization of quality systems at the enterprise level.

11. 运营卓越和合规性依赖于准确的数据和实时的文件管理。虽然从纸质或混合系统转换到完全自动化系统是一个具有挑战性的过程，但最近对产品安全的监管以及审查要求使得这一转变成为必要。使用自动化系统的公司报告了快速回报的投资，通过加快和有效的文件控制，推动企业级质量系统的整体符合性和协调性。

12. A robust Document Control process lies at the heart of a Quality Management system.Nearly every element of auditing and compliance is verified by examining documented evidence. That's the regulatory inspectors’ bread and butter,so to stay compliant, you need to keep your organization's documents fresh and handy.

12. 强大的文件控制流程是质量管理体系的核心。几乎每个审计和合规性元素都是通过检查文件证据来验证的。这是监管检查员的基本要求，所以为了保持合规性，您需要保持组织的文件新鲜和可用。

13. The use of contract manufacturers has grown,and today's supplier relationships have expanded in global reach and material/component complexity.As a result,the need for collaborative workspaces and effective version control have become paramount to ensure valid,safe,and legal operations.

13. 使用合同制造商的需求不断增长，今天的供应商关系在全球范围和材料/零部件复杂性方面扩大。因此，确保有效的协作工作空间和版本控制至关重要，以确保合法、安全和合规的运营。

14. A well designed, documented system has many benefits, it ensures quality standards are routinely met, minimizes the potential for error, reduces downtime when deviations occur due to being able to quickly access relevant data,and allows for easy monitoring of the processes such that process outputs are analyzed and appropriate adjustments are made.QMS documentation fulfills many functions such as communication of information,providing evidence of conformity and sharing knowledge and as such many different types and levels of documents are needed,for example a quality manual,quality policy, documented procedures and work instructions.

14. 设计良好且有文档支持的系统具有许多好处，它确保质量标准被持续满足，最大程度地减少错误的可能性，当偏离发生时减少停机时间，因为可以快速访问相关数据，并且允许轻松监控流程以分析过程输出并进行适当的调整。质量管理体系文件满足许多功能，如信息传递、提供符合性证据和共享知识等，因此需要许多不同类型和层次的文件，例如质量手册、质量政策、文件化的程序和工作指示。

15. Documentation is also required for regulatory purposes and must demonstrate the effective planning, operation and control of the organization's processes and the implementation and continual improvement of the effectiveness of its QMS.It is evident that good documentation is critical to a functioning QMS,in fact it forms the foundation of the organizations QMS as it gives effect to the QMS for the life-cycle of the product/service being delivered.

15. 文件也需要出于监管目的，并且必须展示组织的过程的有效规划、运营和控制，以及其质量管理体系的实施和持续改进的有效性。显然，良好的文件编制对于运行良好的质量管理体系至关重要，事实上，它构成了组织质量管理体系的基础，因为它在产品/服务的整个生命周期中对质量管理体系产生了影响。

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