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ISO9001:2015标准为组织提供了实施质量管理体系的战略决策，旨在提升整体绩效并为可持续发展奠定基础。该标准强调了满足顾客及法规要求、增强顾客满意度、应对风险和机会、展示符合规定要求的能力。它采用过程方法，结合PDCA循环和基于风险的思维，使组织能够规划和管理其过程，确保改进和预防措施的实施。

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ISO9001-2015-标准中英文

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ISO 9001：2015

Quality management systems —Requirements

质量管理体系-要求

Introduction引言

0.1 General 总则

The adoption of a quality management system is a strategic decision for an organization that can help

to improve its overall performance and provide a sound basis for sustainable development initiatives.

The potential benefits to an organization of implementing a quality management system based on this

International Standard are:

a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;

b) facilitating opportunities to enhance customer satisfaction;

c) addressing risks and opportunities associated with its context and objectives;

d) the ability to demonstrate conformity to specified quality management system requirements.

This International Standard can be used by internal and external parties.

It is not the intent of this International Standard to imply the need for:

— uniformity in the structure of different quality management systems;

— alignment of documentation to the clause structure of this International Standard;

— the use of the specific terminology of this International Standard within the organization.

The quality management system requirements specified in this International Standard are complementary to requirements for products and services.

This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.

The process approach enables an organization to plan its processes and their interactions.

The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on.

Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative e