What is ISO 9001?
ISO 9001 is a globally recognized standard for quality management. It helps organizations of all sizes and sectors to improve their performance, meet customer expectations and demonstrate their commitment to quality. Its requirements define how to establish, implement, maintain, and continually improve a quality management system (QMS).
Implementing ISO 9001 means your organization has put in place effective processes and trained staff to deliver flawless products or services time after time.
Why is ISO 9001 important?
With more than one million certificates issued to organizations in 189 countries, ISO 9001 is the most widely used quality management standard in the world. Within the ISO 9000 family, which defines seven quality management principles including a strong customer focus and continual improvement, ISO 9001 is the only standard that can be certified to (though certification is not mandatory).
Business benefits include:
Customer confidence: The standard ensures that organizations have robust quality control processes in place, leading to increased customer trust and satisfaction.Effective complaint resolution: ISO 9001 offers guidelines for resolving customer complaints efficiently, contributing to timely and satisfactory problem-solving.Process improvement: The standard helps identify and eliminate inefficiencies, reduce waste, streamline operations, and promote informed decision-making, resulting in cost savings and better outcomes.Ongoing optimization: Regular audits and reviews encouraged by ISO 9001 enable organizations to continually refine their quality management systems, stay competitive, and achieve long-term success.
ISO 9001 和 ISO 13485 有什么区别？
国际标准 ISO 9001 和 ISO 13485 都定义了质量管理体系的要求，但其中一个标准的用户群体比另一个标准广泛得多。ISO 9001 提供了一个质量管理框架，适用于任何规模或行业的组织。另一方面，ISO 13485 是专门为医疗器械行业开发的，重点关注监管合规性。该标准有助于确保医疗器械的安全性和有效性，包括风险管理、可追溯性和过程验证。与 ISO 9001 相比，它包含针对参与医疗器械生命周期的组织的附加要求，而 ISO 9001 中与监管要求无关的元素不属于 ISO 13485 的一部分。
简而言之，ISO 9001 规定了质量管理的总体框架，而 ISO 13485则为医疗器械行业提供了具体指导。
什么是 ISO 9001 认证？我的公司是否需要获得认证？
ISO 9001 认证是向利益相关者和客户证明您致力于并能够始终如一地提供高质量产品或服务的一种方式。持有经认可的合格评定机构颁发的证书可能会带来额外的信心，因为认可机构已对认证机构的能力提供了独立的确认。
与其他 ISO 管理体系标准一样，实施 ISO 9001 的公司可以选择是否要通过认证流程。
检查体系是否正常运行是 ISO 9001 的重要组成部分。该标准建议组织进行内部审核，以检查其质量管理体系的运行情况。组织可以决定邀请独立的认证机构来验证其是否符合标准，但对此没有任何要求。或者，您可以邀请您的客户亲自审核质量体系。
与其他情况一样，在认证声明中应始终引用标准的完整参考信息，例如“已通过 ISO 9001:2015 认证”（而不仅仅是：“已通过 ISO 9001 认证”）。如果您希望使用徽标来证明认证，请联系为您颁发证书的认证机构。查看有关ISO 徽标使用的完整详细信息。
