News and Information

News and Information

[Company News] ISO 9001:2015 Quality Management System Training Course


  The new edition of the ISO 9001 quality management system standard has now been officially released. Compared with the 2008 version, the revised standard introduces significant changes. To ensure that organizations are well‑versed in and fully grasp the requirements of ISO 9001:2015, to help them accurately interpret the new content, and to support a smooth transition to the updated standard—while also meeting the needs of internal auditors seeking certification under the new version—the following measures have been put in place.

  On April 13–14, the Suzhou Municipal Bureau of Quality and Technical Supervision, in collaboration with Beijing Huaguang National Medical Device Co., Ltd., jointly organized a training course for internal auditors on the ISO 9001:2015 quality management system standard. Our company’s Liu Xiaowei, Yang Jun, and Huang Jueqing attended the training. The session featured lectures by Mr. Guo, a nationally certified senior auditor, who provided a comprehensive overview of the standard from seven perspectives: the background and development process of the ISO 9001:2015 revision; the new standard’s general requirements, expectations, and objectives; changes to the overall structure of the standard; interpretations of specific content changes; answers to practical application questions; document preparation and auditing; and internal audits of the quality management system. Mr. Guo’s explanations were both thorough and accessible, delivered in an engaging and innovative style, thereby deepening participants’ understanding of the relevant provisions of the ISO 9001:2015 standard.

  In addition to significant structural changes, the new standard introduces several new concepts and requirements, including “4.1 Understanding the organization and its context,” “4.2 Understanding the needs and expectations of interested parties,” “6.1 Actions to address risks and opportunities,” “7.5 Documented information,” and “8.6 Release of products and services.” Compared with the 2008 edition, the 2015 version features a more rational and refined structure and content, while also being more practical for organizations and embodying the principle of continuous improvement.

  All certified organizations must complete the transition to the new ISO 9001:2015 standard no later than 2018. It is therefore essential to familiarize themselves with the revised standard’s requirements and to revise and enhance their existing management systems in accordance with these new criteria. Participants unanimously agreed that this training was highly timely and of great significance, as it not only deepened their understanding of the ISO 9001:2015 quality management system standard but also laid a solid foundation for enterprises to successfully implement the transition to the new version.

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