ISO 13485：2003标准(以下简称新标准)有许多特点，现简介如下。
ISO 13485 : 2003 standards ( hereinafter referred to as the new standard ) has many features, show brief introduction to be as follows.
　　一、新标准是独立的标准，不再是ISO9001标准在医疗器械行业中的实施指南，两者不能兼容。
One, the new standard is an independent standard ISO9001, is no longer in the medical equipment industry standards implementation guide, the two are incompatible.
　　新标准的名称是《医疗器械 质量管理体系 用于法规的要求》。新标准1.1总则"指出："本标准的主要目的是便于实施经协调的质量管理体系的法规要求。因此，本标准包含了一些医疗器械的专用要求，删减了ISO 9001中不适于作为法规要求的某些要求。由于这些删减，质量管理体系符合本标准的组织不能声称符合ISO 9001标准，除非其质量管理体系还符合ISO 9001中所有的要求。"
The new standard" quality management system for medical equipment regulations". New standard 1.1 general" pointed out:" the main purpose of this standard is to facilitate the implementation of quality management system to coordinate the regulatory requirements. Therefore, this standard contains some special requirements of medical devices, the deletion of the ISO 9001 are not suitable for regulations require certain requirements. As a result of these exclusions, quality management system conforms to the standards organization cannot claim according to the standard of ISO 9001, unless the quality management system in line with all the requirements in ISO 9001. "
　二、新标准的作用。
In two, the new standard.
　　新标准0.1"总则"指出："本标准规定了质量管理体系要求，组织可依此要求进行医疗器械的设计和开发、生产、安装和服务，以及相关服务的设计、开发和提供。本标准也可用于内部和外部(包括认证机构)评定组织满足顾客和法规要求的能力。值得强调的是，本标准所规定的质量管理体系要求是对产品技术要求的补充。"
New standard 0.1" general" pointed out:" this standard specifies requirements for a quality management system, the organization can and requirements of medical instrument design and development, production, installation and service, as well as related services design, development and delivery of. This standard also can be used for internal and external ( including certification bodies ) to assess the organization 's ability to meet customer and regulatory requirements. It is worth emphasizing, this standard specifies requirements for a quality management system requirements of the technical requirements of the product supplement. "
　　三、在0.2"过程方法"中，新标准只作了简要说明，也没有过程模式图。
Three, in the 0.2 "process approach", a brief description of the new standard, no process model diagram.
　　新标准这样做的原因是，在ISO 9001标准的0.2条款中，有许多指南被认为包含在ISO/TR 14969的技术报告中。该技术报告正在制定中，旨在为ISO 13485的应用提供指南。
The new standard is the reason for this is that, in the ISO 9001 standard 0.2 terms, there are many guide deemed to be included in ISO / TR 14969 technical report. This technical report is being developed, designed for ISO 13485 application guide.