ISO/DIS13485 is based on ISO9001:2000. It adopts the structure and main content of each chapter and article of ISO9001:2000. However, since medical devices are directly related to human life and health, China and other countries in the world have formulated more laws and regulations for them than other products, and put forward stricter control requirements in order to achieve safe and effective medical devices. the main purpose. To this end, ISO/DIS13485 divides the content of ISO9001:2000 into required chapters and articles and informative chapters and articles. The standard divides the content of ISO9001:2000 changes into three categories: the first category is to delete or revise the substantive requirements in the form of deletion or major modification. The second category is to amend the required chapters and articles by adding provisions. The third category is to make changes to the required chapters and articles by adding information or tailoring them to meet the requirements of medical device regulations.

To sum up, the revision of ISO/DIS13485 to ISO9001:2000 includes: two major deletions - "customer satisfaction" and "continuous improvement"; enhancement of four important requirements (regulatory requirements, documentation requirements, requirements for medical devices Specific requirements and production requirements); the clarification of a key requirement - risk management of medical devices in the whole process of product realization; a change in an important related standard - by ISO9004:2000 "Quality Management System - Performance Improvement Guide" Changed to ISO14969 "Medical Devices - Guidelines for the Application of ISO13485".

For each difference between ISO/DIS13485 and ISO9001, the reasons are explained in Appendix B of the standard, for example: 5.1 The standard clearly states: "The goal of current medical device regulations is to maintain the ability to continue to produce safe and effective medical devices. effectiveness of the quality management system” rather than “continuous improvement of the quality management system”.

The most important and basic requirements for medical devices in the current regulations of various countries in the world are safety and effectiveness. Before being put on the market, medical devices should be subject to corresponding clinical research, testing or clinical verification according to the different types of regulations, and , It is necessary to make a convincing appraisal based on the above results, and then report it to the government supervision and management department for approval, and obtain the trial production registration before it can be put on the market. Thereafter, any technical status involving safety and efficacy issues should not be easily changed, but should be frozen. Improvement is of course very necessary, but it must be done very carefully and in stages; if there is too much emphasis on continuous improvement and frequent improvement, it may have adverse clinical consequences, and even affect patient safety and therapeutic effects. speaking, this is inappropriate.

5.2 "Customer satisfaction is inappropriate for the objectives of medical device regulations and, moreover, has an adverse effect on an organization's ability to produce safe and effective medical devices".

ISO9000:2000 3.3.5 "customer" is defined as "organizations and individuals who receive products", which means that customers refer to consumers, shoppers, end users, retailers, beneficiaries and purchasers outside the organization, and also Refers to the departments, positions and individuals that receive the output of the previous process in the production, services and activities within the organization. However, the final user (the final customer) is the group who uses the product. For medical devices, the patient is the ultimate beneficiary, and the doctor also serves them. Often, however, patients are not physicians, and it is sometimes difficult for patients to make objective judgments about safety and efficacy. For example, according to clinical trials, the intra-aortic capsule counter-pulsator can reduce the mortality rate by 30% when rescuing critically ill patients. For a certain patient, it is difficult to feel the actual meaning of this statistic.