ISO13485 is based on ISO9001, which adopts the structure and main content of each chapter and article of ISO9001. 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, ISO13485 divides the content of ISO9001 into required chapters and articles and informative chapters and articles. The standard divides the content of changes to ISO9001 into three categories:

The first category is the deletion or revision of 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 make them meet the requirements of medical device regulations.

To sum up, the modification of ISO13485 to ISO9001 includes: two major deletions - customer satisfaction and continuous improvement; four important requirements are strengthened (regulatory requirements, documentation requirements, specific requirements for medical devices and production requirements); a key Clarification of requirements - risk management of medical devices in the whole process of product realization; change of an important related standard - from ISO9004:2008 "Quality Management System - Performance Improvement Guide" to ISO14969 "Medical Devices - Application Guidelines to ISO13485" ".

The reasons for each difference between ISO13485 and ISO9001 are explained in Appendix B of the standard, for example: 5.1 The standard clearly states that the goal of current medical device regulations is to maintain quality management that can sustainably produce safe and effective medical devices The effectiveness of the system, not the 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 a detrimental effect on an organization's ability to produce safe and effective medical devices.

The definition of 3.3.5 customer in ISO9000 is the organization and individual who receive the product, which means that the customer not only refers to the consumers, shoppers, end users, retailers, beneficiaries and purchasers outside the organization, but also refers to the production, Departments, positions, and individuals in services and activities that receive the output of the previous process. 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.