Medical equipment industry has been using the ISO13485 standard (Chinese equivalent standard YY/T 0287) as the certification of quality management system based on. The standard is the increase in the medical device industry special requirements in the ISO9001:1994 standard on the basis of. So it satisfies the ISO13485 is in line with the requirements of ISO9001:1994. Since ISO9001:2000 standards promulgated after repeated discussions, ISO/TC210, in 2003 issued a new ISO13485:2003 international standard, the new standards have greatly changed compared with the old standard, it has many characteristics of medical equipment industry.

ISO13485 is an independent standard, ISO9001 standards implementation guide is not in the medical device industry, the two can not be compatible.

This look out from the new standard for the title, ISO13485:2003 international standard name is: "medical quality management system

For regulatory requirements". The new standard special emphasis is to meet the requirements of laws and regulations. The standard in the general said: "the main purpose of this standard is to facilitate the implementation of requirements of quality management system to coordinate the regulations. Therefore, this standard contains some special requirements of medical devices, the deletion of the certain requirements as required by the regulations are not suitable for ISO9001. As a result of these exclusions, the quality management system conforms to the standards organization cannot claim conforms to the ISO9001 standard, unless the quality management system to meet the requirements of all the ISO9001."

The ISO13485 standard is complementary to the technical requirements of the product, this point, clearly pointed out that in the general introduction of standard:"...... It is worth emphasizing, requirements specified in this international standard quality management system is complementary to the technical requirements of the product."

No process model of ISO13485 standard

In the 0.2 process approach the standard section, the standard only briefly, no process model.

For the deletion of the provisions of the ISO13485 standard

There are more detailed provisions in section 1.2, "the standard application". All requirements of this international standard is to provide the medical equipment organization, regardless of tissue type or size. If regulations allow for the exclusion of control of design and development, in the quality management system. They can be considered reasonable. These regulations can provide an alternative arrangements, these arrangements should be explained in quality management system. The organization has the responsibility to ensure that meet the criteria in the statement reflected on the design and development control.

ISO13485 standards emphasize "the validity"

In ISO9001 standards in many "continuous improvement" in the ISO13485 standards were changed to "maintain its effectiveness", this is because the current regulations is the target of the effectiveness of the quality management system, to sustain the production of safe and effective products.

ISO13485 standards emphasize regulatory requirements

New standards emphasize regulatory requirements, many places do not emphasize the customer requirements. This is because the customer satisfaction is not suitable as a medical device regulatory goals, which is consistent with the goal of coordination of global management system and regulations.

According to the characteristics of medical equipment industry, ISO13485 standard on the formation procedure of requirement increase.

According to the characteristics of medical equipment industry, they are ISO13485 documented procedures required by the standard, there are more than 20, work instructions or requirements: file control program (4.2.3); the record control procedure (4.2.4) (6.2.2); training; infrastructure maintenance; working environment (6.4); risk management (7.1); the product requirements (7.2.2); design and development program (7.3.1); procurement procedure (7.4.1); control of production and service provision (7.5.1.1b), (7.5.1.2.1), (7.5.1.2.2), (7.5.1.2.3); computer software validation procedures and sterilization process validation program (7.5.2.1); product identification procedure (7.5.3.1); can traceability program (7.5.3.2.1); procedures or work instructions for the preservation of product (7.5.5); the monitoring and measuring device control program (7.6); feedback system program (early warning, provide quality problem and can process the input of corrective and preventive measures) (8.2.1); the internal audit program (8.2.2); product monitoring and measurement program (8.2.4.1); nonconforming product control procedure (8.3) reworking instruction; data analysis program (8.4); advice issued and implemented the program (8 .5.1) adverse events administrative departments in charge of the program (regulatory requirements) (8.5.1); the corrective action procedure (8.5.2); prevention program (8.5.3).

ISO13485 standard of medical equipment industry characteristics, has increased in many professional provisions. According to the characteristics of medical equipment industry, ISO13485:2003 standard made many professional provisions, such as 4.2.4 recording control regulation: "lifetime medical organization record keeping period shall be at least equivalent to that provided by the organization, but the organization from the release date not less than 2 years, according to the requirements of relevant laws and regulations or provisions." 6.4 the work environment, increase the product cleaning, pollution prevention, health and other aspects of the request; increase the "advice" 7.2.3 customer communication; 8.2.1 headline read "feedback", rather than the ISO 9001 8.2.1 customer satisfaction, and increases the quality problem of early warning and assessment after production stage experience etc.. Because the customer satisfaction and customer perception is not suitable as a requirement to implement laws and regulations. In addition to the active implantable medical devices and implantable medical devices have special requirements, namely "the organization shall record the inspection and test status of personnel."

In short, the new ISO13485 standard is an independent standard, although the section structure with the same ISO9001:2000, some chapters are the same as ISO9001, but because the ISO13485 standard according to the characteristics of medical equipment industry, highlighting the legal and regulatory requirements, downplaying the customer satisfaction, the deletion of the ISO9001:2000 some important requirements, thus to meet the ISO13485 requirements, not equal to meet the requirements of ISO 9001:2000. Therefore in the medical equipment company auditors must seriously study the new standard.