ISO13485:2003 has been officially promulgated, and this standard will cancel and replace ISO13485:1996 and ISO13488:1996 (equivalent to Chinese medical device industry standards YY/T0287:1996 and YY/T0288:1996). China's equivalent medical device industry standard YY/T0287:2003 "Medical Device Quality Management System Requirements for Regulations" (replacing YY/T0287:1996), was also officially approved by the State Food and Drug Administration on September 17, 2003 Published, the standard has been implemented since April 1, 2004.

  ISO13485:2003 is an independent standard that can be used independently of ISO9001:2000 for companies operating only in the medical product industry.

  ISO13485 is a quality certification system, especially for medical devices. In many cases, when pharmaceutical companies export their products to the international market, passing ISO9001/ISO13485 is advantageous and even necessary. In the European Union, EU regulation enables free trade in medical devices. An important requirement for compliance with EU management is the establishment and independent assessment of a quality system.

  ISO13485 is the most accepted standard by medical device manufacturers all over the world (such as: the United States, Japan, Canada, the European Union). This standard includes requirements specific to this industry and defines other terms such as medical device, active medical device, active transplant device, and sterile medical device.

  ISO13485 supports those companies that manufacture or use medical products and services, helping these companies reduce unforeseen risks. The system seeks to improve a company's reputation in the eyes of customers and authoritative organizations.

   Europe's unified medical device quality system standards are ISO13485:2000 and ISO13488:2000. According to the official publication of the European Union on July 31, 2002, these two standards will replace the current harmonized standards 46001 and 46002 (used until March 2004).

   When manufacturers are active in the international market, focusing on international standards (eg: ISO) is not only a competitive advantage, but the standard may also become the prescribed standard in some countries. For example, Canada requires that manufacturers of medical devices sold in the Canadian market must pass an ISO13485 or ISO13488 quality system after January 2003.

  The medical device industry has always used the ISO13485 standard (my country's equivalent standard number is YY/T 0287) as the basis for quality management system certification. In the past, this standard was formulated based on the ISO9001:1994 standard with the addition of special requirements for the medical device industry. Therefore, meeting ISO13485 also meets the requirements of ISO9001:1994. Since the promulgation of the ISO9001:2000 standard, ISO/TC210 has been discussed repeatedly, and the new ISO13485:2003 international standard was promulgated in 2003. Compared with the old standard, the new standard has major changes, and it has many characteristics of the medical device industry.

  ISO13485 standard is a supplement to product technical requirements

   This point is clearly pointed out in the general provisions of the standard introduction: "...It is worth emphasizing that the quality management system requirements specified in this standard are supplements to the product technical requirements."

  ISO13485 standard has no process pattern diagram

   In the standard 0.2 process method section, the standard only gives a brief description, no process pattern diagram.

  The provisions on deletion in the ISO13485 standard

   This is specified in more detail in Section 1.2 "Application" of this standard. All requirements of this standard are directed to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements allow for the exclusion of design and development controls, it may be considered reasonable to exclude them from the quality management system. These regulations can provide alternative arrangements that are to be described in the quality management system. It is the responsibility of the organization to ensure that the exclusion of design and development controls is reflected in the declaration of conformity to this standard.

  ISO13485 standard emphasizes "maintain its validity"

   Many of the "continuous improvement" in the ISO9001 standard clauses have been changed to "maintain its effectiveness" in the ISO13485 standard because the goal of current regulations is the effectiveness of the quality management system to continuously produce safe and effective products.

  ISO13485 standard emphasizes regulatory requirements

  The new standard emphasizes regulatory requirements, and many places do not overemphasize customer requirements. This is because customer satisfaction is not suitable as a regulatory goal for medical devices, which is consistent with the harmonization goal of management system regulations around the world.

  According to the characteristics of the medical device industry, the ISO13485 standard has more requirements for documenting procedures.

  According to the characteristics of the medical device industry, the ISO13485 standard requires more than 20 documented procedures, work instructions or requirements, which are:

Document control procedures (4.2.3); record control procedures (4.2.4); training (6.2.2 note); infrastructure maintenance; work environment (6.4); risk management (7.1); product requirements (7.2.2); Design and development procedures (7.3.1); Procurement procedures (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 confirmation procedures and sterilization process confirmation procedures (7.5.2.1); product identification procedures (7.5.3.1); traceability procedures (7.5.3.2.1); product protection procedures or work instructions (7.5.5); monitoring and measuring device control procedures (7.6); feedback system procedures (providing early warning of quality problems and enabling input into corrective and preventive action processes) (8.2.1); internal audit procedures (8.2.2) ; Product monitoring and measurement procedures (8.2.4.1); Nonconforming product control procedures (8.3) Return to work instructions; Data analysis procedures (8.4); Advisory notice issuance and implementation procedures (8.5.1) Adverse event notification to administrative authorities (8.5.1); Corrective Action Procedure (8.5.2); Preventive Action Procedure (8.5.3).

  ISO13485 standard combines the characteristics of the medical device industry and adds many professional regulations.

According to the industry characteristics of medical devices, ISO13485:2003 standard has made many professional regulations, such as 4.2.4 record control stipulates: "The period of record keeping by the organization should be at least equal to the life period of the medical device specified by the organization, but from Not less than 2 years from the date the product is released by the organization, or as required by relevant laws and regulations." 6.4 In the working environment, requirements for product cleaning, pollution prevention, personnel health, etc. have been added; 7.2.3 "Advice" is added in customer communication 8.2.1 titled "Feedback" instead of ISO 9001 8.2.1 Customer Satisfaction, and added content such as providing early warning of quality problems and reviewing experience in the post-production phase. Because customer satisfaction and customer perception are not suitable for implementation as requirements in regulations. In addition, there are specific requirements for active implantable medical devices and implantable medical devices, that is, "the organization shall record the identity of inspection and testing personnel."

  ISO13485 is an independent standard, not a guide for the implementation of ISO9001 standard in the medical device industry, and the two are not compatible.

   This can be seen from the title of the new standard, the name of the ISO13485:2003 international standard is: "Medical device quality management system for regulatory requirements". The new standard places particular emphasis on meeting legal and regulatory requirements. The standard says in the general provisions: "The main purpose of this standard is to facilitate the implementation of the regulatory requirements for a harmonized quality management system. Therefore, this standard contains some specific requirements for medical devices, and deletes those in ISO9001 that are not suitable as regulatory requirements. Certain requirements. Because of these exclusions, an organization whose quality management system complies with this standard cannot claim to be in compliance with ISO 9001 unless its quality management system also complies with all the requirements in ISO 9001.”

In a word, the new ISO13485 standard is an independent standard. Although its chapter structure is the same as that of ISO9001:2000, and the content of some chapters is also the same as that of ISO9001, the ISO13485 standard highlights the requirements of laws and regulations according to the characteristics of the medical device industry, and dilutes the requirements of laws and regulations. In order to satisfy customers, some important requirements of ISO9001:2000 are deleted, so meeting the requirements of ISO13485 does not mean meeting the requirements of ISO 9001:2000 at the same time. Therefore, auditors engaged in the audit of medical device enterprises must study this new standard seriously.