Medical Device Quality Management System "Medical Device Quality Management System" is also called ISO13485

Since medical devices are special products for saving lives, preventing and curing diseases, it is not enough to standardize only according to the general requirements of ISO9000 standard. The quality management system of device manufacturers has put forward special requirements, which has played a good role in promoting the quality of medical devices to be safe and effective.

  With the development of history, the ISO organization has revised this standard on this basis and upgraded it to ISO13485:2003. At present, most medical equipment manufacturers start to consider ISO9001: 2000 version + ISO13485: 2003 version + CE certification as a package solution when establishing a quality management system. The medical device industry has always used the ISO 13485 standard (my country's equivalent conversion standard number is YY/T0287) as the basis for quality management system certification. This standard is formulated on the basis of ISO 9001: 1994 standard with the addition of special requirements for the medical device industry, which is the so-called 1+1 standard. Therefore, meeting the ISO 13485 standard also meets the requirements of the ISO 9001:1994 standard. After the promulgation of the ISO 9001:2000 standard, ISO/TC 210 promulgated a new ISO 13485:2003 standard (the equivalent YY/T 0287-200X standard in my country is being submitted for approval).

The   ISO 13485:2003 standard (hereinafter referred to as the new standard) has many features, which are briefly described as follows.

   1. The new standard is an independent standard and is no longer a guide for the implementation of the ISO9001 standard in the medical device industry, and the two are not compatible.

   The name of the new standard is "Requirements for Medical Device Quality Management Systems for Regulations". The new standard 1.1 General "points out:" 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 some requirements in ISO 9001 that are not suitable as regulatory 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. "

   Second, the role of the new standard.

The new standard 0.1 "General Provisions" states: "This standard specifies the requirements for a quality management system, according to which organizations may design and develop, produce, install and service medical devices, as well as design, develop and provide related services. This standard also Can be used both internally and externally (including certification bodies) to assess an organization's ability to meet customer and regulatory requirements. It is worth emphasizing that the quality management system requirements specified in this standard are complementary to product technical requirements."

   3. In 0.2 "Process Approach", the new standard only gives a brief description, and there is no process pattern diagram.

   The new standard does this because, in clause 0.2 of the ISO 9001 standard, there are a number of guidelines that are considered to be included in the technical reports of ISO/TR 14969. This technical report is under development to provide guidance on the application of ISO 13485.

   Four, the new standard's provisions on deletion.

   In 1.2 "Application" of the new standard, more detailed provisions for deletion are made:

  "All requirements of this standard are directed to organizations providing medical devices, regardless of the type or size of the organization."

"If regulatory requirements permit exclusions from design and development controls, reasonable exclusions may be made in 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 ensure that in compliance with

   Reductions in design and development controls are reflected in the statement of this standard. "

"Any requirement in Clause 7 of this standard that is not applicable because of the characteristics of the medical device covered by the quality management system, the organization need not include such requirement in the quality management system. For the requirements in this standard applicable to processes for medical devices, but not implemented within the organization, the organization is responsible for these processes and describes them in its quality management system." The latter refers to outsourced processes.

  5. The new standard changes the "continuous improvement" in the ISO 9001 standard to "maintain its effectiveness".

   Currently, the goal of regulations is the effectiveness of the quality management system to consistently produce safe and effective products. Therefore, the new standard 4.1 "General requirements" requires that "the organization shall establish, document, implement and maintain a quality management system in accordance with the requirements of this standard, and maintain its effectiveness", rather than "continuously improve its effectiveness". "5.1 "Management Commitment" requires that the organization's "top management shall provide evidence of its commitment to establish, implement and maintain its effectiveness" through the following activities, not to "continue to improve its effectiveness" ".

   6. The new standard emphasizes regulatory requirements, rather than overemphasizing customer requirements.