Introduction to ISO13485:2003 standard in the medical device industry
in the past, the medical device industry has always used ISO13485 standard (China's equivalent standard number is yy/t 0287) as the basis for quality management system certification. In the past, this standard was formulated by adding special requirements for the medical device industry on the basis of iso9001:1994 standard. Therefore, meeting ISO13485 also meets the requirements of iso9001:1994. Since the promulgation of ISO9001:2000 standard, iso/tc210 has been discussed repeatedly, and the new ISO13485:2003 international standard was issued in 2003. Compared with the old standard, the new standard has a larger 84 matrix keyboard interface change, which has many characteristics of the medical device industry
iso13485 is an independent standard, not the implementation guide of ISO9001 standard in the medical device industry, and the two are incompatible
from the title of the new standard, the name of ISO13485:2003 international standard is "medical device quality management system for regulatory requirements". The new standard places special emphasis on meeting the requirements of laws and regulations. The standard says in its general provisions: "The main purpose of this standard is to facilitate the implementation of the regulatory requirements of the coordinated quality management system. Therefore, this standard contains some special requirements for medical devices and deletes some requirements in ISO9001 that are not suitable for regulatory requirements. Due to these deletions, organizations whose quality management system conforms to this standard cannot claim to conform to ISO9001 unless their quality management system also conforms to all the requirements in ISO9001."
iso13485 standard is a supplement to the technical requirements of products. This point is clearly pointed out in the general provisions of the introduction of the standard: "... It is worth emphasizing that the quality management system requirements specified in this standard are a supplement to the technical requirements of products."
iso13485 standard has no process mode diagram
in the 0.2 process method section of the standard, the standard only gives a brief description, and there is no process mode diagram
iso13485 standard changes the provisions on deletion in the precautions in the experiment of the experimental machine
this is more detailed in section 1.2 "application" of the standard. All requirements of this standard are for organizations providing medical devices, regardless of the type or size of the organization. If the regulatory requirements allow the deletion of design and development control, it can be considered reasonable to delete them in the quality management system. These regulations can provide another arrangement, which should be explained in the quality management system. The organization has the responsibility to ensure that the deletion of design and development controls is reflected in the declaration of compliance with this standard
iso13485 standard emphasizes "maintain its effectiveness"
many "continuous improvement" in the provisions of ISO9001 standard are changed to "maintain its effectiveness" in ISO13485 standard, because the goal of current regulations is the effectiveness of quality management system to continue to produce safe and effective products
iso13485 standard emphasizes more regulatory requirements
the new standard emphasizes regulatory requirements, and many places do not overemphasize customer requirements. This is because customer satisfaction is not suitable for the regulatory goal of medical devices, which is consistent with the coordination goal of management system regulations all over the world
according to the characteristics of the medical device industry, ISO13485 standard has increased requirements for documented procedures
according to the characteristics of the medical device industry, ISO13485 standard requires that there are almost no parts movement, operation instructions or more than 20 requirements when maintaining the pressure. They are:
document control procedure (4.2.3); Record control procedure (4.2.4); Training (6.2.2 note); Infrastructure maintenance; Working environment (6.4); Risk management (7.1); Product requirements (7.2.2); Design and development procedures (7.3.1); Procurement procedure (7.4.1); Control of production and service provision (7.5. Specific classification of Jinan impact testing machine, 1.1b), (126.96.36.199.1), (188.8.131.52.2), (184.108.40.206.3); Computer software confirmation procedure and sterilization process confirmation procedure (220.127.116.11); Product identification procedure (18.104.22.168); Traceability procedure (22.214.171.124.1); Procedures or work instructions for product protection (7.5.5); Monitoring and measuring device control procedure (7.6); Feedback system procedure (provide early alarm of quality problems and input the process of corrective and preventive measures) (8.2.1); Internal audit procedure (8.2.2); Product monitoring and measurement procedures (126.96.36.199); Nonconforming product control procedure (8.3) rework operation instructions; Data analysis procedure (8.4); Procedures for issuing and implementing Advisory notices (8.5.1) procedures for informing administrative departments of adverse events (when required by laws and regulations) (8.5.1); Corrective action procedure (8.5.2); Preventive measures procedure (8.5.3)
iso13485 standard has added many professional regulations in combination with the characteristics of the medical device industry
according to the industry characteristics of medical devices, ISO13485:2003 standard has made many professional provisions, such as the provisions in 4.2.4 record control: "the period of record keeping by the organization should be at least equivalent to the life span of the medical devices specified by the organization, but not less than 2 years from the date of product release by the organization, or as required by relevant regulations." 6.4 in the working environment, requirements for product cleaning, pollution prevention, personnel health, etc. have been added; 7.2.3 add "advisory notice" to customer communication; The title of 8.2.1 is changed to "feedback", instead of customer satisfaction in 8.2.1 of ISO 9001, and contents such as providing early warning of quality problems and reviewing experience in the post production stage are added. Because customer satisfaction and customer perception are not suitable for implementation as requirements in laws and regulations. In addition, there are special requirements for active implantable medical devices and implantable medical devices, that is, "the organization shall record the identity of inspection and testing personnel."
in a word, the new ISO13485 standard is an independent standard. Although its chapter structure is the same as that of ISO9001:2000, and some chapter contents are the same as that of ISO9001, the ISO13485 standard highlights the requirements of laws and regulations, desalinates customer satisfaction, and deletes some important requirements of ISO9001:2000 according to the characteristics of the medical device industry. Therefore, meeting the requirements of ISO13485 is not equal to meeting the requirements of ISO 9001:2000 at the same time. Therefore, auditors engaged in the audit of medical device enterprises must seriously study this new standard. (end)
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