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In the past, this standard was formulated on the basis of the ISO9001:1994 standard by adding 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 repeatedly discussed and promulgated the new ISO13485:2003 international standard in 2003. The new standard has major changes compared to the old standard, and it has many characteristics of the medical device industry.

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

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 particularly emphasizes meeting the requirements of laws and regulations. The standard says in the general provisions: "The main purpose of this standard is to facilitate the implementation of the regulatory requirements of a coordinated quality management system. Therefore, this standard contains some special requirements for medical devices and deletes some requirements in ISO9001 that are not suitable as regulatory requirements. Due to these deletions, an organization whose quality management system complies with this standard cannot claim to comply with the ISO9001 standard unless its quality management system also complies with all the requirements of ISO9001."

ISO13485 standard is a supplement to the technical requirements of products

This point is clearly stated in the general provisions of the standard introduction: "... 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 does not have a process model diagram

In the standard's 0.2 process method section, the standard only gives a brief description and no process model diagram.

Provisions on deletions in ISO13485 standard

This is more detailed in Section 1.2 "Application" of the standard. All requirements of this standard are for organizations that provide medical devices, regardless of the type or size of the organization. If regulatory requirements allow for the elimination of design and development controls, it may be reasonable to eliminate them in the quality management system. These regulations can provide alternative arrangements, which should be described in the quality management system. The organization is responsible for ensuring that the elimination of design and development controls is reflected in the statement of conformity with this standard.

ISO13485 emphasizes "maintaining its effectiveness"

Many "continuous improvement" in the ISO9001 standard clauses are changed to "maintaining its effectiveness" in the ISO13485 standard. This is because the current regulatory goal is the effectiveness of the quality management system to continuously produce safe and effective products.

ISO13485 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 goal of harmonization of management system regulations around the world.

According to the characteristics of the medical device industry, ISO13485 has increased the requirements for documented procedures.

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

Document control procedures (4.2.3); record control procedures (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 procedures (7.4.1); production and service provision control (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 operating instructions (7.5.5); monitoring and measuring device control procedures (7.6); feedback system procedures (providing early warning of quality problems and being able to input corrective and preventive measures) (8.2.1); internal audit procedures (8.2.2); product monitoring and measurement procedures (8.2.4.1); nonconforming product control procedures (8.3); rework instructions; data analysis procedures (8.4); advisory notice issuance and implementation procedures (8.5.1); procedures for notifying administrative departments of adverse events (when required by regulations) (8.5.1); corrective action procedures (8.5.2); preventive measures procedures (8.5.3).

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

According to the characteristics of the medical device industry, ISO13485:2003 standard has made many professional regulations, such as 4.2.4 record control stipulates: "The period of record retention by the organization shall be at least equivalent to the life of the medical device 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." In 6.4 working environment, requirements for product cleanliness, pollution prevention, personnel health, etc. are added; "advisory notice" is added to 7.2.3 customer communication; the title of 8.2.1 is changed to "feedback" instead of ISO 9001's 8.2.1 customer satisfaction, and the content of providing early warning of quality problems and reviewing the experience of the post-production stage is added. Because customer satisfaction and customer perception are not suitable for implementation as requirements in regulations. In addition, there are special requirements for active implantable medical devices and implantable medical devices, namely, "the organization shall record the identity of inspection and testing personnel."

In short, the new ISO13485 standard is an independent standard. Although its chapter structure is the same as ISO9001:2000, and some chapter contents are also the same as ISO9001, the ISO13485 standard highlights the requirements of laws and regulations and downplays customer satisfaction according to the characteristics of the medical device industry, and deletes some important requirements of ISO9001:2000. Therefore, 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 companies must carefully study this new standard.