ISO13485:2016 was officially released and implemented on March 1, 2016. ISO13485 "Medical device - Quality management system -requirements for regulatory purpose" is an independent standard formulated by ISO/TC210 Technical Committee on Medical Device Quality Management and General Requirements, which is applied to the medical device industry and operates under the requirements of regulatory purposes. Now I will introduce the new version of ISO13485.

1. Background and process of changing version

Since 1996, ISO13485 has been released for the first time, and the second revision (ISO13485:2003) was released on July 15, 2003. In view of the changes in the operation mode of the medical device market and the requirements of regulatory harmonization, the revision of the 201X version of ISO13485 was started in 2011. By 2014, a total of 868 comments were collected and the first version of DIS was voted. Due to the failure to meet the specified requirements , the first version of the DIS draft was rejected, mainly because of the standard structure and the harmonization of regulations. The second draft of the DIS was voted on in February 2015. It was officially announced in May. The FDIS was discussed in London in August. The FDIS draft was released for voting in October. There were only 2 negative votes. By voting. In view of the specification requirements of the standard, ISO13485:2016 was adopted and officially released on March 1, 2016.

2. Content changes

According to the requirements of the current third edition of ISO 13485 medical device quality management system, the important change is to introduce the concept of life cycle, which runs through every link of product design and development, production, storage, installation, service and disposal.

Specific changes include the following:

(1) The scope of application is clearer. The new version has clearly explained the applicability of product storage and distribution, internal and external supplier services, and even related services. For example, operators of equipment; suppliers of transportation services, sterilization services, installation and maintenance services, hardware and software, and spare parts.

(2) The deleted terms are more reasonable. The new version expands the inapplicable terms, allowing organizations to make reasonable deletions from the terms of Chapter 6, 7 or 8. This change caters to the current business operation model and reflects the standard applicability.

(3) More practical terms and definitions The new edition adds and revises terms. There are 8 definitions in the 2003 edition. By modifying and deleting the definitions in the 03 edition, the new edition has increased to 14 definitions, such as risk-related definitions. Terms related to EU and US regulations and terms of sterile product requirements, such as clinical evaluation, life cycle, manufacturer, importer, distributor, authorized representative, performance evaluation, complaint, post-market surveillance, risk, risk management, etc. Terminology.

(IV) Risk management is more strengthened. The new version clarifies the requirements for risk management, mentions "risk" and "risk management" in 20 places, puts forward the control of supplier risk, and further refines the risk and feedback mechanism of medical devices. , complaint handling and data analysis to make the post-market risk monitoring system more operational.

(5) The changes in the clauses are more compliant. The new version takes more into account the regulatory requirements. There are as many as 60 “regulations” mentioned in the full text, and 37 “regulations requirements”, highlighting compliance with regulatory requirements to ensure the safety and effectiveness of medical devices. , the coordination is compatible with many regulatory requirements, such as US FDA QSR820, Japanese JPAL regulation MO169, Brazilian GMP, EU F regulation MDR and IVDR, Canada and Australia and China's regulatory requirements, adapting to broader coordination and compliance requirements. For example, the introduction of new requirements for Usability and software application; the refinement of the control of the design process; the clarification of change control requirements; the strengthening of supplier control requirements; the clarification of the requirements and purposes of traceability (UDI); processing requests.

3. Transitional arrangements

The 2003 version of ISO13485 will expire 3 years after the new standard is released. It is recommended to complete the transition period within 2 years after the 2016 version is released. After 2019, enterprises will no longer run the requirements of the 2003 version. The specific transition arrangements are as follows:

(1) The 2016 version of the ISO13485 standard was released on March 1, 2016. From March 2016 to September 2018 (one and a half years after the release of the new standard), new certification or re-certification organizations are free to apply for the 2003 version or the 2016 version Standard certification.

(2) After September 1, 2018, the newly certified or re-certified organization must implement the 2016 version of the standard certification, and the certificate of the organization that has obtained the 2003 version of the certificate can be used until March 1, 2019.

(3) After March 1, 2019, all ISO13485 certificates of the 2003 edition will be invalid.

4. Implementation reference

For the implementation arrangements of the new version of the standard, it is recommended that enterprises follow the steps below. Before training, it is necessary to have an in-depth understanding of the technical requirements, such as the rationality of the sample size for design verification, such as system software application confirmation requirements, and so on. Secondly, carry out gap analysis, select applicable standards, regulations and technical support system changes to implement, relatively speaking, there are many supporting documents for system operation and many guidelines in Europe and the United States to help enterprises implement the requirements in the system, such as the introduction of statistical tools, Such as the introduction of AAMI TIR 36, such as the selection and optimization of risk tools, etc. Then there is the planning and implementation of the system change project plan, and appropriate internal audit and management review. If there is any non-compliance, corrective and preventive measures are taken until the gap is closed.

In a word, the requirements of the new standard are more practical, scientific, clearer, and more extensively harmonize regulatory requirements, minimize risks, ensure the safety and performance of medical devices and function effectively, and provide future new technology applications and regulatory audits. for better consistency.