Overview of medical devices
Medical devices, in essence, are important tools for humans to fight diseases and maintain health. They cover a wide range of product types, and their uses are mainly concentrated in the diagnosis, prevention, and treatment of diseases. As small as wound dressings, which seem like simple products, can provide protection for wounds in daily life, prevent infections, and accelerate healing; cardiac pacemakers are like "life guardians", helping patients with heart problems maintain a normal heartbeat rhythm. As large as dental chairs, they provide the necessary support and operating platform for dental treatment; life support instruments play an irreplaceable role in scenarios such as intensive care, ensuring the stability of patients' vital signs; in vitro diagnostic reagents provide accurate diagnostic basis for doctors through the detection of human samples.
In most countries around the world, governments attach great importance to the quality and safety of medical devices. Since these products are directly related to the health and life safety of citizens, if manufacturers produce shoddy products, the consequences will be unimaginable. Many medical devices are placed inside the human body. Their functions are not only to examine the body and treat diseases, and some will remain in patients' bodies for a long time. For example, artificial hip joints enable patients with damaged hip joints to regain the ability to walk; cardiovascular stents can dilate narrow blood vessels to ensure normal blood circulation; artificial heart valves and cardiac pacemakers play a key role in the repair and maintenance of heart function.
The development history of ISO 13485 standard
The ISO 13485 standard has a unique development history. It was first published in 1996, then named "Medical devices - Quality management systems - Particular requirements for the application of ISO 9001". The birth of this version marked the beginning of specialized standard guidance for the quality management system of medical devices. With the passage of time and the development of the industry, it was revised in 2003 and renamed "Medical devices - Quality management systems - Requirements for regulatory purposes". This change in the name reflects that the standard pays more attention to the combination with regulations. The latest version, ISO 13485:2016, was developed on the basis of continuously adapting to the new needs of the industry and technological development.
Scope of application and key rules of ISO 13485
ISO 13485:2016 mainly describes the requirements for the quality management system. Its core purpose is to prove that institutions providing medical devices and related services can meet the requirements of customers and relevant regulations. Due to the differences in laws among different countries, the ISO 13485 standard does not define the regulatory requirements in detail. Instead, it gives medical institutions a certain degree of autonomy, allowing them to identify relevant regulatory requirements according to their own situations and integrate them into the quality management system. It is worth noting that some medical products are not regarded as medical devices in certain regions. For example, assistive devices for people with disabilities, which are mainly used to help them improve their self-care ability; instruments containing animal and/or human tissues, the management of such products involves multiple aspects such as ethics and safety; disinfection substances, whose main function is disinfection; instruments for in vitro fertilization or assisted reproductive technology, the use of such instruments involves special medical fields and ethical norms.
Although the ISO 13485 standard is built on the basis of the ISO 9001 standard, there are obvious differences between the two. The ISO 13485 standard has compliance with regulations as its core nature, so it does not include some content of the ISO 9001 standard. For example, the ISO 9001 standard requires organizations to continuously improve their quality management systems and evaluate customer satisfaction, while the ISO 13485 standard requires organizations to evaluate the opinions of medical device users, mainly focusing on aspects such as whether the medical devices meet the intended use requirements, whether they comply with regulatory requirements, whether the residual risks are under control, and whether new risks are discovered.
In addition, as a standard complementary to ISO 13485, "ISO 14971 Medical devices — Application of risk management" details how to conduct systematic risk management throughout the entire life cycle of medical devices, providing more comprehensive protection for the safe use of medical devices.
Amendments to ISO 13485:2016
Compared with the old version, the new version has many improvements. It strengthens the interaction between the quality management system and regulatory requirements, enabling the quality management system to better adapt to regulatory changes; expands the scope of application of the standard throughout the product lifecycle, including distributors and importers of medical devices; and more extensively incorporates the principles of risk management into the quality management system, improving the ability to control risks.
Unless otherwise specified, the requirements of the ISO 13485:2016 standard apply to organizations of any size and type. Moreover, all the requirements applicable to medical devices in the standard also apply to the related services provided by the organizations. Overall, the new version of the ISO 13485 standard has expanded the scope of application to all organizations related to the entire product lifecycle, strengthened the coordination with regulatory requirements, and enhanced the post-market surveillance of products (such as complaint handling).
The specific main update contents of the new version are as follows:
1. Strengthen the responsibilities of the top management to ensure that they can strictly comply with applicable regulatory requirements and guarantee the quality and safety of medical devices from the management level.
2. Emphasize risk management throughout the entire product lifecycle and integrate risk awareness into every stage of medical devices from design to disposal.
3. Optimize the requirements for individual applicable facilities. In particular, for the production of disinfected medical devices, there are additional requirements for the verification of the performance of the sterile barrier, which improves the hygiene and safety standards in the production process of medical devices.
4. Strengthen cooperation with regulatory requirements and keep records of regulatory documents to make the operation of the institution more standardized and transparent.
5. Expand the scope of application of the standard to all institutions that interact with medical device manufacturers, including those involved in design, development, repair and maintenance, those providing raw materials, parts or partial assemblies, contract manufacturers or those providing services such as disinfection, logistics, and calibration of measuring instruments, as well as importers or distributors of medical devices, thus forming a more complete quality management ecosystem.
6. New requirements for the design and development of medical devices are added, taking into account their usability and the use of standards. Detailed planning is required for the verification, validation, transfer of the product, and preservation of records of design and development activities, which improves the scientific nature and standardization of the design and development of medical devices.
7. Unify the approval requirements for different software applications, including quality management system software, process control software, monitoring and measurement software, etc., to ensure the reliability and stability of software in the production and management of medical devices.
8. Define the skills and experience requirements that quality management personnel should possess, providing clear standards for the selection and cultivation of quality management personnel.
9. When conducting training, there should be documentary records, and the effectiveness of the training should be evaluated to ensure the effectiveness and traceability of the training.
10. Enhance the control over suppliers and outsourced work to ensure the quality and stability of the entire supply chain.
11. Review the aseptic barrier system and the disinfection process to ensure the aseptic environment and disinfection effect of medical devices.
12. Establish and maintain files for medical technology devices and files for design and development to facilitate the management and traceability of the entire life cycle of medical devices.
13. Strengthen the post - market supervision of products, such as handling complaints and submitting regulatory management reports, to promptly identify and solve problems that occur during the market use of products.
Relationship with ISO 9001:2015 standard
Although the ISO 13485:2016 standard was published later than the ISO 9001:2015 standard, since the revision process of the ISO 13485 standard started before 2010, earlier than the publication of "Annex SL" in the ISO Guidelines, the ISO 13485 standard does not adopt the "High-Level Structure" and "Identical Text" in "Annex SL", and its clause structure is closer to the 2008 old version of the ISO 9001 standard.
However, the ISO 13485 standard refers to the ISO 9001:2015 standard in the definition of terms. Of course, the definitions of some terms in ISO 9000 have been modified according to the specified connotations of the ISO 13485 standard. "Annex B" of the ISO 13485:2016 standard also provides a comparison with the content of the ISO 9001:2015 standard. Since the ISO 13485 standard is aimed at industries that require a high degree of regulatory constraints, it has more explicitly stipulated requirements than the ISO 9001:2015 standard, including the quality manual and other documented procedures that need to be prepared, to ensure that the quality management in the medical device industry is more rigorous and standardized.
How to transition to ISO 13485:2016
The International Accreditation Forum (IAF) has agreed that certification bodies certified to the 2003 edition of ISO 13485 standard shall have a three - year transition period, which means their existing certificates will remain valid until March 1st, 2019. The setting of this transition period provides relevant institutions with sufficient time to adapt to and implement the ISO 13485:2016 standard, ensuring a smooth transition in the industry and a gradual improvement in the quality management level.