Unsurprisingly, the medical device industry is very heavily regulated. Any tool used to sustain human life can also potentially cause injury or even worse, making it critical that these tools be as reliable as possible. To ensure that medical device companies worldwide adhere to the same guidelines and level of quality, the International Standards Organization implemented ISO 13485.
ISO 13485 isn't just a fancy piece of paper or a rubber stamp given out to anyone who asks for it; to qualify for the certification, a company has to demonstrate a serious commitment to the practices it demands and regularly pass audits ensuring their compliance.
What is ISO 13485?
ISO 13485 is the quality management system (QMS) standard for the medical device industry implemented by ISO. Originally published in 1996 and continually updated since then, ISO 13485 does not try to lay out the standards for every medical device to exist, as that would be far too broad and nuanced a topic. There's a vast difference between a stethoscope and an anesthesia machine, for instance.
Instead, ISO 13485 lays out the requirements and practices for the manufacturing process. It doesn't focus on the device itself but rather the "how" it is manufactured and the company's attitude to its manufacturing process. In essence, ISO 13485 isn't about making a specific product better or safer but being a better, safer manufacturer.
Components of ISO 13485
The following are the primary sections of ISO 13485:
Definition of a Quality Management System And Its Requirements
This section is fairly self-explanatory and lays out the requirements of the certification, as well as the need to establish, implement, and maintain the required procedures and activities as documented by the standard.
ISO 13485 also requires documenting which roles are responsible for this task. It mandates the creation of a quality manual that includes the scope of the QMS, the procedures of the QMS, and how those procedures interact.
Responsibilities of Management
This part of the certification details the requirements for a company's management to show its commitment to developing and implementing the QMS. This includes establishing measurable objectives, reviewing its efforts, communicating the priorities of the QMS to the rest of the company, and ensuring that resources are available to uphold the QMS.
Resource Management
Another requirement of ISO 13485 is the allocation of resources, both human and material, necessary to implement the QMS. This includes training and educating personnel, evaluating the effectiveness of actions taken, and ensuring that the workforce is aware of the relevance and importance of their efforts.
It also includes creating a work environment that meets QMS standards, such as having infrastructure that prevents product mix-ups and has contamination control plans in place.
Product Realization
Product realization, the process of designing, manufacturing, and offering a new product, is also covered by ISO 13485. When developing products like healthcare computers, quality objectives must be established and fulfilled to ensure the safety and satisfaction of customers. The company must also establish processes, documentation, and resources specific to the product and ensure that all information is recorded and accessible.
One major emphasis of ISO 13485 in this section concerns device sterilization, which is more than appropriate for medical device manufacturing. If the device in question must be sterilized, the company must maintain traceable records for the processes used to sterilize each batch.
Measurements, Analysis, and Improvement
Any organization that maintains compliance must implement methods for monitoring, measuring, and improving processes that demonstrate conformity of product and conformity of the QMS.
This category also includes requirements for gathering and implementing customer feedback and complaints, as well as reporting information to regulatory authorities as needed.
Lastly, the company must ensure that any products that do not conform to requirements must be identified and disposed of. Steps must be taken to prevent further defective products from occurring as well.
Benefits of ISO 13485
Adhering to ISO's standard gives medical device manufacturers the tools and framework they need to ensure their products are safe and reliable. This leads to deeper customer trust; even if the average consumer doesn't know what ISO 13485 is, they know their purchase comes from a reputable manufacturer.
While the certification is not technically required in order to manufacture medical devices, it is so highly recommended that it may as well be. Most major healthcare buyers, such as hospitals, will only purchase from ISO 13485-certified manufacturers, and most companies in the sector will only partner with original equipment manufacturers (OEMs) that have the certification.
As an internationally recognized standard, ISO 13485 is also helpful for selling products overseas. Foreign nations with strict national-level regulations will often require ISO 13485 certification before even considering a company's products.
Lastly, ISO 13485 provides legal protection. If an accident occurs involving one of your medical devices, the documentation trail that the certification mandates can help prove that the fault doesn't lie with your product.
Final Thoughts
While exhaustive, ISO 13485 is the most thorough method for ensuring medical devices are designed and manufactured to the highest standards possible. By implementing the standard's procedures, a medical device manufacturer can protect consumers and reach a wider market at the same time.
If you're looking for medical tablets and computers manufactured under ISO 13485 standards or looking for an OEM with the certification, contact the team at Cybernet Manufacturing. We'd happily explain how we uphold our ISO 13485 certification throughout our manufacturing process.
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