ISO 13485 in PCB Assembly

By Albert Howard

Unsurprisingly, many countries are paying attention to the quality and safety of medical devices and enforcing standards for manufacturers. ISO 13485 is one of the surest ways to prove your healthcare product has been built in alignment with governmental requirements. The industry of PCB assembly of medical equipment is no exception.

ISO 13485 certification

The full name of ISO 13485 is Medical devices – Quality management systems – Requirements. This can be understood as a set of standards focused on a specific quality management system used for all of the steps of the lifecycle of a medical device including the design phase, manufacturing and installation. Furthermore, it also spreads on any services based on the usage of this device.

The idea behind this approach is to make sure a company is utilising a well-developed system for quality management which indicates its products or services related to the usage of medical devices are of the required level of quality.

It is crucial to understand that while ISO 13485 has strict standards for quality management, it does not include any certain technical specification for products and services. Thus, manufacturers and service providers still have a lot of flexibility while they are taking care of quality.

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Is ISO 13485 compulsory?

Currently, ISO 13485 is one of the leading standards for medical devices used in many countries and especially respected by the European Union and USA. This might create an impression the ISO 13485 certification is obligatory if a company would like to launch its healthcare devices or related services in one of these locations.

In reality, such certification is not required and, in theory, it is possible to enter the market without it. Yet, the process of gaining approval by almost any government can be rather challenging and extremely time-consuming, as public institutions will still have to check the compliance with their own standards for medical devices.

For example, the Medical Device Regulation or MDR introduced in the European Union has a set of requirements for launching such products. A company has to prove it indeed meets all of them and has to repeat the process for other markets.

That is where an ISO 13485 certificate becomes extremely useful since many countries regard it as a solid proof of compliance with quality regulations. Even though an electronics manufacturer can make do without such a certificate, this can be a rather troublesome and cost-ineffective strategy. After all, quality requirements have to be satisfied even for the local market.

Are ISO 13485 and ISO 9001 interchangeable?

One of the most commonly used standards for goods and services of various types is ISO 9001 which is also designed for quality management in the manufacturing and service provider companies. In fact, the ideas of ISO 9001 and ISO 13485 are the same, so it might appear ISO 9001 could be enough for medical devices.

In practice, while ISO 9001 can be applied virtually to any industry, ISO 13485 has been developed specifically for maintaining the highest quality of medical devices and healthcare services. ISO 13485 has an extended list of requirements for data supervision and documentation maintenance. In addition to it, it has special requirements for pollution control and enforces environmental standards.

Finally, ISO 13485 pays a great emphasis on the entire lifecycle of a medical device and reaches the level of interaction with customers, for example, through feedback procedures. The demands of this standard includes monitoring the devices that are already on the market and maintaining special procedures for handling faulty products. It also goes deeper into the supply chain management.

To a certain point, ISO 13485 acts as an extended version of ISO 9001 tailored to the healthcare sector. Mere ISO 9001 certification does not cover all of the crucial points of the quality management regarding medical device manufacturing.

ISO 13485 and PCB assembly

It is essential for an electronics manufacturer to be certified with ISO 13485 if this company plans to offer PCB assembly or more complex services such as box build and electro-mechanical integration for medical equipment. Not only does the healthcare industry itself have rather high standards, but also electronic devices are regarded as products with a high potential for health risks. Indeed, if anything goes wrong with electronics even if it is not meant to be used for medical purposes, it can have a rather serious impact on health.

That is why the requirements for PCBs used in medical devices are particularly stringent and manufacturers have to pay extra effort to meet the standards.

The list of such standards is extensive. For instance, for electronic medical device production, documented material and component traceability is required. In practice, this means a manufacturer has to be sure of the component quality and have this quality documented. Any processes involved in PCB assembly have to be traceable as well. An example of the practical appliance of such a requirement is identifying the source a faulty component.

Another essential point of ISO 13485 is risk management which is aiming to predict possible risks and avoid them with efficient procedures.

Co-operation with a certified EMS provider

Meeting the requirements of the medical device market can be extremely difficult even if a company indeed offers the goods of the highest quality. Actually, maintaining the quality is only a half of success, as the system used for quality maintenance has to be comprehensive and traceable for third parties.

For some companies, preparation for ISO 13485 certification means complete design and establishment of a quality management system if they have not used such an approach before. For others, this means documenting their existing system so that there will be a proof for their quality management.

While it sounds like a massive project, it is possible to minimise the effort needed for ISO 13485 certification by co-operating with a certified EMS provider. If you are using the services for PCB assembly from such an electronic manufacturer, the entire process of assembly and other related procedures will be documented according to the requirements of ISO 13485. Experienced certified EMS providers such as Assel, also have sufficient knowledge of the quality standards for the medical industry.  This in turn, will help you to gain certification for your final device.

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