Medical Device Supplier Audits


It is of utmost importance to have quality medical devices that are consumed daily by hospitals, since the level required by healthcare institutions is high due to the close relationship with patients’ health and safety. The demand for medical devices is constant, both in Mexico and abroad, so providing timely medical service to patients is a great logistical challenge.

Demand figures are increasing because the healthcare sector is essential to a country’s well-being. In 2020 and so far in 2021 the demand for medical devices increased due to the pandemic, however, it will continue as it is essential and Mexico is among the main exporters of these.

Currently, the biggest challenge for the medical device industry is to improve the chain, channels and communication with industry suppliers and customers. On the other hand, it should be noted that 92% of the total inputs required for the manufacture of electronic medical equipment are imported, while 32% of disposable equipment is imported.


Medical devices are those accessories, instruments and apparatus for specific use in medical and surgical care, examination procedures, diagnosis, treatment and rehabilitation of patients. They include healing materials, prostheses, and X-ray and ultrasound machines.

According to ProMéxico data, medical devices are classified according to the risk involved in their use, being Class I, II and III.

Class I: those inputs known in medical practice whose safety and efficacy are proven and are generally not introduced into the organism.
Class II: those inputs known in medical practice that are generally introduced into the organism and remain in the organism for less than thirty days.
Class III: those inputs recently accepted in medical practice that are introduced into the body and remain in the body for more than thirty days.


Supply chain management is about the flow and transformation of goods and information from raw materials to the end consumer. In many cases, companies get trapped in a single line, and do not see the possibility of entering the entire supply chain due to the funnel generated in the medical device industry market that leads organizations to venture into a single phase or line of the value chain.

Supply chain management is considered to be giving a continuous integration of distributors and suppliers, so the role of IT (information technology) is predominant in the current context, especially because it is the basis for the correct realization in every way.

Lately the supply chain has focused on operational issues such as rapid response, replenishment and just-in-time that together make the operation itself more efficient, but there are other aspects that must also be taken into account, such as demand.

It is not that this management fails, it just hasn’t done the full job and that is because there are objectives, but they are not aligned, for example: procurement and purchasing focused on flexible lead times, as well as volume stability; manufacturing is concerned with quality, long lead times and quantities; warehousing seeks to have low inventory and low transportation costs and speed.

All of these points are important to each area, however, they are not aligned to get to the point where they want to maximize the supply value chain.


You can take many measures to avoid having to make too many changes in your organization such as establishing links between areas, implementing computer systems where all your areas can have complete information to standardize processes, as well as knowing the specifications to meet your common objectives. .

Another measure you can take to validate the robustness of your supply chain is second party audits, which are a detailed review of your suppliers or your own facilities based on your specific needs to ensure compliance.

Second party or supplier audits strengthen your supply chain and, in some cases, define it.

It is recommended that you have a second party audit program for sustainable progress in this area.

The process for a second party audit consists of 7 steps:

Account executive assignment
Proposal generation
Contract signing
Audit schedule
Audit schedule Audit agenda
Opening meeting
Development of the audit

The most important thing is to be clear about the points, requirements and needs that your suppliers must meet in order for these audits to generate value.

If you are looking to boost your organization, at QAlliance we have highly qualified personnel to follow you and take you by the hand in the process of your certification, providing you with the best service. Contact us for more information!

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