Working with trustworthy and reliable suppliers is critical for all manufacturers, but it is especially important for medical device, equipment, and supplies manufacturers. Your suppliers’ items must meet regulatory standards, otherwise, you will be held responsible. Don’t get trapped paying the price for your suppliers’ mistakes. In this blog, we will cover how medical manufacturers can evaluate their suppliers using an Approved Supplier List (ASL) by taking advantage of Enterprise Resource Planning (ERP).
Approved Supplier List (ASL)
A simple way to evaluate and manage your suppliers is to generate an Approved Supplier List (ASL), which can be inputted into your ERP for easy access. An Approved Supplier List contains all the suppliers you’ve qualified and what items or services you have qualified them for. Because you are held responsible for each component of your devices, you must qualify suppliers for each new item/service you want to purchase from them.
If you need help setting up your ERP to include your ASL, look to a trusted consultant like Datix. After delivering thousands of ERP solutions, we know how to optimally create features like an ASL and always take a business-first approach with our clients so that we understand their unique needs before suggesting a solution. Learn more about working with Datix.
The level of supplier assessment should be proportionate to the level of risk associated with the medical device being created and should consider how critical the component/service is to your product. To determine if a supplier should be added to the ASL for a particular item/service, you should create a set list of questions to ask each supplier based on the level of risk involved.
One of the main questions to ask suppliers is what regulations they currently follow and what standards they are accredited to. For instance, ISO 13485 certified suppliers must meet numerous quality requirements, so you may ask these suppliers an abbreviated list of questions to determine if they meet your standards. You can still use suppliers without an ISO 13485 certification, but you need to be strict about vetting them carefully.
For suppliers of critical components/services, you should have them sign a written agreement saying that they will communicate all changes to their item/service to you and ask them to send over a production sample which you can validate during the evaluation process. In the event that a supplier changes their item in some way, it is best to re-evaluate the new version of the item to ensure that it continues to meet your requirements. No matter what happens, an ERP consultant like Datix can assist you in implementing and maintaining your ASL within an ERP. We support our clients every step of the way, from planning to implementation and beyond.
Tracking your ASL and evaluation process in your ERP makes it easy to quickly see who an approved supplier for a particular item is, as well as your order history for each supplier.
Evaluating suppliers and adding them to your Approved Supplier List is just one way an ERP supports supply chain management for medical manufacturers. Gain the tools you need to meet regulatory requirements and grow your business with help from Datix.
Read more on Effectively Managing Your Multi-Level Supply Chain
Datix is the ERP consultant of choice for medical manufacturers. Our consultants understand the medical device, equipment and supply industries and dedicate themselves to analyzing each of our clients so that we can develop the best software solutions to maximize their investments to the fullest.