In the international arena that is filled with medical device companies that assert that their products are the best, how will your company stand out from the rest? This is possible when your mantra is “Quality at all levels and every step”. One key aspect that may be ignored, at considerable cost, are the suppliers.
If you are a medical device company that is focused on quality, then your ability to acquire, retain, and collaborate with your suppliers is crucial. It is a foundational responsibility for any medical device company to have reliable and top-class suppliers so that your products and services are of the highest industry standards, and, will match or exceed customers’ expectations.
In this article, we will discuss the importance of medical device supplier management, and the benefits you will accrue with effective supplier quality management. We will also touch on the requirements, as well as the various steps in the supplier management process. Finally, we will emphasize the importance of a modern and efficient QMS solution for managing all your supplier-related documents and records.
But first, the basics:
- Why Is Medical Device Supplier Quality Management Important?
- Benefits of Effective Medical Device Supplier Management
- Medical Device Supplier Management Requirements
- 8-Step Medical Device Supplier Management Process
- SimplerQMS Streamlines Medical Device Supplier Quality Management
Why Is Medical Device Supplier Quality Management Important?
For medical device companies selling their products in the US market or the European Union, supplier quality management is a core requirement as per regulatory requirements. Both the US FDA (specifically FDA 21 CFR 820.50) and ISO (ISO 13485:2016 Section 7.4) explain in detail purchasing controls and supplier evaluation.
Considering its importance, we will look at it in greater detail in a subsequent section.
We also need to understand that medical device supplier quality management is not just a regulatory requirement, but a crucial business practice. Companies operating in the medical device industry need to ensure that the suppliers chosen are up to industry standards. Oftentimes, this will become evident when the parts are supplied.
For instance, the supplier you have chosen to deliver electrodes for your implantable cardioverter-defibrillator may not be to your specifications. Maybe in another instance, the deliveries aren’t on time.
The examples above go to show that the suppliers you choose impact your operations, safety, brand value, and profits.
You can manage these risks by:
- Having an Approved Supplier List (ASL)
- Having procedures in place for evaluating and selecting suppliers
- Monitoring the performance of the approved suppliers
These points will be elaborated further in a subsequent section of this article.
Supply chain networks and supplier quality management processes are now complex and expensive, and therefore, challenging. For instance, your company may be getting certain components from Taiwan, while some other parts may be supplied from India.
If your medical device company is still reliant on the “traditional” manual paper-based processes, the challenges that you face will only worsen. With paper-based processes, you need to constantly be on the lookout for human errors, slower process execution, security risks, storage issues, and much more.
These challenges can be minimized when you invest in modern, efficient, medical device QMS software with an in-built supplier management module such as SimplerQMS. Which will help you streamline and automate many of your supplier-related tasks, including supplier selection, evaluation, quantification, and monitoring.
Each of these steps is crucial both from a business point of view and for regulatory purposes.
Benefits of Effective Medical Device Supplier Management
There are 4 key benefits to having an effective medical device supplier quality management system in place.
- Regulatory compliance: An essential requirement of international regulatory standards, including FDA 21 CFR 820.50 and ISO 13485:2016 Section 7.4, is that your organization needs to have in place validated purchasing controls and supplier evaluation processes. With an effective supplier management system, it will be easier for you to meet these regulatory requirements.
- Quality control: When quality is at the forefront of your operations, you cannot compromise with your third-party vendors. The parts they supply should match your expectations. This is easier to achieve with an effective supplier management system in place.
- Increased supply chain agility: The agility of your supply chain will determine how quickly and efficiently you react to end-user demands. For instance, the COVID-19 pandemic has resulted in an increased demand for ventilators. If you are in the business of manufacturing ventilators, but unable to meet the current demands because of supplier issues, a competitor with an efficient supplier quality management system in place will step in.
- Brand value: A good business tactic is to be proactive, feel the pulse of the market requirements and demands, and ensure that you can supply top-quality products. This will not only increase the confidence of your investors but also, enhance your brand value.
Medical Device Supplier Management Requirements
When your medical device company is planning to market products in either the North American market or the European Union, you will need to be well-versed with the US FDA 21 CFR 820.50 or ISO 13485:2016 Section 7.4 that give comprehensive requirements for your company’s purchasing controls and supplier(s) assessment.
These regulatory standards emphasize the establishment and maintenance of various requirements, including quality requirements, that suppliers, contractors, and consultants must meet.
The requirements are as follows:
- Evaluation: You must first evaluate potential suppliers based on your specific requirements. This will also include quality requirements. The entire process of evaluation should be documented.
- Purchasing data: Your medical device company must maintain all data pertaining to purchased (or otherwise received) products/services. These data must highlight requirements, including quality requirements.
- Purchasing information: Your company must have relevant purchasing information, including product specifications, QMS requirements, and the processes for acceptance/rejection of products.
- Verification: Your medical device company must have a proper process for verifying whether the products supplied meet specified purchasing requirements. In case there are any changes in a product that is supplied, you need to analyze whether the changes will affect the ensuing medical device.
Additionally, when you or your customers wish to verify the premises of your supplier, you need to clearly state the purpose for verification.
We need to further understand that clause 4.1.5 of ISO 13485:2016 highlights the quality requirements needed for medical device supplier management.
The official document states:
“When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes. The organization shall retain responsibility of conformity to this International Standard and to customer and applicable regulatory requirements for outsourced processes. The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements in accordance with 7.4. The controls shall include written quality agreements”.
When your medical device company is outsourcing any requirement, you must monitor and have control over the entire process. These controls will include quality requirements.
Do the US FDA and the European Medical Device Regulation (EU MDR) have similar guidelines?
Neither the US FDA nor the EU MDR has explicit quality agreement requirements. However, you are expected to have quality agreements in place. The FDA has specifically used this term in their Warning Letters.
The SimplerQMS medical device QMS software helps you facilitate your company’s supplier management processes. With this provision, it is easier to ensure compliance with the US FDA 21 CFR Part 820, ISO 13485:2016, EU MDR, and other international requirements.
8-Step Medical Device Supplier Management Process
Step 1. Create an Approved Supplier List
As a medical device manufacturer, one of the first items on your agenda should be to build an Approved Supplier List (ASL).
With ASL, you now have the best means of keeping track of your qualified suppliers based on predetermined criteria. The ASL is a single reference document that highlights which supplier has been approved by your quality management team to supply particular products.
This will eliminate the purchase of products/services from unauthorized suppliers.
Does this mean that any approved supplier can supply any products? It is obvious that this is not the case.
For example, a supplier who is specialized in providing electrodes for your implantable cardioverter-defibrillator will not be able to provide the raw materials required for syringes.
The ASL, when used efficiently, is an excellent tool for your company to monitor suppliers.
The details that you need to maintain on the ASL include:
- Supplier Name
- Supplier Address
- Contact Information
- Qualification Criteria
- Status of Approval (whether the supplier has been approved, or the approval is pending, etc.)
- Supplier Certification and Expiry Date
- Verification Details (date of previous review/next review)
- Approved Product Supply List
The ASL should be an approved document. This means that the ASL has been prepared and reviewed in accordance with your company’s quality protocols by authorized personnel.
When your medical device company is preparing an ASL for the first time, it is good practice if you choose a format that is easy to comprehend. You should also define the processes needed for updating the ASL, as well as approving the document, distributing it to the relevant departments, and controlling it.
With robust document controls built into SimplerQMS, you will be able to create the most appropriate ASL for your organization. And just like all other documents in your Quality Management System, you will be able to author, approve, control, and distribute the ASL across your company.
Step 2. Create Procedures
The next step will be to create documented procedures for evaluating, selecting, and managing your suppliers.
Your company will need to have a prescribed modus operandi for the evaluation of potential suppliers. From this list, you should select your suppliers, again based on prescribed protocols.
The creation of these procedures must follow a risk-centric approach.
“Low Risk” suppliers are those who supply items that are not bespoke.
The next category of suppliers is “Medium Risk”. They supply components that are customized and device-specific. But these items do not have a direct impact on the safety and efficacy of the manufactured device.
The third category of suppliers is “High Risk”. They supply crucial components that will directly impact the safety and efficacy of the manufactured device.
Step 3. Create a Supplier Survey
In the third step of your medical device supplier management process, you will need to create supplier surveys. These surveys will evaluate the supplier against your organization’s Quality Management System.
For instance, you should include Corrective and Preventive Action (CAPA) procedures, wherein issues related to quality concerning the supplier are corrected, and the measures the supplier will take to prevent future recurrences. You can learn more about the topic of CAPA in our dedicated guide about CAPA management for medical device manufacturers.
Another key point that needs to be surveyed is the validation and verification of the products supplied. Verification ensures that every component/product supplied meets the appropriate standards and specifications outlined in your QMS. Validation will determine whether the product/component is doing its function in the manufactured medical device.
At this juncture, you will also set a minimum supplier qualification and/or certifications that the potential supplier needs to meet. This set of criteria will also include the state of the supplier’s facility, labor practices, and current good manufacturing practices (cGMP).
Supplier selection criteria include both purchased product criteria and supplier-focused criteria.
In purchased product criteria your medical device company will look at:
- Quality of the products supplied
- Possible impact these products will have on your finished medical device
- Possible risks with the finished medical device
When you consider supplier-focused criteria, your company will focus on:
- Overall performance of the supplier
- Customer response time
- Potential communication issues
- Ability to meet your requirements
Not every supplier will come under the scope of supplier quality management. For instance, suppliers providing office stationary or supplies for your company’s cafeteria will not have to go through the above-mentioned process.
Step 4. Perform Supplier Qualification and Gather Evidence
Using the set of predefined criteria, your company has now evaluated several potential suppliers. The next step is to select one or more of your supplies. Verify the predefined supplier criteria before upgrading a supplier to the approved status on your ASL.
When it comes to low-risk suppliers, additional qualifications are not mandatory.
On the other hand, when it comes to high-risk suppliers, you will need to place them first in a “conditional” approval status, collect all required evidence, and then onboard them.
During this phase of supplier qualification, it is imperative to collect objective evidence by way of measurements, tests, and other observations. This evidence will show that the products supplied do match your expectations.
During each stage of the supplier management process, your medical device company will be generating huge amounts of documents. All these documents need to be managed efficiently and securely. With SimplerQMS, you can be sure that all your supplier-related documents and records are readily stored in secure, cloud-based storage systems. Any document can be retrieved as and when required using only the controls of a computer mouse!
Step 5. Add Suppliers to Your Approved Supplier List
Once you have short-listed potential suppliers based on the previous steps, you will now need to get the supplier added to the Approved Supplier List (ASL).
At every step, it is imperative that you take proper caution and a thorough evaluation process before onboarding these suppliers. This is where the previous step 4., will play a crucial role.
As already highlighted, low-risk suppliers do not need additional qualifications, however, high-risk suppliers need to be placed on a conditional approval list before onboarding.
Step 6. Generate Agreements Between You and the Supplier
At this stage, you will generate a supplier quality agreement with your approved suppliers.
Key aspects that are incorporated include quality agreement, supply agreement specifications, and material/component specifications. These agreements will summarize both the manufacturer’s and supplier’s expectations and requirements.
The quality agreement will highlight whether the entire QMS is covered or only basic requirements.
Do not include pricing, delivery requirements, and confidentiality clauses in this document. Instead, pricing, delivery requirements, and confidentiality clauses are all sensitive information that would typically be part of the Non-Disclosure Agreement (NDA) that you and the supplier would be signatories to.
You will also define your responsibilities concerning the acceptance or rejection of the products/materials/services provided by the supplier. The document will include test methods for analyzing the products supplied and process control properties that are required.
In a supply agreement, the supplier will agree to supply the required products/services to your company. The material/component specification agreement indicates that the supplier will supply specified materials/components as per the agreement.
These agreements should not be a “One size fits all”. It is better to have customized agreements for your suppliers. The initial resources spent will be worth it in the long run.
If the supplier is planning on making any changes to a product, the same will have to be notified to your company. This will then be mentioned in the quality agreement. Also, the supplier has to communicate in case there are any non-conformances in the products that they are going to supply.
With efficient QMS software like SimplerQMS, you have special features such as automated document workflows, email notifications, real-time dashboards, and assignment reminders. All these help ensure that all procedures and policies are diligently followed.
Step 7. Monitor Approved Supplier Performance
Evaluation of your suppliers’ performance is a continuous process and not a single event at the beginning. Based on previously agreed metrics your supplier will exactly know the ways and means by which you will be evaluating them.
Supplier performance monitoring can be done by way of supplier performance data, supplier performance scorecards, and supplier audits.
Your company’s supplier performance data can include the following:
- Inspection data
- Delivery dates and quantities
- Customer complaints related to the products supplied
- Non-conformances related to their product
- On-site audits
- The supplier’s third-party audits
- Regulatory notices
- And more
As a medical device manufacturer, you can also manage the performance of your suppliers by using a supplier performance scorecard, also known as a vendor scorecard. With it, you will be able to quantify, track and manage the performance of your supplier. The supplier performance scorecard or vendor scorecard splits the supplier’s performance into quantifiable categories and factors. Metrics include product quality, customer service, costs, and delivery.
Your medical device company can also monitor suppliers’ performances using supplier audits. This audit is used to assess the quality system of the supplier, the workplace environment, cGMP requirements, and so on, as per your requirements.
With the assistance of the SimplerQMS platform, you can facilitate the continuous monitoring of your suppliers. The audit-ready dashboards will provide the relevant evidence and records to inspectors and auditors. The system allows you to plan ahead for a supplier audit, link suppliers, audit findings, and CAPAs.
Step 8. Maintain Approved Supplier List
The Approved Supplier List that your company has taken so much time and energy to create should always be updated. For instance, a supplier might have closed the shop, but you still have their details! Another supplier might have been taken over by a new company. These details should be updated.
Now let us look at another instance where a supplier on your ASL is no longer dealing with the products that you require. In such a case, their details should be removed with immediate effect. You cannot have the details of this supplier on your ASL.
The reason is that during auditing, the inspectors will verify every minute detail. If the details provided are not factual, you can get into trouble.
The maintenance of an ASL is not a regulatory requirement, but it is common practice amongst medical device companies. Such a list is expected by regulators.
As a matter of fact, the US FDA can issue warning letters when your company’s ASL does not match with an individual supplier’s approval records.
The following instance is part of a warning letter issued by the US FDA to a medical device company:
“Your firm has failed to include, where possible, an agreement that the suppliers, contractors, and consultants utilized by your firm agree to notify your firm of changes in the products and/or services so your firm can determine whether the changes may affect the quality of a finished device as required in 21 CFR § 820.50(b). For example, your vacuum bag contract manufacturer did not notify you when they changed the nylon used in manufacturing your vacuum bags to a (b)(4) nylon. This (b)(4) nylon caused the vacuum bags distributed by your firm to leak, resulting in the vacuum bags inability to maintain a vacuum.”
That being said, with a QMS software solution such as SimplerQMS, you have ready-in-built features including task scheduling, email notifications, assignment reminders, and much more that will facilitate the maintenance of an up-to-date Approved Supplier List.
SimplerQMS Streamlines Medical Device Supplier Quality Management
You have now put into place crucial requirements, namely, supplier agreements and monitoring protocols. These supplier management activities are time-sensitive and essential documentations that can be difficult to handle using traditional documentation systems.
Rather, with an efficient quality management solution such as SimplerQMS, you will be able to expedite and simplify these processes while making compliance easier.
A dedicated eQMS with a built-in supplier quality management module allows your company to keep all your supplier quality data and documentation in one place. This facilitates the best-in-class supplier quality management experience for your employees.
With the SimplerQMS, you will be able to seamlessly create, store, and maintain your Approved Supplier List, and use forms and templates to create records such as supplier surveys, evaluations, agreements, certifications, and incoming inspections.
The many benefits and features of SimplerQMS include a secure cloud-based storage location, linking of various documents, automated document workflows, electronic signatures, reminders, and email notifications, to name a few.
As a manufacturer of medical devices, you will know the importance of quality in every aspect of your business. The same quality standards are expected when you acquire, retain, and collaborate with trusted suppliers for products that will form a part of your medical devices.
A quality medical device supplier management system is not only a regulatory requirement but also a core responsibility of medical device manufacturers towards their stakeholders, including the end-users.
Considering the importance of a robust, regulatory-compliant, and efficient QMS. It will not be sufficient to continue with paper-based manual documentation and record maintenance.
With the SimplerQMS QMS suite, you are assured of streamlining your supplier quality management processes and making compliance with all applicable regulatory requirements much easier. If you are interested in such a scenario, we recommend you book a personalized demo and talk to our specialists.