Medical Device Distributor Quality Agreement Template
Additional FDA controls: In addition to design controls, you should also describe the labeling, production, process, and packaging controls that your device must follow. Just like with design controls, you need to clarify in your agreement the steps your contract manufacturer must take to comply with the regulations. Terms and Conditions: Use this section to determine working hours and any termination clauses and to determine who should be contacted regarding anything outside of CAPA and the quality issues described in the quality agreement. Quality assurance (QA) agreements for suppliers can play a crucial role in helping companies not only prove to regulators that they are properly controlling their suppliers, but also to show that they are informed and informed about what their suppliers are doing. Manufacturers of all types of medical devices are responsible for the product they manufacture and sell. However, more and more companies are outsourcing all or part of their production or other processes. Regulators and certification authorities therefore expect companies that sell the product to have sufficient knowledge and control over their suppliers to ensure that the products are safe and meet the claims made to them. This article explains why supplier agreements are desirable and sometimes even necessary, which suppliers should have quality agreements with suppliers and what should be included in these agreements. A quality agreement should specify which party defines component specifications and which part defines the processes for auditing, qualifying and monitoring component suppliers.
It should also be specified who will carry out the tests or sampling necessary to comply with GMP. All relevant stakeholders meet and start working together on the agreement. Lawyers don`t have to be present, but their insight is valuable. Keep in mind that involving lawyers can lead to a longer process. Companies often have written agreements with their major suppliers, but these are often supply agreements that focus on financial and legal agreements between the two. It is preferable to separate quality or quality assurance (QA) agreements from agreements with suppliers, although they are usually incorporated by reference into the main supply contract. Supplier and quality agreements should be kept at least somewhat separate, as supplier agreements often require legal review and approval from a business manager and can last for many years of the relationship between the manufacturer and the supplier. On the other hand, quality agreements, such as annexes such as annual prices and quantities, must be flexible, based on day-to-day operations and easily modifiable if necessary without legal control. See Figure 2 for key points of supplier agreements and quality assurance. 8 Created by Ombu Enterprises, LLC. ISO 13485:2003 Requirements for quality management systems for medical devices for regulatory purposes ISO 14971:2007 Application of medical device risk management to medical device products and services covered by this Agreement This Agreement applies to the products listed in the table below. Note: List the products that the supplier makes available to the customer.
The list must be specific, but must not contain revision levels or other information at that specific level. For example, it would be better to say power supply part number: A1234. instead of power supply part number: A1234 Revision C. You probably don`t want to reconfirm the vendor agreement for every revision change to the product. Products covered by this Agreement Product Name Supplier Part Number Customer Part Number The Supplier manufactures the product at one of the locations listed below. Work closely with your subcontractor or supplier to ensure that the agreement is satisfactory. Several drafts on round-trip communication are likely. MEDICAL DEVICE GUIDANCE DOCUMENT, Medical Device Guidance Document, Guidelines, Medical Devices, Medical Devices, MEDICAL DEVICES: Guidance Document, DOCUMENT, Medical Device (SaMD): Application of Quality Management Requirements: Describe whether you require the supplier to use a quality management system (QMS).
You must provide details on how to manage the appropriate processes within the QMS and assign responsibility for the tasks to be performed by members of your organization. For example, you need someone to take care of updating a supplier relationship movement within the QMS. Plus, it`s a good idea to invite them to your quality management platform if you`re already using one. 5 Note: The name of the supplier and the name of the customer may be supplemented by other descriptive information about the company, such as.B. Company X, a contract manufacturer of medical devices properly organized and compliant with the laws of . Definitions, Abbreviations and Acronyms The following terms are contained in this Agreement. Precision A statement of how close a measured value is to the actual (true) value. See also Precision. Complaint A written, electronic or oral communication alleging deficiencies in the identity, quality, durability, reliability, safety, efficacy or performance of a device after it has been released. Model agreement on the quality of medical devices Page 4 of 17.
Created by Ombu Enterprises, LLC. Concession authorization to use or release equipment that does not meet the specified requirements. A quality agreement ensures that you and your material supplier or contracted manufacturer are on the same page by laying the foundation for quality and communication standards. It plays a crucial role in avoiding fines, which can amount to tens of millions of dollars for some medical device companies, and in providing the best possible product. A reasonably detailed quality agreement can help avoid assumptions that lead to compliance errors. However, while a quality agreement defines the specific quality parameters of a project and which parties are responsible for their execution, the level of detail varies depending on the development phase of the project. At the very least, a quality agreement should delineate the obligations and responsibilities of each party in the following basic elements listed in the guidelines: The ultimate goal of your quality agreement: Determine the scope of the project, the expectations of both parties, and the ultimate goal of the agreement. This section is essentially the terms of the entire relationship.
Liability issues: Contact your legal counsel to clarify any liability issues in advance and explain these safeguards in your agreement with the provider. Quality Management Protocols: Specify how the supplier is to handle material storage, a CAPA event or non-compliance, or other quality factors. .