ISO 13485:2016 explicitly requires a quality agreement with suppliers on different sections of the standard. 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. 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. Chances are you`re not making your own medical device – custom medical device manufacturing is growing at a compound annual growth rate of around 11%.
Even if you make the device yourself, you probably use a material supplier. As mentioned in the previous section, section 4.1.5 of ISO 13485:2016 specifies the need to establish a quality agreement as a form of control for people for outsourced activities. 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. In addition, also in the context of ISO 13485, in the section on procurement control, in particular in section 7.4.2, another requirement is defined in relation to the quality agreement. In fact, it is mentioned that the success of your medical device is based on a successful partnership with your subcontractors. But how can you achieve this? 8 Established by Ombu Enterprises, LLC.ISO 13485:2003 Requirements for medical device quality management systems 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. Betty Lane has over 20 years of experience in medical device quality assurance and regulatory affairs. It has established or updated quality systems for many small and medium-sized medical device and diagnostic companies. Their work allows companies to manage their operations in accordance with FDA and ISO 13485 requirements, enabling the global sale of their products. His experience in digital systems engineering allowed him to facilitate software design controls and validation as it became FDA and industry requirements. 7 QMS Quality Management System Repair measure for non-compliant equipment to make it acceptable for intended use Take-back action for non-compliant equipment to meet requirements RMS Risk Management System Disposal on non-compliant equipment to exclude its original intended use Supplier The supplier delivers the product to the customer. The term supplier includes, but is not limited to, contractors, consultants, sister organizations and parent organizations. Referenced documents 21 CFR Part 820 Quality System Regulation GHTF/SG3/N15R8 Implementation of risk management principles and activities within a quality management system GHTF/SG3/N17:2008 Quality management system Medical devices Guidelines for the control of products and services Received from suppliers ISO 9001:2008 Requirements for quality management systems Quality agreement for medical devices Page 5 of 17. . .