A medical device vendor or supplier audit is a comprehensive assessment carried out by a medical device manufacturer to evaluate the quality management systems and practices of their vendors and suppliers. The purpose of such an audit is to ensure that the vendors and suppliers meet the necessary regulatory requirements, maintain high-quality standards, and consistently deliver products and services that comply with the medical device manufacturer’s specifications.
Regulators are increasingly looking at how device companies manage the risk to product quality associated with their suppliers. Internal audits should be routinely conducted with appropriate documentation. The “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 5: Audits of Manufacturer Control of Suppliers”, originally released by the GHTF (now IMDRF) should be used to audit your suppliers.
Outsourcing your supplier audits
Your internal auditors may not have the experience or the time to audit your suppliers as often as they should. PharmOut has experienced auditors available to audit on your behalf.
Our pharmaceutical compliance audit methodology can be applied to your suppliers, as appropriate. We’ll supply a PharmOut consultant with experience in the relevant areas i.e, IVD, Medical Devices, microbiology, sterilisation, to do the audit.
Register to be notified of PharmOut’s international supplier audit tours
Our auditors are often travelling in various parts of the world, performing supplier audits for our customers. If you would like to take advantage of sharing travel costs to have your suppliers in the same country audited cost effectively then register to be notified of when we have auditors travelling to specific countries. If we happen to be auditing a supplier of yours for another customer then we may be able to negotiate splitting the cost of the audit.
Training your auditors
PharmOut offers training courses both in how to conduct an audit (including interpersonal skills, not just the technical skills) and how to survive an audit as the auditee. If your internal auditors need training to support your supplier audit program then you might consider investing in one of our on-site auditor training programs.
Medical device vendor management refers to the process of effectively selecting, qualifying, and managing vendors or suppliers of medical devices to ensure the delivery of high-quality products and services. It involves establishing strong relationships with vendors, monitoring their performance, and mitigating risks associated with the supply chain. As PharmOut works with many manufacturers across the Asia Pacific, we are well positioned to help you find, assess and a potential overseas supplier.
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