R&D, Supplier Management
The quality of medical devices used every day relies heavily on the supplier management tools and techniques. Based on a risk profile, these tools and techniques can be used for all types of suppliers.
Section 820.50 of 1996 Quality System Regulation put emphasis on ensuring that device manufacturers select only those suppliers, contractors, and consultants who have the capability to provide quality product and services.
QABASA can help establishing a process of effectively selecting, evaluating and implementing applicable controls based on the evaluation and ongoing proactive management of suppliers, contractors and consultants.
Our expert Supplier Management team can help with following aspects:
- Planning – This includes identification of products and services, specifications, part requirements, procedures, work instructions, name and contact of potential suppliers, risk documentation, process and product control document.
- Selection of Potential Suppliers – This includes selection criteria for potential suppliers including capabilities, logistics, quality, technical risks and other details.
- Supplier Evaluation and Acceptance – This includes initial agreements, decision documents and other records.
- Finalization of Controls – This includes master agreements, purchase orders, acceptance procedures, specifications and requirements and other records.
- Delivery, Measurement and Monitoring – This includes all records for receiving, inspection, acceptance, results and corrections.
- Feedback and Communication – This includes the correspondence between the manufacturer and the supplier includes any documents and records of CAPA process.