SOP Medical Device Materials Control

Medical Device Standard Operating Procedure Template Group MD500 consists of MD50, MD51, MD52, MD54, MD55, MD56, MD57, MD58, and MD59 procedures, forms and log books.

Medical Device Standard Operating Procedure Template- Describes the process for selection, approval, development and monitoring of supplies providing components, materials and services used to support the manufacture of company products and the Quality Management System. Package consists of the procedure, a Supplier Approval Report, A Supplier Quality Audit, an Audit Plan, a Supplier Survey, an Approved Supplier Log and a Supplier History Log.

Medical Device Standard Operating Procedure Template- Describes the process for the identification, documentation, evaluation, investigation, segregation and disposition of nonconforming materials at the company. Package consists of the procedure, a Nonconforming Material Report (2 parts) and a Nonconforming Materials Log.

Medical Device Standard Operating Procedure Template- Describes the process used to assure that only those finished products approved for release are distributed and to assure that adequate records are maintained for distribution activities. Package consists of the procedure, a Product Distribution Record and a Product Distribution Log.

Medical Device Standard Operating Procedure Template- Describes procedures for receiving, identifying, documenting, disposition and storing products returned after distribution to ensure that quality and safety of the product. Package consists of the procedure, a Product Return Record and a Product Return Log.

Medical Device Standard Operating Procedure Template- Describes the procedure for the control, accountability and use of labeling associated with company medical device products. Package consists of the procedure, a Labeling Accountability Record and a Labeling Accountability Log.

Medical Device Standard Operating Procedure Template- Describes the requirements for the contents of Quality Agreements when such agreements are necessary. Package consists of the procedure and a Medical Device Quality Agreement form.

Medical Device Standard Operating Procedure Template- Describes the process for communication of product quality issues (Defects, discrepancies) to suppliers by using the Supplier Quality Alert form. Package consists of the procedure, a Supplier Corrective Action Request and a Supplier Quality Alert Log.

Medical Device Standard Operating Procedure Template- This procedure establishes the requirements for the control of storage areas and stock rooms and handling of product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed, as well as the methods for authorizing receipt from and dispatch to storage areas and stock rooms.

Medical Device Standard Operating Procedure Template- This procedure describes the steps and assigns responsibilities for documenting the receipt and subsequent inspection and release of materials used in the manufacture of medical devices at the company. Package consists of the procedure, and Inspection Record, an Inspection Log, and a Receiving Log.