Regulatory and Standards
This FDA regulation defines the Quality System Regulation (QSR) for medical device manufacturers.
What is 21 CFR Part 820?
This quality process is used to identify the root cause of problems and implement actions to prevent them from recurring.
What is CAPA?
This document is to provide an outline of the facility’s quality management system and its scope including details and justification for exclusions and non-application. This document details how Linde Gas & Equipment inc.’s location in Livingston, TN has established a Quality System.
What is the Quality Manual (LVN-PRO-001)?
Your training record shows you are trained on LVN-PRO-020.
What would the auditor ask?
Can you explain what this procedure covers and how you follow it in your daily work?
This international standard specifies requirements for a quality management system specific to medical devices.
What is ISO 13485?
This process captures and investigates reports of device issues or dissatisfaction from users or customers.
What is Complaint Handling?
This procedure defines the processes used to ensure that documentation is controlled, from generation through identification, approval, introduction, distribution, modification and obsolescence.
What is Document and Record Control (LVN-PRO-003)?
Your department performs incoming inspection of components.
What would the auditor ask?
Show me the acceptance criteria you use and where those criteria are documented.
What is the sampling size you use and how was that determined?
This FDA regulation requires manufacturers to report certain device-related adverse events and malfunctions.
What is 21 CFR Part 803?
This process documents when products, components, or processes fail to meet specified requirements.
What are Nonconformances?
This procedure defines the Management of Change (MOC) processes used to ensure that changes made to product, process, or system are assessed, actioned, documented, reviewed verified, and approved.
What is Change Control (LVN-PRO-002)?
You made a change to a work instruction last month.
What would the auditor ask?
Walk me through your change control process. How was this change evaluated, approved, and communicated?
This international standard outlines the risk management process manufacturers must apply throughout the life cycle of a medical device.
What is ISO 14971?
This process ensures that external suppliers are evaluated, approved, and monitored to ensure they meet quality requirements.
What is Supplier Management?
To establish and define the system to be used for controlling the handling of products for repair and service and to ensure the safe handling of these products.
What is Service and Repair (LVN-PRO-014)?
You have a CAPA open for over 9 months.
What would the auditor ask?
Why is this CAPA still open? What objective evidence shows progress, and how have you ensured containment of risk in the interim?
This European regulation governs the safety, performance, and post-market requirements for medical devices sold in the EU and replaced the former Medical Device Directive (MDD).
What is the European Medical Device Regulation (EU) 2017/745 — MDR?
This process checks whether a company is following its procedures and quality system requirements.
What are Internal Audits?
This procedure defines the controls used for quarantine and the controlling the handling of materials and products throughout the manufacturing process and for their packaging, preservation, and delivery to their final destination to ensure they are protected at all times against damage and environmental degradation.
What is Stores Control and Quarantine (LVN-PRO-013)?
Your complaint file shows an investigation closed with “no fault found.”
What would the auditor ask?
What steps did you take to investigate? Show me the data supporting the conclusion.