Quality Management System (QMS)
ISO 13485 requires organizations to establish and maintain this system to manage quality effectively.
Quality Management System (QMS)
This term refers to the process of identifying and minimizing potential dangers in medical device development.
What is risk management
ISO 13485 helps companies comply with these types of legal requirements in the medical device industry.
What are regulatory requirements
Process control ensures that manufacturing processes are consistent and produce products that meet these.
Answer: What are quality requirements or specifications
This ISO principle focuses on making ongoing improvements to products and processes.
Answer: What is continuous improvement?
This document outlines the structure of the QMS, including processes and responsibilities
What is a Quality Manual?
The three key steps in risk management are risk identification, risk evaluation, and this process to reduce risks.
What is risk control
ISO 13485 compliance helps organizations meet the regulations of this U.S. government agency overseeing medical devices.
Answer: What is the FDA (Food and Drug Administration
This type of documentation outlines how to perform specific tasks within a controlled process.
his type of documentation outlines how to perform specific tasks within a controlled process.
Answer: What are work instructions or standard operating procedures (SOPs)
This type of review, conducted by top management, evaluates the effectiveness of the QMS and identifies opportunities for improvement.
Answer: What is a management review?
The QMS must be regularly reviewed by this group to ensure its effectiveness and compliance.
What is top management
After risks are controlled, this process ensures that new risks have not been unintentionally introduced.
What is risk re-evaluation
rganizations must maintain these records to demonstrate compliance during audits and inspections.
Answer: What are regulatory records or documentation
ISO 13485 requires that organizations validate these types of processes where the output cannot be fully verified later.
Answer: What are special or critical processes
Corrective actions address current issues, while these actions aim to prevent potential future problems.
Answer: What are preventive actions?
Document control within a QMS ensures documents are current and accessible. This is the term for ensuring old versions are not mistakenly used.
What is version control
Before releasing a new medical device, this type of assessment is conducted to identify potential risks in the design and manufacturing process.
Answer: What is a Failure Mode and Effects Analysis (FMEA)
This process ensures that medical devices continue to meet regulatory requirements after they are on the market.
Answer: What is post-market surveillance?
This statistical method is often used in process control to monitor and improve manufacturing consistency.
Answer: What is Statistical Process Control (SPC)
This tool, often represented as a cycle, is used in continuous improvement to plan, implement, check, and adjust processes.
Answer: What is the PDCA (Plan-Do-Check-Act) cycle?
ISO 13485 requires the QMS to address the entire product lifecycle, from design to this final stage.
What is post-market surveillance
isk management must be applied not only during design but throughout this complete phase of the device's life.
What is the product lifecycle
If a product defect poses a safety risk after distribution, regulatory compliance requires initiating this formal process to correct or remove the product from the market.
Answer: What is a product recall
When a process deviates from its expected outcome, this type of action is taken to correct the issue and prevent recurrence.
Answer: What is corrective action?
Continuous improvement relies on feedback from these activities that evaluate QMS performance and identify gaps.
Answer: What are internal audits?