QMS Overview
How often must Management Review be conducted?
Annually
Who determines if the customer feedback meets the definition of a complaint?
The Quality Department.
Does a bug fix require a design change?
Yes.
A supplier must be placed on the _____________ prior to using the supplier.
Approved Supplier List
How does DeepHealth "DO" Quality Assurance (4 items)?
Plan, Do, Check, and Act
Name one of the steps required to investigate a complaint.
The problem statement, Risk Review, Root Cause Analysis, Actions Needed, Actions Completed, or Verification of Actions
How many phases are in the Design Process?
6
Instructions for Use is an example of what?
Labeling
What area of the Quality System must be audited annually?
All areas of the Quality System.
Where are complaints documented?
In Greenlight Guru.
Which phase defines how the product is supposed to work including the user needs?
Phase 2 - Design Inputs
Servicing reports are documented and reviewed for what?
Possible complaints.
What is included in a personnel file?
Job description, resume, and all training records.
What complaints are evaluated for regulatory reporting?
All complaints
Name the 5 elements in the risk management process.
Risk Management Planning, Risk Analysis, Risk Evaluation, Risk Control, Production and post-production activities.
The action taken to eliminate the cause of an existing nonconformity, defect, or other undesirable situation in order to prevent recurrence is called what?
Corrective Action
DeepHealth's QMS is established to meet what regulatory requirement?
FDA
Who is responsible for investigating a complaint?
Engineering, DevOps, and/or Quality
The risk management process ensure the ______ and __________ of products throughout it's intended life cycle.
Safety and effectiveness
Is it required to document all installation activities?
Yes