True or False. An audit report should include specific examples to support the findings, where appropriate?
What is true?
100
Name two question types that are appropriate to use during audit interviews.
What are (chooses two) Factual, Direct, General, or Hypothetical questions?
100
Consistency (of delivery of service), Customer or Patient Satisfaction, and Continual Improvement?
What are the three fundamentals of ISO 9001.
100
An international organization with a global reputation for quality and integrity in certification.
What is DNV?
200
Quality Management Oversight Committee
What is the QMOC?
200
Set of policies, procedures or requirements used as a reference against which audit evidence is compared.
What is audit criteria?
200
Name three listening techniques that you can use to be a strong auditor.
What is (pick 3) Neutral, Exploratory, Restatement, Reflective, and Summarizing?
200
The international quality management system standard that provides a framework to drive operational excellence by integrating business objectives, accreditation efforts, quality initiatives and risk management activities.
What is ISO 9001?
200
A management system whose purpose is to direct and control an organization with regard to quality.
What is a Quality Management System?
300
Records, data, statements of fact or other information which are relevant to the audit criteria and verifiable.
What is audit evidence?
300
Product (or material) which doesn’t conform to requirements.
What is a Non-Conforming Product?
300
Allows us to ‘access the right document, with the right content, at the right time, in order to make the right decision.’
What is Document Control?
300
Name three records at Advocate that need to be controlled.
What are (any three) Patient records, lab data, adverse event records, purchasing records, Imaging records, QMS Meeting minutes, training records, CAPAs, Completed forms?
300
An electronic system for managing Advocate's controlled documents, i.e., policies, procedures, etc.
What is the Advocate Document System?
400
Senior leadership of an organization that reviews the organization’s quality management system at planned intervals to ensure its continuing stability, adequacy and effectiveness.
Who is Top Management?
400
Action taken to eliminate the causes of nonconformities.
What is Corrective Action?
400
What can bias the way an auditor interprets a situation?
What is perception? Also acceptable, what are past experiences?
400
What are pre-audit planning, conducting the audit, and reporting and follow-up?
What are the three phases of an audit, in order of occurrence.
400
The introduction used by the audit team to explain to auditees what is going to take place and answer any questions.
What is an Opening Meeting?
500
A party that joins the audit team to learn about auditing.
Who is an Observer?
500
Action to eliminate the causes of potential nonconformities.
What is Preventive Action?
500
Results of audits, process performance, and changes that could affect the QMS are just three of these.
What are inputs to Management Review?
500
What are the six specific ISO required documented procedures? Name three of the six.
(any 3) What are Control of Documents * Control of Records * Control of Non-conforming Product * Internal Audits (or QMS Audits) * Corrective Action * Preventive Action?
500
To determine effectiveness is one purpose of an audit. Please name two more.
What are (any 2) to confirm established goals and objectives are being met, to compare against established criteria or level of conformance, to establish a baseline, to identify opportunities for improvement/ process problems, to anticipate risks, and to raise process knowledge?