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Who's Who
A Dab of Vocab
Conceptual Conceptions
ICE, ICE, Ohhh
I can report, can you?
100
A person qualified to conduct an audit.
Who is an auditor?
100
The non-fulfillment of a requirement OR an occurence that does not meet planned arrangements.
What is a non-conformance or non-conformity?
100
Name two question types that are appropriate to use during audit interviews.
What are (pick two) Factual, Direct, General, or Hypothetical?
100
The three fundamentals of ISO 9001.
What are Consistency (of delivery of service), Customer or Patient Satisfaction, and Continual Improvement? (the 3 C's)
100
True or False. An audit report should include specific examples to support the findings, where appropriate.
What is TRUE?
200
A person who provides specific knowledge or expertise to the audit team.
Who is the technical expert?
200
The path that the auditor takes for the audit.
What is the audit trail?
200
Name three listening techniquest that you can use to be a strong auditor.
What are (pick 3) Neutral, Exploratory, Restatement, Reflective, and Summarizing?
200
Three words the ISO 9001 standard uses to introduce responsibilities for leadership.
What are Top Management Shall?
200
These are issued as a result of audit findings to ensure someone takes responsibility for addressing the finding.
What are Corrective Action/ Preventive Action Reports, OR CAPA's, OR Corrective Actions?
300
The person who is ultimately responsible for keeping the audit on track and submitting the audit report.
Who is the Lead Auditor?
300
Extent or boundaries of the audit.
What is the audit scope?
300
Name three question types that should be avoided during audit interviews.
What are (pick 3) Alternative, Leading, Justifying, Controversial, and Rhetorical?
300
Minutes from a Management Review meeting is an example of this ISO 9001 topic.
What are records?
300
True or False. The Audit Team Members should each submit their part of the audit report to the person administering the audits.
What is False? (The Lead Auditor should work with the Audit Team Members to ensure one report is submitted to the person administering the audits.)
400
A party that joins the audit team to learn about auditing.
Who is an Observer?
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?
400
What can bias the way an auditor interprets a situation?
What is perception? Also acceptable, what are past experiences?
400
ISO 9001 requires six specific documented procedures. Please name three of the six.
What are (any 3) Control of Documents * Control of Records * Control of Non-conforming Product * Internal Audits (or QMS Audits) * Corrective Action * Preventive Action?
400
These are the three phases of an audit, in order of occurence.
What are pre-audit planning, conducting the audit, and reporting and follow-up?
500
The group identified by ISO 9001 as being responsible for reviewing results of audits.
Who is Top Management ... OR ... QMOC ... OR ... Leadership participating in Management Review
500
The record that is generated as a result of the audit being performed.
What is the audit report?
500
The concept of choosing which auditees to interview or which records to review during an audit.
What is sampling?
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
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?