Who's Who
A person qualified to conduct a QMS internal audit.
Who is a QMS auditor?
Set of policies, procedures or requirements used as a reference against which audit evidence is compared.
What is audit criteria?
This can impact the way an auditor interprets a situation.
What is perception? (Also acceptable, what are past experiences, personal relationships, emotional sentiment regarding topic.)
The international quality management system set of standards that provides a framework to drive operational excellence by integrating business objectives, accreditation efforts, quality initiatives and risk management activities
What is ISO 9001?
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 Session?
The acronym for Quality Management Oversight Committee
What is the QMOC?
This is used to retroactively mitigate or eliminate process breakdown or variation.
What is a Corrective Action?
To decrease the number of steps in a process.
What is one way to increase the yield of a process?
The three phases of this process are: pre-audit planning, conducting the audit, and reporting and follow-up.
What is QMS auditing?
Records, data, statements of fact or other information which are relevant to the audit criteria.
What is audit evidence?
The associate who is asked/ answers the audit questions.
Who is the Auditee?
Product or process which doesn’t conform to requirements.
What is a Non-Conforming Product?
This practice leads to more consistent, safer and standardized care.
What is a consistent process? Or standardization or reducing variation.
Consistency (of delivery of service), Customer or Patient Satisfaction, and Continual Improvement?
What are the 3 fundamentals / 3 Cs of ISO 9001?
This is the result of the comparison of the audit evidence to the audit criteria.
What is an audit finding?
This is an international organization with a global reputation for quality and integrity in certification that is an accrediting body for ISO 9001 certification.
What /who is DNV?
Action to eliminate the causes of potential nonconformities.
What is Preventive Action or Risk Assessment?
A collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.
What is the Quality Management System?
Three examples of hospital records 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?
These are two desired qualities for QMS Auditors.
What is objectivity and integrity? (Can also be strong communication and listening skills, comfort with interviewing associates, interest and appreciation for principles of quality management/continual improvement, good documentation skills.
Someone who participates in at least 3 QMS audits can become one of these.
Who is a Lead QMS Auditor?
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?
Results of audits, process performance, and changes that could affect the QMS are just three of the inputs to this process.
What are inputs to Management Review/ QMOC?
Three of the six specific ISO 9001 documented procedures which have been foundational to Advocate’s QMS.
(any 3) What are Control of Documents * Control of Records * Control of Non-conforming Product * Internal Audits (or QMS Audits) * Corrective Action * Preventive Action?
These are 2 purposes of an audit.
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, determine effectiveness of a process, and to raise process knowledge?