General Knowledge
This cycle is commonly used to drive continual improvement within a Quality Management System.
What is PDCA (Plan-Do-Check-Act)?
Clause 5 is dedicated to this topic.
What is leadership?
This type of audit is performed by the organization on itself.
What is an internal audit?
OR
What is a first party audit?
During interviews, every employee describes the process correctly, but no training records exist. Does this automatically result in a nonconformity?
What is no or not necessarily?
A hospital employee uses Rev. 3 of a procedure when Rev. 5 is the current approved version.
What is document control finding?
ISO 9001 is based on this management philosophy and is also one of the seven principles of ISO.
What is the Process Approach?
Internal audits and management review are discussed in this clause.
What is Clause 9 - Performance Evaluation?
A surveyor should collect this to support audit findings.
What is objective evidence?
A quality objective states, "Improve patient satisfaction." No numeric target exists, but management can show surveys and evidence that satisfaction improved. Is this acceptable?
What is yes?
Two of five personnel files reviewed contain no evidence of competency evaluation.
What is a competency nonconformance (7.2)
This is one of the core concepts of ISO 9001, continual improvement, consistency and…
What is customer satisfaction?
Training, competence, and awareness are covered in this clause.
What is Clause 7 - Support?
Surveyors should focus on processes rather than these.
What is people?
A corrective action was closed six months ago. The same type of issue occurs again, but in a different department. The organization failed to do this as part of the correct action process?
What is determine if similar nonconformities exist, or could potentially occur else where?
A new service is being implemented, the organization states that risks have been considered but cannot provide any examples of actions taken to address them.
What is a planning nonconformance (6.1.1)
This term refers to persons or organizations that can affect, be affected by, or perceive themselves to be affected by an organization's decisions or activities..
What are interested parties?
Risks and opportunities are addressed in this clause.
What is Clause 6 - Planning?
A failure to meet a requirement is called this.
What is a nonconformity?
An employee cannot recite the Quality Policy word-for-word during an audit. Is this automatically a nonconformity?
What is no. Employees need awareness of how the policy relates to their work, not necessarily memorization.
Fact or Fiction
ISO 9001 requires a Quality Manual.
What is Fiction?
These are seven Quality Management Principles upon which ISO 9001 is based, Process Approach, Engagement of People, Leadership, Customer Focus, Relationship Management and these two principles..
What are Improvement and Evidence-Based Decision Making?
In Clause 8, the requirement that speaks to unverifiable process…a process can not be verified without destroying the output…is in this specific section.
What is 8.5.1?
During sampling, a surveyor reviews 10 records and finds one record missing a required element. All other records were compliant. The auditor cannot automatically conclude the entire process is ineffective because of this auditing principle, therefore we classify this as a..
What is an opportunity for improvement?
A surveyor identifies a nonconformity. Before the end of the survey the process owner fixes the problem. Should the auditor remove the finding?
What is no?
Documentation states a process should occur monthly. Records demonstrate it occurs quarterly. The process is achieving all intended results and leadership is satisfied.