ISO 19011:2011 Correct Answer: sets out guidance on internal and external audits of
quality management systems
ISO 9000:2015 Correct Answer: Describes the fundamental concepts and principles of
quality management which are universal
Audit Correct Answer: Systematic, independent and documented process for obtaining
evidence and evaluating it objectively to determine the extent to which the criteria are
fulfilled
Audit client Correct Answer: Organization or person requesting an audit. Determines the
scope of the audit. Jointly determines the purpose and criteria of an internal audit with
the lead auditor.
Audit conclusion Correct Answer: Outcome of an audit, provided by the audit team after
consideration of the audit objectives and all audit findings
Audit criteria Correct Answer: Set of policies, procedures or requirements
Audit evidence Correct Answer: Records, statements of fact or other info, which are
relevant to the audit criteria and verifiable
Audit findings Correct Answer: Results of the evaluation of the collected evidence
against criteria
Audit plan Correct Answer: Description of the activities and arrangements for an audit
Audit Program Correct Answer: Set of one or more audits planned for a specific time
frame and directed towards a specific purpose
Audit scope Correct Answer: Extent and boundaries of an audit. Normally defines the
organizations and time period for the audit. Can include physical locations,
departments, products, processes, or systems, exclusions, timelines, relevant polices or
procedures, and applicable regulations or contracts.
Audit team Correct Answer: One or more auditors conducting an audit, supported if
needed by technical experts
Auditee Correct Answer: Organization being audited
Auditor Correct Answer: Person with the competence to conduct an audit
Part I Correct Answer: Auditing fundamentals
Part I A Correct Answer: Types of quality audits
Part I B Correct Answer: Purpose and scope of audits
Part I C Correct Answer: Criteria to audit against
Part I D Correct Answer: Roles and responsibilities of audit participants
Part I E Correct Answer: Professional conduct and consequences for auditors
Product or Service Audit Correct Answer: Examination of a particular item or service
(hardware, processed material, software) to evaluate whether it conforms to
requirements (that is, specifications, performance standards, and customer
requirements).
Conducted at completed stage of production and has passed final inspection.
Can also measure quality of item going to customer (product quality audit).
Technical exam of the form, fit and function of a completed item after final inspection.
Process audit Correct Answer: Verifies that procedures are working within established
limits. It examines an activity to verify that the inputs, actions, and outputs are in
accordance with defined requirements. It is very focused on a single activity.
General Audit Types Correct Answer: 3 discrete types are product (which includes
services), process, and system
Process audit technique Correct Answer: Audit method of following process steps
System audit Correct Answer: Exam conducted on a management system. A
documented activity performed to verify, by exam and evaluation of objective evidence,
that applicable elements of the system are appropriate and effective and have been
developed, documented and implemented in accordance and in conjunction with
specified requirements.
It encompasses all the practices of a facility that assist in providing an acceptable
product or service that is safe and conforms to applicable local, regional, national, and
international requirements
A S M E Correct Answer: American Society of mechanical engineers
Desk Audit or Document Review Correct Answer: An audit of an organization’s
documents. It can be done prior to or in conjunction with other audit methods but must
be performed prior to auditing a new area to verify documents meet requirements
before activity observation.
Audit classifications Correct Answer: Internal or external dependent on the auditor –
auditee relationship