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Course Outline
I. Introduction to Auditing
II. ISO 19011:2011 Updates
III. Audit Objectives, Principles, and Concepts
IV. Audit Planning
V. Conducting On-site Audit
VI. Audit Reporting
VII. Auditor Selection and Evaluation
3.1 AUDIT
Systematic, independent and documented process for
obtaining audit evidence (3.3) and evaluating it
objectively to determine the extent to which the audit
criteria (3.2) are fulfilled.
3.7 AUDITEE
Organization being audited
3.8 AUDITOR
Person conducting the audit (3.1)
3.11 OBSERVER
Person who accompanies the audit team but does
not audit.
Note 1: Not part of the audit team and does not
influence or interfere with the conduct of the audit
Note 2: Can be from the auditee, a regulator or
other interested party who witnesses the audit.
3.12 GUIDE
Person appointed by the auditee to assist the audit
team
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3.0 Terms and definitions
3.16 RISK
Effect of uncertainty on objectives
3.17 COMPETENCE
Ability to apply knowledge and skills to achieve
intended results.
Note 1: Ability implies the appropriate application of
personal behavior during the audit process
3.18 CONFORMITY
Fulfillment of a requirement
3.19 NONCONFORMITY
Non-fulfillment of a requirement
PRINCIPLES DETAILS
Integrity Foundation of professionalism:
Honesty, diligence, responsibility,
demonstration of competence,
impartiality
Fair presentation Obligation to report truthfully and
accurately:
Significant obstacles and unresolved
diverging opinions between auditor
and auditee are reported and
disclosed
Auditor Toolkit
• Clipboard
• Logbook
• Checklist
• Audit plan
• Report Forms
• ISO 9001:2008 standard
• With Auditee
– Opening meeting
– Daily review
– Informal communications
– Closing meeting
• Within Audit team
– Regular communications (normally
each half day)
– Internal meeting
Question
( ask them what they do)
Observe Check
( see what they actually do) ( what the process says
they should do)
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Interviewing Process
NONCONFORMANCE (NC):
A nonconformance relates to the absence, or total
failure, of a process to meet the internal requirements
resulting in an actual or potential adverse effect on
customer satisfaction and quality of the product or
service.
A number of lapses against one clause of guidelines
when acting together reduce the effectiveness of a
process to the extent that there are actual adverse
effects on customer satisfaction and product quality
which can represent a nonconformance.
OBSERVATION (O):
Single observed lapse or failure to comply with a
requirement of the guidelines or an internal
requirement which however, as based on objective
evidence, does not jeopardize product quality.
• Be factual / objective
• Be clear and concise
• Give clause number of Quality Standard /
Company Document
• Be locatable by the Auditors
• Define the exact instance
• Be given a unique identifier
• Be categorized (ex. NC / O / I)
• Be accepted / signed by the audited
company
• Clause No.
• Criteria statement
• However…
• Factual description (Audit Evidence)
– When
– Where
– Who
– What
NONCONFORMANCE REPORT
Company: XYZ Co. Classification: NC
Area: Warehouse ISO Clause:
Reference:
Detail of Nonconformance:
Auditor:
Corrective Action: Remarks:
• Audit objectives
• Audit Scope
• Audit client
• Audit team and auditee’s participants
• Dates and locations of audit
• Audit criteria
• Audit findings and relevant evidence
• Audit conclusions
• Statement on the degree on which the
audit criteria have been fulfilled
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Corrective vs. Preventive Action
Confirm NC
Identify Solution
Implement , close
• Report circulated
• Audit program updated
• Checklist filed
• Corrective action performed
• Trends/findings fed to management review
• Corrective action verified
Education
Auditor’s should have:
Formal education / training
contributing to development of
knowledge and skills in the
management system discipline /
sector that the auditor intends to
audit