ISO 19011 - Section 8
Explanations in Plain English
ISO 19011 - Section 8 - What The Auditor Is Looking
For
What the auditor is looking for:
The most critical factor for an auditor to record in the audit findings and report
is all conclusions must be supported by objective evidence. Objective evidence is provable and retrievable. The
auditor must not present or record subjective evidence or conclusions. If it can't be verified, it can't be
presented. The auditor is looking for:
· Objective evidence of compliance to procedures and work instructions
· Objective evidence of compliance to the ISO 9001 or other standards’
requirements
ISO 19011 says the objective evidence can be:
- Records
- Documentation (work instructions, procedures, standards)
- Knowledge/training of employees from interviews
- Compliant product handling
The types of nonconformances outlined in ISO 19011:
A nonconformity, sometimes called a discrepancy or finding, is when you find
objective evidence of noncompliance to:
1. Procedures, work instructions or workmanship standards:
The auditor finds objective evidence that the procedure, work instruction,
workmanship standard, checklist, or specification is not being followed, (i.e. the procedure calls for keeping a
record of an inspection on the traveler/router, or for signing-off on a sales order as evidence of contract review,
and while auditing the records the auditor finds that this not being done.)
2. The requirements of the standard that is being audited to:
The auditor finds objective evidence that a requirement of the standard is not met
in the procedure or in the implementation of the procedure, (i.e. the procedure calls for an inspection to be made
but does not require a record of the inspection to be made nor for the inspection/verification status on the
inspected product be maintained. This is nonconformity to clauses 8.2.4 and 7.5.2 of ISO 9001:2008. Or, orders are
being shipped late without agreement from the customer, clause 7.2.2 of ISO 9001:2000.
3. Customer requirements not fulfilled:
This is one of the most often found nonconformances. Sometimes it is caused by
product requirements not being met. However, ignoring the customers’ shipping date or packaging and labeling
requirements are more apt to be the reason for nonconformity.
Levels of nonconformities specified in ISO 19011:
Minor nonconformity: objective evidence of deviations from the procedure’s or the
standard’s requirements.
1. The deviation is NOT systemic (throughout the management system).
2. The deviation does NOT imply that nonconforming products are systematically
shipped to the customer.
3. The deviation does NOT imply that nonconforming products are KNOWINGLY shipped
to the customer.
Major nonconformity: objective evidence of deviations from the procedure’s or the
standard’s requirements.
1. The deviation IS systemic (throughout the management system). For example, a
requirement is not addressed anywhere in the management system.
2. The deviation implies that nonconforming products ARE systematically shipped to
customers.
3. The deviation implies that nonconforming product IS knowingly shipped to
customers.
The links below are
excerpts from the our e-book
"Explanations and
Definitions for ISO 19011:2002" 
Section 1. ISO 19011 Scope
reference and definitions
Section 2. ISO 19011 Principles of
auditing
Section 3. ISO 19011 Managing an
audit program
Section 4. ISO 19011 Audit program
implementation
Section 5. ISO 19011 Audit
activities
Section 6. ISO 19011 Preparing for
onsite activities
Section 7. ISO 19011 Conducting
onsite activities
Section 8. ISO 19011 What the
auditor is looking for
Section 9 ISO 19011 Audit
reporting
Section 10. ISO 19011 Audit
techniques
Section 11. ISO 19011 Audit
path
Section 12. ISO 19011 Effective
communications
Section 13. ISO 19011
Sampling
Section 14. ISO 19011 Audit
completion and follow-up
Section 15. ISO 19011 Competence
and evaluation of auditors
This represents a summary of the section in ISO 19011:2002. It's
suggested that you obtain a copy of our ebook to refer to when auditing.
EBook "Explanations and Definitions for ISO 19011:2002
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