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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
The
objective evidence can be:
- Records
- Documentation (work instructions, procedures, standards)
- Knowledge/training of employees from interviews
- Compliant product handling
The types of nonconformances:
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
9001:2000. 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:
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 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 an actual copy of the standard to refer to
for auditing program purposes.
EBook
"Explanations and Definitions for ISO 19011:2002"
Online
ISO 9000 Introduction Course
Auditor Training:
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Courseware
What
is a Quality Management System?
What is ISO 9000?
What is ISO 9001?
What is ISO 9004? |
