ISO 19011 - Section 7
Explanations In Plain English
ISO 19011 - Section 7 - Audit Activities Stage
4
Stage 4 - Conducting the on-site activities
An opening meeting should be held with auditee’s management and process owners for
the functions or processes to be audited. The purpose of an opening meeting is:
a) To confirm the audit plan,
b) To provide a short summary of how the audit activities will be
undertaken,
c) To confirm communication channels,
d) To provide an opportunity for the auditee to ask questions.
An attendance record for the opening meeting should be kept, as well as a record
of topics covered and questions asked and answered.
This is the time for the auditee to get clarification for any aspect of the audit
process. For example, if your audit program classifies nonconformances as either minor or major and the auditee
isn't clear on the difference, now is the time to discuss it. Don't wait until the nonconformances have been
written and classified, then attempt to argue the auditor out of his/her decision.
Contrary to what some auditees believe auditors are human and can become
aggravated. And, you don't want to have to deal with an angry auditor. I'm not saying you shouldn't present your
position and objective evidence for issues the auditor is mistaken about. Gather your evidence and present it in a
professional manner. Hopefully, the auditor has presented the situation to you before the nonconformance has been
written and any misunderstandings are avoided.
Opening meetings are not a mandatory internal audit activity and many companies
don't hold them. As long as everyone involved in the internal audit is clear on the methods and process to be used,
an opening meeting may not be necessary.
Communications during the audit: ISO 19011 - Section 7
Depending upon the scope and complexity of the audit, it can be necessary to make
formal arrangements for communication within the audit team and with the auditee during the audit. The audit team
should get together occasionally to exchange information, assess audit progress, and to reassign work between the
audit team members as needed.
During the audit, the audit team leader should periodically communicate the
progress of the audit and any concerns to the auditee and audit client, as needed. Objective evidence collected
during the audit that shows an immediate and significant risk (e.g. safety, environmental or quality) should be
reported without delay. Any concern about an issue outside the audit scope should be noted and reported to the
audit team leader, for possible communication to the audit client and auditee.
Where the available audit evidence indicates that the audit objectives are
unattainable, the audit team leader should report the reasons to the audit client and the auditee to determine
appropriate action. Such action may include reconfirmation or modification of the audit plan, changes to the audit
objectives or audit scope, or termination of the audit.
Guides, escorts and observers: ISO 19011 - Section 7
Guides, escorts and observers may accompany the audit team but are not a part of
it. They should not influence or interfere with the conduct of the audit. However, they must protect their
company's interests and information.
When guides are appointed by the auditee, they should assist the audit team and
act on the request of the audit team leader. Their responsibilities may include the following:
a) Establishing contacts and timing for interviews,
b) Arranging visits to specific parts of the site or organization,
c) Ensuring that rules concerning site safety and security procedures are known
and respected by the audit team members,
d) Witnessing the audit on behalf of the auditee,
e) Providing clarification or assisting in collecting information.
Collecting and verifying information: ISO 19011 - Section
7
Information and data relevant to the audit including information relating to
interfaces between functions, activities and processes should be collected by appropriate sampling and interviewing
techniques and must be verified before being recorded. Only information that is verifiable may be objective
evidence. All audit objective evidence should be recorded.
A question I'm asked "Is verbal/oral evidence considered to be objective
evidence?" Yes, if the person being interviewed is responsible and accountable for the activity the statement
refers to. However, before you record any information from the exchange, you must verify that what you heard is
what the interviewee said.
The audit evidence is based on samples of the available information. Therefore,
there is always an element of uncertainty in auditing, and all those involved should be aware of this
uncertainty.
Generating audit findings: ISO 19011 - Section 7
Objective evidence should be evaluated against the audit criteria to generate the
audit findings. Audit findings can indicate conformity or nonconformity with audit criteria. In other words,
findings are just relevant audit information. Findings must be determined as okay or not. It isn't unusual to hear
an auditor that has been auditing for years to refer to a nonconformity as a finding. Nonconformities were commonly
called findings when the first edition (1987) of the ISO 9000 standards came into existence.
When specified by the audit objectives, audit findings can identify an opportunity
for improvement (OFI). An example of an OFI might be when an operation is currently functioning at a minimally
acceptable level but shows signs of deterioration. The audit team should meet as needed to review audit findings at
appropriate stages during the audit. If more than one auditor finds the same type of an OFI in different operations
the OFI may need to be elevated to a nonconformity.
Preparing audit conclusions:
The audit team needs to get together prior to the closing meeting to:
a) Review the audit findings against the audit objectives,
b) Agree on audit conclusions, always taking into account the uncertainty inherent
in the audit process,
c) Prepare recommendations, if specified by the audit objectives, and
d) Discuss audit follow-up, if included in the audit plan.
Conducting the closing meeting:
Although many companies do not conduct opening meetings in their internal audits,
a closing meeting should be. Always have a list of attendees and topics presented.
A closing meeting, chaired by the audit team leader, should be held to present the
audit findings and conclusions in such a manner that they are understood and acknowledged by the auditee, and to
agree, if appropriate, on the timeframe for the auditee to present a corrective action plan.
The people attending the closing meeting should include the auditee, and may also
include the audit client and other parties. If necessary, the audit team leader should advise the auditee of
problems from the audit that may effect the reliability of the audit conclusions. For example, there was minimal
audit evidence to reach a comfortable level of confidence for a conclusion. The evidence that was available
appeared satisfactory but, it's volume was very small.
In a small company, the closing meeting may consist of just communicating the
audit findings and conclusions.
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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