This
section summarizes ISO 10011-1. It highlights the main points.
It does not present
detail. If you need a detailed and complete interpretation
of the ISO 10011-1 standard, please consider purchasing our hardcopy version.
ISO
prepared ISO 10011-1 in order to explain how to plan and perform
audits.
- Purpose
of a quality audit. Quality audits are performed in
order to:
- Determine to
what extent a quality system:
- Achieves
its objectives.
- Adheres
to corporate requirements.
- Complies
with regulatory requirements.
- Meets
customers' contractual requirements.
- Conforms
to a recognized quality standard.
- Improve the
performance of a quality system.
- List a
quality system in the registry of an independent
agency.
- Verify that a
quality system continues to meet requirements.
- An
auditee
is the organization being audited.
- A
lead auditor's job is to:
- Manage the
audit.
- Assign audit
tasks.
- Help select
auditors.
- Orient the
audit team.
- Prepare the
audit plan.
- Define
auditor qualifications.
- Clarify
quality audit requirements.
- Communicate
audit requirements.
- Prepare audit
forms and checklists.
- Review
quality system documents.
- Report major
nonconformities immediately.
- Interact with
auditee's management and staff.
- Prepare and
submit audit reports.
- An
auditor's job
is to:
- Evaluate the
quality system.
- Carry out
assigned audit tasks.
- Comply with
audit requirements.
- Respect all
confidentiality requirements.
- Collect
evidence about the quality system.
- Document
audit observations and conclusions.
- Safeguard
audit documents, records, and reports.
- Detect
evidence that might invalidate audit results.
- Determine
whether the quality policy is being applied.
- Determine
whether quality system procedures are being
followed.
- Establish
whether quality system is able to achieve its
objectives.
- A
client
is the organization that asked for the audit. The client
could be an auditee, a customer, a regulatory body, or a
registrar.
- A
client's job
is to:
- Initiate the
audit process.
- Select the
auditor organization.
- Decide
whether an audit needs to be done.
- Define the
purpose and scope of the audit.
- Ensure that
audit resources are adequate.
- Determine how
often audits should be done.
- Define the
steps that the auditee should take.
- Tell the
auditee about the steps they need to take.
- Indicate
which standards should be used to evaluate
compliance.
- Select the
elements, activities, and locations that should
be audited.
- Ensure that
sufficient evidence is collected to draw
conclusions.
- Receive and
review the reports prepared by the auditors.
- An
auditee's job
is to:
- Explain the
nature and purpose of the audit to employees.
- Appoint
employees to accompany and assist the auditors.
- Ensure that
all personnel cooperate fully with the audit
team.
- Provide the
resources the audit team needs in order to do the
audit.
- Allow the
auditors to examine all documents, records, and
facilities.
- Correct and
prevent the problems that were identified by the
audit.
- A
client may initiate an audit because:
- A regulatory
agency requires an audit.
- A previous
audit indicated that a follow-up audit was
needed.
- An auditee
has made important changes.
- An
auditee may carry out audits on a regular basis to
improve quality system performance or to achieve business
objectives.
- The
auditor should begin planning the audit by reviewing documents
which describe the quality system and explain how it is
attempting to meet quality system requirements. If this
preliminary review shows that the quality system is
inadequate, the audit process should go no further.
- Prepare
an audit plan.
The plan should be prepared by the lead auditor and
approved by the client before the audit begins.
- Start
the quality audit. Start the audit by having
an opening meeting with the auditee's senior management.
- Prepare
audit working papers. Prepare:
- Checklists.
These are used to evaluate quality system
elements.
- Forms. These
are used to document observations and evidence.
- Collect
evidence. Audit evidence is collected by:
- Interviewing
personnel.
- Reading
documents.
- Reviewing
manuals.
- Studying
records.
- Analyzing
data.
- Observing
activities.
- Examining
conditions.
- Confirm
interview evidence. Evidence collected through
interviews should, whenever possible, be confirmed by
more objective means.
- Investigate
clues.
Clues that point to possible quality system
nonconformities should be thoroughly investigated.
- Document
observations. Quality system auditors
must study the evidence and document their observations.
- List
nonconformities. Auditors must study the
evidence and review their observations and then make a
list of key nonconformities.
- Draw
conclusions.
Auditors must draw conclusions about how well the quality
system is applying its policies and achieving its
objectives.
- Discuss
results.
Auditors must discuss evidence, observations,
conclusions, and nonconformities with auditee senior
managers before they prepare a final audit report.
- Prepare
audit report.
The lead auditor should date and sign the report.
- Submit
audit report.
The lead auditor should send the audit report to the
client, and the client should send it to the auditee.
- Take
remedial actions. The auditee is expected to take
whatever actions are necessary to correct or prevent
quality system nonconformities.
- Schedule
follow-up audit. Follow-up audits should be
scheduled in order to verify that corrective and
preventive actions were taken.
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This
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