ISO 10011

ISO 10011-1 : 1990
(Guidelines for Planning and Performing Quality Audits)
Pedoman untuk Perencanaan dan Pelaksanaan Audit Mutu

Quality audit
objectives
·      Quality audits are intended to achieve
the following kinds of objectives:
·     To determine to what extent your quality system:
o    Achieves its objectives. 
o    Conforms to your requirements. 
o    Complies with regulatory requirements. 
o    Meets customers' contractual requirements. 
o    Conforms to a recognized quality standard. 
·     To improve the efficiency and effectiveness
of your quality management system. 
·     To list your quality system in
registry of an independent agency. 
·     To verify that your quality system
continues to meet requirements.
Professional
conduct
·      Auditors must behave in a professional manner. Auditors must:
·      Have integrity and be independent and objective. 
·      Have the authority they need to do a proper job. 
·      Avoid compromising the audit by discussing
audit details with auditees during the audit.
The lead
auditor's job
·      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, submit, and discuss audit reports.
Auditor's job
·       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. 
·         Determine whether quality policy is being applied.
·         Find out if the quality objectives are being achieved.
·         See whether quality procedures are being followed.
·         Detect evidence that might invalidate audit results. 
Client's job 
·     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 must be done. 
·         Specify which follow-up actions
the auditee should take. 
·         Indicate which standards should
be used to evaluate compliance. 
·         Select the elements, activities, and
locations that must be audited. 
·         Ensure enough evidence is collected
to draw valid conclusions. 
·         Receive and review the
reports prepared by auditors.
Auditee's job
·     An auditee's job is to:
·         Explain the nature, purpose, and
scope 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 to do the audit. 
·         Allow auditors to examine all
documents, records, and facilities. 
·         Correct and prevent problems
that were identified by the audit.
NOTE: An " auditee" is the organization being
audited or a member of that organization.
When to do
an audit
·     A client may initiate an audit because:
o   A regulatory agency requires an audit. 
o   A previous audit indicated that
a follow-up audit was necessary. 
o   An auditee has made important changes in:
·      Policies or procedures.
·      Technologies or techniques.
·      Management or organization. 
·       An auditee may carry out audits on a regular basis to improve
quality system performance or to achieve business objectives.
Prepare an
audit plan 
·     The auditor should begin planning the audit by
reviewing documents (e.g. manuals) that both describe
the quality management system and explain how it is
attempting to meet quality requirements.
o  If this preliminary review shows that the quality
management system is inadequate, the audit process
should be suspended until this inadequacy is resolved.
·     Prepare an audit plan. The plan should be prepared by
the lead auditor and approved by the client before the
audit begins. The  audit plan should:
·         Define the objectives and scope of the audit. 
·         Explain how long each phase of the audit will take. 
·         Specify where and when the audit will be carried out. 
·         Introduce the lead auditor and his team members.
·         Identify the quality elements that will be audited.
·         Identify the groups and areas that will be audited.
·         List the documents and records that will be studied. 
·         List the people who are responsible for quality and
whose areas and functions will be audited.
·         Explain when meetings will be held with
auditee's senior management. 
·         Clarify who will get the final audit
report and when it will be ready.
Perform the
quality audit 
·     Start the quality audit. Start the audit by having an
opening meeting with the auditee's senior management.
This meeting should:
·         Introduce the audit team.
·         Clarify scope, objectives, and schedule. 
·         Explain how the audit will be carried out. 
·         Confirm that the auditee is ready
to support the audit process. 
·       Prepare audit working papers.
·         Prepare checklists (use to evaluate
quality management system elements). 
·         Prepare forms (use to record
observations and collect evidence). 
·       Collect evidence by:
·         Interviewing personnel. 
·         Reading documents. 
·         Reviewing manuals. 
·         Studying records.
·         Reading reports.
·         Scanning files.
·         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 management system nonconformities
should be thoroughly and completely investigated. 
·      Document observations. Auditors must study the
evidence and document their observations. 
·       List nonconformities. Auditors must study their observations
and make a list of key nonconformities. They must ensure
that nonconformities are:
·         Supported by the evidence. 
·         Cross-referenced to the standards that are being violated. 
·      Draw conclusions. Auditors must draw conclusions about
how well the quality system is applying its policies and
achieving its objectives. 
·      Discuss results. Auditors should discuss evidence,
observations, conclusions, recommendations, and
nonconformities with auditee senior managers
before they prepare a final audit report. 
Prepare the
audit report 
·     Prepare the final audit report. The audit report should
be dated and signed by the lead auditor. This report
should include:
·         The detailed audit plan. 
·         A review of the evidence that was collected.
·         A discussion of the conclusions that were drawn. 
·         A list of the nonconformities that were identified.
·         A judgment about how well the quality system
complies with all quality system requirements. 
·         An assessment of the quality system's ability to achieve
quality objectives and apply the quality system policy. 
·      Submit the audit report. The lead auditor should send
the audit report to the client, and the client should
send it to the auditee.
Follow-up
steps 
·      Take remedial actions. The auditee is expected
to take whatever actions are necessary to correct
or prevent 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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