ISO 10011-1 1990 Audit Standard in Plain English

Guidelines for Planning and Performing Quality Audits

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Quality audit
objectives 

• Quality audits are intended to achieve 
  the following kinds of objectives:

  • To determine to what extent your quality system:

    • Achieves its objectives. 

    • Conforms to your requirements. 

    • Complies with regulatory requirements. 

    • Meets customers' contractual requirements. 

    • 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.

NOTE: A " client" is the organization that asked for the audit. The client 
could be an auditee, a customer, a regulatory body, or a registrar.

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:

  • A regulatory agency requires an audit. 

  • A previous audit indicated that
    a follow-up audit was necessary. 

  • 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.

  • 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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