ISO 10011-1 1990 Audit Standard in Plain English

Guidelines for Planning and Performing Quality Audits

Also see our Plain English Audit Tools and Programs

This web page is based on the ISO 10011-1:1990 Quality Standard 
published by the International Organization for Standardization
It presents a comprehensive interpretation of this standard 
using language that is clear and easy to understand.

>>>  ISO 10011-1 1990 is now OBSOLETE <<<

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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First published on June 6, 1997. Updated on December 10, 2011.

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