ISO 10011-1 1990 Audit Standard in Plain English

Guidelines for Planning and Performing Quality Audits

The ISO 10011-1 standard is now obsolete. It has been
replaced by the new ISO 19011 2011 auditing standard.

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 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. 

    • Prepare forms. 

  • 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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Updated on July 19, 2012. First published on June 6, 1997.

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