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.