Photocopies.pptVIP

NRL Seminar on ISO Guide 25 and Related Issues Photocopies Occasionally need uncontrolled copies induction? information for client? Mark copy as uncontrolled Explain how in documentation Handwritten Amendments May be permitted Explain how in documentation Must be authorised All copies must be amended Minimise Control of Records Documented procedures, records of: testing equipment calibration internal audits management review corrective, preventive actions Control of Records What was done Who did it Immediate recording Preservation Alterations - no erasure Outline What is an internal audit ? Types of Audits How to meet standard requirements Effective auditing Preparing for an audit Conducting an audit Internal Audits Required: By ISO 9000 clause 4.17 By ISO/IEC 17025 clause 4.13 (management requirements) What is an Internal Audit ? Systematic and independent examination of the quality management system (QMS) By someone within the organisation In addition to external audits The Internal Audit Process Scheduled Audits programme managed by Quality Manager examine documents, results, processes identify problems improve Unscheduled Audits investigate problem improve Why Internal Auditing ? Is QMS implemented exactly as intended ? To investigate a problem why did it occur ? how can it be resolved ? how can it be prevented in future ? Identify opportunities to improve Does the QMS meet requirements of standards ? Types of Internal Audits Horizontal all departments audited against one element of standard or procedure Vertical one department audited against all element of standard or procedure Standard Requirements:ISO 9001 and 17025 Audit program Documented procedures Auditors independent of activity Audit results documented and reported to management Prompt action after problems identified Follow up activities Management’s Responsibility Define internal auditing policy Assign responsibility of internal audit program Quality Manager Must be advised of