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ISO 15189 Requirements for Internal Audits The Audit Process Templates for Meeting Requirements
All elements 15 management and 8 technical of ISO 15189 should be audited during a calendar year. Must have a procedure for planning and implementing internal quality audits so as to verify the elements and systems of the quality management system are implemented and effective.
Audits should be planned and performed by the Quality Manager/ Officer or nominee You cannot audit your own activities The procedure for internal audits should define:- Audit types vertical/ horizontal to be performed - Frequency of these audits (schedule)
The procedure for internal audits should define:- Methodology for performing the audit including reporting and close out processes - Corrective action/ preventative action must be documented and taken within an agreed time frame Results of internal audits form part of the Quality Management System review process
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Vertical Audit - Will review in detail the testing departments in a laboratory. - All testing departments should be audited over the course of 12 months. - A vertical audit is designed to cover activities from procurement of specimen to issue of results. - The audit uses the details of 2 known specimens
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Vertical Audit The auditors must consider:Man (trained, competent, motivated) Materials (traceable, correct type, passed incoming inspection, correctly used, cleaned etc.) Machine (calibrated, validated, maintenance QC) Method (clear, up to date, correct version) Mileau (temperature, particulate count, humidity etc.)
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Identify, obtain and review all relevant documentation prior to the audit relevant to the scope of the audit. - previous audit reports (follow up) - quality manual - procedures Develop audit checklist or have them pre prepared for horizontal or vertical audits. The audit checklist controls the continuity and depth of the audit.
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Entry meeting (2 mins):- Introductions - Confirm purpose/ scope - Timetable including time for exit meeting - Confirm escorts for duration of the audit
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1 hour to 1 day Obtain objective evidence to verify compliance/ non compliance and document same on checklist documentation. Questions should be asked to illicate full response. Following completion of the audit and before the closing meeting the audit team will meet to evaluate the evidence and agree on non conformances found and their classification. A list of non compliances is then made.
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