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Abstract: . . . Certification does not certify the product It merely states that the company has a quality system that meets the scope of the stated standard. Write down what you do, do what you say you do, , document what you have done, and audit to conform compliances 84 Similarities Fundamental to a process Focus on preventing rather than detecting or correcting problems Their main objective is to prevent problems rather than discover them during final inspection Are complimentary to each other Require commitment by the company . 85 In summary GMP/GHP is a prerequisite of an effective HACCP system HACCP is a precursor to an effective quality system The quality system is a precursor to TQM. Management commitment is essential to their successes 86 Thank You 87 ISO 88 . . . . . . carried out in a manner that is consistent with the monitoring and measurement requirements. 66 ISO 9001 :2000, CLAUSE 7, PRODUCT REALIZATION Where necessary to ensure valid results, measuring equipment shall: Be calibrated or verified at specified intervals, or prior to use, against measurement standards traceability to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded; Be adjusted or re-adjusted as necessary; Be identified to enable the calibration status to be determined; Be safeguarded from adjustments that would invalidate the measurement results; Be protected from damage and deterioration during handling, maintenance and storage. 67 ISO 9001 :2000 Requirements ISO 9001 , CLAUSE 8, MEASUREMENT, ANALYSIS AND IMPROVEMENT General (8.1) Monitoring and measurement (8.2) Control of nonconforming product (8.3) Analysis of data (8.4) Improvement (8.5) 68 ISO 9001 , CLAUSE 8, MEASUREMENT, ANALYSIS AND IMPROVEMENT General (8.1) The organisation shall plan and implement the monitoring, measurement, analysis and improvement processes needed: a) To demonstrate conformity of the product, b) To ensure conformity of the quality management system, and To continually improve the effectiveness of the quality management system. This shall include determination of applicable methods, including statistical techniques, and the extent of their use. 69 ISO 9001 , CLAUSE 8, MEASUREMENT, ANALYSIS AND IMPROVEMENT . . . --3000,2,750,2417,31977
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