Monthly Archives: January 2014

ISO 9001:2008 Quality Manager Titles

Question: Is it a requirement that a person in an ISO 9001 registered organization who is responsible for fulfilling the duties and requirements of the management representative hold the title of Management Representative, i.e., is it a noncompliance that such … Continue reading

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Recommended AQLs for Packaging Material in the Pharmaceutical Industry

Question: Are there recommended AQLs (critical, major and minor defects) for packaging material (primary and secondary) for the Pharmaceutical Industry? Thank you Response: Though there are no recommended AQLs (or LTPD) for packaging materials, some industry standards have begun to … Continue reading

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ISO 9001:2008

QUESTION ISO 9001:2008 states in 8.2.4 Monitoring and measurement of product:  “Evidence of conformity with the acceptance criteria shall be maintained.” When our plan identifies periodic inspections, variable or attribute, are performed, how can we show evidence without recording the … Continue reading

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