Author Archives: Ask The Experts

TS16949 Certification Requirements

Question My company is a fabless semiconductor company and we provide ASIC design and custom IP services, and manage our customers’ supply chain from foundry to assembly and test, and drop ship. We are gearing ourselves up to supply IC … Continue reading

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Lead Auditor Qualification

Question My manager and I have a question about internal lead auditor and auditor qualification. As stated in section 8.2.2 of ISO9001:2008, “the organization shall conduct internal audits at planned intervals to determine whether the quality management system…” Our question … Continue reading

Posted in Auditing, ISO 19011 - Auditing, ISO 9001 - Quality Management Systems | 1 Comment

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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Statistical Methods/Control Charts

Question: My question is regarding a threading process.  There is 100% inspection for go/no go check and about 5% rejection/rework.  The batch size is 5,000 nos and is completed in 3 days of production. Two such batches are produced in … Continue reading

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Internal Lead Auditor/Auditor Qualifcations

Question: Dear ASQ Associate, My manager and I have a question about internal lead auditor and auditor qualification. As stated in section 8.2.2 of ISO9001:2008, “the organization shall conduct internal audits at planned intervals to determine whether the quality management … Continue reading

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ISO 9001 Training Requirements

Question: Are there specific training requirements for professionals (i.e. university graduates) in respect to ISO 9001-2008?  Are there any specific records that need to be kept on these individuals? Response: Good Morning, This is an interesting question as it can … Continue reading

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ISO/TS Exclusions

Question: I have a question regarding exclusions from the ISO/TS standards. The majority of our business is the design and manufacture of enclosure hardware.  Recently though, a small portion of our business has become the sole North American Distributor for … Continue reading

Posted in ISO 9001 - Quality Management Systems, Other, TS16949 - Automobiles | Tagged ,

AS9100- Temperature Control

Question: There is a form for recording the temperature etc. of the measuring and calibrating equipment, but should there also be a requirement that the temperature be set at 20 degrees Celsius as that is the temperature in which all … Continue reading

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