Monthly Archives: November 2012

Terminology for Inspected Material (GMP, ISO 13485)

Q: There is often confusion with the labeling of purchased materials  after they have been “inspected, tested and/or verified” according to good manufacturing practice (GMP) requirements.  Once out of quarantine, are purchased materials labeled as accepted, approved or released?  I’ve … Continue reading

Posted in ISO 13485 - Medical Devices | Tagged , , , , , , | 1 Comment

ISO 9001 electronic records

Q: I have a few questions about employee training records.  My company is certified to ISO 9001:2008 Quality management systems–Requirements, and we are considering transitioning to electronic records. However, we don’t know what the requirements are from an ISO perspective. Specifically, we want to know: … Continue reading

Posted in ISO 9001 - Quality Management Systems | Tagged , , , ,

Control Chart to Analyze Customer Satisfaction Data

Q: Let’s assume we have a process that is under control and we want to monitor a number of key quality characteristics expressed through small subjective scales, such as: excellent, very good, good, acceptable, poor and awful. This kind of data is … Continue reading

Posted in Statistics | Tagged , , , , , , ,

ISO 9001 Certification to Meet Customer Requirements

Q: My company is a small manufacturer that makes one product that I designed and engineered. We have a contract to produce the part for a much larger company. The larger company wants us to become certified to ISO 9001:2008 … Continue reading

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Sampling in a Call Center

Q: I work as a quality assessor (QA) and I am assisting with a number of analyses in a call center. I need a little help with sampling. My questions are as follows: 1. How do I sample calls taken by … Continue reading

Posted in Z1.4 & Z1.9 - Sampling | Tagged , , , , , ,

Establishing and Maintaining a CAPA System

Q: We have a Corrective Action and Preventative Action (CAPA) system, and we find that CAPAs are almost always completed late — even though we do have an extension request form for CAPAs, and the system sends automated reminders to  employees in … Continue reading

Posted in ISO 13485 - Medical Devices, ISO 9001 - Quality Management Systems | Tagged , , , , , , , | 1 Comment