Tag Archives: john surak

Work Instructions and Audits

Question Regarding ISO 9001: 2008 (or 2015) auditing, I have always been trained that a work instruction when implemented as supporting the QMS can be audited as it is supporting the effectiveness of the QMS. I was recently told by … Continue reading

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Transition to ISO 9001: 2015

Question We are in the process of reviewing our policies and procedures to be compliant with the ISO 9001: 2015 standard. When converting from ISO 9001: 2008 to ISO 9001: 2015, how should the version control be handled? Should we … Continue reading

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ISO Certification and Suppliers

Question I work for a small family company that purchases items and potentially processes or packages them into heat protection materials. One of my existing customers is asking for ISO certification for some materials that I will sell to them. … Continue reading

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FDA regulation for food and beverage labels

Q: I have been asked to do a quality audit of a label manufacturer whose products are used on beverages and food packaging. They are currently asking to be audited using 21CFR211 (pharmaceuticals). Is there another standard that is more … Continue reading

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Integrating ISO 22000, ISO 14001

Q: In a food manufacturing company, with certifications to ISO 22000:2005 Food safety management systems — Requirements for any organization in the food chain as well as ISO 14001-2004: Environmental management systems – Requirements with guidance for use, the certification to ISO … Continue reading

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