Nonconformance Disposition

Question Should the person writing a non-conformance also be the person who dispositions the same non-conformance? Answers From John Surak: This question is interesting.  In addition, there may be a lack of information to properly answer the question.  There is nothing in ISO 9001:2015 that prohibits the person who wrote the non-conformance from ensuring that … Continue reading “Nonconformance Disposition”

ISO 9001: 2015 Clause 8.3.4 and Product Design

Question My company is implementing ISO 9001:2015 and my question is regarding Clause 8.3.4 d. Our company designs product for only 20% of our customer base. We do not have a validation process. We do send a prototype to the customer to test the part for a period of time to approve the design. In … Continue reading “ISO 9001: 2015 Clause 8.3.4 and Product Design”

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 a business owner that not only is that not true, he does not have to … Continue reading “Work Instructions and Audits”

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 start at 0 again or move on to the next number? Answer I would recommend … Continue reading “Transition to ISO 9001: 2015”

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. The material I’m trying to sell him comes from my supplier who is ISO 9001 … Continue reading “ISO Certification and Suppliers”

Food Safety and Sampling

Question I like to know how to sample a finished product or ingredient so that the sample to be tested is representative of the product as a whole so it will increase confidence in subsequent test result. This is needed to verify a particular finished product lot or incoming ingredient lot is allergen free. Response … Continue reading “Food Safety and Sampling”

FDA Regulation for Food and Beverage Labels

Question 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 appropriate for their product? Answer 21CFR211 is the FDA regulation for cGMP for finished pharmaceuticals. … Continue reading “FDA Regulation for Food and Beverage Labels”

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 22000 allows the company to operate with exemption from the Food Act. The exemption from … Continue reading “Integrating ISO 22000, ISO 14001”