Monthly Archives: June 2013

Method Validation of Analytical Procedures

Question: I would like to ask if there is a specific acceptance criteria for an Accuracy Test, in method validation of Assay procedure of a general pharmaceutical finished product, which has been agreed by ISO, ICH and USP? Based on … Continue reading

Posted in Analytical Method Validation | Tagged , ,

ISO 9001 Implementation

Question: As Quality Manager I have been assigned the task of getting the company ISO Certified. Certification was granted in 2000, but their old system is in bad condition. The structure is incomplete, the organization and wording were created by … Continue reading

Posted in ISO 9001 - Quality Management Systems | Tagged

Best Practices for Non-Compliance Reporting in ISO 9001

Question: I have just assumed the role of Quality Assurance Manager for a worldwide manufacturer and installer of transportation systems.  As part of learning my new responsibilities and getting familiar the existing Quality Management System (we are currently ISO 9001:2008 … Continue reading

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

Method of Using Gauge Pins

Question: We recently received a complaint from a customer who claims a diameter hole is oversize. The method of gauging the diameter is with minus gauge pins.  The part is a plastic molded part (the material used is PBT). The … Continue reading

Posted in Measuring, Other | Tagged | 1 Comment

ISO 9001- Cost of Implementation

Question: What are the estimated costs of implementing ISO 9001? We are a company of five divisions, Contract Manufacturing, Structural Fabrication (AISC & ASME cert), Steel Service Ctr, Rebar (CRSI vert) & Metal Castings. We employ approximately 200 people and … Continue reading

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

ISO 9001 Management Checklist

Question: Is there a list of duties for implementing ISO 9001:2008 for the management representative? I am interested in a checklist of responsibilities for that individual to use as a guide to help a company prepare for an ISO 9001:08 … Continue reading

Posted in ISO 9001 - Quality Management Systems | Tagged ,