Standards and Auditing : Compliance
World of Confusion
U.S. manufacturers of medical devices must comply with U.S. Food and Drug Administration (FDA) labeling requirements and also face the challenge of labeling in multiple languages if they want to sell their products in the global marketplace....
Two Are Better Than One
Management need and my personal curiosity recently led me to take a closer look at the Sarbanes-Oxley Act (SOX). My work pointed out similarities and differences between SOX and ISO 9001....
One Good Idea: Compliance Requirement Matrix
One of the best pre-audit tools is the compliance requirement matrix (CRM), which can be used to verify compliance requirements for any regulation. The CRM is useful at any stage of the quality system....
One Good Idea: Compliance Requirement Matrix-Expanded Table
Compliance Requirement Matrix for Medical Device QSR of 21 CFR Part 820 (Abridged)....
Achieve Compliance Through CI
Using Six Sigma tools for continuous improvement (CI) is a proven method for meeting or exceeding FDA requirements for medical devices. Optical Integrity Inc., a manufacturer of medical devices, used the Six Sigma define, measure, analyze, improve...
Advancing From Compliance To Performance
Poor ethics has recently been recognized as a controllable factor that can either make or break and organization. If organizations would practice ethics as a logic-based discipline and quality problem, they would reach higher levels of performance that...
Two Controls, One Result
In the three years since the enactment of the Sarbanes-Oxley Act (SOX), implementing organizations have begun to realize that operating with separate SOX controls is expensive, and they are now looking for a way to integrate SOX controls into their...
Sarbanes-Oxley and ISO 9000
Critics say ISO 9000 doesn't measure up to robust quality programs such as Baldrige Award criteria, lean and Six Sigma, and they complain about the law's excessive documentation requirements. Yet by providing records and internal controls, the...
Basic Requirements of a Quality Manual
If your company is implementing a quality management system based on ISO 9000:2000 standards, the content of the quality manual should reflect ISO 9001 requirements, but it need not match the format. Basically, ISO 9001 asks that you document actions...
13 Steps to Certification in Less Than a Year
Ultratech Stepper (UTS), a manufacturer of photolithography equipment, became both ISO 9001:2000 and ISO 14000 certified in less than a year at a cost under $200,000, using only two employees to manage the effort part-time. UTS's quality steering...
A Quality Manual For the Transition and Beyond
Companies may wonder whether quality manuals structured around the new ISO 9001:2000 format would be acceptable while the firm is still registered to the old ISO 9001:1994 standard. Consensus warrants that if the manual meets all the requirements of the...
ISO 9001:2000 and Customer Satisfaction
One of the most important changes in ISO 9001:2000 is the inclusion of customer satisfaction data as an indicator of the value of processes adopted by an organization. Three of the most significant improvements are provisions that: Require registrants...
ISO 9000:2000 Experiences: First Results Are In
Results from a product support initiative (PSI) measuring the experiences of organizations using the ISO 9001:2000 quality management system standard will enable the International Organization for Standardization's Technical Committee 176 to determine...
Demystifying ISO 9001:2000 (Part 2)
Three sections of the new ISO 9001:2000 standard, not examined in Part I of this article, are reviewed. Section 6.1 covers provision of resources, section 6.3, infrastructure, and section 6.4, work environment. Section 6.1 requires an organization to...
Beyond Compliance
Most quality auditors perform compliance audits to verify the implementation of written procedures. Compliance audits can be second party audits used to review the activities of suppliers, or they can be third party audits performed by independent...
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