Standards and Auditing : Compliance

Standards Outlook: External Demands

by Ramu, Govind

This author explains ISO 9001:2015’s requirements for external providers....

Standards Outlook: Where Is Preventive Action?

by Gaskill, Tyler

Prevention is emphasized through risk-based thinking in ISO 9001:2015. What does this change in emphasis, wording and direction mean? It depends on your QMS’s content and how it was deployed....

Standards Outlook: Small Change, Big Impact

by Palmes, Paul

You might easily overlook a small item in the 2015 revision of ISO 9001. Clause 5.1.1, adds several prescriptive requirements for top management to demonstrate leadership and commitment to the QMS, beginning with accountability for its effectiveness....

Standards Outlook: Regulatory Nightmares

by Schnoll, Les

“Do it right the first time” is a mantra often used by quality professionals. In the associated world of regulatory affairs and compliance, this adage also represents an appropriate mindset....

World of Confusion

by Schnoll, Les

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

by Nanda, Vivek "Vic"

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....

Open Access

One Good Idea: Compliance Requirement Matrix

by Chow, Alan

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....

Open Access

One Good Idea: Compliance Requirement Matrix-Expanded Table

by Chow, Alan

Compliance Requirement Matrix for Medical Device QSR of 21 CFR Part 820 (Abridged)....

Open Access

Achieve Compliance Through CI

by Chow, Alan F.; Bowman, Ronald; Wittenberg, Leonard C.

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

by Bottoroff, Dean L.

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

by Hofmann, Andy

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...

Open Access

Sarbanes-Oxley and ISO 9000

by Stimson, William A.

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

by Grimes, Kevin R.

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

by Landon, Tammy

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

by Kaganov, Mark

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

by Vavra, Terry G.

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

by Liebesman, Sanford; Mroz, James

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)

by Ketola, Jeanne; Roberts, Kathy

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

by Arter, Dennis

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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