ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488. Though based on ISO 9001, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes.

Tech Showcase: X-Ray Inspection Today

October 3, 2007

By Steve Wichelecki

No Comments

The use of X-ray-based nondestructive test methods dates back more than a hundred years, with the advent of film-based radiography. This article describes a number of X-ray-based offerings for today’s nondestructive testing applications.

Updating ISO/IEC 17025

September 28, 2007

By Steve Wichelecki

No Comments

This summer marked the deadline for implementation of ISO/IEC 17025: 2005 General Requirements for the Competence of Calibration and Testing Laboratories. This came after a two-year transitional period in which accreditation bodies recognized by the International Laboratory Accreditation Cooperation (ILAC) had been assessing laboratories to the requirements of the superseding standard, which replaces ISO 17025: 1999.

Tech Showcase: Which Hardness Test Works?

July 31, 2007

By Steve Wichelecki

No Comments

Used to check material uniformity or processing treatment, most hardness tests employed in quality control applications yield numerical values based on a material’s resistance to indentation under the conditions imposed by the particular test. Resistance to scratching and the measurement of the amount of energy absorbed by a material when struck by a falling object also are measures of hardness.

Tech Showcase: The Right Borescope

June 1, 2007

By Steve Wichelecki

No Comments

Industrial borescopes generally fall into two categories: rigid borescopes and flexibleborescopes, also known as fiberscopes. The type of borescope employed is contingenton the application. These devices are used in a number of industries to attainquality assurance, enabling inspection for manufacturing defects withoutnecessitating part destruction. They also are used in equipment maintenance programs,eliminating the need for teardowns when checking for defects.

Videos

Image Galleries

ASQ 2013 World Conference

Podcasts

Bill Arbogast explains his perspective on quality, ISO 9001, and how to manage inevitable business changes.

Read: The 2013 Quality Professional of the Year

Listen

More Podcasts

THE MAGAZINE

Quality Magazine

2013 May

Check out the May 2013 edition of Quality Magazine for features about Measurement, Software and Test & Inspection.

Table Of Contents Subscribe

Plant of the Year

View Results Poll Archive

THE QUALITY MAGAZINE STORE

$M:\General Shared\__AEC Store Katie Z\AEC Store\Images\Quality\prac-field-guide-for-iso.gif$

A Practical Field Guide for ISO 9001:2008

The purpose of this field guide is to assist organizations, step by step, in implementing a quality management system (QMS) in conformance with ISO 9001:2008, whether from scratch or by transitioning from ISO 9001:2000. It examines each sub-clause of Sections 4–8 of ISO 9001:2008, which contain the requirements, and gives a list of the documentation/documents required, internal audit questions, a summary of management’s responsibilities, and a flowchart of the steps that need to be undertaken to satisfy the requirements.

More Products

Clear Seas Research

With access to over one million professionals and more than 60 industry-specific publications,Clear Seas Research offers relevant insights from those who know your industry best. Let us customize a market research solution that exceeds your marketing goals.