Standard Issues


Revisions improve on the ISO 9001 standard

by Russell, J.P.

Auditors and Auditing

Most auditors who conduct third-party registrar audits are certified by the RAB or IRCA. RAB recently announced a reduction in certain quality management system auditor certification program requirements relating to work experience and witness audits. The...

Quality health care--a path forward.

by Reid, R. Dan

ASQ Division, AIAG and accreditation bodies develop guidance document based on ISO 9004

This document is the result of intensified efforts this year by the ASQ Health Care Division, more than 2,000 health care practitioners and the Automotive Industry Action Group (AIAG), including GM, Ford, DaimlerChrysler and the United Auto Workers, with ...

ISO 9000:2000 Revision Process Reaches Final Draft Stage

by West, John E. "Jack"

Last stage before final approval

The Draft International Standards (DIS) of ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000 were submitted for international ballot from November 1999 to May 2000. * ISO 9000:2000, Quality management systems--Fundamentals and vocabulary is a normative refer...

Will ISO 9001 still apply for the medical device industry?

by Tsiakals, Joe

Concerns are resolved at meeting in Kyoto

During more than a week of intense sessions, ISO/TC 176 addressed more than 4,000 comments on the draft international standards (DIS) of ISO/DIS 9000:2000, ISO/DIS 9001:2000 and ISO/DIS 9004:2000. Instead of referencing the complete requirement clauses of...

TL 9000--An Update on the Metrics Process.

by Liebesman, Sandford

Validation of training, registration and metrics completed

3. Software only: four metrics including quality of emergency fixes between software releases (corrective patches), quality of emergency feature improvements (feature patches), quality of software updates and failures of scheduled new software releases (a...

Leveraging a quality system to establish an EMS.

by Block, Marilyn R.

Similarities are many; differences are few

Despite overwhelming similarities between ISO 14001, Environmental Management Systems--Specification With Guidance for Use and ISO 9001 based quality systems, the vast majority of quality assurance managers are as unfamiliar with ISO 14001 today as when i...

The past, present and future direction of aerospace quality standards.

by Gordon, Dale K.

Designed to solve problem of duplication and contradiction

Original equipment manufacturers (OEMs) and suppliers in the aerospace community are very concerned about the proliferation of standards used to define quality system requirements. These requirements were translated into company specific documents and sen...

ISO 9000:2000 will create challenges, require new competencies

by Russell, J.P.

All About Auditing

Third-party environmental and quality system auditors will be interested in the new (still in development) system audit standard. Since the new ISO 9001 standard contains many of these not-so-easy-to-audit requirements, an agreement was reached that requi...

Why QS-9000 was developed and what's in its future.

by Reid, Dan R.

Auto suppliers were troubled by multiple specifications and standards

Chrysler, Ford and GM elected to use the ISO 9001 standard as the base requirements for the automotive sector document called QS-9000. Suppliers with numerous automotive customers requiring third-party certification to their own requirements document can ...

Quality Management Principles and the ISO 9000:2000 Revisions

by West, Jack; Cianfrani, Charles A.; Tsiakals, Joseph J.

* With the development of a basic quality management system, the organization moves to integrate the processes for creating the product or service with those processes that verify that the product or service meets customer needs. * With the development of...

Quality Management Principles: Foundation of ISO 9000:2000 Family

by West, Jack; Cianfrani, Charles A.; Tsiakals, Joseph J.

Practical application came first

This article describes the relationship of the first four quality management principles to the requirements document (ISO 9001:2000) and to the guidelines of ISO 9004:2000. Organizations depend on their customers and therefore should understand current an...

A context for ISO 9001 and ISO 9004.

by Tsiakals, Joseph J.; Cianfrani, Charles A.; West, Jack;

The Big Picture

* ISO 9001 quality management systems (including ISO 9002 and ISO 9003), which focus on process management. ISO 9000 in the listing of criticisms refers collectively to the requirement standards ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994. ISO 9001 thr...

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