Standard Issues


Open Access

The process approach to QMS in ISO 9001 and ISO 9004.

by Hooper, Jeffrey H.

Revisions make the two standards more straightforward and applicable to all organizations

The process approach is therefore one of the strongest approaches for integrating management system standards because each process must be managed and improved simultaneously for all process performance measures. Once process improvement opportunities are...

Column: Standards Outlook: Corrective and Preventive Action In Medical Device Manufacturing

by Schnoll, Les

ISO 9000 made more rigorous to ensure a robust system

21 CFR (Code of Federal Regulations) 820 was revised in 1995 to more closely resemble ISO 9001:1994, and what had been known as "Good Manufacturing Practices" became a Quality System Regulation...

Column: Standards Outlook: ISO 9000:2000 Product Support Initiative

by Liebesman, Sandford; Mroz, Jim

Effort to provide value to users grows out of standards validation work

When the International Organization for Standardization, known as ISO, Technical Committee (TC) 176 began the process of drafting revised editions of the ISO 9000 series in 1996, a significant goal was to verify and validate the drafts to ensure they...

Column: Standards Outlook: ISO 14000 Revisions Likely To Be Minor

by Block, Marilyn R.

Recommendations make additional documentation, regulatory compliance and external communication unlikely

At the June 2000 annual meeting of ISO Technical Committee (TC) 207, delegates determined ISO 14001, Environmental management systems--Specification with guidance for use, should be revised. Interestingly, no changes have...

Column: Standards Outlook: Caveat emptor

by Gordon, Dale K.

Standards and audits will have value only if organizations being audited--and their customers--demand it

The purpose of an audit is simply to establish the standard is being met and assist the client in identifying weaknesses...

Column: Standards Outlook: Auditing ISO 9001:2000.

by Russell, J. P.

Challenges arise because some of the requirements aren't specific or traceable

Because many of its clauses are nonprescriptive--they don't contain specific or traceable requirements--some quality professionals are expressing concern about the auditability of ISO 9001:2000, the new quality management standard. Without...

Column: Standards Outlook: From Deming to ISO 9000:2000

by Reid, R. Dan

Lip service isn't enough; management must understand and carry out its obligations to achieve sustainability and growth

For quality programs to be successful, management must take an active role in their implementation. Plenty of guidelines are available in the work of quality leaders such as W. Edwards Deming and in more recently developed standards and programs such...

Column: Standards Outlook

by West, John E.

Implementing ISO 9001:2000

ANSI/ISO/ASQ Q9001-2000 has been available for several months. This new edition is based on the eight quality management principles and represents a significant departure from the 1987 and 1994 versions. Early feedback indicates six areas of challenge....

ISO 9001 and Regulatory Compliance In the Medical Device Industry

by Tsiakals, Joe

Lack of attention to quality systems can result in hefty fines, indirect costs

The importance of ISO 9000 The entire scope of ISO 9001:2000 covers the necessity for top management to set up and see that quality management systems are followed to ensure safe product and compliance with requirements and specifications. This committee ...

The challenges of auditing TL 9000 requirements.

by Liebesman, Sandford

New interpretations, lack of objective evidence can cause difficulties

Adding requirements related to metrics, including defining targets, tracking data, reporting data to a central database and using data to foster continual quality improvement. SANDFORD LIEBESMAN is ISO manager for corporate quality and customer satisfacti...

ISO 14001 and regulatory compliance.

by Block, Marilyn R.

Three major requirements must be addressed

Many companies with environmental management systems (EMS) also have registered quality management systems (QMS). Limited or no previous exposure to environmental regulatory requirements leads to questions concerning the role ISO 14001 plays in assuring r...

A case study demonstrates the value of ISO 9000 derivatives.

by Gordon, Dale K.

Case study shows different needs exist when safety is at stake

Consequently, BIG Parts missed all the customer flowdown supplier control issues and production inspection requirements such as sampling plans and gage verifications prior to production. While there were procedures and processes in place to trace critical...

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