Standards and Auditing : ISO 9000

Standard Issues: Fundamental to Success

by Cressionnie, L.L. “Buddy”

ISO 9001:2000 was transformational with its introduction of the process approach. Now, almost 20 years later, some organizations still have not embraced the process approach, and some auditors aren’t auditing according to the process approach....

Bridging the Gap

by Ogvozdin; Vitaly

Since 1986, the International Organization for Standardization (ISO) has developed the ISO 9000 family of quality management systems (QMS) standards, and many organizations have used them to create their own quality systems....

Expert Answers: December 2019

by Cressionnie, L.L. “Buddy”

Subject matter experts take on your quality-related queries....

Open Access

My Quality Story: Keep the Spirit Alive

by García-Díaz, Pedro Rafael

People often think: “A new version, a new ISO 9001.” But is it, really?...

Expert Answers: December 2018

by Picciano, Larry; Ramu, Govind

Subject matter experts take on your quality-related queries....

Standard Issues: A Standard's Evolution

by Sheps, Isaac; L’Espérance, Pierre

Organizations must move beyond product quality to the next level of organizational quality by implementing an effective and efficient management system. It must be focused on the organization’s ability to meet the needs and expectations of its customers....

Expert Answers: July 2018

by Ramu, Govind

We have identified several changes to make to our processes, tools and training, but must do more to manage the risk of a major nonconformance. I would appreciate your help defining “deep enough.”...

Standard Issues: Sustaining Success

by Palmes, Paul

The latest revision to ISO 9001, which incorporates Annex SL’s high-level structure and ushers in new clauses and terminology, dominates conversations because of its new approach and emphasis on context, interested parties and risk-based thinking....

Open Access

Volviendo a los Fundamentos: Subir de Nivel

by Harkins, Ray

Además de cumplir con los requisitos de estándares de calidad específicos las métricas del sistema de calidad correctamente diseñadas también pueden servir como indicadores importantes sobre las fortalezas y debilidades de los diversos procesos....

Open Access

Back to Basics: Level Up

by Harkins, Ray

Developing and using metrics such as OEE that highlight an organization’s best opportunities for improvement have the potential to unlock the next level of profitability....

Open Access

Ready or Not_Infographic

by QP Staff

ISO 9001 resources These webpages gather different resources related to the revision, and present specific links to books, articles, case studies, videos, webcasts and training opportunities. collect many resources to strengthen your fundamental underst...

Open Access

Ready or Not

by Ramu, Govind

ISO 9001, the most widely used international standard, was revised in September 2015. Organizations were given three years to transition to the new standard, and the transition period is about to expire. Organizations have until September to transition....

Open Access

Standard Issues: Making the Most of Management Reviews

by Ramu, Govind

ISO 9001:2015 requires top management review of an organization’s quality management system. This provides an opportunity for a quality manager to present to upper management a State of the Union-style report on the organization’s quality health....

Open Access

In Focus

by Breneman, Jim; Burrows, Dan; Durivage, Mark

Probably the most significant change to ISO 9001:2015—Quality management systems—requirements concerns integrating risk-based thinking as part of the quality management system (QMS) and decision-making processes....

Expert Answers: July 2017

by Devos, Denis J.

ISO 9001:2015 clause 6 indicates it is necessary to consider issues identified under clauses 4.1 and 4.2 when determining risks and opportunities. What is the best method of incorporating risks and opportunities in the ISO 9001 quality management system?...

Open Access

Standard Issues: Can, or Must?

by Freeman, Robert; Drown, Jennifer; Black, Byron

The latest set of revisions to standards, including ISO 9001:2015, ISO 14001:2015 and AS9100D, address changes to organizations’ management systems....

Expert Answers: December 2016

by Aston, Bill

Implementation of subclause 6.1 in ISO 9001:2015—actions to address risks and opportunities ......

Standards Outlook: Leaders of Change

by Aston, Bill

A case for risk-based thinking and organizational transformation....

Open Access

Standards Outlook: Putting Things In Context

by Reid, R. Dan

ISO 9001:2015 enhances the role quality management systems play in the success of an organization and its business processes. Evidence of this is in a new requirement in subclause 4.1: “Understanding the organization and its context.”...

Expert Answers: November 2015

by Cogan, Ken; Laman, Scott A.

ISO 9001 .. Adhering to and cross-referencing multiple standards...

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