STANDARDS CENTRAL

Communicating ISO 9001:2015

Presentation slide decks and other documents to help communicate the message of ISO 9001:2015 are available from the ISO sub-committee responsible for the development of International Standards and documents in the ISO 9000 series. Among the documents you can download from the ISO website are:

For more resources and information, visit the homepage of ISO’s Technical Committee no. 176, Sub-committee no. 2. 

BOOK OF THE WEEK

Mastering and Managing the FDA Maze, Second Edition

by Gordon Harnack

People working at all levels in regulated industries will find in this reference book the compliance insight to help them navigate through the maze of FDA regulations and expectations.  

SIX SIGMA FORUM MAGAZINE

Visual Effects

Rajendra Margabandhu’s article in the August 2014 issue of Six Sigma Forum Magazine discusses applying the visual management lean tool in the software sector.

WEBCAST

Mark Ames

Quality Management Systems:

Background, Evolution, and

Future of ISO 9001 

In a webcast presentation, ISO 9001 expert Mark Ames walks through the evolution of quality management systems, from their beginnings and right into the most utilized standard of all, ISO 9001.

BOOK OF THE WEEK

The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals

This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the quality management system (QMS).

A companion CD contains dozens of FDA guidance documents as well as international harmonization documents (WHO, PIC/S, and ICH). A check list for cGMP audit is also included based on risk management criteria. An exam complements the material included in the CD.

AUDIT DIVISION

"Audit" Is Not a Four-Letter Word

In the latest issue of The Audit Report, a member-benefit publication of the Audit Division, Mary Chris Easterly explains why auditors should be welcomed rather than feared and provides a list of steps auditors can take to improve the perception of an audit.

Also in this issue: 
- The History of Auditing, Part 2
- Updating a Quality Audit Program
- Tips from the Trenches

QUALITY PROGRESS

Clues About Culture

QP’s August 2014 cover story provides a look at new research from ASQ and Forbes Insights that examines the importance of building and sustaining a strong culture of quality.

BOOK OF THE WEEK

Innovation Reboot

by Chris Hakes

This book addresses ways to bridge the gap between rhetoric and reality.

Readers will learn innovation-enabling good practice, how to assess an organization’s (or a team’s) performance against a proven Innovation Capability Framework, and how to create performance improvement plans.

STANDARDS

ISO/DIS 14001:2015(E) Now AvailableCall for Public Comments

The Draft International Standard (DIS) version of ISO 14001, which specifies requirements for environmental management systems, is now available. ASQ is providing ISO/DIS 14001:2015 to stakeholders based in the United States, with the condition to review and provide comments to prepare the U.S. position.

Comments will be accepted until October 19, 2014.

Email standards@asq.org to request a copy for review and submission of comments.

GOVERNMENT DIVISION

Pursuing Excellence in the Province of New Brunswick

In the Summer 2014 Government Division News, a member-benefit publication of the Government Division, Jane Washburn details how New Brunswick’s public service has undertaken a cultural change that has increased efficiency and accountability, improved services to the public, and streamlined administration.

BOOK OF THE WEEK

Mastering Lean Six Sigma

by Salman Taghizadegan

This book develops a dynamic program to meet the requirements of a Master Black Belt (MBB) and covers the necessary skills for leading a company in a quality improvement initiative.

CASE STUDY

10-Year Quality Journey Leads to Baldrige Honor for School District

PSD Case Study 1 BaldrigeSee how the Pewaukee School District in Wisconsin has used the Baldrige framework and examiner feedback as it has embraced a systematic problem solving culture over the past ten years, resulting in innovative solutions for serving students, as well as a 2013 Baldrige Award. 

Read the case study.

JOURNAL FOR QUALITY AND PARTICIPATION

The Influence of Senior Leaders in Successful Change

Rick Maurer’s article in the July 2014 issue of Journal for Quality and Participation discusses the findings of two surveys indicating that the direct presence of senior leaders can influence the effectiveness of change initiatives.

BOOK OF THE WEEK

Simply Managing

by Henry Mintzberg

This book presents key learnings from observation of twenty-nine managers in settings ranging from a refugee camp to a symphony orchestra. It considers the intense dynamics of the job of managing, as well as inescapable conundrums, such as the following:

• How is anyone supposed to think, let alone think ahead, in this frenetic job?

• Are leaders really more important than managers?

• Where has all the judgment gone?

• Is email destroying management practice?

• How can managers connect when their job disconnects them from what they are managing?

CASE STUDY

Mayo Clinic Named No. 1 Hospital in U.S. for 2014-2015

The Mayo Clinic has ranked as the No. 1 hospital in the United States in the U.S. News & World Report’s Best Hospitals 2014-2015.

See the 2014-2015 Honor Roll.

Mayo Fellows

Learn more about the Mayo Clinic in ASQ’s Next Generation Quality Leadership case study, "Journey to Perfect."