- Auditing
- Cost of Quality
- Customer Satisfaction and Value
- Engineering
- Environmental Manag. and Sustainability
- Inspection
- ISO 14000
- ISO 9000
- Metrics
- Problem Solving
- Process Management
- Project Management
- Quality Assurance
- Quality Management
- Quality Tools
- Safety
- Six Sigma
- Small Business
- Software Quality
- Standards
- Statistical Process Control (SPC)
- Supplier Quality
- Teams
- Total Quality Management
- AS9000
- TL 9000
- Compliance
- Certification/Registration (management system Standards)
- Information Management
- Customer Requirements
- Food Safety
- Economic Case for Quality
Standards Outlook: Trust, but Verify
Grouping product, service and process audits together is somewhat natural, because a process audit may include a product or service audit. I’ve dubbed the combination a verification audit....
Expert Answers: August 2009
Deciding on a survey strategy ... Gauging the maturity of your quality management system....
Standards Outlook: Effective Audit Programs
Today's organizations need to be agile and responsive to the changing requirements in private and public business sectors. Properly directed, internal audit program resources can help an organization stay focused and uncover improvement opportunities....
Small Change, Big Impact
Little has changed in the fourth edition of ISO 9001, which was issued late last year by the International Organization for Standardization. ISO 9001:2008 contains no new requirements, so the transition should be painless for most organizations....
ISO-lating the Problem
When two healthcare organizations were searching for a way to better manage their activities, both turned to ISO 9001:2000 in the hope that the standard could organize their practices and help them improve service to patients....
Standards Outlook: Conducting a Document Review
Some industry sectors require documentation that has word-for-word traceability between the MS documentation and audit criteria. For internal audits, document reviews can be part of a routine audit of an area, rather than a separate document review. Docum...
Energize Your QMS
Changes to the ISO 9001:2008 amendment are high benefit and low impact. This position stated the following: "ISO 9001:2008 has been developed to introduce clarifications to the existing requirements of ISO 9001:2000 and changes that are intended to improv...
Smooth Approach
Traditional internal audits fulfill a need for companies with fresh ISO 9001 implementations. But for organizations with mature systems, an innovative approach called an appreciative internal quality audit can take them beyond compliance to excellence....
Drill Deep for Strategic Alignment
Internal auditors must understand an organization’s strategy and how each process fits into that strategy. Internal auditing for strategic alignment and execution requires that the auditor understand the organization’s desired strategy and how each proces...
Standards Outlook: Down With Silos
Businesses today have multiple management systems, including financial, quality and environmental. Unfortunately, these management systems usually do not talk to one another....
The Road to Improvement
Registration of public organizations to the ISO 9001 quality management standard can be difficult because of their complex operations and extensive documentation....
Online Baranzelli sidebars
IDOT developed an internal quality system audit team to determine whether the new QMS conforms to planned arrangements, to the requirements of the ISO 9001 and to the QMS requirements established by the Illinois Department of Transportation (IDOT), and is...
Two Are Better Than One
Management need and my personal curiosity recently led me to take a closer look at the Sarbanes-Oxley Act (SOX). My work pointed out similarities and differences between SOX and ISO 9001....
Who's Keeping Score?
There’s one tool you won’t find for sale at Sears. One of the retail giant’s divisions has started using a quality management tool extensively to maintain and improve its own quality management system....
Who's Keeping Score? Scorecard Example
Period: 1st Quarter 2008 Sears Home Services QMS Compliance Status for Region XXX ( r0) 48406- HOF, rev 2 Effective QMS Indicators Graded Categories Last Third Party Audit Mgmt Review C/ PARs CIP Internal Audit Equipment CFC License Complete MRMs MRM Con...
QMS Certification: Down With Disillusionment
Conformity assessment and international standards that cover products and quality and environmental management systems provide mechanisms to ensure the quality of goods and services, but a recent survey reveals that the various certification bodies...
Improving the Internal Audit Experience
Employees don’t always understand how audits relate to ensuring the use of good business processes. Many don’t realize the significant process improvement benefits that can be achieved from an internal audit experience. Cerner Corp. developed...
ASQ Team Says QMS and EMS Standards Support SOX
The intent of the Sarbanes-Oxley Act (SOX) was to make the financial system of control more transparent and to reduce the incidence of corporate fraud. It soon became evident, however, that compliance with the law’s auditing requirements would be...
Standards Outlook: Preparing and Structuring an Audit Report
Preparing a quality management system (QMS) or environmental management system (EMS) audit report can be a hurried, punch list--a list of minor things to be completed at the end of a project....
Standards Outlook: New Version of TL 9000 Released
The global telecommunications industry, an important part of the global economy, will reach $1.3 trillion in revenues by the close of 2007....
Standards Outlook: Generating Audit Findings and Conclusions
The ability to identify audit findings, communicate them and determine the audit conclusions is one of the skills that adds the most value to a management system audit....
Standards Outlook: Developing the Voluntary Healthcare Standard
The new Automotive Industry Action Group (AIAG) voluntary standard for healthcare delivery is in its second review, with an anticipated launch no later than early 2008. AIAG also is pursuing partners for the publication from the healthcare sector....
Back to Basics: Best Practices in Auditing
Organizations conduct audits to examine a business process and evaluate the process’s compliance with internal and external requirements. They also use audits to implement continuous improvements. Internal and supplier audits allow management to:...
New Standard Guides Internal and Supplier Audits
A supplement to enhance ISO 19011:2002, Guidelines on Quality and/or Environmental Management Systems Auditing, has been developed by U.S. experts. The supplement provides guidance for internal and supplier programs and the use of the standard by small...
State Program Offers Hand To Small Business
In the years since ISO 9000 became the international standard for quality management, small businesses have struggled to keep up with the competition, despite limited resources. In 1999, the New Mexico Economic Development Department created New Mexico...
Reflections on the Future of Quality
Over the years, the intent of quality systems has evolved from enhancing customer satisfaction by meeting their needs to improving overall organizational performance and capabilities. But quality management systems have always lagged behind evolving...
How Do You Begin?
So, how did I begin in quality? I began knowing basically nothing about it and evolved my knowledge over 13 years....
ISO 9000 In Service: The Good, the Bad, and the Ugly
When the Centers for Medicare and Medicaid Services began requiring ISO 9001 certification for its new business contracts, claims processing contractor Palmetto GBA decided to pursue certification for its existing contracts as well. Getting a...
Unintended Consequences
The process approach embodied in ISO 9001 emphasizes the actual activities of an organization that would result in providing a product or service that continuously meets the customer's needs....
Sarbanes-Oxley and ISO 9000
Critics say ISO 9000 doesn't measure up to robust quality programs such as Baldrige Award criteria, lean and Six Sigma, and they complain about the law's excessive documentation requirements. Yet by providing records and internal controls, the...
Develop a Process Based Management System
An ISO 9001 team charged with developing a process based quality management system needs a thorough understanding of the company's current business management system in order to avoid conflict and unnecessary paperwork. While the QMS development team...
Healthcare Agreement Revision Nears Release
The first revision of the International Organization for Standardization (ISO) International Workshop Agreement (IWA 1) should be released this month if all goes according to plan....
Sarbanes-Oxley: Pain or Gain?
The Sarbanes-Oxley (SOX) regulatory requirements passed by Congress in 2002 ensures investors are provided with accurate and reliable financial data on all publicly traded companies. Implementation of these requirements can be expensive and difficult....
A Process Interaction Matrix
One of the requirements of ISO 9001 and ISO 13485, specified in paragraph 4.2.2c, requires a company to develop a quality manual that contains “a description of the interaction between the processes of the quality management system.”...
Next generation ISO 14001.
ISO 14001, the international standard on environmental management system (EMS) requirements, has been undergoing review and revision for five years....
Next Generation ISO 14001
ISO 14001, the international standard on environmental management system (EMS) requirements, has been undergoing review and revision for five years....
Who Attends ASQ Section Meetings and Events?
When the Jacksonville, Florida ASQ section was threatened with deactivation due to inactivity, dedicated volunteers used telephone surveys to determine what members wanted. Survey results made clear the necessity to set strategic objectives for planning...
Can TL 9000 Contribute to Telecom's Turnaround?
Since TL 9000’s inception near the end of the 20th century, managers and executives have harbored significant skepticism toward the quality management standard for the telecommunications industry....
Column: Emerging Sectors: All Aboard the ISO 9000 Express
The Chicago Transit System, serving approximately 1.5 million riders every day in Chicago and 38 neighboring suburbs, is a vital component of Northeastern Illinois' economy. Operated by the Chicago Transit Authority (CTA) and including buses, trains and...
Ethics, Auditing and Enron
Were quality auditors to blame for the Enron scandal? No. Do quality auditors face ethical dilemmas such as those faced by the Enron and Arthur Andersen employees? must decide whether or not to...
Column: One Good Idea: Keep Your QMS Implementation on Schedule
Consider this common scenario: An organization wants to implement a quality management system by a particular date. In this situation, the prerequisite is in place-management is committed to the company's goal and has provided the necessary resources....
Management System Integration: Can It Be Done?
In October 1996, the International Organization for Standardization, known as ISO, issued the final version of ISO 14001, an international standard for environmental management systems (EMS)....
Column: Measure for Measure: Getting to the Root of It All
Quality systems the world over, including laboratory quality systems, share several important characteristics. One of the most important is the corrective action system. When a nonconformance is discovered, either by an internal audit, a customer...
Column: Standards Outlook: Auditing a Process Based System
Since the clause-by-clause approach to auditing for ISO 9000 no longer works, auditors will need to understand subjective and objective issues, and to determine whether the processes of the Quality Management System are...
13 Steps to Certification in Less Than a Year
Ultratech Stepper (UTS), a manufacturer of photolithography equipment, became both ISO 9001:2000 and ISO 14000 certified in less than a year at a cost under $200,000, using only two employees to manage the effort part-time. UTS's quality steering...
Toe the Line: No More WorldComs
Revelation of mismanagement at WorldCom, Enron, Adelphia and other companies have led to an unprecedented erosion of confidence in corporate America....
A Global Approach to ISO 9000
The implementation of quality management standards across multiple sites within an organization presents unique challenges. Johnson Controls' Government Systems and Services (GSS) changed its ISO 9000 approach and turned it into a model system for its...
How to Achieve Operational Excellence
Quality improvement systems can contribute to operational improvements, but they cannot eliminate operational costs arising from deviations and nonconformances caused by human error. In order to grow in today's competitive business environment,...
Industry Education Council Gets ISO 9001 Certificate
Result is a stronger, more efficient customer focused organization
As an umbrella organization funded by multiple sources and responsible for facilitating and delivering a wide variety of programs, the Business Education Council (BEC) of Niagara faces complex obligations in terms of management, measurement of goals and a...
Column: Emerging Sectors: Industry Education Council gets ISO 9001 certificate
Result is a stronger, more efficient customer focused organization
As an umbrella organization funded by multiple sources and responsible for facilitating and delivering a wide variety of programs, the Business Education Council (BEC) of Niagara faces complex obligations in terms of...
Column: Career Corner: Add Value To Quality Audits
[Abstract from article]
Quality auditors should understand and align their reports with internal audit reports. Why? Our quality and ISO 9000 audits usually go no higher than a second level manager. Pre-Enron, 24% of internal audits went directly to...
Column: Standards Outlook: Purchaser and Supplier Quality
Going beyond ISO 9001, QS-9000 and TS 16949
For quality to happen, quality control from the supplier's perspective is necessary. But evidence indicates suppliers do not always pursue the actions needed for quality improvement. Quality practitioners...
Column: Standards Outlook: ISO 9001:2000's Process Approach
A new concept or the same old stuff?
Questions and answers on the process approach of ISO...
Column: Standards Outlook: Add Value to ISO 9001:2000 Audits
The standard's revision provides the opportunity to help organizations improve the way they do business
Quality auditors have been criticized for not adding value to what they do for clients. The ISO 9001:2000 revision provides an opportunity to change...
Destination: ISO 9001
When in 1999 Nebraska manufacturer Nucor Corporation announced that it would require each of its Vulcraft divisions to achieve ISO 9001 certification, the Norfolk Division had two paths from which to choose. They decided that rather than wait until the...
Johnson Space Center Reaches for the Stars
ISO 9001 certification leads shift from problem correction to prevention and information sharing
In the late 1990s, the Johnson Space Center (JSC) and NASA's other centers began experiencing flattened and decreasing funding from Congress without an equivalent decline in workload. To ensure JSC's QMS had been thoroughly tested, the center initiated a ...
Column: Emerging Sectors: Johnson Space Center Reaches for the Stars
.]In the late 1990s, the Johnson Space Center (JSC) and NASA's other centers began experiencing flattened and decreasing funding from Congress without an equivalent decline in workload. Management recognized a shift in emphasis from correction to...
Widgetcraft for One Small Paint Company
One tool we found useful during these meetings was an accountability sheet, where we kept track of our progress in relationship to our Q U A L I T Y P R O G R E S S I S E P T E M B E R 2 0 0 1 I 73 Marcus Paint Co. Quality Policy Marcus Paint Co. is comm...
Column: Standards Outlook: Caveat emptor
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.
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...
ISO 9002 Works In an Unusual Setting
Q U A L I T Y P R O G R E S S I J U L Y 2 0 0 1 I 39 ISO 9002 Works In an Unusual Setting Persian Gulf airport registration overcomes multicultural challenges by Lee C. Bravener Y RECENT SUPERVISION OF AN ISO 9002: 1994 registration audit of the Bahrain ...
The Tip of the Iceberg
I have seen too many organizations reduce costs by eliminating essential product or service fea- 30 I Q U A L I T Y P R O G R E S S I M A Y 2 0 0 1 T H E T I P O F T H E I C E B E R G Six Sigma and the Bottom Line FIGURE 1 Good price Market share Fast cy...
The State of Quality Auditing
Internal, quality, operational, safety, environmental, compliance, and customer-supplier audits will converge in the near future. In particular, the model is likely to be adopted by publicly held organizations. Because many concepts of internal control...
A case study demonstrates the value of ISO 9000 derivatives.
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...
Industrywide Shakeout
Q U A L I T Y P R O G R E S S I J A N U A R Y 2 0 0 1 I 61 Industrywide Shakeout Big Three automakers tighten demands on suppliers, auditors and registrars by Bradley A. Pritts Jr. Suppliers with excellent performance histories have even found themselve...
Revisions improve on the ISO 9001 standard
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...
ISO 9000:2000 Revision Process Reaches Final Draft Stage
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...
Semiconductor Assembly Council Promotes Use of Quality Tools
The member companies of the Semiconductor Assembly Council represent manufacturers, assembly and test subcontractors, and end user companies. SAC was established to certify subcontractor quality and process control systems. The member firms represent...
The past, present and future direction of aerospace quality standards.
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
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...
A context for ISO 9001 and ISO 9004.
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...
Column: Standards Outlook: The Big Picture: A Context for ISO 9001 and ISO 9004
[Abstract from article]
This is part four of a series of articles on the year 2000 revision of the ISO 9000 series. The first three articles explained changes in requirements, format, presentation, and terminology and in the processes and approaches...
Column: Standards Outlook: The Art of Creating a Standard
It's easier to be a critic than a playwright
Understanding this process of consensus building may help Quality Progress readers better understand the content of the updated ISO 9001:2000 and ISO 9004:2000 quality management system standards. The ISO Technical Committee (TC) called ISO/TC 176/Sub-Com...
Use Common Law Techniques To Foster Internal Audits
Establishing precedents and documenting case histories
By borrowing the practice of documenting precedents from the common law methodology, my team maintained a consistent decision- making process. The team selected a decision as precedent if the decision involved the interpretation of a standard or policy, o...
Quality System Harmonization for Clinical Laboratories
Clinical laboratories would benefit from a rewriting of CLIA (Clinical Laboratory Improvement Amendments of 1988) regulations into a better fit with the ISO 9000 structure. Differences between CLIA and ISO structure include CLIA's inclusion of seven...
ISO 9001 and health care.
Easier, faster and better than other accreditation programs
Health care providers often struggle when they find as many as 30 different versions of the same form at different locations in a health care facility. After employee health care benefits, purchasing frequently ranks number two in expenditures for health ...
SDI Aerospace implements ISO 9001
An Unexpected Competitive Edge
Bob Ritchie, the vice president in charge of SDI Aerospace, had known of the ISO 9000 series for several years and decided to seek company registration under ISO 9001. As the BVQI auditors told the company, certainly the initial goal is to reach complianc...
An Integrated Approach to Food Safety
HACCP (Hazard Analysis Critical Control Point) and ISO (International Organization for Standardization) 9000 are compatible quality tools for the food industry. Although it can be a challenge to analyze and interpret the ISO 9000 elements, there are...
Quality You Can Bank On
Certification to ISO 9002 for the South Texas Blood and Tissue Center required four phases embedded in the plan-do-check-act (PDCA) cycle. Phase one, planning, included evaluating the Center's competitive and business needs; selecting the ISO 9002...
Do the Right Things Right
A robust and adaptive ISO 9000 quality system fosters efficiency and effectiveness. A proactive strategy will lead to elimination of nonconformities and development of a solid infrastructure. The DISTRO company has done this by adhering to the...
Benchmarking Your Plant Against TQM Best-Practices Plants: Part 2 of 4
The Rosemount Plant of the Emerson Electric Company is the second of four world-class operations described in a series of articles on quality practices. Rosemount has combined flexible manufacturing with total quality management (TQM) techniques and...
Benchmarking Your Plant Against TQM Best-Practices Plants: Part 1 of 4
technically trained but management oriented 7. Clear quality responsibilities for managers of all areas 8. Champions named to lead quality processes 9. Do a good job benchmarking competition Engineering- based practices 10. Practice concurrent engineerin...
The Quality Auditor: Helping Beans Take Root
Awareness of corporate culture enables the quality auditor to go beyond bean counting and become an agent of cultural change. This broader view of quality auditing fits well with the TQM (total quality management) view that behavioral factors are...
Keys to a Successful Internal Audit
An objective, businesslike approach makes internal audits fair and useful. Planning the audit includes making decisions on scope (full or partial), scheme (downstream, upstream, or horizontal), and checklist content. The checklist is a single sheet...
12 Rules to Make Your ISO 9000 Documentation Simple and Easy to Use
Simplicity and usability of an ISO 9000 documentation system is the theme of 12 recommendations. First, create the quality manual only after all other documents have been prepared. Second, a concise quality policy need be only one paragraph or one...
Bored With the Same Old Reference Books?
Registrars for ISO 9000 and QS-9000 certification look for well documented, clear, controlled, and compliant relationships among an organization's entities. Whether the relationships are handled through interface agreements, corporate interlinks, or...
Integrating ISO 9001 and ISO 14001
The integration of standards increases focus while reducing confusion. Elements of the ISO 9001 quality standard can be enhanced with corresponding components of ISO 14001, the environmental management standard. Management responsibilities for the...
Seven Ways to Make Money from ISO 9000
There are bottom-line benefits to preparing for ISO 9000 registration. Tools for these money-making opportunities include information for increasing organizational efficiency and for understanding and subsequently improving processes. Improvements in...
After the Quality Audit: Closing the Loop on the Audit Process
The Audit Function Improvement Process leads to corrective and preventive action based on improved relations among auditees, auditors, management, and other stakeholders. A good audit allows stakeholders to identify and correct or prevent problems that...
Eating the Elephant One Bite at a Time
The ISO 9000 registration process for a software company relies on humor, a sense of proportion, critical success factors, and the avoidance of typical mistakes. A sense of humor can soften internal criticisms, while a sense of proportion helps avoid...
What Do Managers Really Think of the ISO 9000 Registration Process?
Forty Colorado companies were surveyed about the ISO 9000 registration process. Each company was ISO-9000 registered, and the key ISO 9000 person at each firm answered the 22 open-ended survey questions. Results indicate that 85% of the firms sought...
Managing Records for ISO 9000 Compliance
Quality records are evidence of product quality. A professional records management program (RMP) supports all aspects of ISO (International Standards Organization) 9000. However, some areas of the ISO 9000 standards only imply their requirements. For...
