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Auditing as an Integral Part of the Business
Denise Robitaille
Occasionally, when I’m waiting for a flight, the small talk with fellow travelers will meander into discussions about the purpose of our respective trips. When I tell them that I’m on my way to conduct an audit, they immediately jump to the conclusion that I’m a certified public accountant (CPA)…
Carnegie Mellon’s Capability Maturity Model Integration the ISO 9001 Way
For years, many companies have expended countless dollars and painful hours to comply with the various requirements of ISO 9001. Now, some of these companies are being asked to meet the provisions of Carnegie Mellon’s Capability Maturity Model Integration (CMMi). In its former guise as CMM,…
The Cornerstones of ISO/TS 16949
David Parlagreco
The concept of establishing goals and flowing them throughout an organization isn’t new in business or in quality management system standards. In ISO 9001:1994, the establishment of goals was done via the quality policy, following a review of effectiveness in meeting these management goals. QS-9000…
Mr. Rogers and the Process Approach
Denise Robitaille
I was channel surfing the other day, looking for some local news that would tell me why I had woken up to a power outage that had lasted the better part of the morning. I don’t usually watch TV during the day, so I had no idea what stations carried noon time news broadcasts. As I was flipping…
Process Auditing: A Change in How
ISO/TS 16949 and ISO 9001 Auditors Work
Robert Kozak
Adding value by auditing using the process- and metric-driven approach requires new methods and an increased focus on supplier performance metrics (i.e., scorecards). A change in how auditors work the process approach is evolving, with more sophisticated techniques, more rigorous testing and…
Pre-assessment at the North Pole
Denise Robitaille
Good morning, everyone. On behalf of Galactic Registrars Interstellar Network (GRIN), I’d like to express our appreciation to your organization for selecting us as your ISO 9001 registrar. Before we begin the audit, there are a few items we need to cover. This is standard auditing protocol. Certain…
The Standard Answer
Denise Robitaille
I was recently asked to write about the ISO 9001:2000 requirements that are still giving folks a hard time. Recent audits that I’ve conducted have led me to conclude that there are several clauses that continue to give us heartburn. The issue that seems to come up most frequently relates to…
The Standards Answer
Denise Robitaille
I’ve long been frustrated, both as an auditor and as a consultant, by the unique exemption most organizations extend to distributors. It’s a common practice for purchasing personnel to excuse distributors from the vendor qualification requirements they apply to most of the other companies they do…
The Standards Answer
Denise Robitaille
Perhaps the single most pervasive reason top management resists the implementation of a quality management system relates to our failure, as quality professionals, to demonstrate the return on investment. We do a less-than-stellar job of demonstrating to executives the financial value implicit in…
Lean Quality Documentation Systems
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How did your quality system get so complex and redundant? Many companies established their quality systems after having purchased a software program with a “canned” quality manual and procedures. Software companies try to subliminally sell you the concept “more is better.” Purchasing companies…
The ISO 10006 and PMBOK Path to Successful Projects
Michael Stanleigh
ISO 10006:2003, guidelines for quality management projects, was released in the fall of 2003. This standard is creating the next wave in our understanding of project managing processes. But how does ISO 10006 compare to the Project Management Institute’s Project Management Body of…
The Standard Answer
Denise Robitaille
There’s a marauding infestation of adverbs and adjectives that infiltrate the text of quality documents and operating procedures, wreaking havoc wherever they are found. The leader of this menacing bunch is called “All.” Among his compatriots you’ll find “Never,” “Always,” “Every” and “None.” When…
The Standard Answer
Denise Robitaille
We all love exceptions. They afford us unfettered permission to break the rules. They are the vehicles we use to get around “things”—whatever those things happen to be. For those of us who attended elementary school in the sixties, the tradition of exceptions reaches deep down to our grammatical…
Lean Management Systems Revisited
Craig Cochran
Lean means doing the most with what you have. It’s efficiency and intelligence. In the modern economy, lean is a fact of life. Management systems must absolutely be lean, or they will be abandoned as impractical dinosaurs. In the October 2003 issue of Quality Digest, we began exploring…
ISO 9001:2000--Including Suppliers in Your QMS
Ronald J. Bowen
After undergoing an often costly and usually painful process to achieve ISO 9001:2000 registration, organizations invariably ask, "What do we do now to ensure that we maintain our registration and gain maximum benefit?" Under ISO 9001:1994, the old answer was fairly straightforward: Continue doing…
Lean Supplier Management
Craig Cochran
Supplier management is one of the most troublesome disciplines within a management system. There’s nothing inherently difficult about it, though. Companies make it difficult by instilling the process with lots of unwieldy bureaucracy. The trick is to strip the process down to its essential elements…
The Standard Answer
Denise Robitaille
Do not ever, ever, do anything just to please an auditor. This is quickly becoming one of my new favorite mantras. For many individuals, this statement would seem to be self-evident, and yet there are instances when an organization has felt compelled to change a process or implement a new practice…
The Standards Answer
Denise Robitaille
When is faster not better? In our warp-speed, 21st-century lives, getting the task completed on time--or ahead of time or before the competition--has become a goal in itself. We want this project done so we can move on to the next big thing. We tick things off our to-do list and gauge each day’s…
ISO/TS 16949 and the IAOB-IATF Infrastructure
Under QS-9000, suppliers relied on the Supplier Quality Requirements Task Force for guidance and direction in dealing with questions related to the standard’s requirements. With the global application of ISO/TS 16949:2002, a globalized group was needed to offer the same direction that was given…
Ten Essential Audit Questions To Reveal Your Organization’s Overall Performance
Craig Cochran
Editor’s story update 6/15/2017: This article was originally published on our site in 2004. Although it references ISO 9001:2000 rather than the current version of the quality management standard, Cochran’s 10 questions remain useful for organizations preparing for an audit. All experienced…
TL 9000 Outwits the Revolution
Jim Mroz
What roles do quality and quality management systems play in a business sector facing revolution? The term isn’t too strong for what’s currently underway in the telecommunications industry. Competitive pressures and customer demands are driving the sector to introduce next-generation network…
View From the Summit
Robert H. King Jr.
Contrary to what alarmists with an interest in fueling controversy might say, ISO 9001 is still on the rise-and with good reason. The standard is capable of producing the desired results (i.e., consistent quality in goods and services globally), and its full potential is yet to be realized.…
Vive la Revolution! ISO 9000 Enters Government
Frank Holland
Many Americans feel like the winds of change have blown away from them. They turn out on Election Day to provide a gust that blows back to local, state and federal power centers, where the clashing breezes become tornadoes. Consequently, many citizens are left with a sticky, humid feeling of…

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