2009 Newsletter Articles

AS9100C Timeline

Dec 21, 2009 in Newsletter | 0 comments

The International Aerospace Quality Group (IAQG) has announced a new timeline for the transition to the aerospace standards published in 2009: AS9100:2009, Requirements for Aviation, Space, and Defense Organizations AS9110:2009, Requirements for Aviation Maintenance Organizations AS9120:2009, Requirements for Aviation, Space, and Defense Distributors Transition Schedule The IAQP sanctioned auditor training is expected to be available by April 30, 2010. The following 14 month period, ending July 1, 2011, is to provide time for trainers and...

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Critical Safety Items

Dec 21, 2009 in Newsletter | 0 comments

AS9017:2009, Control of Aviation Critical Safety Items, is now available. It is intended to prescribe consistent requirements for CSI management for organizations and suppliers who perform work for prime contractors receiving direct contracts from U.S. government agencies. The contractor, which receives the initial government contract, will receive their CSI requirements directly from the U.S. government agency and be required to maintain a CSI management system that ensures compliance to all requirements. The flow down of this standard is...

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Medical Labs

Dec 21, 2009 in Newsletter | 0 comments

Medical laboratories accredited to ISO 15189:2007 are recognized as meeting the management system principles of ISO 9001:2008 according to a joint communiqué by ISO (the International Organization for Standardization), ILAC (the International Laboratory Accreditation Cooperation), and the IAF (the International Accreditation Forum). The ISO-IAF-ILAC communiqué was issued to address the misconception that medical laboratories accredited to ISO 15189:2007 do not operate a recognized management system. Until now, accredited medical laboratories...

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ISO 9004:2009

Dec 21, 2009 in Newsletter | 0 comments

ISO 9004:2009 The just-published new edition of ISO 9004 provides organizations with a model for “sustained success” in today’s complex, demanding, and ever-changing environment. ISO 9004:2009, Managing for the sustained success of an organization – A quality management approach, is the third edition of the standard first published in 1987. It is intended to support the achievement of sustained success by any organization (regardless of size, type, or activity) through a quality management approach. While the initial...

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Revised 14 CFR 21

Dec 21, 2009 in Newsletter | 0 comments

The Federal Aviation Administration (FAA) recently published significant revisions to 14 CFR 21, the regulations that govern the design, production, and continued airworthiness of U.S. civil aircraft. These changes become effective April 14, 2010. The FAA is amending its certification procedures and identification requirements for aeronautical products and articles. The amendments will update and standardize those requirements for Production Approval Holders (PAHs), revise export airworthiness approval requirements to facilitate global...

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On-time Delivery

Dec 21, 2009 in Newsletter | 0 comments

The QuEST Forum is a unique collaboration of service providers and suppliers dedicated to improving quality and performance in the telecommunications supply chain. The QuEST Forum has helped unify the global telecom community through the implementation of TL 9000, a telecom-specific quality standard that builds on ISO 9001. TL 9000 The performance data requirement of TL 9000 sets it apart from other quality management standards. TL 9000 certified organizations must submit TL 9000 measurement data using predefined counting rules to the QuEST...

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Web Archiving

Dec 21, 2009 in Newsletter | 0 comments

A Web page that is here today, may not be around tomorrow. A new standard, ISO 28500:2009, Information and Documentation – WARC File Format, will ensure that the vast and often valuable information posted on the Web is not lost when a page changes or disappears. ISO 28500 provides a file format known as WARC (Web ARChive), which offers a convention for concatenating multiple data objects into one long file. The format can be used to build applications for harvesting, managing, accessing, and exchanging content. For a long time, keeping...

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ISO 9004 Approved

Nov 21, 2009 in Newsletter | 0 comments

A completely revised ISO 9004 standard has been approved and is in the publication stage. It will be available soon with the new title, “Managing for the Sustained Success of an Organization – A Quality Management Approach”. ISO 9004:2009 provides guidance to organizations to support the achievement of sustained success through a quality management approach. It is applicable to any organization, regardless of size, type, and activity, but it is not intended for certification, regulatory, or contractual use. Do you recall...

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U. S. Manufacturing

Nov 21, 2009 in Newsletter | 0 comments

A recent AIAG e-News Brief included an article by Thomas Duesterberg, President and CEO of the Manufacturers Alliance. An edited version appears below. View on U. S. Manufacturing  In the worst economic climate since the 1930s, and at a time of intensified political change, manufacturers are experiencing difficulties in articulating a clear and strong message about the health of their sector and how policy change might affect it. What follows are ten summary points intended to convey an accurate picture regarding the current state of U.S....

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Travel Safety

Nov 21, 2009 in Newsletter | 0 comments

It often takes a tragedy to make companies address the risks of business travel. An article in the HR Daily Advisor states that personal crimes, such as assaults and robberies, are the most common types of incidents encountered by business travelers. Often, companies make hotel and travel decisions based solely on price, rather than evaluating factors such as the crime rate of the neighborhood where the hotel is located, basic security safeguards utilized at the property, or transportation after dark. Ironically, employers go to great lengths...

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EPA Rules on GHG

Nov 21, 2009 in Newsletter | 0 comments

On January 1, 2010, the Environmental Protection Agency (EPA) will, for the first time, require large emitters of heat-trapping emissions to begin collecting greenhouse gas (GHG) data under a new reporting system. This new program will cover approximately 85 percent of the nation’s GHG emissions and apply to about 10,000 facilities. The EPA expects the new reporting system to provide a better understanding of where GHGs are coming from, as well as, guide development of the best possible policies and programs to reduce emissions. The...

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OSHA on PPE

Oct 21, 2009 in Newsletter | 0 comments

The Occupational Health and Safety Administration (OSHA) has issued a final rule to revise the Personal Protective Equipment (PPE) sections of its general industry standards on the requirements for eye- and face-protective devices, head protection, and foot protection. OSHA is updating the references in its regulations to recognize the more recent editions of the applicable national consensus standards. OSHA is also amending the provision that requires safety shoes to comply with a specific American National Standards Institute (ANSI)...

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E-Verify Becomes Law

Oct 21, 2009 in Newsletter | 0 comments

After several delays and unsuccessful lawsuits, the Department of Homeland Security’s E-Verify program became effective on September 8, 2009. E-Verify is an Internet-based system that is operated by the Department of Homeland Security in partnership with the Social Security Administration. The E-Verify system aids compliance with federal immigration laws, helps deter unauthorized individuals from attempting to work, and helps employers avoid employing unauthorized aliens. According to the E-Verify web site, it should virtually...

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Mandatory Clauses

Oct 21, 2009 in Newsletter | 0 comments

Have you noticed the surveillance audits by your certification body always seem to address some of the same ISO 9001 clauses? The reason is that ISO 17021, a standard that applies to bodies providing audit and certification of management systems, requires a few areas to be a mandatory part of a surveillance audit program. Section 9.3.2.1 of ISO 17021 reminds us that surveillance audits are on-site audits, but not necessarily full system audits. And, surveillance audits must be planned together so the certification body can be confident that...

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Jan-Jun 2010 Classes

Oct 21, 2009 in Newsletter | 0 comments

Check out our recently released January 2010 to June 2010 class schedule. You can see the classes, dates, and locations by clicking on the desired course listed on the left side of our Web Site home page. For example, we have ISO 9001:2008 auditing classes scheduled for Atlanta, Baltimore, Chicago, Dallas, El Paso, Houston, Kansas City, Milwaukee, Minneapolis, Orlando, Philadelphia, Portland, Reston, San Diego, San Jose, and...

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SW Cost Estimating

Oct 21, 2009 in Newsletter | 0 comments

The Software Development Cost Estimating Handbook was developed by the Software Technology Support Center and sponsored by the Naval Center for Cost Analysis and the Air Force Cost Analysis Agency. The purpose of the Handbook is to provide cost analysts and program managers with a resource manual to use in developing credible software development cost estimates. A realistic estimate is based upon a solid understanding of the software development process and the historical data that forms a framework for the expected values. An estimating...

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AS9110 and AS9120

Sep 21, 2009 in Newsletter | 0 comments

The AS9100, Revision C, aerospace standard was published early this year. You can read about the changes introduced by the new edition in this AS9100C PDF file at my web site. Tailored versions of AS9100C for maintenance organizations (AS9110A) and distributors (AS9120A) are now available. AS9110, Revision A, is for organizations that provide maintenance, repair, and overhaul services for commercial and military aviation products. It is also for original equipment manufacturers with maintenance, repair, and overhaul operations that operate...

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ISO 10018 Draft

Sep 21, 2009 in Newsletter | 0 comments

With key elements of ISO 9001 focused on people, ISO 10018 is under development to explain the human element in successful management systems. ISO 10018, “Quality management – Guidelines on people involvement and competences”, is at the Committee Draft stage, with publication targeted for February 2012. According to Paul Simpson, IRCA Technical Manager and Member of the ISO 10018 Working Group, most auditors are aware of the need to consider the people aspects when auditing a management system. He says systems are not...

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Recycling Standards

Sep 21, 2009 in Newsletter | 0 comments

As industry embraces opportunities to lessen their environmental footprint through various recycling programs, the recycling industry finds itself facing new initiatives designed to ensure wastes are handled appropriately. There are currently three such accredited programs – RIOS, R2, and E-Stewards, all designed to deal with electronic waste. RIOS (Recycling Industry Operating Standard) was developed by the Institute of Scrap Recycling Industries (ISRI). RIOS is an integrated management system standard that combines the management of...

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ISO 9001 Corrections

Sep 21, 2009 in Newsletter | 0 comments

ISO 9001:2008 Technical Corrigendum 1 was published on July 15, 2009 with corrections to Annex A and Annex B of the ISO 9001:2008 standard published on November 15, 2008. The corrections were limited to Tables A.1 and A.2, the ISO 9001:2008 and ISO 14001:2004 cross-reference tables, and Table B.1, the ISO 9001:2000 to ISO 9001:2008 changes table. Annex A, Table A.1, Correspondence between ISO 9001:2008 and ISO 14001:2004 The correction says to replace the entire A.1 table with the new A.1 table. Rather than repeat the table in this article, I...

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AS9101D Checklist

Aug 21, 2009 in Newsletter | 0 comments

Bob Parsons with NQA recently published an article in the NQA Update Newsletter explaining the delay in releasing the AS9101D checklist, and therefore, the delay in AS9100C certifications. An edited version of his article, along with information from the NQA website, appears below. The AS9100 Revision C standard was released in January 2009, but to date, no organizations have been registered to it. This holdup is due to the delay in releasing the accompanying AS9101D checklist standard. The new checklist will replace the AS9101C checklist...

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More CMMI Classes

Aug 21, 2009 in Newsletter | 0 comments

We have expanded the class schedule for our Introduction to CMMI – Development Model to include: Milwaukee, WI on September 3-5, 2009 Anchorage, AL on September 3-5, 2009 Columbus, OH on September 8-10, 2009 Raleigh, NC on September 15-17, 2009 Orlando, FL on September 29 – October 1, 2009 Montgomery, AL on October 13-15, 2009 Nashville, TN on October 20-22, 2009 Omaha, NE on October 27-29, 2009 Colorado Springs, CO on November 3-5, 2009 Provo, UT on November 17-19, 2009 Tucson, AZ on November 30 – December 2, 2009 Honolulu,...

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4-Day Lead Auditor

Aug 21, 2009 in Newsletter | 0 comments

Being trained as an ISO 9001:2008 Lead Auditor just got easier. Our 5-day course has been both improved and shortened into a new 4-day version. The 5-day ISO 9001:2008 Lead Auditor course was certified by the RABQSA through the Training Course Certification (TCC) program. The TCC program emphasizes content more than competency. It ensures that the necessary course subjects are covered in satisfactory depth. As a result, the 5-day course required 40 class hours and long days. Students complained it was too much to cover in too little time. Our...

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TL 9000 R5.0 Handbook

Aug 21, 2009 in Newsletter | 0 comments

The QuEST Forum has issued Release 5.0 of the TL 9000 Requirements Handbook, the latest edition of the global quality standard used by the telecommunications industry. The R5.0 Handbook has an effective date of November 15, 2009 to ensure adequate time for organizations to complete their training and seamlessly upgrade to the new release. The new standard can be used after November 15, 2009 and must be used after November 15, 2010. Release 5.0 includes clarifications, additional adders, and notes. Three specific areas emphasized in the...

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ISO/TS 16949:2009

Aug 21, 2009 in Newsletter | 0 comments

The third edition of the automotive quality standard, ISO/TS 16949:2009, has been published to include the text of ISO 9001:2008. ISO/TS 16949:2009 replaces ISO/TS 16949:2002 and can be ordered at this AIAG web page. ISO/TS 16949:2009 can be ordered in hard copy or electronic format at an AIAG member price of $30 or a non-member price of $90. You are allowed to print two copies of the e-standard PDF file before storing it on your hard drive. ISO/TS 16949:2009 was developed by the International Automotive Task Force (IATF). Along with the...

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Root Cause Analysis

Aug 10, 2009 in Newsletter | 0 comments

Does your organization know how to perform effective root cause analysis? If not, you should arrange for us to teach our Root Cause Analysis course at your site. It is offered in 2-day and 3-day versions. ROOT CAUSE ANALYSIS Our 3-day course consisting of lectures, practices, and role plays that will provide attendees with an in-depth understanding of how to analyze a system in order to identify the root causes of problems. The following topics are covered: The difference between problem solving and root cause analysis Why effective root...

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ISO/TS 16949:2009

Jul 21, 2009 in Newsletter | 0 comments

The International Automotive Task Force (IATF) announced in Certification Body (CB) Communique 2009-10 that the automotive quality standard, ISO/TS 16949:2009, has been published. This IATF notice referred readers to the CB Communique 2008-06 for ISO/TS 16949:2009 transition information: 1. No New Requirements ISO/TS 16949:2009 introduces no new or changed requirements. The incorporated ISO 9001:2008 standard is based on clarifications or amendments to ISO 9001:2000 and those intended to improve consistency with ISO 14001:2004. 2....

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Auditing Legal Requirements

Jul 21, 2009 in Newsletter | 0 comments

Part of planning an internal audit is determining the audit criteria, in other words, the policies, procedures, and requirements used as the reference for comparing audit evidence. Primary Requirement Types The four primary types of requirements can be grouped as: 1. Legal, as defined in statutes and regulations 2. Organization, as found in policies and procedures 3. Customer, as expressed in orders and contracts 4. Standard, such as ISO 9001:2008 The requirement types can be remembered using the term LOCS: Legal, Organization,Customer,...

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Medical Devices

Jul 21, 2009 in Newsletter | 0 comments

In addition to our public and on-site ISO 13485 courses, we can now assist medical device companies in bringing their products to market. Our engineers can conduct risk assessments, perform mechanical test design and execution, trouble-shoot products, and help implement quality management systems. Risk Assessment Why do a risk assessment on your medical device? Because it is a legal requirement of GMP 21 CFR Section 820, and reduces liability by finding flaws. The risk assessment should be the basis of both clinical and non-clinical testing....

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LinkedIn to Larry

Jul 21, 2009 in Newsletter | 0 comments

Many of you have been students in my classes or communicated with me over the years on quality and auditing topics. I invite you to connect with me on LinkedIn by going to: http://www.linkedin.com/in/larrywhittington

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Audit Conference: October 15-16, 2009

Jul 21, 2009 in Newsletter | 0 comments

The ASQ Audit Division will hold its 18th Annual Audit Conference on October 15-16, 2009. There are 45 conference sessions planned across the two days. See the tentative presentation and speaker list below. Larry Whittington will be speaking on “Get Tough on Corrective Actions” at 9:30 AM on the first day of the conference. The conference will held at the Hilton Tucson El Conquisador Golf & Tennis Resort, 10000 North Oracle Road, Tucson, AZ 85704. The conference fee is $750. To register, go to this Conference...

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ANAB’s Bill of Rights

Jun 21, 2009 in Newsletter | 0 comments

Third-party accredited certification is a professional relationship between a client being certified, the certification body (CB), the CB’s auditors, the accreditation body (AB), and the AB’s assessors. In the United States, the recognized AB for management systems certification is the ANSI-ASQ National Accreditation Board (ANAB). These parties all contribute to the integrity of accredited certification and continual improvement based on processes that assure capability, competence, and impartiality. From time to time, a certified...

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Ten Audit Questions

Jun 21, 2009 in Newsletter | 0 comments

The Automotive Industry Action Group (AIAG) publishes a monthly newsletter titled, Quality Standards and Tools. Their May and June issues included articles written by Craig Cochran that describe his “10 Essential Audit Questions”. The author suggests ten important questions to ask during an audit to determine the effectiveness of the management system and the overall performance of the organization: 1. How do you contribute to the achievement of your organization’s objectives? 2. What happens if your products (or materials...

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Corrective Actions

Jun 21, 2009 in Newsletter | 0 comments

When reviewing responses to audit nonconformities, you should look for correction, root cause analysis, and then corrective action. The ANSI-ASQ National Accreditation Board (ANAB) that accredits certification bodies (CBs) knows the proper corrective action process. When ANAB was experiencing less than adequate responses to nonconformities they issued during audits of certification bodies, they issued a “Heads Up” to their auditors to provide guidance on evaluating corrective action responses. Guidance: ANAB said that...

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Data Breach Report

Jun 21, 2009 in Newsletter | 0 comments

2008 will likely be remembered as a tumultuous year for corporations and consumers alike. Fear, uncertainty, and doubt seized global financial markets; corporate giants toppled with alarming regularity; and many who previously lived in abundance found providing for just the essentials to be difficult. Among the headlines of economic woes came reports of some of the largest data breaches in history. These events served as a reminder that, in addition to our markets, the safety and security of our information could not be assumed...

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ISO 19772:2009 for Data Security

Jun 21, 2009 in Newsletter | 0 comments

Security is perhaps one of the greatest concerns of millions of users that routinely exchange data over the Internet or store information in computers which may be accessed by unauthorized parties. To protect the confidentiality and integrity of data being transferred or stored, ISO and the International Electrotechnical Commission (IEC) jointly developed a new standard that defines authenticated encryption mechanisms that provide an optimum level of security. ISO 19772:2009, Information technology – Security techniques –...

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ISO 9001:2008 Support

May 21, 2009 in Newsletter | 0 comments

Some of you may have used the ISO 9001:2000 Introduction and Support Package to ease the move to ISO 9001:2000. Well, the package has been revised at the ISO web site to reflect ISO 9001:2008 and may help you with the transition to ISO 9001:2008. The package consists of the following seven guidance documents: 1. Guidance on ISO 9001:2008 sub-clause 1.2 “Application” This document explains the concept of excluding an ISO 9001:2008 requirement from a quality management system, as well as, the need to include your justification in...

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QMS-EMS Audit Days

May 21, 2009 in Newsletter | 0 comments

How many audit days would a registrar estimate for your initial stage 1 and stage 2 certification audits, ongoing surveillance visits, and re-certification audits? The International Accreditation Forum (IAF) recently issued a Mandatory Document (IAF MD 5:2009) for certification bodies that contains mandatory provisions and guidance on the time required to audit their clients. The MD 5:2009 document applies to quality management systems (QMS) and environmental management systems (EMS). The effective number of personnel indicated in the QMS...

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Internal Audit Reports

May 21, 2009 in Newsletter | 0 comments

The audit team leader prepares an audit report that is a complete, correct, concise, and clear record of the audit. The written report may include the topics described below. Some topics may not be applicable for your organization and the topics may be included in a different sequence. The asterisked (*) items are the minimum set of topics suggested by QE19011S:2008 for an internal audit report. Audit Objectives (*): Identify the goals of the audit, e.g., to verify conformity, evaluate effectiveness, and identify opportunities for...

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Cybersecurity Controls

May 21, 2009 in Newsletter | 0 comments

Amid increasing scrutiny over U.S. cybersecurity, experts from the private and public sectors are pushing a set of recommendations they say are sorely needed to help shore up the nation’s defenses against data breaches. The resulting Consensus Audit Guidelines (CAG) map out requirements for security controls needed to protect IT installations in government and the private sector. Their creators include the U.S. Department of Homeland Security’s US-CERT unit, the National Security Agency, and the Department of Defense. Commercial...

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CMMI for Services

May 21, 2009 in Newsletter | 0 comments

The Capability Maturity Model Integration (CMMI) for Services, known as CMMI-SVC, is a new model that provides guidance to service organizations for establishing, managing, and delivering services. The model focuses on service provider processes and integrates bodies of knowledge that are essential for successful service delivery. Service organizations are 80% of the world economy. In these lean times, they can benefit by using process improvement to make the most of their resources to achieve desired business results. The new CMMI-SVC is a...

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Lower Energy Costs

Apr 21, 2009 in Newsletter | 0 comments

The Industrial Technologies Program (ITP) leads national efforts to improve industrial energy efficiency and environmental performance. The ITP is part of the U.S. Department of Energy’s Office of Energy Efficiency and Renewable Energy (EERE). “Save Energy Now” is a national initiative of the ITP to drive a 25% reduction in industrial energy intensity in 10 years. Companies nationwide can participate in no-cost energy assessments and utilize ITP resources to reduce energy use while increasing profits. These energy...

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Supplier Management

Apr 21, 2009 in Newsletter | 0 comments

The ISO 20000 standard for IT Service Management includes requirements in clause 7.3 for Supplier Management. The objective of these requirements is to manage suppliers to ensure the provision of seamless, quality services. Requirements:  An organization conforming to ISO 20000 is required to document their supplier management processes and name a contract manager responsible for each supplier. They are also required to document, and have all parties agree upon, service level agreements that describe the requirements, scope, level of service,...

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Audit Procedure

Apr 21, 2009 in Newsletter | 0 comments

The most searched topic at our web site is “audit procedure”. So, this article includes a sample internal audit procedure. Any comments? 1.0 PURPOSE The purpose of this procedure is to assess the conformity of our quality management system to specified requirements and its effectiveness in meeting quality objectives. 2.0 SCOPE This procedure covers scheduling, initiating, planning, conducting, recording, and reporting internal audits. It also addresses qualifying auditors, performing follow-up audits, and managing the overall audit...

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CMMI vs. ISO 9001

Apr 21, 2009 in Newsletter | 0 comments

The Software Engineering Institute published a March 2009 report, CMU/SEI-2009-SR-005, that compares CMMI-Development, v1.2, to the ISO 9001:2000 international quality standard. Since the more recent ISO 9001:2008 edition didn’t add any new requirements or clause numbering to ISO 9001:2000, the SEI comparison remains valid. The report is meant for anyone with knowledge of either the Capability Maturity Model Integration (CMMI ) Product Suite or the International Organization for Standardization (ISO) 9000 family of standards, that is...

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Data Losses

Apr 21, 2009 in Newsletter | 0 comments

Businesses risk losing over $1 trillion from loss or theft of data and other cybercrime, according to a recent study by security technology firm McAfee. They found that malware increased by 400 percent last year. The malware is being designed to steal your data, steal your identity, or steal your money. The scale, as well as the sophistication, was very alarming according to McAfee. The survey found 80% of the malware is aimed at making a financial gain, rather than the traditional viruses and worms which just have nuisance value. The increase...

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AS9100C Differences

Mar 21, 2009 in Newsletter | 0 comments

AS9100C Transition Plan The International Aerospace Quality Group (IAQG) has proposed a 30-month transition timeline for existing certified organizations. However, due to the need for global harmonization and the release of supporting standards, the start date for transition had not been set (as of the date of this article). A possible scenario could be: January 2009:  AS9100C was released. March 2009 – August 2009  (6 months for training providers to develop training for the new standard) September 2009 – August 2010:  (12...

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How Many Shalls?

Mar 21, 2009 in Newsletter | 0 comments

Have you ever been asked how many requirements are in ISO 9001:2008? Well, one answer might be that there are 136 “shall” statements in the standard, spread across the five major clauses as shown below: Clause 4: Quality Management System = 13 Clause 5: Management Responsibility = 15 Clause 6: Resource Management = 5 Clause 7: Product Realization = 67 Clause 8: Measurement, Analysis, and Improvement = 36 But, how do you count a “shall” with multiple sub-clauses? Should each sub-clause be viewed as a separate...

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Actions After Audits

Mar 21, 2009 in Newsletter | 0 comments

According to ISO 9001:2000, clause 8.2.2, on internal audits, we were to ” … ensure that actions are taken without undue delay to eliminate the detected nonconformities and their causes”. Many organizations interpreted these actions to be taken as “corrective actions”, and they were partially right. ISO 9001:2008 expanded the internal audit requirement to say “ensure that anynecessary corrections and corrective actions are taken … “. This revision tells us that an immediate correction might...

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Prepare for an Audit

Mar 21, 2009 in Newsletter | 0 comments

To prepare your organization for an external audit: Communicate the audit scope and schedule Ensure key contacts are available for interview Verify process owners can clearly describe inputs and outputs resources and methods controls and measures Arrange for auditor access to documentation Plan the logistics for the audit team visit Managers of the areas to be audited should: Become familiar with the documents in their area Walk through the area for a spot check on operations Verify that only valid documents are being used Identify...

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ISO 9001 and Risk

Mar 21, 2009 in Newsletter | 0 comments

What does ISO 9001 say regarding risk management? Well, ISO 9001:2008, clause 0.4, repeats this statement unchanged from the ISO 9001:2000 standard (underlines are my emphasis): This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management, or risk management.  It seems to clearly state there are no requirements in ISO 9001 for risk management. However, the revised statement below from...

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Index for ISO 9001

Feb 21, 2009 in Newsletter | 0 comments

Have you ever struggled to locate a particular term in ISO 9001? For example, you know that the term “outsource” is used in the standard, but you may not recall where to find it. Well, I’ve updated my index file for more than 300 terms used in ISO 9001:2008. The revised index at my web site includes the page numbers and clause references for each term. For example, Outsource (or Outsourced) is mentioned multiple times on page 2 at these clause numbers: 4.1, 4.1, 4.1 (Note 2), 4.1 (Note 3), 4.1 (Note 3), and 4.1 (Note 3.a)....

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AS9100C Available

Feb 21, 2009 in Newsletter | 0 comments

The Aerospace standard, AS9100, Revision C, is available for ordering at the SAE web site for a member price of $48.00 or list price of $61.00. ASQ members can order the standard for $61.00 at the ASQ web site.

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ISO/TS 16949:2009

Feb 21, 2009 in Newsletter | 0 comments

The International Automotive Task Force (IATF) has announced that ISO/TS 16949:2009 will be issued during the first quarter 2009, following the ballot of ISO TC176, and reflects the changes in ISO 9001:2008. As such, the following applies: 1) No New Requirements ISO/TS 16949:2009 introduces no new or changed requirements. ISO 9001:2008 is based on clarifications or amendments to the existing requirements of ISO 9001:2000 and those that are intended to improve consistency with ISO 14001:2004. 2) Application Certification Bodies and...

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Actions after Surveys

Feb 21, 2009 in Newsletter | 0 comments

A key requirement in ISO 9001 is to monitor information relating to the customer’s perception as to how well your organization is meeting customer requirements. The standard goes on to say that the methods for obtaining and using this information must be determined. A new Note in ISO 9001:2008, clause 8.2.1, states that monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments,...

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Need a Web Site?

Feb 21, 2009 in Newsletter | 0 comments

Some of our newsletter readers are independent consultants. Do you need a web site to promote your services and attract more business? Some of our readers work for small businesses. Does your company need an improved web site with an up-to-date and professional look? Or, some of you may belong to an association, or volunteer for a non-profit organization. Does your group’s web site need to be updated with advanced features for better support? For economical web site design and setup, I suggest you contact Frogtown Media. They quickly...

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Reduce Audit Days

Jan 21, 2009 in Newsletter | 0 comments

Did you know your organization may qualify for a reduction of up to 30% in the auditor days paid for third-party audits? To be eligible for the Advanced Surveillance and Recertification Procedures (ASRP), you have to demonstrate that your quality or environmental management system is effective over a period of time. Under this ASRP program, the certification body can place greater reliance on your internal audit and management review processes, as well as, targeted surveillance topics, to evaluate the conformity of your management...

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Cloud Computing

Jan 21, 2009 in Newsletter | 0 comments

Have you heard of “Cloud Computing? The technology firm Gartner has it in second place on their top ten technologies that will dominate for the next three years. And, a search for the term on Google will yield millions of references. Cloud computing is defined on Wikipedia as an Internet-based (Cloud) development and use of computer technology (Computing). As we can see, Cloud is a metaphor for the Internet, based on how it is depicted in computer network diagrams. Cloud computing is a style of computing in which IT-related...

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Business Continuity

Jan 21, 2009 in Newsletter | 0 comments

The Institute of Internal Auditors (IAA) has published its latest Global Technology Audit Guide, which provides guidance on business continuity. According to the guide, the goal of business continuity management (BCM) “is to enable an organization to restore critical business processes after a disaster has been declared.” The guide focuses on how BCM is designed to enable business leaders to manage the level of risk the organization could encounter in the case of a natural or man-made disruptive event that affects the extended...

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TickIT to TickITplus

Jan 21, 2009 in Newsletter | 0 comments

TickIT is a quality-management certification program for software, supported primarily by the United Kingdom and Swedish software industries. However, ISO 9001 certificates under TickIT have been issued in more than 50 countries, including the European Union, USA, Canada, Mexico, Brazil, Australia, China, India, Japan, South Korea, and Taiwan. The TickIT name is derived from the “Tick” or check mark, along with IT for Information Technology. TickIT was introduced in the early 1990’s as a sector scheme under ISO 9001 to...

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Software Quality Costs

Jan 21, 2009 in Newsletter | 0 comments

In decades past, the focus of quality was merely finding problems at the end of an assembly line and removing the defects before shipping to the consumer. If the product didn’t meet specs, it was either reworked or scrapped; both expensive options. This approach is prone to human error and rarely finds all defects. And, this quality control approach only identified the defects found through random sampling, but actually did nothing to determine the root cause of the problem for resolution. If preventive quality measures and rework are...

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