December 2003 e-Newsletter

December, 2003

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December Articles Training in Atlanta

Click on a title to jump to the article:

1. Are You Setting SMART Quality Objectives?

2. New and Revised ISO Standards

3. What Changes are Planned for ISO 9001?

4. Registration Totals for ISO 9000 in USA

5. Most Common ISO 9001:2000 Audit Findings

6. Whittington to Speak at Quality Conferences

7. Class Schedule: December, 2003 - February, 2004

To see previous articles, go to Newsletter Archives.

Note: Students that have attended a class in Atlanta
receive a 20% discount on future Atlanta classes.

ISO 9001:2000 Lead Auditor
March 1-5, 2004

ISO 9001:2000 Internal Auditor
January 27-29, 2004

Quality System Documentation
February 3-4, 2004

Implementing ISO 9001:2000
February 5-6, 2004

Understanding ISO 9001:2000 Requirements
February 2, 2004

Green Belt Certification
January 21-23, 2004

Black Belt Certification (3 weeks)
Group 9: 2/9-13/04; 3/15-19/04; 4/12-16/04
Group 10: 3/29-4/2/04; 5/3-7/04; 6/7-11/04

Training Classes in Other Cities

1. Are You Setting SMART Quality Objectives?

George Doran published an article in the November, 1981 issue of Management Review titled, “There’s a S.M.A.R.T. Way to Write Management Goals and Objectives.” SMART has become a useful acronym for setting objectives that are Specific, Measurable, Achievable, Relevant, and Timed.

Specific: Identify the expected result. Be precise on the desired outcome. All the concerned persons should know what is required.

Measurable: Quantify the result and ensure you have a reliable system for measuring it. You should know when you have achieved the objective.

Achievable: The objective should be realistic given the target and date. Resources must be available to deliver the result with reasonable effort.

Relevant: Links to business success should be clear so people are motivated to meet the objective. Ensure people can influence the outcome.

Timed: Establish a timeframe for reaching the objective. Monitor progress against interim targets on the way to achieving the stated objective.

SMART is a good way to set specific, measurable quality objectives. People will recognize their importance and be committed to achieving them.

2. New and Revised ISO Standards

Are you aware of the following new ISO standards under development?

ISO/AWI 10001 - External customer dispute resolution systems
ISO/AWI 10002 - Market-based codes of conduct
ISO/DIS 10018 - Complaints handling - Guidelines for organizations
ISO/DIS 10019 - Guidelines for the selection of quality management system consultants and use of their services
ISO/DIS 21247 - Quality plans for product acceptance - Combined accept-zero and control procedures

AWI = Approved Work Item; DIS = Draft International Standard

And, several existing standards are being revised:

ISO 9000:2000 WD Amendment 1 - Quality management systems - Fundamentals and vocabulary
ISO/FDIS 90003 - Software and systems engineering - Guidelines for the application of ISO 9001:2000 to computer software
ISO/CD 10005 - Quality management - Guidelines for quality plans
ISO/CD 10014 - Quality management systems - Guidelines for managing the economics of quality

WD = Working Document; CD = Committee Draft; FDIS = Final Draft International Standard.
Note: The "90003" number above is correct. It will replace the current ISO 9000-3:1997.

And, did you spot the release this year of these quality standards?

ISO 10006:2003 - Quality management systems -- Guidelines for quality management in projects
ISO 10007:2003 - Quality management systems - Guidelines for configuration management
ISO 10012:2003 - Measurement management systems - Requirements for measurement processes and measuring equipment
ISO/TR 10017:2003 - Guidance on statistical techniques for ISO 9001: 2000
IWA 2:2003 - Quality management systems - Guidelines for the application of ISO 9001:2000 in education
ISO/TR 9126-2:2003 - Software engineering - Product quality - Part 2: External metrics
ISO/TR 9126-3:2003 - Software engineering - Product quality - Part 3: Internal metrics
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 15189:2003 - Medical laboratories - Particular requirements for quality and competence

TR = Technical Report; IWA = International Workshop Agreement.

You can track the status of the new and revised standards under development at <www.iso.org>.

In addition, the Introduction and Support Package of guidance brochures is being updated. Guidance on ISO 9001:2000 Clause 1.2, Application is being revised, as well as, Guidance on the Concept and Use of the Process Approach. A new brochure, Guidance on Outsourced Processes, is being developed (see our October 2003 newsletter on how to get a draft copy).

3. What Changes are Planned for ISO 9001?

Many of you have just completed the transition to ISO 9001:2000 and may not be ready to hear that work begins this month on the next ISO 9001 edition. However, don't panic, the publication date will likely be in 2008.

The changes to ISO 9001 are expected to be minor and driven by the users of the standard. Any changes will be to clarify the requirements and any additions will be to increase the value of using the standard. Most of the revisions will probably be to the ISO 9004 guidance document.

The US representatives have agreed to the following process for considering any ISO 9001 changes:

1. Do not change its structure.
2. Develop a process to identify weak areas.
3. Review AS9100, ISO/TS 16949, and TL 9000 to consider common add-on requirements.
4. Evaluate any new or changed requirements based on demonstrated, data-driven need.

If you want a voice in the revision process, you can complete the ISO 9001:2000 survey at: <http://www.asq.org/mr/psisurvey.html>.

4. Registration Totals for ISO 9000 in USA

As of September 2003, the total number of registrations for ISO 9000 and related standards in the USA were:

Standard	ISO 9000	AS9100	TL 9000	QS-9000	TS 16949	ISO 13485	ISO 14001
Totals	43113	954	229	7969	186	959	3078

ISO 9000 includes ISO 9001:2000, ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994.
AS9100 includes AS9100 and AS9000.
ISO 13485 includes ISO 13485 and ISO 13488.

5. Most Common ISO 9001:2000 Audit Findings

A report on the user experience with ISO 9001:2000 is available at: <http://standardsgroup.asq.org/news/psi/IMS06-2002E-Implementing_ISO_9001-BD.pdf>. The 227 survey responses included a ranking of the most common audit findings:

Most Common Internal Audit Findings

1. Customer satisfaction data and assessment
2. Documentation gaps
3. Continual improvement process
4. Objectives not measurable
5. Collection and analysis of data
6-7. Top management commitment and responsibility
6-7. Record keeping gaps
8-9. Competency requirements
8-9. Effective control of processes

Most Common Registrar Findings

1. Documentation gaps
2-3. Objectives not measurable
2-3. Top management commitment and responsibility
4. Continual improvement process
5-6. Customer satisfaction data and assessment
5-6. Effective control of processes
7-8. Collection and analysis of data
7-8. Record keeping gaps
9. Competency requirements

6. Whittington to Speak at Quality Conferences

The 12th Annual International Conference on ISO 9000 will be held in Orlando, FL on February 23-25, 2004. The presentation tracks will be:

1. ISO 9000 and Expanding Horizons
2. Integration and Implementation
3. ISO 9000 and Business Synergy
4. Value-Added Auditing
5. Continual Improvement
6. Healthcare and Medical Devices
7. Cutting Edge Tools and Technology
8. Performance Indicators

Larry Whittington will speak on "ISO 9001:2000 Auditing - The Process Approach". To register, go to <http://www.iso9000conference.com>.

The 13th Annual Quality Audit Conference will be held in Atlanta, GA on March 11-12, 2004. The conference is sponsored by the ASQ Quality Audit Division and will have tracks on:

1. Business Performance
2. Standards and Regulations
3. Quality Tools and Metrics
4. Auditing Education - Systems and Techniques
5. Value Based Auditing

Larry Whittington will present a paper on "ISO 9001:2000 Requirements: The Dirty Dozen". More information about the conference will posted at the Quality Audit Division web site <http://www.asqqad.org>.

7. Class Schedule for December, 2003 - February, 2004

To enroll in these public classes, go to Class Schedule at our web site, or call us at 800-404-7585. Classes taught by Larry Whittington are highlighted in yellow.

ISO 9001:2000 Lead Auditor (RAB Accredited) - BSI Management Systems
Initial course version developed by Larry Whittington

December January February

01-05 Dallas, TX 05-09 Houston, TX 02-06 Dallas, TX

08-12 Atlanta, GA 12-16 San Diego, CA 02-06 Detroit, MI

08-12 Orlando, FL - - 09-13 San Diego, CA

15-19 Los Angeles, CA - - 23-27 Reston, VA

15-19 Reston, VA - - - -

ISO 9001:2000 Internal Auditor (RAB Accredited) - BSI Management Systems

December January February

03-05 Orlando, FL 14-16 Houston, TX 18-20 Reston, VA

- - 27-29 Altanta, GA - -

Implementing ISO 9001:2000
Course developed by Larry Whittington

January February

12-13 Houston, TX 05-06 Atlanta, GA

- - 19-20 Reston, VA

Understanding ISO 9001:2000

January

23 Orlando, FL

Understanding ISO 9001:2000 Requirements (Atlanta Only - $295)
Course developed by Larry Whittington

February

02 Atlanta, GA

Quality System Documentation (ISO 9001:2000)
Course developed by Larry Whittington

December January February

08-09 Orlando, FL 22-23 Detroit, MI 03-04 Atlanta, GA

- - - - 23-24 Reston, VA

The above public courses can be offered on-site at your facility. In addition, we offer these on-site courses:

Understanding ISO/TS 16949:2002 Requirements (1 day) - Course developed by Larry Whittington
Internal Quality Auditing (2 Days) - Course developed by Larry Whittington (based on ISO 19011)

To arrange an economical on-site class, please call us at 800-404-7585.

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Whittington & Associates provides training, consulting and auditing services for quality systems based on ISO 9001, ISO/TS16949, TL9000, AS9100, ISO 13485, as well as, ISO 27001, ISO 20000, ISO 22000, and ISO 14001.