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October, 2003

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October Articles
Training in Atlanta


1. Document Control - Basic and Extended

2. Answers to ISO 9001:2000 Questions 

3. Metrics for Customer Satisfaction

4. Quality Conference: October 27-28, 2003

5. Guidance on "Outsourced" Processes

6. Class Schedule: October, 2003 - December, 2003


To see previous articles, go to Newsletter Archives.


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

ISO 9001:2000 Lead Auditor
October  20-24, 2003; December 8-12, 2003

ISO 9001:2000 Internal Auditor
November 19-21, 2003

Quality System Documentation
December 4-5, 2003

Implementing ISO 9001:2000
November 17-18, 2003

Understanding ISO 9001:2000 Requirements
December 3, 2003

Training Classes in Other Cities

1. Document Control - Basic and Extended

You may know the ISO 9001 document control requirements, but what about the industry extensions for AS9100, ISO/TS 16949, and TL 9000, as well as, those for ISO 14001? These additional requirements may suggest good practices beyond the basic ISO 9001 document control.

According to ISO 9001:2000, clause 4.2.3, the document control process must:

  • Approve documents for adequacy prior to issue
  • Review, update as necessary, and re-approve documents
  • Identify changes and the current revision status of documents
  • Ensure relevant versions of applicable documents are available for use
  • Ensure external documents are identified and their distribution controlled
  • Ensure documents remain legible and readily identifiable
  • Prevent the unintended use of obsolete documents
  • Apply suitable identification for obsolete documents that are retained

Documents defined as records (for example, completed forms to be retained as evidence) must also be controlled (per 4.2.4). 

Aerospace:
AS9100:2001, Revision A, clause 4.2.3.1, adds that organizations must coordinate document changes with customers and/or regulatory authorities in accordance with the contract or regulatory requirements.
 
Automotive:
ISO/TS 16949:2002, clause 4.2.3.1, requires organizations to review, distribute, and implement customer engineering specifications and changes. These activities must be completed on the customer-required schedule. Also, the review must be done within two working weeks. Records must be kept of the change implementation date and documents must be updated as part of the implementation.

Telecommunications:
TL 9000:2001, Release 3.0, clause 4.2.3.C.1, states to establish and maintain a documented procedure to control all customer-supplied documents if these documents influence the design, verification, validation, inspection and testing, or servicing of the product.

Environmental:
ISO 14001:1996, clause 4.4.5, requires including the dates of the revision (not just the revision status). Documents must be maintained in an orderly manner and retained for a specified period. The document control procedure must cover the creation and maintenance of various types of documents.

Documents vs. Records:
Some organizations are unclear on the difference between a document and a record. Together, they are referred to by ISO 9001:2000 as documentation. 

  • Documents are plans and change over time. They have revision levels.
  • Records are evidence of what was done. They have retention periods.

When a document is superseded by a new revision, it is usually saved as a record of the previous process description. 
The master copy of a form is a controlled document. Blank copies of the form are uncontrolled copies. The completed forms are controlled as records. Refer to ISO 9001:2000 clause 4.2.3 for document control and clause 4.2.4 for record control.

2. Answers to ISO 9001:2000 Questions 

The U.S. Technical Advisory Group to ISO Technical Committee 176 created the Product Support Initiative (PSI) to aid in the understanding and implementation of ISO 9001:2000. The PSI web site <http://standardsgroup.asq.org/news/psi/index.html> contains answers to the following typical questions:

1. What are some examples of ways in which customer satisfaction can be measured to meet the requirements in Subclause 8.2.1?

2. What different ways or measures can an organization use to determine training ?

3. Have the requirements for evaluation of suppliers or vendors contained in ISO 9001: 1994 changed much in the 2000 edition?

4. What is the intent of Subclause 8.5.1, Continual Improvement?  Is a procedure needed to define this process?

5. What is meant by effectiveness of the QMS? 

6. How must an organization set up its internal audits to audit processes rather than independent clauses?

7. In practical terms, what is meant by demonstrating management commitment?

8. How are organizations implementing and using ISO 9001:2000 and ISO 14001:1996?

9. How do organizations that serve multiple sectors deal with the sector-specific quality management system (QMS) requirements while also dealing with the general QMS requirements of ISO 9001:2000?

10. Does the “review and re-approve” specified in Subclause 4.2.3 mean that an organization must engage in a periodic (e.g., annual) review and re-affirmation of all procedures, work instructions and other controlled documents?

11. When changes do occur (e.g., transitioning, upsizing, downsizing, new equipment/technologies), how does the organization demonstrate that the integrity of the QMS is maintained when changes are planned and implemented?

The answers to these questions (in PDF format) are listed as "Download Question" in the FAQs section of the PSI page.


3. Metrics for Customer Satisfaction 

The TL 9000 Metrics Handbook (for the telecommunications industry) contains guidance on customer satisfaction metrics that would be useful for ISO 9001 quality management systems. It gives basic guidelines for a customer feedback mechanism and refers to a detailed customer satisfaction survey. This information may assist you in the design or review of your own customer feedback program.

The purpose of the described metrics is to measure and improve the degree of customer satisfaction with your organization and its products from the customer point of view. Survey topics might include:

Quality of Delivery
  • on-time delivery
  • due dates met with consistent follow-up
  • competitive lead times
  • proper items and quantities
  • accurate identification and documentation
  • handling of emergency deliveries
Quality of Pricing
  • competitive pricing
  • stable and accurate prices
  • advance notice on price changes
Quality of Customer Service
  • compliance to contract items
  • representatives have sincere desire to serve
  • feedback provided from factory
  • cost effectiveness recognized
  • market insight
  • training provided on products
  • support on technical matters
  • invoicing efficiency
  • issuance of credit notices
  • order acknowledgment
  • adherence to company policy
Quality of Product
  • reliability/durability meets specifications
  • documentation, instructions, technology
  • packaging, suitability, environmental aspects
  • contract service quality
To see a sample survey, go to: <http://questforum.asq.org/public/tl9000support.shtml>. It has more questions than some customers would be willing to answer, and the response key is a little confusing, but you may see some topics of interest.
 
4. Quality Conference: October 27-28, 2003  

The Southeastern Quality Conference will be held at the Cobb Galleria Centre in Atlanta, Georgia on October 27-28, 2003. The conference is sponsored by the Atlanta ASQ Section, Institute of Industrial Engineers, and Georgia Tech Economic Development Institute.

Thirty speakers in up to four conference tracks will present quality subjects across a variety of industry sectors. The price is only $325 and includes lunch both days.

Speakers include:
  • Larry Whittington on ISO 9001:2000 Requirements: The Dirty Dozen
  • Dan Morris and Joe Davis on ISO 9001:2000 Internal Audits: The Process Approach
  • Craig Heier on Protect Your Business Data: Use ISO 17799 for Information Security
  • Paula Hughey on Control Your Quality Records: Use ISO 15489 for Records Management
  • Baskar Kotte on A Simplified Approach to Meeting ISO 9001:2000 Requirements
You can see the abstracts for these and other conference sessions at: <http://www.asqatlanta.org>.  

Please contact Larry Aft at 404-786-1541 or laft@bellsouth.net to register for the conference.

 
5. Guidance on "Outsourced" Processes

A new ISO 9000 "Introduction and Support Package" guidance document on outsourced processes is available at: <http://isotc176sc2.elysium-ltd.net>.

The aim of the draft document is to provide guidance on the intent of ISO 9001:2000 clause 4.1, regarding the control of outsourced processes, and to clarify the relationship between this requirement and those contained in ISO 9001:2000 clause 7.4 (Purchasing). A final version of the document is expected by YE2003.

6. Class Schedule for October, 2003 - December, 2003

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

ISO 9001:2000 Lead Auditor (RAB Accredited) - BSI Management Systems
Initial course version developed by Larry Whittington 
October November December
06-10  Orlando, FL 03-07  Reston, VA 01-05  Dallas, TX
13-17  Woodcliff Lakes, NJ 10-14 St. Louis, MO 08-12  Atlanta, GA
20-24  Atlanta, GA 17-21  Los Angeles, CA 08-12  Orlando, FL
20-24  San Jose, CA   - - 15-19  Los Angeles, CA
27-31  Houston, TX   - - 15-19  Reston, VA

ISO 9001:2000 Internal Auditor (RAB Accredited) - BSI Management Systems
October November December
15-17  San Diego, CA 12-14  Detroit, MI 03-05  Orlando, FL
  - - 19-21  Atlanta, GA   - -

ISO 9001:2000 Auditor Transition (RAB-Approved) - Course developed by Larry Whittington
October November December
23-24  Detroit, MI
03-04  Charlotte, NC 04-05  Dallas, TX
  - - 17-18  Los Angeles, CA 18-19  Orlando, FL

Implementing ISO 9001:2000 (for New Systems) - Course developed by Larry Whittington
October November December
14-15  Detroit, MI 13-14  San Jose, CA 01-02  Orlando, FL
  - -
17-18  Atlanta, GA
  - -

Understanding ISO 9001:2000
October November December
  - - 12  Los Angeles, CA   - -

Understanding ISO 9001:2000 Requirements (Atlanta Only - $295) - Course developed by Larry Whittington
October November December
  - -   - - 03  Atlanta, GA

ISO 9001:2000 Conversion (for Existing Systems) - Course developed by Larry Whittington
October November December
20-22  Detroit, MI 05-07  Charlotte, NC 01-03  Dallas, TX
  - - 19-21  Los Angeles, CA 15-17  Orlando, FL

Quality System Documentation (Revised for ISO 9001:2000) - Course developed by Larry Whittington
October November December
16-17  Detroit, MI   - - 04-05  Atlanta, GA
  - -   - - 08-09  Orlando, FL

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 new ISO 19011)

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


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