October 29, 2007  

Hi MBBP Subscribers,  

ISO 9000 certification vs. compliance... my view is that most customers do not require registration and certification but definitely look for ISO 9000 compliance when evaluating supplier qualifications.  

The difference in costs and the time required to complete each program is huge! In my opinion, the competitive advantages of ISO certification over ISO compliance is just not worth the added monetary and resource investment.  

Achieving compliance to ISO 9000 standards or requirements is one of the highest priorities in many companies today. Yet, for all of the urgency and focus, it s still, in many cases, a misunderstood and therefore misinterpreted requirement.  

This week's article focuses on the resolution of key issues relative to understanding and successfully implementing a program leading to compliance. 

Have a nice day, and stay connected.

Bill Gaw
Business Basics, LLC
bg@bbasicsllc.com
760-945-5596    

P.S. Be sure to visit our six sigma, black belt, and ISO guru's web page at: http://bbasicsllc.com/zalatan.htm

George Zalatan provides in-house training and consultingfor companies serious about optimizing their MRP, ERP, lean manufacturing, six sigma and quality performances. 

Check out his services at:  

http://bbasicsllc.com/zalatan.htm

SELF-DIRECTED ISO 9000 2000 COMPLIANCE 

The ISO requirements were established to provide an international standard of conformance to certain key criteria. The intent is to establish a base of common expectations and disciplines. 

Auditable conformance is then expected with continued adherence. Basically, conformance was originally necessary if you did, or planned to do, business in the European Community. However, the application of ISO 9000 has now spread to all business areas since the intent is for universal application.  

UNDERSTANDING THE REQUIREMENTS 

ISO 9000 requirements are written mainly in a generic or broad sense. This is because of the universal applicability objective which detail beyond a specific level would make impossible. 

The requirements are also written in the sense that the overall intent is accomplished. Specifically, this means that what you do is documented, how you do it is verifiable, and that control of documentation is established and maintained 

The following is a basic outline concerning definition of the key conformance elements: 

1.    Management Responsibility—relates to management role in policy creation, maintenance and conformance. 

2.    Quality System—requires a clearly documented quality system including a quality manual, clear procedures and work instructions, new product quality plan, measurements, capability, and inspection or monitoring methods. 

3.    Contract Review—involves verifying customer process needs, schedule, and cost, plus process conformance. 

4.    Design Control—involves clear documentation concerning the engineering change system. Specific areas include responsibility for changes, effectivity management, and design/process verification. 

5.    Document Control—concerns data base management and control, scheduling control and accuracy. Most important requirements relate to the creation, review, approval and maintenance of documents. These include responsibility and conditions under which documents can be changed. 

6.    Purchasing—involves the evaluation, selection, certification, and control of suppliers. It also involves maintenance and verification of documentation and data.

7.    Purchaser Supplied Product—concerns the storage, control, and accuracy of purchaser supplied items. 

8.    Product Identification and Traceability—looks for defined levels of traceability and specific controls. It also concerns methods of establishing and monitoring product identity. 

9.    Control of Production—concerns process identification, process control, process documentation, and documented work instructions. 

10. Inspection and Testing—looks for actions and controls in conformance with quality manual instructions and inspection/test instructions. These are specifically related to incoming, in-process, and final. 

11. Inspection, Measuring, and Test Equipment—involves conformance to required calibration and adjustment. Also requires protected storage, control, and accurate records. 

12. Inspection and Test Status—concerns documentation relative to conformance and reporting status. 

13. Control of Nonconforming Product—involves storage, control, dispositioning and reporting of non-conforming product. It also involves customer coordination of disposition. 

14. Corrective Action—defined procedures relative to failure analysis (internal and external), corrective action responsibility and control. Also look for verification of implementation and prevention of reoccurrence. 

15. Handling, Storage, Packaging and Delivery—involves packaging procedures, warehouse storage procedures and disciplines, and controls to prevent product deterioration and obsolescence. 

16. Quality Records—involves quality record maintenance, storage and availability. 

17. Internal Quality Audits—concerns conformance to quality manual and management directive. This requirement also requires corrective action procedures as the result of an audit. 

18. Training—requires documentation on training scope and content, responsibility for planning and coordination, authorization and funding. 

19. After-Sales Servicing—involves the need for policies and procedures to meet contractual and committed guarantees, warranties and other service activities. 

20. Statistical Techniques—as necessary, but well documented; to meet customer and/or internal performance standards. Does not require SPC or other specific inspection or monitoring techniques. 

EDUCATION AND TRAINING 

Education initially should involve management and a project team in understanding the requirements of ISO 9000 and which are applicable. This group should also be educated in the best approach toward structuring an implementation process, the key issues to be addressed, and the pitfalls to be avoided. 

Training should be conducted to ensure the following:  

1.    A clear understanding of procedures by those involved in their execution. 

2.    Actions taken are in conformance with the established procedures. Responsibility for education and training is the responsibility of each member of the project team as it applies to his or her area of responsibility.

A SPECIAL OFFER FOR MBBP BULLETIN SUBSCRIBERS

If your company is interested in mastering the 8-Basics of ISO 9001, a good approach would be to consider my Iso-9000:2000, PowerPoint Plus, Training Package... Including my e-Tutorial, "Self-directed ISO 9000:2000 Conformance."   

MBBP Subscribers can purchase their tutorial at a 51% discount from our bookstore price of $597.00; or for $397.00. Now that's a savings of $200 from retail and many more hundreds of dollars less than attending a relevant seminar. (And unlike a seminar, your tutorial will always be available for future reviews) Now that's an offer you shouldn't pass up.

You can check it out at: 

http://bbasicsllc.com/iso9000.MBBP.htm

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