The ISO 9000 Standards for Quality Management Systems. ISO stands for “ I nternational S tandards O rganization” The source of ISO 9000 and more than 13,000 international standards for business government and society - PowerPoint PPT Presentation
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The ISO 9000 Standards for QualityManagement Systems
ISO stands for “International Standards Organization”
The source of ISO 9000 and more than 13,000 international standards for business government and society
A network of national standards institutes from 140 countries working in partnership with international organizations governments industry business and consumer representatives. A bridge between public and private sectors.
Note: ISO has an excellent website: http://www.iso.ch/Alan G Robinson@2002
ISO 9000:2000 ISO/DIS 10012 ISO 9001:2000 ISO 10012-2:1997 ISO 9004:2000 ISO 10013:1995 ISO 19011 ISO/TR 10014:1998 ISO 10005:1995 ISO 10015:1999 ISO 10006:1997 ISO/TS 16949:1999
ISO 9000:2000 Quality management systems - Fundamentals and vocabulary
Establishes a starting point for understanding the standards and defines the fundamental terms and definitions used in the ISO 9000 family which you need to avoid misunderstandings in their use.
ISO 9001:2000 Quality management systems – Requirements
This is the requirement standard you use to assess your ability to meet customer and applicable regulatory requirements and thereby address customer satisfaction. It is now the only standard in the ISO 9000 family against which third-party certification can be carried.
ISO 9001:2000 Quality management systems - Requirements
This is the requirement standard you use to assess your ability to meet customer and applicable regulatory requirements and thereby address customer satisfaction. It is now the only standard in the ISO 9000 family against which third-party certification can be carried.
ISO 9004:2000 Quality management systems - Guidelines for performance improvements
This guideline standard provides guidance for continual improvement of your quality management system to benefit all parties through sustained customer satisfaction.
ISO 19011 Guidelines on Quality and/or Environmental
Management Systems Auditing (currently under development) Provides you with guidelines for verifying the system's ability to achieve defined quality objectives. You can use this standard internally or for auditing your suppliers.
ISO 10005:1995 Quality management - Guidelines for quality plans
Provides guidelines to assist in the preparation review acceptance and revision of quality plans.
ISO 10015:1999 Quality management - Guidelines for training
Provides guidance on the development implementation maintenance and improvement of strategies and systems for training that affects the quality of products.
ISO/TS 16949:1999 Quality systems - Automotive suppliers
Particular requirements for the application of ISO 9001:1994 Sector specific guidance to the application of ISO 9001 in the automotive industry.
The technical, administrative and human factors affecting the quality of (the company’s) products and services will be under control. All such control should be oriented towards the reduction, elimination and, most importantly, prevention of quality deficiencies ...... the quality management system (should) be appropriate to the type of activity and to the product or service being offered.”
“Less than 1 percent of the small and midsize companies in the U.S. presently have a quality system that comes close to satisfying the requirements of ISO 9001 or 9002.”
“In a survey of 600 companies, less than 10 percent of the cost of registration was spent on the registrars themselves.”
The cost is not for the registrars; it is for the internal work to put the system in place.
For most U.S. companies, COQ amounts to between 20% to 40% of sales. In most companies, the cost of poor quality is a large sum, frequently larger than the company’s profits.
Frank Gryna
COQ is comprised of:
Internal Failure Costs:
Scrap, rework, failure analysis, scrap and rework (suppliers), downgrading, 100% sorting inspection, reinsertions/retest, avoidable process losses.
External Failure Costs:
Warranty costs, complaint adjustment, returned material, cost of concessions, liability, litigation.
Receiving inspection and test, in-process inspection and test, final inspection and test, product quality audits, calibration of test equipment, evaluation of materials inventory.
Prevention costs:
Training, supplier quality evaluation, quality planning, new-products review, corrective action system, process planning and control.
There is a direct relationship between productivity and quality. As quality goes up, so does productivity. Quality and productivity are different aspects of the same thing.
W. Edwards Deming
Manpower is something that is beyond measurement. Capabilities can be extended indefinitely when every one begins to think.
Taiichi Ohno
ISO 9000 is really a process improvement standard. It will improve your quality and productivity at the same time.
1. The supplier of a service shall be liable for damage to the health and physical integrity of persons or the physical integrity of movable or immovable property, including the persons or property which were the object of the service, caused by a fault committed by him in the performance of the service.
2. The burden of proving the absence of fault shall fall upon the supplier of the service.
3. In assessing the fault, account shall be taken of the behavior of the supplier of the service, who, in normal and reasonably foreseeable conditions, shall ensure the safety which may reasonably be expected.
There are two kinds of product: regulated and unregulated.Regulated products are those for which the EU has stepped in to
pass Europe-wide directives. They are products that the EU feels have significant and health, safety, or environmental issues associated with them.
According to U.S. Dept. of Commerce, regulated products make up some 50 percent of U.S. exports to Europe.
Unregulated products are those for which no specific European-wide directives have been made.
Trade barriers removed by EC laws requiring mutual acceptance and recognition of unregulated and regulated products that meet EU directives and/or the health, safety and environmental concerns of the receiving state.
Virtually every purchase agreement, contract and specification written by European industries, institutions, and governments will likely include a “boilerplate” requirement that mandates a contractors to demonstrate compliance with ISO 9000.
Rough Implementation Profile 1. Set up a steering group 2. Review existing procedures against the appropriate
ISO9001-9003 standard requirements
3. Identify what needs to be done 4. Establish a program 5. Define and implement new procedures 6. Compile quality manual 7. Meet with assessment body 8. Submit manual for approval 9. Assessor’s visit10. Certification
Standards setting in U.S. performed mainly by private sector.
In the United States:
behind scenes fighting going on between NIST, ANSI and ASQC for control of registrar accreditation;
many U.S. labs or registrars are recognized in EC;
European registrars have established offices in U.S.;
The EC has done a masterful job of exploiting differences between the U.S. and European standard-setting systems and government-business relationships for its own advantage.