An overview of ISO 9000 and a discussion of the required elements for an effective Quality Management System. ISO 9000 is an international Quality Management Standard developed by the International Standardization Organization (ISO). The American National Standard is designated ANSI/ASQC Q9000 and has a word for word correspondence. ISO 9000 evolved from Mil-Q-9858A, the US Military & Aerospace quality standard. ISO 9000 is applicable to the following product categories.
Bass Associates Inc. has been actively involved in Quality Control since 1969, when it was founded as Minnesota's first Consulting Engineering Firm specializing in Electronics, Quality, Reliability & Maintainability Engineering. Bass Associates Inc. can help clients establish ISO 9000 compliant Quality Management Systems in addition to providing Reliability Engineering Analysis for specific products.
ISO 9000 defines WHAT you must do to conform with International Standards for a Quality Management System. Bass Associates Inc. provides the broad scope engineering support to determine HOW to get there, building upon the Quality System that you currently have in place.
Designing and Implementing a ISO 9000 Quality Management System is not a trivial exercise. The Quality and Reliability of a product is a function of the basic design, piece part reliability and the manufacturing process. Everyone involved in producing a product, from the vendors to the field engineers, contributes to a systems Reliability.Virtually every department in a company will have some Quality related responsibilities. Most of the elements of an ISO 9000 compliant Quality Management System already exist in most companies. However, responsibilities are spread between departments, often overlapping and are not coordinated to provide the level of control necessary to meet ISO 9000.
Designing and implementing an ISO 9000 Quality Management System is a delicate job where an outside consultant, with no hidden agenda, has a significant advantage over internal staff. The system should be designed to utilize as much of the existing company structure as possible. The management and control of each element of the system will be assigned to a specific department or person. Implementation of the system will require commitment from senior management and the willingness to accept ownership from virtually every department in the company.
Each company is organized differently with unique requirements and capabilities. All ISO 9000 Quality Management Systems include the following elements.
Quality Management System Elements:
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