ISO 9000 Quality System

 

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A Certified Facility

ISO 9000 QUALITY SYSTEM

WHAT IS ISO 9000?

 ISO 9000 is the generic term for a series of standards sponsored by the International Organization for Standardization which specify the quality system to be established by manufacturing and service firms. It is the descendent of, and almost directly parallel to, British standard BS-5750, and is identical in most respects to European standard EN-29000 and the American standard Q90, sponsored by the American Society for Quality Control.

ISO 9000 is a system for establishing, documenting and maintaining a system for ensuring the quality of the output of a process. ISO 9000 certification is a tangible expression of a firm’s commitment to quality that is internationally understood and accepted. It is not mysterious or esoteric; it is, rather, a group of common sense and generally well known precepts laid out in an organized fashion.

ISO 9000 certified organizations almost universally realize major increases in customer acceptance as well as reductions in costs. Many American firms, already subject to quality systems standards imposed by major customers, find that the major effect of ISO 9000 certification is on their non-manufacturing functions, which tend to be overlooked by manufacturing-based quality systems.

ISO 9000 certification is by facility, not by firm. Facilities become certified when their quality system is shown to meet the ISO 9000 standard in terms of documentation and performance. Certification is carried out by accredited organizations, basically by

1) reviewing the facility’s quality manual to ensure that it complies with the standard, and 2) auditing the firm’s process to ensure that the system documented in the quality manual is in place and effective. Once certification is obtained, the certifying body conducts semi-annual audits of the facility and oversees changes and evolutions of the facility’s quality system to ensure that it continues to meetthe requirements of the Standard.

ISO 9000 has three "parts." Firms apply for certification under the part which most closely fits their form of enterprise.

produce, install and service products or service to customers who specify how the product or service is to perform. ISO 9001 consists of 20 sections.

ISO 9001, the most comprehensive part, applies to facilities which design/develop,
ISO 9002 applies to facilities which provides goods or services consistent with designs or specifications furnished by the customer. It consists of 19 sections.
ISO 9003 applies to final inspection and test procedures only. It consists of 12 sections.

The following chart compares the pertinent sections of each part of the Standard.


ISO 9000 Section Cross Reference

 

SECTION

ISO 9001

ISO 9002

ISO 9003

4.1 MANAGEMENT RESPONSIBILITY

*

* *
4.2 QUALITY SYSTEM * * *
4.3 CONTRACT REVIEW * * n/a
4.4 DESIGN CONTROL * n/a n/a
4.5 DOCUMENT CONTROL * * *
4.6 PURCHASING * * n/a
4.7 PURCHASER SUPPLIED PRODUCT * * n/a
4.8 PRODUCT IDENTIFICATION AND     TRACEABILITY * * *
4.9 PROCESS CONTROL * * n/a
4.10 INSPECTION AND TESTING * * *
4.11 INSPECTION, MEASURING & TEST EQUIPMENT * * *
4.12 INSPECTION AND TEST STATUS * * *
4.13 CONTROL OF NON-CONFORMING PRODUCT * * *
4.14 CORRECTIVE ACTION * * n/a
4.15 HANDLING, STORAGE, PACKAGING, AND DELIVERY * * *
4.16 QUALITY RECORDS * * *
4.17 INTERNAL QUALITY AUDITS * * *
4.18 TRAINING * * *
4.19 SERVICING * * *
4.20 STATISTICAL TECHNIQUES * * *
 

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