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 firms 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 facilitys quality manual
to ensure that it complies with the standard, and 2) auditing the firms 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 facilitys 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.
| |
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 |
* |
* |
* |