ISO 9000: Some truths, half truths and just plain lies

The facts:
ISO 9001: 2000 is a generic standard applicable to any organization irrespective of size and product offering
This standard is built on the PDCA cycle of Deming

ISO 9001 is a shall document and like all shall documents (legal) it is possible to satisfy the shall requirements without addressing the intent of the standard (ISO 9004)

Consultants can can have your Company certified in one month by faking records

Specifications for your product/ service have to be developed by the organization it self unless your customer insists on complying with a specific product standard

Hence an ISO 9001 organization need not make Quality products
All that is required is consistency

Certain industry sectors have used the ISO 9001 structure and added additional requirements:

ISO/TS 16949 for automobile ancillary industry
ISO 13485 for medical devices
IEECEx has developed OD 005 for Ex products manufacturers

ISO 9001: 2008 will soon be released, wherein some of the intents have been converted into shall requirements

for more facts and criticisms
go here

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