Outsources Processes, ISO 9001:2000

Questions concerning outsourced processes and the requirements that will be audited both internally and by external parties

Many clients and friends have had questions concerning outsourced processes and the requirements that will be audited both internally and by external parties. This link, http://www.4iqc.com/N630.pdf, written by ISO/TC 176, clearly explains that an organization must demonstrate how it controls the process (per clause 4.1). The process for selecting and evaluating an outsourced process is contained in Purchasing, 7.4. No where in the document does it state that an auditor can substitute his/her judgment on the qualifications of the process provider. Nor does the document, or the Standard, require that the "control of outsourced processes" be documented. It would be enough to show the process as a component of the Master Process Flow (for those of you who have one) or describe it in a written Quality Manual. The requirement for evaluation of a supplier (of an outsourced process) is in ISO 9001:2000, 7.4.1.

If you have any questions regarding this issue, please email me, george@4iqc.com .

Regards,

-- George