My customer wants to get ISO 9001:2015 certified. He refuses to create a first-article, in-process, and final-inspection report. He has a router sheet that has a tiny space for final inspection brief information and the operator’s initials; no inspection data is available.
In his quality manual and processes he addresses “Time Studies” and “Statistical Process Control” but he refuses to record his inspection data because this “complicates and delays” his production. I told him this is a weakness in his QMS but he says it’s not. Will this issue jeopardize his ISO certification?
I would ask how the organization could present objective evidence with the requirements of Clause 8.5.1 including – ‘shall implement production and service provision under controlled conditions.’
Do EHS procedure have to be managed under ISO 9001:2008 if the company is not ISO 14001 certified?
It depends – are the EHS procedures part of the QMS of the organization. If so, yes. Otherwise no.
Recently one of our business units had an ISO 9001: 2008 audit and during the audit they received a couple NCRs on welding as a special process.
One of the NCRs was “Some welders are not qualified prior to welding on product.”
As a matter of fact, our company has developed its own qualification program based on the our needs consisting of the following steps:
– The minimum requirement of least 2 years or more experience as a welder before starting the job.
– In class training for weld specifications, blue print reading, equipment, weld supplies, visual acceptance/ rejection criteria and equipotent TPM program conducted by our QE.
– Hands on exam – the result of this test is reviewed by a QE and weld supervisor without performing any bend test, pull test or other types of DT.
– Annual recert. program based on a written exam and weld coupons visual inspection results.
The CB auditor is asking us to send the coupons out to a certified lab for bend testing or having all the welders certified by AWS. Is that required per ISO 9001? As a side note, every time we design and develop a new model we conduct all types of crash tests, FEA and durability testing in design validation phase.
From George Hummel:
I would not accept the auditor’s comments. He/she is consulting.
From Charles Cianfrani:
No. It appears that the CB auditor is adding requirements. The organization has a process, and if it is effectively implemented that should be satisfactory evidence of conformity.