View Full Version : How is this for extremes in updating to the ISO9001:2008 rev
ScottK 23rd July 2009, 09:51 AM Background: My company has two facilities making slightly different things. Both are registerd to ISO9001 using different registrars. I'm MR for Plant A. My colleague is MR for plant B.
In order to register to the 2008 rev:
My Registrar: He wants a formal, documented, process with formal review of the new rev and and affected documents plus records of training for senior management and internal auditors. Our next recert audit is next year.
My Colleague's Registrar: Just change the reference in the quality manual and you're good. His next recert audit is in two weeks or so.
According to the ISO guidance:
Organisations that are already certified to ISO 9001:2000 should contact their certification/registration bodies (CB/RB) to agree a programme for analysing the clarifications in ISO 9001:2008 in relation to their individual quality management systems and for upgrading their certificates.
I guess that gives a lot of leeway.
somashekar 23rd July 2009, 10:06 AM Background: My company has two facilities making slightly different things. Both are registerd to ISO9001 using different registrars. I'm MR for Plant A. My colleague is MR for plant B.
In order to register to the 2008 rev:
My Registrar: He wants a formal, documented, process with formal review of the new rev and and affected documents plus records of training for senior management and internal auditors. Our next recert audit is next year.
My Colleague's Registrar: Just change the reference in the quality manual and you're good. His next recert audit is in two weeks or so.
According to the ISO guidance:
I guess that gives a lot of leeway.
There are many ways of doing anything ....... ISO 9001 included. Its all to do with the clarity and sincerity of the purpose.
AndyN 23rd July 2009, 11:18 AM So, Scott, since we're a customer-focused organization where I work, here's ours.....'KISS'......:mg:;):notme:
ScottK 23rd July 2009, 12:08 PM So, Scott, since we're a customer-focused organization where I work, here's ours.....'KISS'......:mg:;):notme:
My registrar is not a proponent of the KISS philosophy.
Thanks for the doc, Andy.
Maybe I'll borrow the method but make it C.R.U.D. I'll think of something for the 'C' :lol:
SteelMaiden 23rd July 2009, 12:29 PM I was asked for a copy of the quality manual prior to the on-site visit (if there were any revisions since the last visit). One of the things the auditor asked for was a record showing that we had reviewed the new standard and identified any changes we needed to make to our system, quality manual or otherwise. Luckily, I had that documented in the management review that I provided the information to the management team and we discussed if we wanted to make any changes because of the new standard.
ralphsulser 23rd July 2009, 03:00 PM My registrar is not a proponent of the KISS philosophy.
Thanks for the doc, Andy.
Maybe I'll borrow the method but make it C.R.U.D. I'll think of something for the 'C' :lol:
Yeah, what a "crock":D
AndyN 23rd July 2009, 03:14 PM My registrar is not a proponent of the KISS philosophy.
Thanks for the doc, Andy.
Maybe I'll borrow the method but make it C.R.U.D. I'll think of something for the 'C' :lol:
As long as it's not 'C'opy.....!!
Kales Veggie 23rd July 2009, 05:09 PM Background: My company has two facilities making slightly different things. Both are registerd to ISO9001 using different registrars. I'm MR for Plant A. My colleague is MR for plant B.
In order to register to the 2008 rev:
My Registrar: He wants a formal, documented, process with formal review of the new rev and and affected documents plus records of training for senior management and internal auditors. Our next recert audit is next year.
My Colleague's Registrar: Just change the reference in the quality manual and you're good. His next recert audit is in two weeks or so.
According to the ISO guidance:
I guess that gives a lot of leeway.
It is time to look into consolidating registrars.
From your perspective, what makes more sense and what is best for your company and its management system?
ScottK 23rd July 2009, 05:21 PM It is time to look into consolidating registrars.
From your perspective, what makes more sense and what is best for your company and its management system?
That's not going to happen any time soon.
The registrar for my plant is also our CE marking notified body based in Belgium - he audits for both when he visits. The other plant doesn't CE mark and it's a separate brand so it's far cheaper to keep them separate and use a registrar with local auditors for that plant.
Kales Veggie 23rd July 2009, 08:58 PM That's not going to happen any time soon.
The registrar for my plant is also our CE marking notified body based in Belgium - he audits for both when he visits. The other plant doesn't CE mark and it's a separate brand so it's far cheaper to keep them separate and use a registrar with local auditors for that plant.
That makes sense.
For CE mark, you need 13485. Is that behind the more strict interpretation?
ScottK 27th July 2009, 10:27 AM That makes sense.
For CE mark, you need 13485. Is that behind the more strict interpretation?
Actually, we don't CE mark to the Medical Device Directive, we CE mark to the Pressure Equipment Directive so we don't need 9001 or 13485.
I think the strict interpretation is just how he makes sure his butt is covered.
Ted Schmitt 27th July 2009, 11:38 AM I'll think of something for the 'C' :lol:
How´s Complicate ? :lmao:
JaneB 28th July 2009, 01:05 AM Background: My company has two facilities making slightly different things. Both are registerd to ISO9001 using different registrars. I'm MR for Plant A. My colleague is MR for plant B.
In order to register to the 2008 rev:
My Registrar: He wants a formal, documented, process with formal review of the new rev and and affected documents plus records of training for senior management and internal auditors. Our next recert audit is next year.
Groan. This is overkill. Pity that you don't have an option to get another registrar.
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