Design Control 4.4
I would give the responsible manager a copy of 4.4 and tell him/her those are the requirements to meet. S/he doen't have a choice if your company plans to pass the audit. Typically this will come to a head when the registrar does a preassessment and the offending department 'fails' the audit.
I was doing an implementation some years ago. The plant manager told me that he didn't have to do mamagement review if he didn't want to and he didn't want to. I said fine. During the preassessment the auditors explained that compliance was not an option if they wanted to be registered. Yes - he complied before the registration audit.
It comes down to 'Who screwed up the registration?' if s/he decides that the ISO requirements do not apply to his/her department. I have no sympathy for 'head in the sand' people.
[This message has been edited by Marc Smith (edited 23 September 1999).]
That definitely won't cut it. I'd have a serious talk with the person in that capacity if they didn't have a defined, documented system. Design activity is more than a little bit important. The person is living in the 1950's.Subject: 4.4 Design Control
Date: Mon, 20 Sep 1999 07:32:56 -0700
From: "D., John"
To: [email protected]
We are preparing for a ISO 9001 audit in early November. Our Design Engineering manager has no structured documentation system but plenty of loose notes.
I really don't have such a check list. Maybe one of the others here can help you out.It has been extremely difficult to convince him that documentation, as described by the ISO standard, is the minimum expected from his department.
I have two questions:
1. Is there a engineering checklist available, one that has a guideline of progressive steps through an engineering design, verification and validation process that you can recommend.
The other option is to not register.2. If the engineering department does not approve in a developing methods that conform to the standard are there any other options?
Thank you for you time and great web site.
I would give the responsible manager a copy of 4.4 and tell him/her those are the requirements to meet. S/he doen't have a choice if your company plans to pass the audit. Typically this will come to a head when the registrar does a preassessment and the offending department 'fails' the audit.
I was doing an implementation some years ago. The plant manager told me that he didn't have to do mamagement review if he didn't want to and he didn't want to. I said fine. During the preassessment the auditors explained that compliance was not an option if they wanted to be registered. Yes - he complied before the registration audit.
It comes down to 'Who screwed up the registration?' if s/he decides that the ISO requirements do not apply to his/her department. I have no sympathy for 'head in the sand' people.
[This message has been edited by Marc Smith (edited 23 September 1999).]