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Updating to ISO 9001:2008 - I need to add section 7.3 Design and Development

Stijloor

Stijloor

Staff member
Super Moderator
#21
#21
artorius22 said:
I am faced with the carnage of a company converting from QS to TS with no changes other than renumbering. Unfortunately the system has grown to 30 procedures, 70 or 80 work instructions, and several hundred forms. My current task has reduced this monstrosity by 65%
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QS to TS? Wow, that's kinda late...
Don't fall in the "re-numbering" trap.
Keep the Process Approach in mind.

Stijloor.
 
Elsmar Forum Sponsor
A

artorius22

#22
#22
Sorry, should have been more specific. The company has been TS registered for several years but the transition did NOT focus on the process approach. An external consultant had been brought in to assist but still utilized the element method.
 
Stijloor

Stijloor

Staff member
Super Moderator
#23
#23
artorius22 said:
Sorry, should have been more specific. The company has been TS registered for several years but the transition did NOT focus on the process approach. An external consultant had been brought in to assist but still utilized the element method.
Click to expand...
Not a good consultant! :mg:

Stijloor.
 
A

AndyN

Moved On
#24
#24
artorius22 said:
Sorry, should have been more specific. The company has been TS registered for several years but the transition did NOT focus on the process approach. An external consultant had been brought in to assist but still utilized the element method.
Click to expand...
Please also seriously consider getting yourself another auditor/CB. If they've let you get this far without making a substantial change, I'm wondering what you've been paying for....
 
J

John Martinez

#25
#25
artorius22 said:
Sorry, should have been more specific. The company has been TS registered for several years but the transition did NOT focus on the process approach. An external consultant had been brought in to assist but still utilized the element method.
Click to expand...
What? For your consultant, the words of Buggs Bunny come to mind "what a maroon". :cool:
 
J

JaneB

#26
#26
Stijloor said:
Not a good consultant! :mg:

Stijloor.
Click to expand...
No, I concur. Such 'consultants' bring the very term consultant into disrepute, alas. You should have better. Any 'consultant' ignoring the process approach and taking an element approach a/doesn't really know what they're doing and b/isn't worthy of the term consultant. But 'someone who knows just a bit about 9001 but not enough' is a long phrase!
 
A

artorius22

#28
#28
Valid point!!! The company is meeting the intent of the standard but controlling documentation was a nightmare.

Regarding the consultant, they have been obsoleted via bringing me in as an internal auditor. Originally the company wanted me to begin auditing but the majority of the nonconformances from prior audits were document related. That's why I opted to revamp everything from the ground up.
 
John Broomfield

John Broomfield

Staff member
Super Moderator
#29
#29
TBDQM said:
Good Day fellow Forumers....

I am in a bit of what I call a pickle.... I have recently been hired on as a quality manager for an optical design and manufacturing company. This company designs and manufactures optical systems for a variety of different industries. They have not had a quality manager for over 12 months, and I was just informed that our surveillance audit is scheduled for December 15th. Prior to this audit, I need to add section 7.3 Design and Development, both policy and procedures to our certification. On top of this I recently found out that the ISO has changed to 2008. From what I have found, the changes are primarily clarifications. I am looking to see if anyone has a simplistic check sheet of what changes need to be made to a quality manual to meet 2008 requirements, this way I can focus more of my time on creating section 7.3, doing internal audits, and trying to have a management review meeting all in about two weeks. Any guidance on this topic will be much appreciated, as this is my first Quality position and I would like to keep it :), I have always been a Production Manager in the past. Thanks in advance to those that help!
Click to expand...
TBDQM,

How did the surveillance audit go? Do you need any help with the corrective actions?

John
 
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