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

T

TBDQM

#1
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!
 
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Jim Wynne

Leader
Admin
#2
Re: Updating to ISO 9001:2008

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!
Welcome to the Cove :bigwave:

What might need to be changed in a QM to account for the 2008 changes depends on the contents of the manual. If its writer was smart, she made no reference to the standard at all, or if she did, she didn't refer to the revision level. On the other hand, if there are references to ISO 9001-2000 you'll need to either eliminate them (my preference) or change them to ISO 9001-2008. If the manual was otherwise compliant with the 2000 version, it will still be compliant with the 2008 version, because there were no substantive changes.
 
D

DrM2u

#3
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!
Indeed, the changes to the 2008 edition are minor, mostly clarifications and wording changes. I do not know what your quality manual looks like, but in general there should not be a need to change it. However, you have indicated that now the requirements of clause 7.3 are applicable. In that case you have to update the scope of the manual not to exclude 7.3 anymore. You will also need to update your definition/description of how the processes interract to include Product Design & Development. You might not need to update your procedures or reference to procedures unless you plan to have a procedure for 7.3 (not required).

As part of document control you will have to get a copy of the ISO 9001:2008 standard (priot to the audit) to replace the 2000 version (I got mine from ASQ, on-line). The new standard highlights the changes between the two; like I said, nothing major. Another source for learning about the changes is your registrar. Most likely they have some presentation or summary of the changes, so contact them ASAP. You might also want to ask the registrar if the audit can be postponed so you can buy some more time; in worst case you can proceed with the audit as planned and see what comes out of it. The worst that can happen is end up with a major finding or more and have to undergo a follow-up audit; the registrar is not going to pull your registration immediately. This should not be a reflection on you since if company did not follow its own quality system for a year. There is no magician who can turn around a QMS in two weeks!

As a side note, make sure you communicate with the executive management the current situation and what is to be expected so their expectations are not unrealistic. Let me know if you need more info and guidance. Good luck with the audit!
 
#4
Can I ask why it is that the section 7.3 must now be added to the manual. Are you now product design responsible? If so, then not only must you update your manual (scope and removed exclusion/justifications) and have a process for product design, (which has the applicable sub-clause requirements) you have to demonstrate it as implemented to be certified. Unlikely, given the short time frame!

Are you really saying that you went from not being design responsible to now being design responsible? Or is there something else in play here? I'd just like to get the fullest picture you understand.
 

Jim Wynne

Leader
Admin
#5
As part of document control you will have to get a copy of the ISO 9001:2008 standard (priot to the audit) to replace the 2000 version (I got mine from ASQ, on-line).
While it's certainly good to have a copy of the standard on hand, there is no requirement (outside of a local one) to have one, no matter what a benighted auditor might think.
 
B

brahmaiah

#6
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!
You donot have to make any major changes in the manuals.You just have to change the Standard No.to ISO 9001:2008 where ever it is referred as ISO 9001:2000.
V.J.Brahmaiah
 
A

anil123

#7
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!
1. At first momnet check your documentation if you would have wriiten ISO9001:2000 then replace it to ISO 9001:2008
2. You have to comply with the stutaory and regulatory requirements applicable to your Organization. For this prepare a list of all approvals you have received from Local Govt. Body.
3. You have to apply the 2nd requirement to your outsourcing process owner if you have any outsource process.
4. If you are outsourcing any service which is directly affecting quality is to be taken under approved supplier list also.

If you do all these 4 points you will get success. Basically these 4 points the externa auditor will check first during the audit.
 
T

TBDQM

#8
Can I ask why it is that the section 7.3 must now be added to the manual. Are you now product design responsible? If so, then not only must you update your manual (scope and removed exclusion/justifications) and have a process for product design, (which has the applicable sub-clause requirements) you have to demonstrate it as implemented to be certified. Unlikely, given the short time frame!

Are you really saying that you went from not being design responsible to now being design responsible? Or is there something else in play here? I'd just like to get the fullest picture you understand.
From what I was told, we have always been the engineering and design for our customers, but our customers have always headed the design process, taking full accountability. We were walking a fine line by excluding it from our original certification, but now we have customers that are requiring us to be certified with section 7.3.
 
T

TBDQM

#9
You might not need to update your procedures or reference to procedures unless you plan to have a procedure for 7.3 (not required).
Are you saying that I do not have to have procedures to reference 7.3?! Where would I find this in writing. Inevitably I will write procedures, because we do meet all of the documentation requirements, but if I could get away from having to have the procedures completed by audit time, this could allow me to focus on more important items.

I would like to thank everyone for there input!!
 

Jim Wynne

Leader
Admin
#10
From what I was told, we have always been the engineering and design for our customers, but our customers have always headed the design process, taking full accountability. We were walking a fine line by excluding it from our original certification, but now we have customers that are requiring us to be certified with section 7.3.
Are you saying that I do not have to have procedures to reference 7.3?! Where would I find this in writing. Inevitably I will write procedures, because we do meet all of the documentation requirements, but if I could get away from having to have the procedures completed by audit time, this could allow me to focus on more important items.
The question is about whether or not your company is design responsible. Without knowing more about the overall design process for your products it's hard to say. Generally speaking, if your company has unilateral authority to develop or change a design, you are design-responsible and 7.3 applies. This is a somewhat murky area. Regardless of the actual requirements of the standard, however, it appears that your company would at least want to control its part in the design process, so some form of internal design control requirements would be appropriate.
 
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