Quality Policy - Standards and reference numbers

[MarkySan]

Hi Folks,

Just a quick query and wonder if anyone could help.

In the past I've never added year references to standards mentioned in the Quality Policy and now a new Tech manager says they are necessary.

Do I need to add the year as in 13485:2016, etc.

Also, he says the company wants to get the CE mark and we should write that in also. To me thats a business objective and not a Quality Objective.

Am I losing my marbles? lol

Thanks folks

 

[FoGia]

The first question was tackled by a recent topic on the forum Essential Requirements Checklist references

I'm not a QA but the second question seems strange to me, what if you want want to develop a product solely to be commercialized in a region outside of the EU/not relying on EU requirements.

 

[ScottK]

Hi Folks,

Just a quick query and wonder if anyone could help.

In the past I've never added year references to standards mentioned in the Quality Policy and now a new Tech manager says they are necessary.

Do I need to add the year as in 13485:2016, etc.

Also, he says the company wants to get the CE mark and we should write that in also. To me thats a business objective and not a Quality Objective.

Am I losing my marbles? lol

Thanks folks

They are not "required" for general documentation. They may be necessary for a technical file submission so it is documented what revision the product was designed to. What I had done in the past for Pressure Equipment Directive was have a list of standards and just call out "current revision" as we actively managed 3rd party standard revision tracking.

I can see attaining CE mark approval as a quality objective. I would personally consider it a business objective because its purpose is opening new markets for the product, but much of attaining the approval is quality related so I could fit. But I would also consider that a goal... my quality objectives are more in the nature of ongoing KPI's and not single events.

 

[John C. Abnet]

Good day @markysan;
I would highly recommend against applying revision "dates" to any reference. This will make it very difficult to sustain and maintain accurate information/documentation. The "new"/"'current" version always supersedes the prior. A great example of poor foresight regarding this is Daimler/Chrysler's recent (current?) fleet of semi-trailers that boldly/proudly display a painted sign stating the long obsolete "ISO 9001:2000 certified". How embarrassing.
It is not a requirement of standard. I suggest always asking "why?". Why is it needed? Why would it be helpful? If there are no good answers to these questions, then I would opt to not.
Be well.

 

[AndyN]

Hi Folks,

Just a quick query and wonder if anyone could help.

In the past I've never added year references to standards mentioned in the Quality Policy and now a new Tech manager says they are necessary.

Do I need to add the year as in 13485:2016, etc.

Also, he says the company wants to get the CE mark and we should write that in also. To me thats a business objective and not a Quality Objective.

Am I losing my marbles? lol

Thanks folks

As John Abnet suggests, not required. I'd BET your Tech Mgr has had a bad previous experience with an auditor who demanded it...

 

[MarkySan]

Thank you everyone for your replies.

I haven't been putting the revisions on any documentation bar the controlled master stds list. The documents all do have a note say that the latest version is inferred.

I think AndyN you hit the nail on the head. Further discussion this morning I found that the questions came from a bad experience with an auditor who want 'everything' in exact detail. So I'm trying to assure the person that our method is proven and safe.

As for the CE - that is another battle for another day. But for now I've added as as a discussion point to our pending Management review so the discussion group includes all our top management.

Thanks again folks.

 

[kzachawk]

Mark, there are two issues
1. The Technical Manager is requesting a specific dating requirement for reference documents in the Quality Policy, which is not a requirement of ISO 9001. You might want to ask why he wants such so you can understand his point. Especially if the Quality Policy is electronic and allows one to select the related documents from the Quality Policy. My question would be does that specific dating indicate your revision status of a related document? If so, then he/she is simply asking for revision reference to be included.
It is a management request, therefore it can be viewed as a requirement, however the point of reasonableness could be argued as well as the cost which will fall upon the manager requesting such a revision.
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2 The second is the CE mark which arguably can be included under the interested party requirement of the revised standard however if you are 18001/45001 and or 14001, (EHS) then read this remark concerning the EU CE mark .....
-
CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.*
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Therefore it might be best served if the CE mark fall under the respective EMS and or HSMS management systems. and not your QMS system.

 

[QualitySteve]

Just had an ISO 9001:2015 surveillance audit and the auditor wrote this. I don't see this as a nonconformance. What difference does it make if I add the word "effectiveness" to the policy.


Auditor statement:

The Quality Policy indicates a commitment to continually improve the effectiveness of the QMS. The requirement is now to continually improve the QMS. There is a difference. An organization can improve a QMS without improving the effectiveness of the QMS

 

[AndyN]

Just had an ISO 9001:2015 surveillance audit and the auditor wrote this. I don't see this as a nonconformance. What difference does it make if I add the word "effectiveness" to the policy.


Auditor statement:

The Quality Policy indicates a commitment to continually improve the effectiveness of the QMS. The requirement is now to continually improve the QMS. There is a difference. An organization can improve a QMS without improving the effectiveness of the QMS

Your auditor is grasping at straws. Some CB auditors are under pressure to "find" things to report. Reject the finding to the CB and suggest this is semantics. Ask for the auditor's qualification in English language which proves they understand the difference...

 

[QualitySteve]

Thanks AndyN!