Quality for value adding or certification?

[Jen Kirley]

Such good responses so far.

I agree that the basic issue is top management not seeing a connection between the ISO 9001 elements and the business case. That has happened a lot in the 2008 version. The next version of the standard will be a bigger help in making a system with clearer connections to business interests, if it's true that your top management is already considering risk and do not blunder along with blinders on.

So you might as well start with that, but management needs to understand the internal audits are needed and resourcing of support processes will still be expected.

I also agree that you should start shopping for a new, accredited registrar with a good reputation. I haven't seen the audit reports and notes, but based on what you describe I find it really troubling to think your organization has kept its certificate. You can't do anything about the past but the enabling can't continue.

If, as you go along you continue to get pushback or dragging of feet from Management, by all means I would look elsewhere. Your job is hard enough in a group that cares.


Information on the new ISO 9001 standard can be found here:

http://www.iaf.nu/upFiles/IAFID9Transition9001PublicationVersion.pdf
http://isotc.iso.org/livelink/livel...-8835848/8835872/8835883/ISO9001Revision.pptx
http://isotc.iso.org/livelink/livel...35872/8835883/ISO9001Risk_Based_Thinking.pptx
http://isotc.iso.org/livelink/livel.../-8835848/8835872/8835883/ISO9001andRisk.docx
http://isotc.iso.org/livelink/livel...35883/ISO9001Transition_Planning_Guidance.pdf
http://isotc.iso.org/livelink/livel...5872/8835883/ISO 9001Correlation_Matrices.doc

I hope this helps!

 

[Golfman25]

I'm going to venture a guess that something is missing in this story. Seems as thought the person is new to the company and there probably is a communication failure somewhere. I find it hard to believe there have been un-corrected majors since 2013. I wonder if they are even certified.

 

[Big Jim]

I'm going to venture a guess that something is missing in this story. Seems as thought the person is new to the company and there probably is a communication failure somewhere. I find it hard to believe there have been un-corrected majors since 2013. I wonder if they are even certified.

The sense I'm getting here is that something was turned into the registrar, but it was just window dressing, not real, and the in fact nothing changed other than something was written on paper but never really addressed.

It also occurres to me that top management doesn't want either a different auditor or a different certification body. They like things how they are. That will make it harder for the OP to really accomplish anything.

 

[PaulJSmith]

First - Purchase a copy (or borough) of ISO 9001:2015 ...

That has not yet been published in its final form, so they would only be buying (or borrowing) a draft copy, which may or may not change between now and actual publication. There's no reason they cannot accomplish what needs to be done using the current 9001:2008 standard, to which they would be certified.

Aside form that, though, all great advice from everyone.

Admire your determination to stay and make a difference, wc. Good luck.

 

[dsanabria]

That has not yet been published in its final form, so they would only be buying (or borrowing) a draft copy, which may or may not change between now and actual publication. There's no reason they cannot accomplish what needs to be done using the current 9001:2008 standard, to which they would be certified.

Aside form that, though, all great advice from everyone.

Admire your determination to stay and make a difference, wc. Good luck.

Agree...

Meant to say draft copy .. but the reality is that they should use the actual standard that has not changed in requirements.

Thanks for the catch and observation.

 

[normzone]

All of the above replies hit the spot. It sounds as though our original poster is the " second person through the mine field ". It's much better to be the third person, but you take your challenges as they are offered to you.

Yes, do an exhaustive internal audit WITHOUT breaking whatever is working so far. And write nonconformances wherever appropriate, but no need to rub it in - one for every clause of the standard should be sufficient

Research your certifying body. Are they known as a " we certify anybody for money " outfit ? Be prepared to have to change CBs if so. Your cert will not be respected by your customer base if it is a sham. If top management is happy with that, then plan your own survival, since the task is a lost cause.

And lay all your cards on the table to the external auditor. Ask their assistance in documenting the lack of support and resources.

Keep digging - there must be more records someplace. Do an archeological dig on your predecessor's office.

 

[wileycomet]

Thanks everyone. I think the biggest challenge is a lack of understanding, so I aim to tackle that and then hopefully set about changing people's mindsets.

My predecessor didn't believe in filing or keeping things on the network so a lot of the necessary information is lost.

 

[jmlacroix]

What I do not understand is how the company kept the ISO 9001 certification with a major conformity on internal audit: with a major, it has to be resolved within a plan within 30 days ir so, and compliance has to be seen at the next maintenance audit, ortherwise the certification is lost. And to get 9001 in the first pla e, you absolutely need a working internal audit system with no major non-conformities.

 

[wileycomet]

So, it turns out the previous quality coordinator had been conducting audits at each site. However they were using a basic compliance checklist that asked questions like:

Confirm that documents are on letter-headed paper.

Confirm meetings are being conducted

Confirm records are maintained

These were all maintained in paper-format in a cabinet elsewhere which is why everybody had a hard time finding them.

I am proposing a process audit approach so that we can actually add value to the business by auditing, rather than ticking boxes for the sake of it.

Thanks for all of the advice.

 

[prady2581]

Hi All,
I agree to the view points shared by all in this post. For NC it is CB responsibility to seek the CA / PA mutually convincing to your organization and Auditor, then the follow-up activities starts and usual time-frame is 60 to 90 days for closure. It is indeed surprising how your registrar deviated from this imp aspect revealed from your facts.
Change in Registrar is a good suggestion. If at all it gets detected in the Random Audit from Accreditation Body of CB then it is time for suspension I believe.

He has to fix the issues in whatever ways and very soon.