Who is registered to ISO 9001:2015?

Crusader

Trusted Information Resource
#1
who's registered and/or beyond the stage 1 assessment? What was/is the trickiest hurdle to get past?

I'm only just beginning to address. Again, I'm a one girl band and I have a lot of work to do!
 
Elsmar Forum Sponsor
#2
Re: Anyone registered yet to ISO 9001:2015?

We will go for it next year, but the Gap Analysis is done, and we are set up for a workshop with the Management Group, where we will work our way through 4.1, 4.2 & 4.3. :read:
 

Kales Veggie

People: The Vital Few
#3
Re: Anyone registered yet to ISO 9001:2015?

As a CB auditor, I have completed two ISO 9001:2015 certification audits (stage 1 and stage 2) and have recommended both companies for registration to my CB. Both are now certified. They were not certified to 9001:2008. Several transitions scheduled for the next few months. As a consultant I have trained 10s of ISO 9001:2015 internal auditors and have augmented two ISO 9001:2015 QMS.

If you are already 2008, a stage 1 and stage 2 are not necessary. Your organization will undergo a transition audit (should be about 50% of the annual surveillance audit duration). This maybe negotiable with your CB as well. The best solution, I think, is to combine the transition with the surveillance audit.

There is a lot of hype about risk based thinking. Some forget the positive side: opportunities. Risk exists every day in the business world (competition, new technology, new regulation, customer requirements, suppliers, material shortages, personnel shortages, sometimes global events). It is often just a matter of linking RBT with what an organization does daily, medium term and long term.

Biggest hurdle for some organizations: Leadership involvement. (pawning it off to the Quality Manager is no longer acceptable).

Do not wait too long. Come 2017 and 2018 the CBs will be buried with transitions and recertifications and there maybe a shortage of auditors.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Re: Anyone registered yet to ISO 9001:2015?

I am doing my 3rd Stage 1. It is for a corporate office that provides management services support to its various military contracting sites. I must admit it is a challenge, even how often I have preached "We CB auditors will need to grow some more imagination in how the requirements are applied" it is not so easy to decide on conformance in all cases. I can forsee a lot of variation in CB expectations and the need to "recalibrate" the thinking of old horse auditors who would prefer a more linear approach versus the rather abstract nature of the thing now.

It's important to come back to the basics and not read too much into it. And harken back to the Technical Committee's guidance as often as needed.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#6
Re: Anyone registered yet to ISO 9001:2015?

If you are already 2008, a stage 1 and stage 2 are not necessary. Your organization will undergo a transition audit (should be about 50% of the annual surveillance audit duration). This maybe negotiable with your CB as well. The best solution, I think, is to combine the transition with the surveillance audit.
My CB is doing it with a full number of S1+S2 audit days, with no reductions allowed except for integration with other standards. I don't know how your accreditation differs from ours in that you can do it in less time, but I can offer that I have seen no directive about time from IAF or ANAB.
There is a lot of hype about risk based thinking. Some forget the positive side: opportunities.
I am not sure if you are referring to ISO/TC 176/SC2/N1222 (July 2014), but it has been updated to ISO/TC 176/SC2/N1284, in which the verbiage was changed to say "Opportunity is not the upside of risk." (I hope I didn't misunderstand you)
 

DRAMMAN

Quite Involved in Discussions
#8
Re: Anyone registered yet to ISO 9001:2015?

Kales
What have been the challenges with leadership involvement? What do you look for in an audit?
 

dsanabria

Quite Involved in Discussions
#9
Re: Anyone registered yet to ISO 9001:2015?

Biggest hurdle for some organizations: Leadership involvement. (pawning it off to the Quality Manager is no longer acceptable).

I spent a lot of time looking for this requirement but I cold not find it - can you let me know which clause is in. My concern is the newbies will take this as gospel and possible create a new requirement.:rolleyes:

NOTE: Top management and Quality Manager are one and the same in small companies.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
Re: Anyone registered yet to ISO 9001:2015?

NOTE: Top management and Quality Manager are one and the same in small companies.
In my auditing experience, which spanned two decades, the opposite was true. Especially in smaller organizations, the person leading the quality function had very limited authority over the direction of the company. Actually, their scope of authority was limited, even in issues related to product conformity and customer satisfaction issues.

I am surprised that you deal with so many small companies where the quality manager directs the organization.

Just to keep us sane, the ISO 9000 definition of top management:
3.1.1 top management:
person or group of people who directs and controls an organization at the highest level
 
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