Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025

[John Broomfield]

Is the top-down design and operation of a general QMS (i.e., agnostic to any particular standard) taught anywhere? Or is this found only in the lore of the grizzled veterans of quality who have in the past battled and slain the hydra of multiple standards?

Or have we all (or most) learned from the bottom-up, typically by mgmt saying 'here is a standard we need to comply with, so it says we need something called a "QMS" - go build it'? Then, when another standard becomes an additional requirement, the extant QMS may be so tailored to the first standard and ill-fitting for the new standard that - for a moment - it seems almost more practical to make a second system side-by-side. And thus the struggle to generalize the QMS begins anew for each org; some with duct tape and staples to just barely make the second standard fit, others with more grandiose hopes of a QMS paradise where all standards are equal and welcome; all of us striving to reinvent the wheel of a general QMS a thousand times over.

Methodologies for developing the way an organization works as a system of interacting processes so such a system conforms to ISO 9001 and other system standards exist and have done for over 30 years.

We start with the organization or system as it is. We are not there to impose our system, the standard or procedures from our laptop.

Here is an example from the Cove six years ago:

Implementing ISO 9001 and ISO 22000 systems at the same time

Admittedly, many folk are led astray by that unfortunate term “implement the standard” instead “develop your management system”.

Consequently, we were also slow to recognize that QMS is a subsystem, part of the BMS or, better still, part of the system that is the organization.

 

[Sidney Vianna]

Admittedly, many folk are led astray by that unfortunate term “implement the standard” instead “develop your management system”.

I would go one step even further: many folks (in many cases, several pay grades below the top) are told: get us certified, cheaply and quickly.

 

[Johnnymo62]

Where, in your QMS, do you deal with cash flow? Or waste management?

The BMS is enterprise-wide and goes way beyond the issues related to customer satisfaction and product conformity, since, there is so much more to run a business than to keep customers happy.

Start by adding both to the objectives, 6.2. Then they would be resources and infrastructure, respectively.

 

[John Broomfield]

Indeed, prompt payment may be a quality metric...

 

[Sidney Vianna]

Start by adding both to the objectives, 6.2. Then they would be resources and infrastructure, respectively.

So, you seem to be in that camp of people who thinks ISO 9001 is the answer to all business challenges. Oddly enough, no program for Masters in Business Admin touch on quality management.

And ISO is just wasting their time developing a myriad of other management system standards.

 

[Johnnymo62]

So, you seem to be in that camp of people who thinks ISO 9001 is the answer to all business challenges. Oddly enough, no program for Masters in Business Admin touch on quality management.

And ISO is just wasting their time developing a myriad of other management system standards.

I think a B/QMS is needed because customers have learned not to trust suppliers to be reliable. The customers have been burnt and have pushed the liability down to suppliers.

Most of the rest of my opinions like this get political, like the ideas of globalization, over-regulation and coercive business practices. I do not want to go there, on this forum.

Opinions are like arm pits, almost everyone has them and they almost always stink.

 

[Ninja]

I think a B/QMS is needed because customers have learned not to trust suppliers to be reliable.

FWIW, I think a QMS (and BMS) is needed because it optimizes Net Profit After Taxes..."doing it cheap and easy" without getting to the core purpose of it avoids the core purpose of sustainably increasing NPAT.

 

[techlady]

My company is very convoluted with several "separate" systems for ISO/ IATF 16949 and ISO14001, and then looking into implementing ISO 45001. We have issues with document control and trying to manage all these documents. I noticed some of the findings for ISO/IATF 16949 and ISO 14001 were against the same ISO9001 clauses and category, because our systems are not integrated, corrective actions and findings are managed separately. Our current registrar is telling me that ISO/IATF cannot be audited as part of an Integrated Management System (IMS). I looked in the IATF 16949 Rules 5th and did not see anything that says it cannot be audited with together. Since the basis of these standards is ISO9001 the system can be integrated. So why can't the registrar audit the IMS with different auditors for the specified disciplines, one auditor for ISO 14001 and one auditor for ISO/IATF? I need some understanding....please help

 

[techlady]

So, you seem to be in that camp of people who thinks ISO 9001 is the answer to all business challenges. Oddly enough, no program for Masters in Business Admin touch on quality management.

And ISO is just wasting their time developing a myriad of other management system standards.

Hi Sidney,
Just sayin, I got these 2 before I got my BBA both are in Quality Systems Technology, There are some programs out there, my BBA major studis were in Quality Management Systems.

 

[John Broomfield]

techlady,

I agree with you. Juggling several subsystems of documents written around several standards must be confounding, ineffective and costly.

Instead, we seek to understand the system of interacting processes that is the organization adding value and preventing loss. When our colleagues understand their business system (note the singular) and how it naturally (with a few tweaks) conforms to the standards we never go back to our collections of documents. What’s more, everyone can see how their system helps them do better work as they continually improve their organization and its processes.

BTW, processes are work not procedures which specify the way work is done and may be documented to the extent necessary for effective planning and control with due regard for risk.