What should be changed in the ISO 9001:2015 Standard?

[Sidney Vianna]

Just for information ISO has published a series of standards on six sigma and has a working group looking at a guidance standard for 'lean' - interesting, eh?

Thanks, Paul. A couple of years ago, when the standards were still in draft mode, we had a thread here. I know that YOU know this, but just to be clear for those who are not as well informed. ISO 13053-1 and -2 as well as other quality tools will not be considered for the 5th Edition of ISO 9001. Let's remember that, ISO 9001 has to cater for the unsophisticated, immature, small organizations out there. Otherwise, we would not have over 1.2 million organizations certified to the standard. Many people don't like to hear this, but ISO 9001 has to be, BY DESIGN, a simple and flexible document to allow for it's almost universal range of application. While the ISO TC's gradually raise the bar from one edition of the document to the next one, we must keep it real, so standards can be used in the real world, by organizations in the early stages of their maturity journey.

Just out of curiosity, does anyone know if anyone who is on TC 176 is monitoring this discussion?

There are several covers who belong to the TAG's supporting the TC 176. In this (4-year old) thread, at least a couple of people have mentioned that.

 

[Paul Simpson]

Thanks, Paul. A couple of years ago, when the standards were still in draft mode, we had a thread here. I know that YOU know this, but just to be clear for those who are not as well informed. ISO 13053-1 and -2 as well as other quality tools will not be considered for the 5th Edition of ISO 9001. Let's remember that, ISO 9001 has to cater for the unsophisticated, immature, small organizations out there. Otherwise, we would not have over 1.2 million organizations certified to the standard. Many people don't like to hear this, but ISO 9001 has to be, BY DESIGN, a simple and flexible document to allow for it's almost universal range of application. While the ISO TC's gradually raise the bar from one edition of the document to the next one, we must keep it real, so standards can be used in the real world, by organizations in the early stages of their maturity journey.

Now, Sidney, of course I remember, even if I didn't comment. You should have seen some of my comments in the Mirror Group when reviewing the first drafts of these standards!

My response was specifically in answer to the question whether six sigma methodology was 'standard'.

BTW do you consider the principles of DMAIC more complex than (for example) quality costing that you mentioned in the OP?

There are several covers who belong to the TAG's supporting the TC 176. In this (4-year old) thread, at least a couple of people have mentioned that.

There are others who are members of other groups that shadow TC 176 (in the UK we call them Mirror Groups) and there are others who take part in both the Mirror Group and TC 176. I might even have mentioned this before!

 

[Sidney Vianna]

BTW do you consider the principles of DMAIC more complex than (for example) quality costing that you mentioned in the OP?

Good question. As we say over here, the "devil is in the details". Maybe it was wishful thinking from my end to consider COPQ as part of the standard, but, as many of us believe, associating monetary impact with the performance of the quality system is a way to engage with top management and make the connection, missed by so many organizations, between the quality system and business process effectiveness and efficiency.

Imagine something as simple as part of the mandatory input into management review activities for the organization to:

The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.
h) financial impact of product nonconformity and customer dissatisfaction.

 

[ChoctawChuck]

Thanks, Sidney, for the opportunity to offer my opinion on what should be changed.

I also agree with ----
Everyone knows that Preventative Maintenance of equipment and infrastructure is a good business practice...but there are no definitive requirements for this in the current version.
Correct me if I am wrong about this.

Whitey115,
I agree totally. I just completed an audit (to a customer's requirement, not a full ISO9001) at a facility that had been recently 3d party certified to ISO9001:2008. The facility had a "preventive maintenance" program in name only - they have PM cards on their machines, but there is no procedure telling the operator what to check or how often. I can't write them up, I could only try to convince them that they need a procedure - obviously, because every machine operator has his own idea. They tried to convince me that they "use the directions on the owners manual as their guide" - LOL!!
I asked to look at the owners manual and it recommended checking every 8 hours of use, whereas the PM card indicated they were checking once a month!
This is not effective Preventive Maintenance IMHO, but what can we do unless there is better definition in the standard? I believe that I was able to convince them that it is their best interest. Time will tell.

 

[Marc]

Also see: The ISO 9001:2015 Standard Draft

 

[Paul Simpson]

<snip>The facility had a "preventive maintenance" program in name only - they have PM cards on their machines, but there is no procedure telling the operator what to check or how often. I can't write them up, I could only try to convince them that they need a procedure - obviously, because every machine operator has his own idea. They tried to convince me that they "use the directions on the owners manual as their guide" - LOL!! </snip>

From the information you have posted I think you have enought to write an NC under clause 6.3:

The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable,
...
b) process equipment (both hardware and software), and

. So if there is a PM program in place and it is not being followed then it is non conforming. You can also refer to clause

4.1 c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,

You have done enough background digging to have the discussion and convince any reasonable QM.

 

[Phiobi]

Good question. As we say over here, the "devil is in the details". Maybe it was wishful thinking from my end to consider COPQ as part of the standard, but, as many of us believe, associating monetary impact with the performance of the quality system is a way to engage with top management and make the connection, missed by so many organizations, between the quality system and business process effectiveness and efficiency.

Imagine something as simple as part of the mandatory input into management review activities for the organization to:

I can see the value but fear "and customer dissatisfaction." will be subject to too much debate over how it is measured and reported.

 

[Antonio Vieira]

And according to Sandford Liebesman, in November issue of Quality Progress:

There also are several future concepts that should be considered. The U.S. TAG to TC 176 was asked to consider this list of 20 concepts, the most important of which are in bold:
1. Financial resources of the organization.
2. Communication.
3. Time, speed, agility and related aspects.
4. Quality management principles and leadership.
5. Alignment with business management practices.
6. Inclusion of risk-based thinking approach.
7. Life cycle management.
8. Plan, source, make and deliver.
9. Focus on product conformance.
10. Process results and effectiveness.
11. Clarification and differentiation of the multiple customers of an organization.
12. Process innovation.
13. Maintenance of infrastructure.
14. Process management.
15. Knowledge management.
16. Competence.
17. Quality tools.
18. Structure of QMS and relationship with management system standards work.
19. Impact of technology and changes in information management.
20. People involvement.

 

[Phiobi]

Thats quite a list, though I am not seeing any in bold.
2,5,6,7,10,12,14,17 and 20 look like great topics to consider!

 

[LUV-d-4UM]

How about changing the major clauses to reflect Demings PDCA Philosophy buckets. Then put all the 20 elements inside the buckets. The effectiveness of Internal Audits should be reflected in the achievement of measurable improvements.