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

[Antonio Vieira]

We have to remember many organizations (such as many service organizations) monitor and measure without physical devices per se.

Even though the standard didn't change anything in the title of requirement 7.6 from 2000 version to 2008 version, the translation to Portuguese has changed!
:mg:


It was MMDevices and in 2008 version it is MMEquipment!!!

And why?

Because here, there was a big discussion that surveys should not be considered as MMD. So they changed the name of device to equipment...

Funny, now I can literally calibrate survey questionnaires with a mathematical operator...

Anyway, I still have the opinion that clause 7.6 shouldn't be a part of Product Realization, but placed in 6.3 Infrastructure.

 

[Ettore]

Mmmm,
But what we can do if in the ten point of the new draft the 6.3 isn't about infrastructure?
We will go to dance tango. A milonga is ever a milonga.

 

[Sidney Vianna]

Re: The Future Structure of ISO Management System Standards

Implementing ANY Management System is, by definition, putting processes in place to PREVENT problems. Even corrective actions PREVENT recurrence of a problem. Still, just because something is PREVENTIVE in nature, it does not necessarily fit the definition of preventive action in ISO 9000, according to the wisdom of the standard authors. We have several threads on the issue and I would hope that we don't take this thread too off course.

Looks like the ISO TMB has been reading my posts.... In the NEW ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2013 document, Appendix 3 they state:

This High Level Structure and Identical text does not include a clause giving specific requirements for “preventive action”. This is because one of the key purposes of a formal management system is to act as a preventive tool. Consequently, the High Level Structure and Identical text require an assessment of the organization’s “external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcome(s)” in clause 4.1, and to “determine the risks and opportunities that need to be addressed to: assure the XXX management system can achieve its intended outcome(s); prevent, or reduce, undesired effects; achieve continual improvement.” in clause 6.1. These two sets of requirements are considered to cover the concept of “preventive action”, and also to take a wider view that looks at risks and opportunities.

Anyone interested in the ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2013 document, point your browsers to http://isotc.iso.org/livelink/livel...13_(PDF_format).pdf?nodeid=14883571&vernum=-2

 

[mohsinroxy]

I think Management involvement should be more expanded. The Data Analysis needs more inputs such as KPI or KSF, etc. Structure wise Preventive action can be re-worded to something new and exciting like "Improvement (based) ideas"

 

[insect warfare]

I've got a suggestion for the 5th edition that hasn't been brought up yet in this thread (I think)....it has to do with clarifying the intent of management reviews and (maybe) what they can be.

Add a note after the paragragh in 5.6.1 along the lines of:
"Management reviews may consist of reviewing one or more inputs of an organization's quality management system, simultaneously or separately, at the discretion of the organization."

Of course, this may preclude that the next edition of ISO 9000 include a bonafide definition for "management review", something like:
"An activity undertaken to determine the suitability, adequacy and effectiveness of an aspect to, or input of, management".

I would like to see something like this included for the benefit of the users. Not too difficult to interpret - it would allow organizations (at least those that feel a perceived restraint) to customize their review structures in a manner that is most beneficial to their organization, and not to perpetuate a "common myth" that management review is one or two meetings a year covering all the minimum inputs. This particular methodology (I admit) works for some smaller organizations, but are larger corporations really selling CB's on the claim that they only do one or two reviews (not necessarily meetings, but reviews) in the course of an entire year? We all know that most reviews happen more frequently than that, in smaller doses, but we often don't call those "management reviews" but rather "reviews", "meetings", "conference calls", "pow-wows", etc. because they don't always include the inputs mentioned in 5.6.2, but include other inputs which are still important to the organization nonetheless.

Plus this "common myth" does create a perceived fear of CB reprisal for other organizations who may benefit from a more optimal approach, but either just didn't think of it beforehand as an improvement, or don't have the gravitas or proper backing to take that leap. I believe that the "common myth" still exists to this day, especially when I look at the results of this poll that I recently set up. Maybe I shouldn't assume so much, but it gets me thinking anyway.

In my mind, I believe the boldface type above is almost fitting for standard inclusion. What say you?

Brian

 

[AndyN]

Brian:
If I understand your post, I believe there's a danger in diluting the real benefit of a management review which takes a look at the 30,000ft version of the management system in operation. Some of these "tactical" meetings you describe are just that, tactical. I totally agree with the once or twice a year review being totally ineffectual, but believe the answer lies in not allowing the inclusion of all manner of these "tactical" meetings, but to emphasize the strategic nature of the reviews - in setting policy and objectives, measurements and monitoring and subsequently being used to review progress and identify the resources needed to take action to ensure those objectives etc are met...(for example)

 

[insect warfare]

Brian:
If I understand your post, I believe there's a danger in diluting the real benefit of a management review which takes a look at the 30,000ft version of the management system in operation. Some of these "tactical" meetings you describe are just that, tactical. I totally agree with the once or twice a year review being totally ineffectual, but believe the answer lies in not allowing the inclusion of all manner of these "tactical" meetings, but to emphasize the strategic nature of the reviews - in setting policy and objectives, measurements and monitoring and subsequently being used to review progress and identify the resources needed to take action to ensure those objectives etc are met...(for example)

And I’m not saying that all-inclusion is best either. I don't believe in overkill. You’re right – it should be done “strategically”…. I just think that the planning of management review should be a “strategic but flexible” decision by top management on how best to conduct their reviews throughout time.

I believe “management review” as it exists today in some of these organizations is almost seen as an afterthought; the amount of planning that goes into it is pretty minimal “we’ll just set up a meeting and go through the ISO inputs” and because of that lack of planning, what they tend to get out may barely serve as anything of value unless they also consider some of the other “not mentioned in ISO” inputs as part of the total feedback. I’ve been involved in a few company startups, and more than half of them don’t seem to like anyone "growing a brain” during startups, instead resorting to tactics like "What do our competitors do? OK, then I guess we should do it their way...." and that's how opportunities get missed.

The point I was trying to make with my suggestion is that if an organization can show evidence of effective planning for management review, then that organization has demonstrated their due diligence in ensuring that their management reviews continue to provide real and everlasting value. How they do that should not be pre-determined by ill-perpetuated mythologies.

Brian

 

[AndyN]

Totally agree, Brian. Sorry if I misinterpreted you thought here. From what I've seen too many Management Reviews are some kind of dog and pony or powerpoint show done exclusively by the management rep.

 

[insect warfare]

Not a problem at all, Andy. I always appreciate your feedback - especially the positive aspects - it lets me know my train of thought is on the right track.

Brian

 

[mguilbert]

I just looked at another thread containing the draft. Is there any reason they need to change the clause numbering? During my management reviews I use these clause numbers not just for the year but I show them how we have been trending over time. This is really going to throw a wrench into the charts having to line up new clause numbering with the old.

Just a thought.

Thread with draft: ISO 9001:2015 Draft - Status