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

[Sidney Vianna]

Now that the amendment of ISO 9001:2008 is done with, hopefully the TC 176 will have the courage to instill significant changes in the next revision of ISO 9001.

I thought we should start a thread so people could suggest possible changes to the standard. We have Cove members that participate in the US TAG and can convey (should they agree) our collective requests.

In my opinion, certain things need to be significantly revised.

The first one is preventive action. The TC 176 should re-phrase the requirements associated with preventive actions, so it can be meaningfully implemented in the real world. At present, the requirement is unclear and difficult to assess compliance against.

Another suggestion I have is for emphasis on process and system effectiveness. 8.2.3, for example, is completely disregarded by many organizations.

Quality economics, a.k.a cost of quality and mandatory review during management reviews is another candidate in my book.

Other ideas?

 

[Randy]

Re: What should be changed in the ISO 9001:2014 Standard?

Competency!

The whole stinkin CTA (6.2.1 & 6.2.2) mess needs better clarification. You ask about competency during an audit and you immediately can tell the person your talking with isn't. "Blank stare" "Deer-in-the-headlights" and the ever stated "We train everyone - duh-oh".

TC 176 needs to input a requirement that "minimum" competencies for tasks performed by folks working for and/or on behalf of the organization that could effect product quality and/or customer satisfaction be documented and the competency evaluation process be documented as well. TC 176 also needs be very specific in stating that Training does not equal competency, neither does Education, or Experience by themselves.

The competency requirment also needs to be clearly stated that it is required at all levels starting with Top Management.


My next suggestion would be to toss the phrase "Top Management" for some more meaningful thing like "senior management" or "executive management" and include in the definition "intrinsic or inherent authority to establish strategic direction for the organization" and "ultimate control of organizational resource disposition"


Just a start...............

 

[Patricia Ravanello]

Re: What should be changed in the ISO 9001:2014 Standard?

Great idea to start collecting suggestions....

Suggestion: ISO 9000 Standards - Change in Format

My first suggestion is to provide an electronic version of the Standard formatted in MS Excel, so that organizations can effectively and efficiently identify where the Standard's requirements interface with their Business Operating System through the use of an interface matrix, and then plan the changes to their existing documentation, in a methodical, organized manner.

This would be an incredible savings in time for each organization, and preserve the accuracy of the document.

It would also preclude the need for copyright approvals (doing this is presently a violation of their copyright - Currently the total content of the standard included in such a Matrix can not represent more than 25% of the Matrix, or it would be subject to additional copyright charges. There would be a charge of $36.00 for each use of the Matrix containing the standard (Source: per personal communication with Mr. Nicolas Fleury Director Marketing and Communication, ISO Central Secretariat, Geneva, Switzerland, as communicated by Anne Sharkey, Information Resource Officer Standards Council of Canada)

This format would also allow Auditors to verify that each requirement has been addressed somewhere, and where they would find it in the documentation. This document is critical for a true "Stage 1 Document Audit", and should be provided to the C.B. as a roadmap to the System.

I've attached an example of a proposed "ISO/TS and B.O.S. Interface Matrix" to demonstrate how this should be carried out.

Along with this, the Standard should recommend this methodology for the implementation of their Standard.

I have some other suggestions but I think I'll post them separately.

Thanks again for the opportunity to contribute.

Patricia Ravanello

 

[Patricia Ravanello]

Re: What should be changed in the ISO 9001:2014 Standard?

Competency!

The whole stinkin CTA (6.2.1 & 6.2.2) mess needs better clarification. You ask about competency during an audit and you immediately can tell the person your talking with isn't. "Blank stare" "Deer-in-the-headlights" and the ever stated "We train everyone - duh-oh".

Thanks for kick-starting the discussion. I, for one, value your experience and perspective, and I feel equally strongly about the Competence issue. It's not rocket science, but for some reason, in my observations, the obstinate disposition and incompetence of a disturbingly large proportion HR personnel precludes the likelihood that this requirement is even understood, much less met.

Enough said...I second Randy's motion.

Patricia Ravanello

P.S...Sidney, to keep us focused, maybe you should restrict this thread to "Suggestions ONLY" and to discourage the discussion of the merit of the suggestions (or lack thereof). If people want to discuss the pro's and con's, maybe they should be encouraged to begin a separate thread.

 

[Sidney Vianna]

Re: What should be changed in the ISO 9001:2014 Standard?

P.S...Sidney, to keep us focused, maybe you should restrict this thread to "Suggestions ONLY" and to discourage the discussion of the merit of the suggestions (or lack thereof). If people want to discuss the pro's and con's, maybe they should be encouraged to begin a separate thread.

Thanks for the suggestion, Patricia, but I don't mind the healthy exchange of ideas, even if it might derail the thread.

The one thing I would like to suggest is that people who would like to contribute to this thread (obviously including myself) should suggest a draft of the text they would like to see in the (ISO 9001) standard. If one forces oneself to think of how the requirement should be phrased, you have to think harder about the subject. How to re-phrase preventive action, for example? That will be one of my own challenges.

 

[Colin]

Re: What should be changed in the ISO 9001:2014 Standard?

Maybe a simple one but get rid of the duplication. So we could get rid of (or change considerably) 4.2.1. Why have a clause which tells you what is coming somewhere else? e.g. a) documented quality policy and objectives - they are addressed properly in 5.3 & 5.4.

I also agree that the phrase 'top management' should be replaced.

Perhaps controversially, I would like to see a return for the requirement to document the method of controlling the main processes e.g. sales, design, purchasing, etc. I know all about the reasons for removing them but we now have a situation where I see companies who have a 3 page procedure for controlling records but no procedure for controlling design.

 

[ScottK]

Re: What should be changed in the ISO 9001:2014 Standard?

The main thorn in my side has been Design and Development.
The whole thing need to be rethought and made less cumbersome. It seems to be written for projects that take months to years from concept to validation where a project manager is leading things and having regular, regimented project meetings.

Places I've worked have a one or two engineers who can bang out a project in days and the design reviews happen on the fly.

I take particular issue with the D&D Review section (7.3.4).
These guys would spend as much time documenting design reviews as they would actually designing the part.

And then lets say a leaner system is designed and meets the requirements of the standard...You can spend hours trying to get an auditor to understand the process and how it's compliant because most I've known think of this process in the terms I described in the first paragraph.... you either are excluded or you have a a regimented, by-the-book, inflexible system.

 

[20110108 Request]

Re: What should be changed in the ISO 9001:2014 Standard?

As a member of the US TAG to TC 176, I am extremely interested in this thread. We have already started collecting potential revisions. I will gladly take any and all suggestions to our March meeting in Dallas. Thanks for priming the pump!

 

[Sidney Vianna]

Split top management: At the beginning and at the end.

In line with ISO 14001 (a perennial sister of ISO 9001 and target for enhanced compatibility), the 5th edition of ISO 9001 should split the requirements associated with top management in two distinct sections.
In line with the PDCA cycle, top management should be addressed early in the standard, in terms of setting policy, objectives, targets demonstrating commitment to customer focus, and internal communication, etc....

Then, at the end of the standard, top management should be addressed again on management review of the performance of the QMS, need for corrections, improvement, (potentially) re-setting policy, objectives, targets, etc...

With this model, I believe, the connection with the PDCA cycle becomes clearer. Top management's involvement with the P & A (from PDCA) would be more evident.

 

[somerqc]

Re: What should be changed in the ISO 9001:2014 Standard?

I'm with Scott. The D&D is very cumbersome for companies that have very fast turnaround on their projects (re: days, or even hours). You literally double your time just trying to meet the requirements.

I have managed to streamline ours to the point when we can work with it; however, I have spent many an hour working the auditor so he fully understands it as well. It isn't bad now (2.5 years later) however there was a lot of legwork at the start to get the auditor to understand the system so he could ensure it met requirements.

Secondly, tighter requirements regarding CAPA. I received an "OFI" for not having any corrective actions triggered by data. I understand this is part of the maturing of the program; however, there is no requirement for this. Maybe we need to have "staged" requirements. For example, there is a basic requirement to get registered; within one year meet new requirements, by re-registration time there are higher requirements. This would promote the CI philosophy and ensure people are aware of and practicing the philosophy.



John