SBS - The best value in QMS software

Reasons for the Decline of ISO 9001 Registrations in North America (circa 2010)

Big Jim

Super Moderator
#41
Re: What are the reasons for the decline of ISO 9001 registrations in North America?

In my opinion, that is one of the reasons for the decline: ludicrous feedback from CB auditors, in many cases. If I were in the receiving end of an external audit and got this type of "audit result", I would seriously question the value of that relationship.

It is hard to accept that 3[sup]rd[/sup] party auditors still don't understand the meaning of value added audits. As I mentioned already, part of the non-conformance triggering process for CB auditors should have a step that would force the auditor to ask him/herself: If I write up this non-conformance and the organization implements corrective action, can I assure the outcome results in a higher level of performance or provides additional confidence to interested parties? If the answer is NO, then, no non-conformance should be written.

Still, as I state that only accountability at all levels can save the accredited certification process from oblivion, if I were in the receiving end of a finding as the one Bev reported, I would be having a serious conversation with a manager at the CB and make them understand that, if this is representative of their auditors performance, they would not be my CB for long.

CB's will only remain accountable to the intent of the certification process if the proper stakeholders keep us straight.
I completely agree and often encourage clients to appeal an outlandish nonconformance. It amazes me as to how often the clients are reluctant to do so. They don't want to anger the auditor or they don't want to make waves. As long as they are willing to be abused, they will be abused. It doesn't seem to matter who the CB is either.
 
Elsmar Forum Sponsor
J

JaneB

#42
Re: What are the Reasons for the Decline of ISO 9001 Registrations in North America?

All opinion, really (admittedly).
I'll add mine: I query how accurate and valid these reported results actually are.

They show a huge drop in Australian (& NZ registrations), more than halving:

Aust from 17,440 (2006) down 8,773 (2008)

If that were so, I'd have some idea of it & there'd be signs.
For example, I might expect that my company phone calls would dwindle. There'd be fewer (zero?) leads and enquiries coming in. There'd be heaps of people looking for work. CBs wouldn't be flat out trying to recruit good auditors. And professional contacts, including other consultants, auditors, CB personnel etc, would be moaning about the downturn and poor outlook.

Not a single one of which is happening. Indeed, the reverse.
 

Wes Bucey

Prophet of Profit
#43
Re: What are the Reasons for the Decline of ISO 9001 Registrations in North America?

All opinion, really (admittedly).
I'll add mine: I query how accurate and valid these reported results actually are.

They show a huge drop in Australian (& NZ registrations), more than halving:

Aust from 17,440 (2006) down 8,773 (2008)

If that were so, I'd have some idea of it & there'd be signs.
For example, I might expect that my company phone calls would dwindle. There'd be fewer (zero?) leads and enquiries coming in. There'd be heaps of people looking for work. CBs wouldn't be flat out trying to recruit good auditors. And professional contacts, including other consultants, auditors, CB personnel etc, would be moaning about the downturn and poor outlook.

Not a single one of which is happening. Indeed, the reverse.
It seems to me we have one of the best demographics of quality professionals in the world right here in the Cove. The anecdotal evidence from that demographic [so far] appears to contradict the results of the survey.

I suggest there is no real benefit to be gained from further berating the survey here in the Cove. Folks who are seriously concerned the apparently flawed survey may have a negative impact on industry and instigate a headlong rush to drop registrations should probably direct their surmises, complaints and queries to the publisher of the survey, requesting concrete validation of the survey results. My guess, based on similar situations in the past, is that those requests will be ignored. What a shame!
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#44
Re: What are the Reasons for the Decline of ISO 9001 Registrations in North America?

I query how accurate and valid these reported results actually are.

They show a huge drop in Australian (& NZ registrations), more than halving:

Aust from 17,440 (2006) down 8,773 (2008)

If that were so, I'd have some idea of it & there'd be signs.
Remember the comment from the 2008 Survey
Because of these downward revisions, the ISO 9001 and ISO 14001 totals for the countries indicated appear to have dropped sharply in the 2008 survey, when in fact this is an impression created by the over-inflation of figures in 2006 and 2007.
 
J

JaneB

#45
Re: What are the Reasons for the Decline of ISO 9001 Registrations in North America?

Remember the comment from the 2008 Survey
Yes, meant to acknowledge that, and thanks for the reminder.
It does make it all rather confusing though. At least to this brain. :lol:
 

Jim Wynne

Staff member
Admin
#46
Re: What are the Reasons for the Decline of ISO 9001 Registrations in North America?

I agree with some of Sidney's concern about the value-added aspect of auditing. I know that is the part my client's appreciate the most. They want to get benefits from these audits, and not just silly parking tickets.
When I see the term "value added" in this context, it's almost always coming from someone who's trying to sell something, and hardly ever from the people who are being targeted. Right now, with the statistics being what they are, it shouldn't be surprising that CBs and others who stand to lose business would be rethinking their marketing strategies. Nonetheless, I remain unconvinced that "value added" has any real meaning.

Speaking only for myself, I hope--as I always have--that a CB auditor will be knowledgeable, deport herself professionally, do an objective survey of the QMS in the time allotted and then get the hell out and let me get back to work.

Can someone give me a concrete example of a service that a CB auditor might perform that is (a) not "consulting" and (b) adds value? Of course I assume that if a claim to add value is made it will be somehow quantifiable. Otherwise the word "value" is definitely being abused.
 

Pancho

wikineer
Super Moderator
#47
Re: What are the Reasons for the Decline of ISO 9001 Registrations in North America?

Can someone give me a concrete example of a service that a CB auditor might perform that is (a) not "consulting" and (b) adds value? Of course I assume that if a claim to add value is made it will be somehow quantifiable. Otherwise the word "value" is definitely being abused.
Hmm... I don't believe that you need to be able to quantify value in order to know it is there.

Our folks seem to be much more concerned of possible NCs detected by the external auditor than those detected by the internal ones. This may not be a rational behavior, but when you think about it, our propensity for irrational behavior is exactly the reason we need a qms in the first place.

A knowledgeable auditor adds value by focusing on the important bits and by prompting our people to make sure the processes, documentation and records are all consistent and properly applied and kept. I don't know how to quantify this value, but it is there.
 

Jim Wynne

Staff member
Admin
#48
Re: What are the Reasons for the Decline of ISO 9001 Registrations in North America?

Hmm... I don't believe that you need to be able to quantify value in order to know it is there.
Then if I say it's there, but you say it's not, we just have to leave it at that, I guess. A concept that explains everything explains nothing.

<snip>
A knowledgeable auditor adds value by focusing on the important bits and by prompting our people to make sure the processes, documentation and records are all consistent and properly applied and kept. I don't know how to quantify this value, but it is there.
I'm still looking for a concrete example. Are you saying that "the organization" isn't likely to know what its "important bits" are or how to deal with them effectively without the help of a third-party auditor who's not supposed to be acting as a consultant? At what point does such a failure of leadership constitute an ineffective system?
 
J

JaneB

#49
Re: What are the Reasons for the Decline of ISO 9001 Registrations in North America?

Speaking only for myself, I hope--as I always have--that a CB auditor will be knowledgeable, deport herself professionally, do an objective survey of the QMS in the time allotted and then get the hell out and let me get back to work.
Ah, me too. Would that this were always the case. :yes:

But I would add: I hope the auditor leaves behind a client perception that the audit was a valuable exercise.

Again, some do this; some don't.

What I mean by 'a valuable exercise' can be as simple as a perception that their system was thoroughly and professionally tested by a skilled auditor. That the 'test questions' were directed at suitable topics, issues of risk, importance, etc etc (not trivial). And thus that the objective findings on the status of the system, whether 'good' or 'bad' status are of use.

I repeat: not all auditors do this, even if they do the things you listed. Indeed, I've seen people quite staggered (after a change of auditor or CB) at the difference between an audit that was a valuable exercise and one that wasn't.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#50
Re: What are the Reasons for the Decline of ISO 9001 Registrations in North America?

Can someone give me a concrete example of a service that a CB auditor might perform that is (a) not "consulting" and (b) adds value?
I could give you hundreds of examples, but, let me limit myself to just a couple; both are real-world cases, not academic exercises, not fantasy.

1. Major aerospace organization with multiple sites all over the World. Auditor writes up a major non-conformity, after verifying that purchase orders being placed with suppliers had totally incorrect quality clauses listed. Root cause analysis identifies that the recently installed procurement module of the ERP system had a bug and was identifying wrong clauses for the products and commodities being procured. This problem, left unattended for a longer time would have cost the organization millions of dollars in wrongly procured parts and could have been the subject of a major regulatory fine.

2. Supplier of solar cells and panels for spacecraft applications (no longer in business). While auditing their supplier monitoring processes, I realized that they had a process owner that was too lenient with their own suppliers. Request for corrective actions lingered for months on end, with no resolution. Requests for prompt corrections went unattended for weeks. That was a MAJOR disconnect between the registrant's customer expectations and how they fail to flow down the sense of urgency towards their direct suppliers. Since the registrant was in the critical path of timely spacecraft launches, it was just a matter of time until a serious issue would happen. Situation was reported as an observation during the exit meeting. Top management looked dumbfounded as how the dysfunction/leniency with suppliers was allowed to creep in.

Any time an auditor identifies an ineffective process and keeps the registrant accountable to meaningful root cause analysis and effective corrective action, s/he is adding value; either to the registrant or their customers.

While The Cove is full of idiotic, moronic, stupid examples of audit findings, the opposite happens on a daily basis. They just don't get reported here. Everyday, competent auditors identify process failures, which, when corrected, result in higher system performance. I feel sorry for those organizations and individuals who have never had a chance of being assessed by competent, professional, value-adding auditors. If you have only experienced the moronic kind, you might think all auditors would be like that. But you would be wrong. There are many extremely professional 3[sup]rd[/sup]-party auditors out there who assist organizations in improving their performance without ever compromising their impartiality.
 
Last edited:
Thread starter Similar threads Forum Replies Date
L Reasons to submit a new PPAP or notify the customer APQP and PPAP 3
T Reasons to change certification body and typical costs Registrars and Notified Bodies 16
L Valid reasons to omit an "ear-tag" type label on a cable? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Common Reasons for Out Of Tolerance condition of DC Calibrator or any reference std General Measurement Device and Calibration Topics 1
C Reasons for Approval Signatures for Records 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
V Monitoring Specific Reasons and Categories of Yield Loss of Online Rejects ISO 13485:2016 - Medical Device Quality Management Systems 1
P 25 Reasons why I owe my mother Funny Stuff - Jokes and Humour 0
K Reasons for Issuing Uncontrolled Documents Document Control Systems, Procedures, Forms and Templates 10
S Root Cause Analysis Taxonomy - Categorising the reasons for non-conformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Top Three Reasons why TPM (Total Productive Maintenance) Initiatives Fail Manufacturing and Related Processes 39
P Seeking sample Resignation Letter - Health and Relocation reasons Career and Occupation Discussions 3
E What are the main reasons to update data in MDS Sheet? RoHS, REACH, ELV, IMDS and Restricted Substances 4
M Practical Reasons Behind The ISO 13485/QSR Regulations ISO 13485:2016 - Medical Device Quality Management Systems 6
T Reasons for retaining Obsolete Documents and Retention Time Document Control Systems, Procedures, Forms and Templates 13
Q Dock Audit - Reasons to do dimensional checks during product dock audit Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Wes Bucey More reasons to think before clicking on links After Work and Weekend Discussion Topics 12
J Reasons for Implementing ISO 9001 - Findings from a Survey of 326 Businesses The Reading Room 0
N Non UKAS certification bodies - reasons for their avoidance required... Registrars and Notified Bodies 41
Q Top 10 reasons why ASQ is not ISO 9001 registered ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 7
K Compelling reasons for a certifying agency to withdraw a ISO certificate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Reasons for early termination of an audit? General Auditing Discussions 23
A Reasons to Continue QS-9000 in a Company? QS-9000 - American Automotive Manufacturers Standard 4
Sidney Vianna Continual decline of ASQ - can it be saved? Nov 2019 ASQ - American Society for Quality 20
Marc The Continuing Decline of Google Search - 2013 - 2014 Coffee Break and Water Cooler Discussions 37
Wes Bucey Disturbing news - No decline in medical errors World News 11
Marc The Decline: The Geography of a Recession in the US - 2007 thru July 2010 Career and Occupation Discussions 1
M General decline in good manners / common courtesy? Coffee Break and Water Cooler Discussions 26
K Statistical Hypothesis Testing to prove signficant quality improvement or decline Statistical Analysis Tools, Techniques and SPC 6
G ISO 13485 Certification - Can we get the ISO 13485 certification prior to shipment of the device? ISO 13485:2016 - Medical Device Quality Management Systems 6
Richard Regalado Informational ISO/IEC DIS 27001:2021, to be published soon. IEC 27001 - Information Security Management Systems (ISMS) 0
Q Audit report template ISO 9001/14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
Q Process matrix examples of ISO 9001 & 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 4
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom