Misinterpretation of ISO9K-2K - Not much has really changed (Discussion)


Fully vaccinated are you?
Staff member
From: ISO Standards Discussion
Date: Wed, 3 May 2000 19:36:48 -0500
Subject: Q: Misinterpretation of ISO9K-2K /Humphries

From: Edwin Humphries

G'day all,

There seems to be a widespread view that the new version of ISO9K will provide all sorts of challenges for companies to do things differently. In my view, the only companies so challenged will be those that took a shortcut to ISO9K in the first place.

How could a good quality system not look at, for example, customer satisfaction, and provide, even by exception, a means of monitoring it? Surely an effective method of dealing with customer complaints and feedback provides an excellent method of assessing customer satisfaction, and correcting it? This was required in the 1994 version of the Standard, and implied in the 1984 version.

I'm becoming increasingly worried that the new version of the Standard will be abused, in several ways:

1. By those who circumstances have prevented from being exposed to a sound background in Quality Management Systems, and who have (for example) only ever seen the system they live in. These people will frequently be interpreting the new Standard in the same (generally literal) method their predecessors interpreted the old version. In this case, it not these people themselves who are abusing the new Standard, but the people who set up their system and trained them in it.

2. By employees who see the new version as their long-sought-after lever to have the company managed as THEY believe it should be. These people are likely to use "we'll lose our certification/registration" as the Damocles blade to hold over the head of the company's management and make them change. The employee will probably be motivated by what they believe to be the best for the company, but it'll be on the basis of "any means to the end", and the end may not be what the managers or owners - or even the customers - want.

3. By consultants, who see the new changes as a wonderful means to earn lots of money by adding to their client's systems heavy overheads of monitoring, measuring, auditing, etc. Most of these "changes" were implied by the older version of the standards to the same extent they are now expressly stated.

I think we need, as a profession, to be making lots of noise to promote a more reasoning and minimalist interpretation of the new revision.

For example, the new requirements to measure customer satisfaction need not be interpreted as mandating extensive customer surveys and similar processes: there are, for those who choose to really think about their systems (or their clients systems) far more simple and inexpensive, but still effective, methods of achieving the same results. This same philosophy applies to most of the other "new" requirements of ISO9K-2K.

Let's not allow ISO's latest attempt to make Quality Management Systems more relevant and accepted go the same way as the previous attempts.

Best Regards
Edwin Humphries
Elsmar Forum Sponsor

Alan Cotterell

I agree that we should promote a more reasoned approach to management system implementation, however I don't know that the term 'minimalist' is applicable.
I think it is important to do what is appropriate to control the risk of supplying nonconforming items to a customer. If this involves writing an extensive manual - so be it. However I feel that some people seem to take a very draconion approach to management (particularly those who feel they have to justify their existence).


ya know, eveybody has to play the cards they ae dealt. I am one of the GDC (G** D*** consultants).

My customers are mostly small manufacturers. A lot of the folks in the quality world don't understand what it means to a small manufacturing firm to comply to the ISO 9000 Quality management system.

It is huge! We all know, and if they work with me I make sure they know this is a minimal system, but, by god, they were audited and they are compliant to a international standard. To a company with less than 200 employes, this validates they have arrived!

Companies with 2000 employees dont understand this. I don't expect them to.



Fully vaccinated are you?
Staff member
...see the new version as their long-sought-after lever to have the company managed as THEY believe it should be...
I also see this as a problem. This is one reason I disagree with you so often, Alan.

I agree with the minimalist statement and believe minimalist is the appropriate adjective.

The customer satisfaction thing is a good example. One small client (14 souls) doesn't need a survey - the owner visits customers regularly 'just to say hello' and to make sure everyone is happy. This is just how they do business. They don't need a survey. They don't need to do anything other than what they do now. And they don't need a mandate to do it in the first place.

But I also believe it is not the place of an 'international standard' to require monityoring of, or even consideration of, customer satisfaction in the first place. What ever happened to survival of the fittest? I thought that businesses competed for customers in their market place where, if they abuse their customers their competitors will get their business. This requirement is just plain stupid. An international standard like ISO 9000 is midway between a government requirement (and as we all know in many cases ISO 9001 actually is a government requirement) and freedom to do whatever you want to. So - effectively, if the standard passes as is, monitoring and reacting to customer satisfaction will be a government mandate. How absurd.

I can understand customer satisfaction with respect to QS-9000. But QS-9000 is a requirement of GM, Ford and Chrysler. It is in their interest to make requirements such as: "Damnit - you will satisfy us!" You also have the APQP process you must follow and 5 other documents from the AIAG alone to satisfy (MSA, FMEA, etc.). This is not to say I believe MSA, FMEA and such are bad. In fact, I see FMEAs as basic to any business - even the service industry. But QS-9000 is an automotive specific document.

[This message has been edited by Marc Smith (edited 09 May 2000).]


Fully vaccinated are you?
Staff member
From: ISO Standards Discussion
Date: Mon, 8 May 2000 09:25:58 -0500
Subject: Re: Misinterpretation of ISO9K-2K /../Whitcomb/Summerfield/Whitcomb

From: Gary Whitcomb

George: I want to try and point out a subtle nuance as it relates to the
your reply. In your reply, to my reply, you wrote:

> I agree that it's just a matter of people becoming accustomed to the
> changes; however I believe that they go beyond being nuances - in
> a very good way. The scope that you quoted is basically a vague
> statement of "what" the requirement "intends" the registered
> company to achieve through complying with the ISO standards.

Let's take a look at the definition of quality as defined in ISO 9000-94 version compared with the DIS 9k-2K. "94: "quality is the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs" (ISO 8402-1986). I would also call your attention the note #7 in this same publication: "In some reference sources, quality is referred to as "fitness for use "or ...use or "customer satisfaction"..." Here is the catch phrase in this: "Since these represent only certain facets of quality fuller explanations are usually required that eventually lead to the concept defined above".

9K-2K: quality is defined as :" ability of a set of inherent characteristics of a product, system, or process to fulfill requirements of customers and other interested parties"

I am not disagreeing with what you say but I think with this somewhat new definition of quality , the scope becomes more focused and less vague. I may have gone way off the deep end, but one of little nuances is Customer Requirements are more than just facets. It seems to me, companies will have to be better able to define customer needs and show they are incorporating these needs and requirements in the quality system. OR, some thing like that!!!



From: ISO Standards Discussion
Date: Mon, 8 May 2000 09:30:24 -0500
Subject: Re: Q: Misinterpretation of ISO9K-2K /Humphries/Darracott


I agree with Edwin.

I have an even greater concern that 3rd Party certification auditors may expect to see activities in documented management systems which they believe are specified by ISO 9001 - 2000 but which are not actually specified in ISO 9001 - 2000. These activities may well contribute nothing to either profitability or compliance with specification.


From: ISO Standards Discussion
Date: Mon, 8 May 2000 09:49:05 -0500
Subject: Re: Q: Misinterpretation of ISO9K-2K /Humphries/Whitcomb/Humphries

From: Edwin Humphries


I'm sorry to disagree with you, but I think the example you raise is an excellent case in point.

> In the '94 version, paragraph one: SCOPE says: "The requirements
> specified are aimed primarily at achieving customer satisfaction by
> preventing nonconformity at all stages from design through to
> servicing".
> In the new version DIS/ISO 9000-2000 SCOPE sets a somewhat
> different tone by stating: "Monitoring of customer satisfaction, as
> stated in b) requires the evaluation of information relating to customer
> perceptions of whether or not the organization has met the customer
> requirements". (DIS/ISO 9001,1.1)
> IMHO the new version is requiring organizations to do more than just
> monitor customer satisfaction, after-all perceptions are different from
> satisfaction(s), and satisfactions are a different focus from
> nonconformities. I doubt many organizations have asked or measured
> customers perceptions. I think most organizations are going to have to
> put more thought and some measurements in place that were not in
> place to meet the requirements of ISO 9000-2000.

The original scope was, unfortunately, open to several interpretations. In the same way that the traditional definition of Quality (fit for purpose) implied some basic questions (what purpose? who defines the purpose? who defines what's fit?), the 1994 scope did not define how customer satisfaction was to be assessed. A common sense response would have been "by the customer", but common sense is not a particularly common phenomenon, and for a company wanting a "quick and dirty" quality system, such considerations were not specifically defined by the standard, and were therefore regarded as optional.

The new version merely clarifies whose judgment is important: the customer's. Although the word perception is often used to identify "fuzzy judgment", its dictionary meaning is "The representation of what is detected by means of the senses; basic component in the formation of a concept; A way of conceiving something; The process of detection by means of the senses; Knowledge gained by detection by means of the senses; Becoming aware of something via the senses". Clearly, this extends well beyond subjective judgments, to include all means of forming a view of customer satisfaction.

As you quoted, the new version requires the "evaluation of information"; it does NOT require the implementation of entirely new measurement system: that is merely one possible response (and may not be the best, or for many companies, necessary).

> So, I am not so sure we have misinterpreted the standard as much as we
> have yet come to fully understand all of the nuances of the requirements.

I think it would be more accurate to say that many are finally coming to terms with the nuances that were, in fact, in the original, 1987, version of ISO9K.

Best Regards
Edwin Humphries


Sorry, I didn't realize that there were businesses out there who didn't see customer satisfaction as a major factor in business.
If the customer isn't satisfied, what cause does he have for product loyalty?
Also, how do you increase marketshare without satifying your customers.
I would think that your marketing functions would be vitally interested in making customer satisfaction a prime mover in your business plan.
I do agree that not all companies need a formal survey for this. However, even if it's just a plan for your sales staff to visit each customer site on a yearly/monthly/weekly basis, you are conducting informal surveys.

[This message has been edited by AJPaton (edited 09 May 2000).]


Fully vaccinated are you?
Staff member
This is my point exactly. This is part of the 'typical' business process. My question is should this be mandated by ISO9001.

Alan Cotterell

I get the impression that a lot of people take a 'what do we have to do' approach to ISO9000. And this might be well and good to get the flag flying outside the door, and get access when tendering, or entering markets. But I ask the question - what should the real objective of having a quality system be?

I suggest the prime reason for having a quality system is to control the risk of supplying a nonconforming product or service to a customer. A second reason is to empower our workers to make the necessary decisions involved in supplying the product or service, by providing documented guidance material. A third reason is to provide a system for 'locking in' improvements to the delivery process (the 'act' part of TQM).
A fourth reason is to provide an audit trail for certifying bodies, customers and the organisations management, to prove that all necessary operations in the delivery process have been performed.

I agree with Marc, that the documentation should be 'minimal', however it should be sufficient to fulfil the above objectives.

Of the three types of audit, second party audit can be the most harrowing. When the customer approaches your organisation to see how you are handling his contract, by assessing its processing, referencing your quality manual, you will find the real gaps in the documentation - too late! Second party audit directly affects the bottom line, and will really spark your CEO's interest.

I realise that many organisations are involved in continuous production and the customer is one or more steps away, they wouldn't usually experience this type of audit. For organisations involved in production of custom built equipment the second pary audit is more likely to occur.

When it happens you will realise what nice guys the auditors from certifying bodies are.

The reason you do the ISO9000 thing is that it benefits your organisation by facilitating its management, everything else is secondary.

If you don't at least satisfy your customer, you might not get paid.


Fully vaccinated are you?
Staff member
For some reason, Alan, you seem to believe every company needs ISO9000 and/or needs a formal quality system. That simply is not the case.

Alan, you say: "... But I ask the question - what should the real objective of having a quality system be?" I suggest the first question is does the company need a formal quality system...

I have many clients who did not need ISO or a defined quality system. What they were doing was fine. Then came along a couple of customers who wanted ISO. One client was required because the customer (MTD Yard Machines) also serviced the US automotives as well as the consumer market. MTD passed down the ISO requirement (MTD first requested QS, of course). So my client did it and raised prices to customers requiring ISO.

In this instance I define minimalist as the least a company must do above and beyond what they already do to meet the intent.

"...The reason you do the ISO9000 thing is that it benefits your organisation by facilitating its management..." Nope - most companies do the ISO dance because they are required to do so by a major customer and/or because the company sees the potential for increased sales. ISO does benefit some companies but for many it does little to nothing.

"...If you don't at least satisfy your customer, you might not get paid..." It is in no way an issue of being paid. If companies weren't satisfying their customers before ISO they wouldn't have customers and wouldn't be in business. You may want to argue % of satisfied customers, but that's an incursion into YOUR perception of what a satisfied customer is.

I recently bought a pellet rifle made by Crosman. It failed as I sighted in the scope. I was pissed. The mon&pop shop I bought it from made me madder. I sent a copy of my e-mail to the the shop I was dealing with to Crosman. A representative from Crosman called me (yes, called me on the phone) and told me if there is any question at all in my dealings with the company I bought it from that they would be happy to refund my money or exchange it for a new one. I asked if Crosman knew what ISO 9000 is. I was told yes but they aren't registered. I'll tell you what - Crosman, like many companies, do not need a mandate, or lessons, on customer satisfaction.
Thread starter Similar threads Forum Replies Date
W Misinterpretation of requirement acceptable as root cause? Problem Solving, Root Cause Fault and Failure Analysis 19
D Nonconformance or Misinterpretation - When an operator does a Nonconformance Report Nonconformance and Corrective Action 31
somashekar Is IAF an AB (Accreditation Body) for the ISO9k? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Raffy Ideal way or steps in preparing the system certification for ISO9K:2K? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
M Hiring Decisions - How much effort do you put into the hiring process these days? (7/2020) Misc. Quality Assurance and Business Systems Related Topics 6
M Do I Expect Too Much of Job Candidates? Career and Occupation Discussions 33
B ISO 9001:2015 Transition: Much Easier Than You Think! Misc. Quality Assurance and Business Systems Related Topics 0
E How much a bioequivalence study will cost in the UK Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
P So much turnover, How to improve our training process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
T ISO 9001:2008 to 2015 transition - How much work to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
P ISO 9001:2015 4.2 and 6.1 - Interested Parties - How much detail is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
I How much does an eQMS (Electronic/Software QMS) cost? Quality Assurance and Compliance Software Tools and Solutions 1
J Process Capability - How much percentage of tolerance? VDA Standards - Germany's Automotive Standards 3
W How much would it cost to setup a Quality System for a Repackager or Relabeler? Quality Manager and Management Related Issues 1
G How much to pay a Freelance Six Sigma Trainer in India Six Sigma 1
M Traceability - How much traceability is required? ISO 13485:2016 - Medical Device Quality Management Systems 6
S How much do trainers charge typically for an Adobe Connect / WebEx based training? Training - Internal, External, Online and Distance Learning 3
kedarg6500 How much test force to be applied for Vickers hardness Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
D AS9100 Recertification Audits - How much in advance of the Certificate Expiration AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
J Sourcing a Sterile Product - Asking for supplier for too much regulatory stuff? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D IMR (Individuals and Moving Range) Chart for Short-Run SPC - How much data to include Statistical Analysis Tools, Techniques and SPC 1
V How much Supplier Information do I have to provide to a Customer? APQP and PPAP 6
V For an RSM, how much R-sq is good R-sq Using Minitab Software 3
R How much Protective Current Rating of Building Branch Circuit should be considered? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R How much "harder" is an ISO 13485 Registration Audit compared to ISO 9001 ISO 13485:2016 - Medical Device Quality Management Systems 6
M MSA - According to the formula cg how much tolerance should be put in place? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
Sidney Vianna The frequent flyers that flew too much... Unlimited AAirpass Coffee Break and Water Cooler Discussions 11
E Consulting Fees - How much to charge Career and Occupation Discussions 33
A How Much Validation is needed for OTS Software - Marketing material only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G How much time must pass after the first Certification Audit for us to appear in OASIS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Advice on setting up BD Distribution Deals - How much oversight is required? Quality Manager and Management Related Issues 2
K Key Employees and Officers - How much conflict is tolerable? Quality Manager and Management Related Issues 19
A How much effort is needed for Certification of Class II Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 9
Stijloor Thank you very much!! Covegratulations 5
K Supplier Audit - How much information do we have to give them? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Document Control Procedure - Too much detail? Document Control Systems, Procedures, Forms and Templates 8
somashekar Too much data, Too little analysis - Manual Stages Assembly Shop Data Collection Quality Tools, Improvement and Analysis 2
R OASIS Database Fees - How much are you paying your CB? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M Defining what is a Medical Device Accessory and what isn't - Much Confusion EU Medical Device Regulations 8
A Customer SQE - Within Specification but too much Variance Customer Complaints 7
A What to do when customer requirements are too much? Quality Manager and Management Related Issues 29
D How much Tolerance do I use to Calibrate a 150kgs capacity Scale? General Measurement Device and Calibration Topics 5
M How much Process Description is required or needed? ISO 13485:2016 - Medical Device Quality Management Systems 10
D How much Deviation is Acceptable when Calibrating a Hygrometer? General Measurement Device and Calibration Topics 3
L FDA Audit - How much advance notice do foreign manufacturers get? ISO 13485:2016 - Medical Device Quality Management Systems 4
R MSDS Sheets for Products - How much is too much - Or is there ever too much? Occupational Health & Safety Management Standards 12
T How much information should I keep in my Master Document Register? Document Control Systems, Procedures, Forms and Templates 8
4 Change Control Systems - How much is too much? Document Control Systems, Procedures, Forms and Templates 10

Similar threads

Top Bottom