What is ISO 9001 Certification and how does it relate to Product Quality?

[AndyN]

But in the end, the company is expected to fully meet customer requirements ? Right ? So the company has to show that it is doing everything so the washing machine keeps working for 10 years ?

If you are looking for someone to tell you that you have a case against a washing machine maker who didn't meet your expectations, then I'm afraid this is the wrong place to get that! When a customer buys a product like a washing machine, that customer doesn't specify the warranty period! You might expect that, but the contract is with the seller, not the manufacturer, anyway!

A manufacturer often specifies their product warranty period - like car makers do 3 years, 30,000 miles. You accept that when you buy the product, whether you like it or not! The seller may not have drawn your attention to the warranty, but I believe in contract law (in Europe) the provision of 'caveat emptor' still applies!

If you find that there are a number of similar failures with washing machines, you might have a case for a class action, but unless it involved safety, not simply life expectancy, you won't be lucky with that approach.

 

[Arise]

No, no, no!

My 20 year old washing machine is working fine.

Look, I recently started working in a ISO9001 certified company and I'm going to be involved in it a bit. So I'd like to grasp this thing for work sake and also pure interest.

I really like the standard, it's really "well d'uh" but most things you should be doing aren't being done in most companies, so that's good. I just don't get the auditing part, what is the auditor auditing ? a) that all procedures are in place b) that customer requirements are being met. c) ...

This is where the washing machine comes in, the standard is really abstract and I can't see how you can really measure something abstract, so I'm using an example here. This is also where I don't understand the auditing, how can you audit something abstract...

 

[Stijloor]

No, no, no!

My 20 year old washing machine is working fine.

Look, I recently started working in a ISO9001 certified company and I'm going to be involved in it a bit. So I'd like to grasp this thing for work sake and also pure interest.

I really like the standard, it's really "well d'uh" but most things you should be doing aren't being done in most companies, so that's good. I just don't get the auditing part, what is the auditor auditing ? a) that all procedures are in place b) that customer requirements are being met. c) ...

This is where the washing machine comes in, the standard is really abstract and I can't see how you can really measure something abstract, so I'm using an example here. This is also where I don't understand the auditing, how can you audit something abstract...

Arise,

Our Fellow Cover Mr. Sidney Vienna has posted this great piece of information about ISO 9001:2000(8). Sidney works for a major Registrar/Certification Body. And so does AndyN. So please read Sidney's post and heed AndyN's advise. Hearing it from these experts, it can not get any better!

Good Luck.

Stijloor (een voormalige hollandse noorderbuur)

 

[Patricia Ravanello]

I really like the standard, it's really "well d'uh" but most things you should be doing aren't being done in most companies, so that's good. I just don't get the auditing part, what is the auditor auditing ? a) that all procedures are in place b) that customer requirements are being met. c) ...

This is where the washing machine comes in, the standard is really abstract and I can't see how you can really measure something abstract, so I'm using an example here. This is also where I don't understand the auditing, how can you audit something abstract...

Dear Arise,

Hope I can shed some light on this subject.

1) The auditor is auditing that your SYSTEM complies with:

a) respective Standards (as applicable...ISO 9000, ISO 14000, etc. )
b) Customer-specific requirements​

2) Auditors don't audit the "Product" per se...they audit the records of internal inspections of the product. So they aren't auditing the Product, but the process that created the product.

I think a lot of confusion arises from the fact that ISO 9000 is called a Quality Management System, which to many people implies a "high Quality product" system. It is first and foremost a "MANAGEMENT SYSTEM". There is NO assurance whatsoever of "High Quality" with ISO...it should ensure only "consistent" quality, and quality in compliance with defined characteristics.

The truth is, if the customer-defined characteristics and specifications generate a low-quality product, then, an ISO-managed system will ensure the output of a consistently low-quality product.

Let's use the auto as an example.

CARCO Inc. designs an auto and wants my company, SEATCO to supply seating for their auto. They (CARCO, our customer), define the characteristics and specifications that this seat must meet. Those characteristics may result in what you, the end-user might consider a "High-quality" seat, or a "low-quality seat" (or anything in between). As the manufacturer, who is ISO-certified, my obligation is to ensure that the seat meets the defined characteristics and specifications as defined by CARCO...which might not necessarily be what the end user is happy with.

The onus really is on CARCO to ensure that they know what their customer's expectations and perceptions of "high quality" vs "low quality" are. That's what market research is for. Also, a customer's expectations for "High Quality" might vary considerably, if the price is right (value for the money). CARCO then must translate the customer's preferences into a product which will be perceived to meet or exceed the customer's expectations for quality and value.

So ISO is really just a tool to ensure consistency in the processes which create a product. While the Standard may appear abstract in and of itself, it takes on a personality once it is interfaced with a company's defined processes, and becomes the "lines that you must stay within".

Hope this response hasn't been too abstract.

Patricia Ravanello

 

[AndyN]

No, no, no!

My 20 year old washing machine is working fine.

Look, I recently started working in a ISO9001 certified company and I'm going to be involved in it a bit. So I'd like to grasp this thing for work sake and also pure interest.

I really like the standard, it's really "well d'uh" but most things you should be doing aren't being done in most companies, so that's good. I just don't get the auditing part, what is the auditor auditing ? a) that all procedures are in place b) that customer requirements are being met. c) ...

This is where the washing machine comes in, the standard is really abstract and I can't see how you can really measure something abstract, so I'm using an example here. This is also where I don't understand the auditing, how can you audit something abstract...

Phew, you had me worried there, for a minute.......

 

[Arise]

Take ISO9001:2008 5.2, it explicitely says that customer requirements must be met. It doens't tolerate margins of error. They must be met!
Now, no consumers require that a product can't fail, but the expectation of let's say a television is that at the very least is that it should work for 5 years. Thus, given that no manufacturer can produce televisions with 0 defects, the manufacturer must provide warrancy for 5 years (unless he explicitely states that he only guarentees working condition for x years), otherwise he is breaching 5.2.

Right ?

Arise (een lastige belg)

 

[Arise]

Hi Patricia,

I've actually figured that out, althought you are right that quality != high-quality is also very confusing.

But my problem is more with my post above, the system is designed to and I quote "

needs to demonstrate its ability to consistently provide product that meets customer and applicable
statutory and regulatory requirements,"

In your B2B case, there will be a formal contract between the two and some specifications as to what SEATCO must deliver. If it delivers something inferiour to the contract it has a problem. Now, from what I understand of ISO, this will also be a problem because customer requirements (=CARCO's contract) haven't been met. Thus SEATCO must do everything to improve meet the contract. It doesn't have a choice and if it fails it will get a lawsuit from CARCO AND lose ISO certification...

Right ?​

 

[Patricia Ravanello]

Hi Patricia,

But my problem is more with my post above, the system is designed to and I quote "

needs to demonstrate its ability to consistently provide product that meets customer and applicable
statutory and regulatory requirements,"

In your B2B case, there will be a formal contract between the two and some specifications as to what SEATCO must deliver. If it delivers something inferiour to the contract it has a problem. Now, from what I understand of ISO, this will also be a problem because customer requirements (=CARCO's contract) haven't been met. Thus SEATCO must do everything to improve meet the contract. It doesn't have a choice and if it fails it will get a lawsuit from CARCO AND lose ISO certification...

Right ?​

Yes, Seatco has an obligation to perform...however, usually, the failure to doesn't net a lawsuit (although it could).

Most suppliers have constraints within which they must live. Most customers have a "tolerance" for how much defect they will accept. When stated "objectives" for quality are not met, the supplier may be subject to any of the following:

1) Financial Penalties (dollar charges by customer for delivering sub-standard product)
2) Increased Scrutiny (the supplier may be subjected to addition inspections by third-party companies until they can demonstrate stability and capability of their processes.
3) Loss/reduction of Business - the customer may choose to find another source of supply.
4) Lawsuit - Customer may choose to exercise legal rights if supplier fails to meet contractual obligations.
5) Probation and/or Potential De-certification - the supplier could be placed on probation or their certificate suspended until compliance is demonstrated and customer requirements are met..​

Even without ISO, a supplier has an obligation to meet their contractual obligations, and failure to do so could result in legal battles. ISO provides the customer and the supplier with some assurance that a process is in place to ensure product consistency and to continually improve the System.

Patricia Ravanello

 

[AndyN]

This is also where I don't understand the auditing, how can you audit something abstract...

Try this...... http://www.nqa-usa.com/articles/articles_detail.php?id=39

 

[Big Jim]

Take ISO9001:2008 5.2, it explicitely says that customer requirements must be met. It doens't tolerate margins of error. They must be met!
Now, no consumers require that a product can't fail, but the expectation of let's say a television is that at the very least is that it should work for 5 years. Thus, given that no manufacturer can produce televisions with 0 defects, the manufacturer must provide warrancy for 5 years (unless he explicitely states that he only guarentees working condition for x years), otherwise he is breaching 5.2.

Right ?

Arise (een lastige belg)

In a perfect world, maybe. We don't live in one.

The true explicit requirement in 5.2 is that top management is focused on determining and meeting customer requirements.

Back to your original question. I have an analogy about how the ISO 9001 standard fits into the overall scheme of things.

Consider that on a pleasant Saturday afternoon you decide to go to the park to play softball. When you get to the park, you talk to several at the park and put together enough players to field two teams to enjoy the game.

Some of those recruits only heard "ball" and envisioned something else, and when you got underway, some were playing softball, others playing baseball, still others playing basketball, some more playing football, and even a few trying to play soccer. Perhaps a few were even playing Calvin ball and making up the rules as they went along. That would make for a very unusual game.

Think of the ISO 9001:2000(8) standard as being the game rule book. If all members of the team and all teams are using the same rule book, it is much easier for all of you to understand each other. Using the same standard, makes it easier for you to understand your customers and suppliers and for them to understand you.

If ISO 9001:2000(8) is the "softball" rulebook, then the AS9100B standard could be likened to the major league baseball rule book (ISO on steroids). Since ISO 9001:2000(8) is the parent standard, there is still a reasonable level of understanding.

ISO 9001:2000(8) doesn't directly impact product quality, it impacts an organizations quality management system. As a result, ISO does not certify product, only the quality management system.

An auditor is looking for evidence that you are conforming to the the ISO 9001:2000(8) standard.

Organizations can choose to follow the standard and not get registered. They can claim to be "conforming" to the standard. My experience is that companies that claim to be conforming but are not registered, really are not. They need the discipline of external audits to stay the course.