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

[Arise]

Hello,

As I understand ISO 9001, they seem like good bussiness practices, however I don't understand how you can certify such a thing.

Does ISO 9001 actually require that the outcome product is quality ?
If there are no explicit requirements to what product quality constitutes, how do you judge this ?
Lets take an example : suppose a machine exists that is extremely costly but makes that product defects over a 5 year period decreases from 2% to 1%, does management need to buy this or can they just decide that they are happy with 2% defects. Where do you draw the line ?

 

[DannyK]

Re: ISO 9001 Certification

ISO 9001 is a quality system certification. It has nothing to do with product certification. The main objective of the standard is for continual improvement and customer satisfaction.
The company decides on what the product quality requirements and sets target or objectives.
ISO 9001 is a tool that requires management commitment. The standard is used in many manufacturing and service industries.

 

[Arise]

Customer satisfaction implies that it meets my expectations. For most goods (in the consumer market) this means that they have to work for 10 years. (for example, washing machine, television,...) , yet no manufacturer provides a 10 year warranty. Wouldn't ISO9001 demand that a 10 year warranty period is provided ?

So doesn't certification = meeting customer expectations ?

 

[AndyN]

Hello,

As I understand ISO 9001, they seem like good bussiness practices, however I don't understand how you can certify such a thing.

Does ISO 9001 actually require that the outcome product is quality ?
If there are no explicit requirements to what product quality constitutes, how do you judge this ?
Lets take an example : suppose a machine exists that is extremely costly but makes that product defects over a 5 year period decreases from 2% to 1%, does management need to buy this or can they just decide that they are happy with 2% defects. Where do you draw the line ?

Welcome, Arise! You'll find most of the answers to your questions here, if you perform a search.

In a nutshell, ISO 9001 is a document which contains the requirements for organizations who want to manage it's operational processes to result in products which; meet requirements, deliver customer satisfaction and continually improve.

It has little or nothing to do with certification, in and of itself. (sorry DannyK, but that's the truth)

Certification is the process of having an independent organization - a 'Certification Body' (aka 'registrar) - evaluate those operations against the standard, by auditing. ISO certification may be required by customers or by the organization's management to show it has a quality system in place etc.

ISO 9001 doesn't - explicitly - say the outcome must be a 'quality product'. But it does say that the organization has to define a system which ensures requirements are met - so that is another way of saying that you've got to have product integrity.

In fact, you may have read that 'ISO allows you to make concrete life preservers"! That's a popular misconception based on certified companies not delivering to the customers requirements! Actually, it says more about the poor level of CB audits, than anything about 'ISO' requirements.

In your example, it's not 'required' to do anything like that. It's management's decision on what they want to do to improve. I'm guessing you imagine the expense of the equipment to outweigh any cost benefit from the 1% improvement.......

Stick around the Cove, you'll get the idea behind 'ISO' systems!

 

[AndyN]

Customer satisfaction implies that it meets my expectations. For most goods (in the consumer market) this means that they have to work for 10 years. (for example, washing machine, television,...) , yet no manufacturer provides a 10 year warranty. Wouldn't ISO9001 demand that a 10 year warranty period is provided ?

So doesn't certification = meeting customer expectations ?

No! See above!

One form of customer satisfaction is meeting expectations. Depending on the marketplace, it's also meeting (specified) requirements! I don't agree with your example, who said these things have to work for 10 years. My washer and dryer have been working for 16 years! My Whirlpool washer cost $5 to fix (myself) and I'm delighted with it! Warranties are usually minimum periods of coverage.

ISO certainly doesn't require anyone to even offer a warranty!

 

[ajb57]

All of what's been said here is true. ISO certification is many things to different people. First off by following the ISO framework, your arranging your organization along a management system framework that seems to cover the vast majority of processess needed for either a manufacturing or service type of organization. And yes true, ISO does not certifiy product, but rather the processess that help to create the product. The actual certification part is your statement to customers that your serious about quality and have the external 3rd party audit to prove that.

 

[Arise]

Sorry for being a pain in the ass, but I'm still not getting it.

Suppose a lot of company X's washing machines break down after 6 month, then :
a) customer expectations are not met
b) somethings wrong with their purchasing or production processes.

So, can company X stay ISO certified in this condition if they don't improve ?

 

[AndyN]

Sorry for being a pain in the ass, but I'm still not getting it.

Suppose a lot of company X's washing machines break down after 6 month, then :
a) customer expectations are not met
b) somethings wrong with their purchasing or production processes.

So, can company X stay ISO certified in this condition if they don't improve ?

What don't you get? Your previous post shows you have a good grasp of the topic!

Sure, if you have a number of products with a fault, the chances are customer expectations aren't met. However, we can't determine if it's a break down in manufacturing or purchasing - you're jumping to conclusions! It could be a (latent) design fault, for example. The company can remain certified, why not? Nothing says you have to have perfect performance!

What is expected by the requirements of the ISO standard, is that the organization will have processes in place to systematically step through such a situation and respond (using the quality management system).

The Certification Body auditor will want to evaluate what was done by the organization. Based on the results of that evaluation, they will make a recommendation - which may result in removal of the certification.

 

[Arise]

Nothing says you have to have perfect performance!

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 ?

 

[Stijloor]

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 ?

Arise,

With all due respect, it seems to me that you have a serious concern about ISO 9001:2000(8). Would you mind sharing with us what "your point" is?

Stijloor.