ISO 9001 - Gigantic waste or Beneficial? Why does ISO 9001 exist? Got data/facts?

[Bill Levinson]

ISO 9001 works in health care (service).

 

[Mike S.]

I have watched performance improve and improve and improve.... 20+ years ago, performance of 1/4-1/2% defects shipped was considered to be pretty good performance, in many cases... certainly common... (that would be 2500-5000 ppm in today's calculations).... that improved to where most companies were at 1000 ppm, then 500, then 100 became common..... imagine, a million parts shipped and only a random 100 were defective..... that continued to improve to 50, then 25 was the "industry standard".... and today, for a majority of companies, 5, 10 or even 0 ppm, month after month... 10 months, 12 months, 15 months.... with a rare occasional break.... And the types of defects are often tiny, silly things that would never even have been a complaint in the "old days." .... .

I have to ask, in what industry or industries are you seeing "a majority of companies" at 0-10 ppm defects shipped?

 

[Watchcat]

I have watched performance improve and improve and improve.... 20+ years ago, performance of 1/4-1/2% defects shipped was considered to be pretty good... (...2500-5000 ppm in today's calculations).... that improved to ..1000 ppm, then 500, then 100 ..... 50, then 25 .... and today 5, 10 or even 0 ppm, month after month

So, among other reasons, ISO 9001 apparently exists to enable companies to equate quality with a lack of "defects." This is what is meant by "compliance hijacked quality years ago."

It is interesting how often I see those who are pursuing compliance over quality refer to "performance," rather than to "quality," and yet ISO 9001 isn't a performance management standard. Apparently it has been hijacked as well.

 

[Sidney Vianna]

and yet ISO 9001 isn't a performance management standard.

The very first paragraph of ISO 9001:2015 reads:

The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives

A quality system that does not assist the organization in improving it's performance is seriously dysfunctional.

 

[Watchcat]

The very first paragraph of ISO 9001:2015 reads:
A quality system that does not assist the organization in improving it's performance is dysfunctional.

A functional quality system is one that enables a company to manage the quality of the goods or services that it delivers. It is up to the company to decide what level of quality it wants to deliver. If it chooses to deliver poor quality and its quality system makes it possible to achieve this quality goal, its quality system is functioning superbly well.

How well the company performs in the process of delivering whatever level of quality it delivers is unrelated to that quality:

- A company that produces 50% defects and delivers 50% no-defects has terrible performance. If the 50% no-defects that it delivers do not meet user needs, it also has terrible quality. If the 50% no-defects meet user needs, it has great quality, in spite of its terrible performance.

- A company that produces .0001% defects and delivers 99.9999% no-defects has great performance. If the 99.9999% no-defects that it delivers meet user needs, it also has great quality. If the 99.9999% no-defects do not meet user needs, it has terrible quality, in spite of its great performance.

 

[Sidney Vianna]

A company that produces 50% defects and delivers 50% no-defects has terrible performance.

There are no absolutes. In my previous life as a management system auditor, I remember auditing an organization that was involved with producing crystals that were used in the very early versions of military night vision equipment. Their yields were atrocious, compared to "mature products". They would reject, in average, 70%+ of the early batches. Nevertheless, technology evolved and their yields improved gradually over time. The improvement, obviously came as a result of a plethora of improvement initiatives; some need capital equipment expenditure, some came as improvement in the production processes. Without a functional quality system, they would have never improved their yields and be out of business, by now.