How ISO is usually implemented...in a BAD, BAD way
Second Scenario: DROP DEAD...QUICKER
Reference the "First Scenario: Drop Dead." In that case we have shown a lack of documented systems "killing" a technical manufacturing company at the point it attempts to expand and grow.
In the following case, a large advanced customer requires a "Good Deal Company" to implement ISO 9001.
MICROMANAGERS run "Good Deal Company." They believe that quality controlled, accurately documented sales, production, test, and engineering systems are barriers to speedy manufacture. They believe that without them they can produce a product much faster and cheaper.
"Good Deal Company" has no intention of ever really implementing controlled documented systems. They are going to act like they have them...sort of a "dog and pony show" to be put on every time they are audited.
So they buy ISO in a can. You can get ISO templates that are already written "generic" specifications. All you have to do is plug your company's name into the generic specs...and that is exactly what "Good Deal Company" does.
They pay an ISO Registrar $10,000 for a certification audit...that they fail. The ISO Registrar discovers that most of their specifications do not match actual process. They know it's ISO in a can.
Further "Good Deal Company" failed to implement INDUSTRY STANDARDS that are not part of the ISO outline. Most ISO Registrars are now industry specific and are experienced in your industry. They know all the standards organizations applicable to the products you make.
ISO requires management understanding of all standards applicable to your Industry. Management must make certain that industry standards are applied in production, test, and engineering procedural specifications. Beyond ISO, this is a requirement of proper management in general.
An example is SEMI - standards for the semiconductor industry. But wait semiconductor process equipment utilizes high purity stainless steel tubing and those standards are created by the American Society of Tubing Manufacturers (ASTM). Hold on there's more...the electrics are governed by the Institute of Electrical and Electronics Engineers (IEEE).
That's why the ISO outline is so simple! You are supposed to be an expert about, and confirm application of, all standards that govern manufacturing, test, engineering, and storage of your product in your industry, AND the industry you are selling to.
You must also be an expert about, and confirm application of, all standards that govern manufacturing and storage of raw materials and components you buy from outside sources. Not so simple! Typically the list of standards that can govern your manufacturing is long.
Industry standards, not ISO standards govern manufacturing, test, and engineering procedures. They are much more complex and harder to implement. A failure to implement industry standards is immediately perceived by a good auditor. Your production specs will be too simple to be real.
ISO Registrars won't really fail you...they won't get any more money from you if they do. In the worst case scenario they will assign you about 50 preventative actions that must be implemented in about 90 days. Then you pay them to re-audit you and you get certified.
"Good Deal Companies" frequently don't realize ISO never ends...you are audited annually by your ISO registrar.
Most companies don't realize that ISO requires they audit themselves, typically annually. Most companies think of internal audits as unnecessary work. They don't realize that effective internal audits are the only path to sound process development and that internal audits will prevent failures of external audits by the ISO registrar or customers.
Most companies are not prepared for the extra work of the ISO Registrar's preventative actions. Worse yet, the bulk of the old system still exists and rules. ISO registrars can not and do not even come close to auditing your entire system.
Now there is a devilishly confusing third path for new employees to follow. Before ISO, there were only two paths a new employee could follow to receive training:
Path one - direct instruction from an experienced employee. This path gives a lot of INFORMAL POWER to employees. If they are threatened by, want something from, or just don't like a new employee or the company, they can withhold or misdirect causing defective product. Documented procedures eliminate INFORMAL POWER within your organization.
Path two - uncontrolled written instructions produced by better employees. The problem with these are that without document control they become outdated and still exist in production. I have seen many organizations following old production instructions with added notes scribbled on them to make them current. Without the notes they produce defective products.
Path three - new production specifications produced by ISO in a can. These specs were created for "dog and pony show" audits and are a sure path to producing defective products. The real problem here is that they look good...just like real accurate specs being created in response to ISO preventative actions. How does a new employee know the difference?
Employees may never know the difference...because new specifications, and in turn the entire ISO program, frequently loses credibility with all employees because of "ISO in a can specifications" and "dog and pony show audits."
Go back to our First Scenario: Drop Dead and follow each step adding extra work created by ISO preventative actions and confusion created by the new deadly "third path." You can see implemented erroneously ISO or QS can create more chaos and even more defective products.
The company Drop's Dead...quicker...instantly into vapor.