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What to Know: History of ISO9001
History of the ISO Standard
First, a little history lesson. This is the History of ISO9001.
This system started in the mid-19th century and was focused on shipping.
If you were a manufacturer, and wanted to hire a ship to transport your goods you had a problem. This might be on some long voyage. You would need to contract out a ship to do so.
The problem is, that you may not be familiar with the nuances of the sailing ship industry. You might well go down to the docks, and ask around for a ship that would carry your cargo.
What do you, the shipper, really need? You need reliable delivery. Avoid pirates. You want a crew that won’t panic and jettison your cargo in the face of a little adversity.
So, you would call in a third-party expert. This expert would validate the vessel and crew, and at least you would have a way of independently reducing risk. A system of “international standards” for shipping was developed by the British. This industrious nation did a lot of this type of work.
At some point “international standards” were developed for everything. There is a story that the train station in Kuala Lumpur, Malaysia, is capable of withstanding 12 inches of snow. The roof was built to British Imperial Standards.
History of the ISO Standard as it applies to You
ISO9001 Standard was established in 1992. The ISO standard is a high-level quality system standard that could be adapted to various industries
The standard is based on the same fundamental system of third-party validation. A third party “expert” surveys your organization, He or she makes a determination as to whether your management system meets the international standard, as defined by ISO9001.
The ISO standard not guarantee the product. It does give assurance that the client’s quality system meets the minimum expectations. This is because we have an underlying expectation. A properly run management system is capable of understanding whether or not its products are terrible. Therefore one would then hope they would continually improve them.
There are currently about 1 million active ISO9001 Certificates, a lot of these are issued to companies in China.
Supplier Quality Auditing
When the system developed It was seen as a way to standardize and reduce “supplier quality” auditing. I used to work for a company with a plant way in the back woods of Louisiana. In this place there were five major customers, and they each had a quarterly supplier audit. It was literally one person’s job to do nothing but guide the customer quality audits and then entertain the customers. Maybe this was at one of the local places, which was fun for a while. But we’ve evolved beyond that at this point.
In order to cut down on this type of thing, this system was established. The previous system often resulted in multiple standards, and multiple specifications. This was seen as a way to reduce some of this activity.
One of the main motivations for being ISO certified is that someone is “making you”. This someone might be a customer that wants to have some kind of third- party validation of you. Also there are many risk-reducing reasons that this is a useful thing to do.
The ISO Certification Basics
This all starts with not the client company, but the customer.
The system is about customer focus. The customers have needs. They need product conformity, continual improvement, and some assurances that you aren’t breaking the law. This is because from the point of view of the customer, they are making an investment in you as a supplier. Also they need some assurances that you, the supplier, are going to be around.
When the ISO standard says “the organization” it means “you,” who provides the product or service.
The basis for this is commitment. Customers want you to be committed. They also want you to know what you are doing. There is such a thing as a “scope of supply.” This is because a company might be perfectly fine at providing chemicals, for a chemical mixing business. But not know anything about providing nuts and bolts and hardware and packaging.
The example I usually use in auditing is “goat herding.” It is possible to be ISO certified in goat herding. But that does not make anybody a competent supplier in chemicals. So, the “scope of supply” is very important, and we’re going to talk about it in clause 4.3.
Your Registrar
The company that does the third-party validation is the registrar. This company competently conducts the audits, and maintains the certification status. The registrar issues and maintains your ISO certificate, and any potential customers that want to check up on your certification status may look you up.
The person that actually does the audit is either an employee or contractor for the registrar.
Both the registrar and the auditor have organizations that certify them.
Everyone in the system is subject to a set of standards, and audits. For auditing it is ISO19011 and for being a registrar it is ISO17021.
Specialized Standards
As we said, there are standards for all of this.
At some point, in the late 1990s, there came a need in certain industries to have more stringent standards, with higher level requirements.
Among these are the 13485 medical goods standard, the 16949 automotive standard, the AS9100 Aerospace standard, and the ISO14001 and 45001 environmental, health and safety standards.
Both the auditor and registrar need to be approved to audit and conduct registrar activities in these areas, and the intent of all of this is that even though there are multiple standards, the structure of all of them is based on the 9001 standard.
It is not uncommon for someone, either an organization or an auditor, to start out as ISO9001 certified and then upgrade as needed.
PS: Have you checked my course in Udemy?
Here is my link to Udemy course, “How Not to Fail at ISO9001”
https://www.udemy.com/course/how-not-to-fail-at-iso9001/learn/lecture/34733460#content
Here’s the link to my Quality Systems Training. You can hire me to give this training in person, complete with questions and answers, and along with a few decades worth of horror stories about product quality, dangerous products, and why people don’t do their jobs.
