Is QMS like a set of rules and regulations that a company follows?

[Seekingknowledgee]

Hi All,

I'm pretty new to this. So one of the basic questions I want to verify is what a Quality Management System is. I know that every company has its own QMS.
But is QMS like a set of rules and regulations that a company follows? Is that it? Like if a company follows all the quality regulations of, Let's say, ISO 13485, then if a question arises, "What is your company's QMS?/ What kind of QMS does your company follow?" Then the answer would be, " My company follows a QMS of ISO13485" .
Is that how it would go?

 

[William55401]

You are on the right track. Depending on the markets your company participates in, there will be local country requirements too. 13485 is a good starting point to build on. Enjoy the ride.

 

[Seekingknowledgee]

You are on the right track. Depending on the markets your company participates in, there will be local country requirements too. 13485 is a good start point to build on. Enjoy the ride.

Thanks William. Quick question. Lets say two companies, both certified as ISO13485 only. No other QMS/Certifications that they have. Both manufacture same product, in same country.
Since they both are ISO13485, Will both be following the same rules/regulations? In other words asking " Is it possible that in spite both companies manufacture same product in same country and same everything, they follow different rules and regulations, and both still be ISO13485? "

In other words, Does ISO13485 (or any other QMS) give leniency/flexibility to companies that would not like to follow some of the rules and regs imposed by ISO13485, and still be certified as ISO13485(or whichever QMS)?

 

[Tagin]

From ISO 9000:2015 -

2.2.2 Quality management system

A QMS comprises activities by which the organization identifies its objectives and determines the processes and resources required to achieve desired results.
The QMS manages the interacting processes and resources required to provide value and realize results for relevant interested parties.
The QMS enables top management to optimize the use of resources considering the long and short term consequences of their decision.
A QMS provides the means to identify actions to address intended and unintended consequences in providing products and services.

Typically, a QMS is going to comply with one or more standards, such as 9001 or 13485, and also any applicable regulations, etc.; but the QMS itself is an organization-specific entity.

 

[Tagin]

In other words, Does ISO13485 (or any other QMS) give leniency/flexibility to companies that would not like to follow some of the rules and regs imposed by ISO13485, and still be certified as ISO13485(or whichever QMS)?

The ISO standards like 13485 are not rules or regulations per se. Rather, the standards like 13485 try to specify a number of things that 'shall' be done by the QMS without specifying exactly how to do them. So, one company might document nonconformances with paper forms handled by a single person, whereas another company might have an electronic QMS system and a team or board that reviews nonconformances. As long as both companies meet the intent of the standard in documenting. reviewing and taking action, etc. on nonconformances, then they will both comply with applicable shalls in the standard.

 

[Marc]

Will both be following the same rules/regulations?

The ISO standards are NOT "regulations".

[standards] specify a number of things that 'shall' be done by the QMS without specifying exactly how to do them.

Correct.

local country requirements

Typically these are "regulations".

 

[Seekingknowledgee]

Thanks William, Tagin and Marc. Very Helpful. I'm getting a good picture of QMS.

 

[Ninja]

I tend to think of a QMS as a ship.
The QMS does not tell you how to steer the ship, but it requires that you verify that someone is steering.
If two companies decide to go to the same place, the QMS does NOT require that they take the same route, or have the same type of ship... but it does make sure that someone paid attention to what type of ship, and that someone thought about whether or not the route goes toward the destination.

I was in a company with a robust QMS, single owner private company, and we made stuff and sold it.
It was purchased by a company that ran a completely different QMS under the same standard, a public company that tried (and failed) to make the same stuff and sell it.
The method of making the stuff was radically different, the corporate goals were totally different, HR was totally different, quality of product was totally different.

Both companies had a plan for making "stuff"...but the plans differed wildly.
Both companies had an end goal they were trying to achieve...but the targets differed wildly.
Both companies tried to make the same thing...on totally different ships, by totally different routes.
The QMS commonality was that those high level choices were made and documented...and to a great degree, that's what a QMS "is".
Making sure that someone is steering and making decisions...not forcing all to make the same choices, just forcing said choices.

HTH

 

[Seekingknowledgee]

I tend to think of a QMS as a ship.
The QMS does not tell you how to steer the ship, but it requires that you verify that someone is steering.
If two companies decide to go to the same place, the QMS does NOT require that they take the same route, or have the same type of ship... but it does make sure that someone paid attention to what type of ship, and that someone thought about whether or not the route goes toward the destination.

I was in a company with a robust QMS, single owner private company, and we made stuff and sold it.
It was purchased by a company that ran a completely different QMS under the same standard, a public company that tried (and failed) to make the same stuff and sell it.
The method of making the stuff was radically different, the corporate goals were totally different, HR was totally different, quality of product was totally different.

Both companies had a plan for making "stuff"...but the plans differed wildly.
Both companies had an end goal they were trying to achieve...but the targets differed wildly.
Both companies tried to make the same thing...on totally different ships, by totally different routes.
The QMS commonality was that those high level choices were made and documented...and to a great degree, that's what a QMS "is".
Making sure that someone is steering and making decisions...not forcing all to make the same choices, just forcing said choices.

HTH

That's a nice analogy. Thanks for that. That's one step closer to understanding QMS for me.

 

[John Broomfield]

Also, most companies that decide to develop the way their organization works as a system to fulfill requirements already have their own unique cultures (shared beliefs), designs of services, designs of products, processes for delivering their services and products etc...

...and yet all can comply with legal requirements and the ISO system standards because of the way they are written for our use in the free world.

A totalitarian state may be a different matter!