ISO 9001 is an international standard that tells a company how to structure their quality system. It is used as a benchmark by governments/other organizations to tell us if a company has minimum organizational structure. Does it really apply to trades people or small mom and pop shops? No. But larger companies often need that structure to not be a mess to deal with (will explain below). Being certified to that or other relevant ISO standards is a key indicator in vendor selection for many organizations.
So, what does it encompass?
It places importance on things like management responsibility (is management looking at the health of their company and responding to indicators and trends of bad quality, customer/employee problems, resourcing problems, etc), purchasing controls (are they managing their supplier to ensure good product comes in the door or buying black box slave labor shit from Libya), various aspects of quality control (investigating problems broadly - these could be customer deaths related to your product, or breaks in your system that result in bad product going out the door, employee injury, etc), and product design/validation/testing to ensure ongoing compliance.
Is it hard to comply to? No, not unless your management sucks or people refuse to adopt a quality mindset. I’ve worked in manufacturing for over 10 years, auditing suppliers and other partner companies as well as ourselves and the only companies that can’t figure it out are the ones I’d genuinely rather avoid.
A lot of Chinese companies do little red envelope certification, that is they bribe their certifying bodies and have a fake quality system which is why their products, on the whole, suck and they have such a hard time fixing a problem when it comes up.
In short, it’s a boilerplate set of baseline principles to ensure good product goes out the door. It says ‘you, generally, need to have these rules...but how you write and apply them is up to you’
ISO 9001 is an international standard that tells a company how to structure their quality system. It is used as a benchmark by governments/other organizations to tell us if a company has minimum organizational structure. Does it really apply to trades people or small mom and pop shops? No. But larger companies often need that structure to not be a mess to deal with (will explain below). Being certified to that or other relevant ISO standards is a key indicator in vendor selection for many organizations.
So, what does it encompass?
It places importance on things like management responsibility (is management looking at the health of their company and responding to indicators and trends of bad quality, customer/employee problems, resourcing problems, etc), purchasing controls (are they managing their supplier to ensure good product comes in the door or buying black box slave labor shit from Libya), various aspects of quality control (investigating problems broadly - these could be customer deaths related to your product, or breaks in your system that result in bad product going out the door, employee injury, etc), and product design/validation/testing to ensure ongoing compliance.
Is it hard to comply to? No, not unless your management sucks or people refuse to adopt a quality mindset. I’ve worked in manufacturing for over 10 years, auditing suppliers and other partner companies as well as ourselves and the only companies that can’t figure it out are the ones I’d genuinely rather avoid.
A lot of Chinese companies do little red envelope certification, that is they bribe their certifying bodies and have a fake quality system which is why their products, on the whole, suck and they have such a hard time fixing a problem when it comes up.
In short, it’s a boilerplate set of baseline principles to ensure good product goes out the door. It says ‘you, generally, need to have these rules...but how you write and apply them is up to you’