The differences between ISO 9001 vs a QMS (Quality Management System)

K

KuttyPapa

#1
Dear All,

1. QMS is a set of policies, process and procedure and ISO is a standard which prescribe the mandated stuff for building QMS. ISO 9001 does not mean QMS.
Please correct me If am wrong

2. ISO 9001 requirement vs ISO 9004 guidance Kindly explain me the difference by explaining what requirements offers and guidance offers to the organisation.

Thanks in advance!


Kind regards,
Kuttypapa:cfingers:
 
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P

PaulJSmith

#2
Re: ISO 9001 vs QMS

Viewing your QMS as a "set of policies, process and procedure" is kind of like viewing your home as a pile of wood, wiring, and pipes. There is much more to a successful QMS than just its basic elements.

It's difficult to answer a question that begins with such a premise.
 

Pancho

wikineer
Super Moderator
#3
1. QMS is a set of policies, process and procedure and ISO is a standard which prescribe the mandated stuff for building QMS. ISO 9001 does not mean QMS.
Please correct me If am wrong
Ok. Your sentence that says "ISO 9001 does not mean QMS." is correct. The other one is wrong.

QMS is a Quality Management System. As a system, it consists of several interrelated parts that allow the organization to manage its quality. These parts include the organization processes (like sales, engineering, production, etc.), and the proper caring for of those processes (like evaluating their effectiveness, ensuring availability of resources to support them, and improving continuously). Note that these "caring for" activities may also be processes.

Documentation is indispensable to control processes effectively, but the documentation is not the system.


2. ISO 9001 requirement vs ISO 9004 guidance Kindly explain me the difference by explaining what requirements offers and guidance offers to the organisation.
ISO 9001 is an international standard that specifies a minimum set of requirements for an effective QMS. Organizations can get their compliance to this standard audited by their clients or audited and certified by third parties.

ISO 9004 improves on 9001. It provides guidance for further improvement of an organization's QMS with a look to long-term success. Organizations cannot get certified to this standard.
 
M

maaquilino

#4
Great answer, Pancho. I would only add that if one is subject to FDA regulation, then one's QMS is based on a standard (for example, 21CFR820) that specifies the minimum requirements one must meet to comply with those regulations. The policies and procedures in the QMS document what processes will be followed to meet the regulations required by the standard.
 
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