Guarantee is defined as;
1.Something that assures a particular outcome or condition: Lack of interest is a guarantee of failure.
2.
a. A promise or an assurance, especially one given in writing, that attests to the quality or durability of a product or service.
b. A pledge that something will be performed in a specified manner.

ISO 9001 does non of this.
What it does do, is that it gets the business to look at itself, make sure that it’s systems and processes are inline with what their Quality Objectives are.

But, it does ensure that it can meet customer requirements. If the organisation follows it’s design and planning, and is met with its commitment from Management, customer requirements should be met (has it has to do verification, validation etc, not doing this, could be a failure of the company and its ISO QMS)

In the terms of the ISO, they use ‘shall’ not should, that means the company must rather than be advised.

ISO 9001 standards are high enough, if they are applied properly, question should be, are they in depth enough. That I don’t think so, you only have to look at ISO 9004:2009 and it goes way beyond what 9001 is.

In my opion, 9004 is the new 9001. It’s the way forward

I personally struggle to see how the authors of the standard (even if we consider both 9001 and 9004) can trace the way that ISO 9001 certification promotes some of those quality management principles, Involvement of People, for example

It is heartening that the ISO 9000 series acknowledges the role that staff play in the success of the company, although it has come somewhat late to the party, but I cannot see how the principle has been translated into any meaningful requirements

I can’t really see how the limited requirements of section 5 can be seen as anything but superficial when considering the highly complex issue of “leadership” with all its competing models and philosophies

ISO 9001 has its uses, but let’s keep everything in its place, it has its limitations too

* Customer focus
* Leadership
* Involvement of people
* Documented processes
* Integrated systems
* Continuous improvement
* A factual approach to decision making
* Mutually beneficial supplier relationships