TS 29001/API spec Q1- help needed

[claire_deen]

Hi guys,

I really need help. Very inexperienced and this is my first big project! I have a manual which is ISO 9001 compliant. I'm trying to integrate API spec Q1 ed 8 and some of the terminology is so confusing. Trying to work with someone elses manual and understand this is killing me lol.

I am taking it that 7.2.2.1 means that there needs to be documents when the requirements in 7.2.2 are being met.

a) product requirements are defined
b)contract or order requirements differing from those previously expressed are resolved.
c) Organisation has the ability to meet the defined requirements

Is this correct? Would I include forms for study specific requirements and a system for changing the requirements.

In short what I'm asking is of the supplemental requirement is simply saying have a documented system?

Any help is appreciated as I'm sinking here

Claire

 

[Duke Okes]

Hi guys,I really need help. Very inexperienced and this is my first big project! I have a manual which is ISO 9001 compliant. I'm trying to integrate API spec Q1 ed 8 and some of the terminology is so confusing. Trying to work with someone elses manual and understand this is killing me lol.I am taking it that 7.2.2.1 means that there needs to be documents when the requirements in 7.2.2 are being met.

a) product requirements are defined
b)contract or order requirements differing from those previously expressed are resolved.
c) Organisation has the ability to meet the defined requirements

Is this correct? Would I include forms for study specific requirements and a system for changing the requirements.In short what I'm asking is of the supplemental requirement is simply saying have a documented system?
Any help is appreciated as I'm sinking here Claire

I don't have the latest API available, but for 7.2 there are two records I normally expect to see (although it may differ from one organization to another):
- Quotes (e.g., indicates that what the customer has requested has been reviewed to see if the organization can meet it, and that a proposal has been submitted to the customer offering to do so)
- Orders (e.g., document indicating that the customer has accepted the proposal and placed an order against it)

Both quotes and orders might also be changed as new information becomes available, new requirements added, etc., so revisions to quotes & orders would also be documented.