Determining the requirements for the products and services

[sunrizenew]

Hi,

in ISO 9001:2015 clause 8.1 item a

8.1 Operational planning and control
The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by:
a. determining the requirements for the products and services;

the standard state "determining the requirements for the products and services"

i have some confusion in what is the meaning of "the requirements for the products"

is that, is the requirements needed to achieve the product ?


or

this mean the feature and purpose of this products

 

[Jen Kirley]

Hello sunrizenew,

Requirements needed to achieve the product are based on the product requirements. Here are a few examples:

• If we need sterile products as per FDA and MDU requirements, we will likely need clean room and/or sterilization process(es).
• If our computer chips need to be protected from ESD damage, we will need to install ESD protections in our process areas, as well as specific packaging to protect the product(s).
• If we are required to provide lead-free products, we will need to ensure raw materials are free of lead, as well as all of our processes and materials that could be introducing this type of contamination.

I hope this helps!

 

[John C. Abnet]

Good day @sunrizenew ;
In addition to the good council you received from @Jen Kirley , consider this...

Note the title of clause..." Operational planning and control"
Now consider the opening statement of the clause...
"The organization shall plan, implement and control the processes..."

So, based on the above, I now ask a few questions to help you think through this...
1- How does your organization control processes ? (work instructions? digital recipes? etc..etc..?
2- How does your organization WANT to control processes? (these reviews are often a good opportunity to critique and improve. )
3- How will the controls put in place be sustained? (posted or digital documents which are under the governance of change point control? Training
curriculum "linked" to title/position to ensure all in those moving into that role will receive the same training?)

Hope this helps.

Be well.

 

[Tagin]

in ISO 9001:2015 clause 8.1 item a

the standard state "determining the requirements for the products and services"

i have some confusion in what is the meaning of "the requirements for the products"

It is the product requirements (specifications, dimensions, functional abilities, etc.)

"...the requirements needed to achieve the product " would be b ("establishing criteria for") and c ("determining the resources"), and also e ("determining...").