Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

8.3 what is development ?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, May 22, 2019.

  1. Qualmx

    Qualmx Well-Known Member

    Joined:
    Oct 7, 2015
    Messages:
    428
    Likes Received:
    52
    Trophy Points:
    27
    Location:
    Mexico
    hi all
    Please give some comments about this.
    I manufacture steel parts, bins, steel supports, but all of these is based on client drawing, specs. and standards, I don’t design anything, just I ensure is well fabricated by 8.1, 8.5.
    Question could I declare non applicable 8.3 ? But... what about development?
    Can be also declared non applicable?
    Or in this case where is left development? Should be managed together design and development or can be separated?
    Thanks
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,719
    Likes Received:
    1,886
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    OK, simply ask yourself: do we develop these products? If you can't change the specification without customer approval, then the answer is no and you don't have a development process. I think you're over thinking the requirements...
     
    John C. Abnet and Qualmx like this.
  3. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,172
    Likes Received:
    867
    Trophy Points:
    112
    Location:
    Laguna Philippines
    I believe, you don't have to separate "design" from "development". Even ISO 9000:2015 didn't have separate definitions for both words. See below:

    3.4.8
    design and development

    set of processes that transform requirements for an object into more detailed requirements for that object

    Note 2 to entry: In English, the words "design" and "development" and the term "design and development" are sometimes used synonymously and sometimes used to define different stages of the overall design and development.
     
  4. Frank Palladino

    Frank Palladino New Member

    Joined:
    May 22, 2019
    Messages:
    1
    Likes Received:
    0
    Trophy Points:
    1
    Hi Folks - this is my first entry.

    It is reasonable for a contract manufacturer (for example) to not have any design capabilities. All drawings/BOMs are provided by their customers. They just need to be prepared to demonstrate a QMS process that records/deciphers/ and understands the customers requirements as they are flowed down - that would constitute the development part. Designing the product requirements and associated drawing configuration controls is all on the customer.
     
  5. Qualmx

    Qualmx Well-Known Member

    Joined:
    Oct 7, 2015
    Messages:
    428
    Likes Received:
    52
    Trophy Points:
    27
    Location:
    Mexico
    Thanks Tonys
    So is not possible to have an exact frontier for design and development, where design finishes and when development starts.neither I could apply if Ionly development if I only fabricate.
    So in this Case, If I don't design, only fabricate, could I declare non applicable 8.3?
    Thanks
     
  6. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,172
    Likes Received:
    867
    Trophy Points:
    112
    Location:
    Laguna Philippines
    From your original post:
    I'm certain that 8.3 is not applicable to your scope of QMS.
     
    Qualmx likes this.
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,719
    Likes Received:
    1,886
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Welcome! In most cases, this isn't product "development". It's more pertinent to the sale process under 8.2 than anything. Typically, for contract machining etc, the whole of 8.3 isn't applicable. The practices and activities of development, when applied to product, mean things like build, test, review, modify, test, review and so on. These go on through phases like "Feasibility", "Prototype" and "Engineering Model" iterations.
     
    Qualmx likes this.

Share This Page