1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
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.

ISO and API Q1 for R&D department in the mechanical sector

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Jennin77, Nov 11, 2023.

  1. Jennin77

    Jennin77 New Member

    Joined:
    Nov 11, 2023
    Messages:
    3
    Likes Received:
    2
    Trophy Points:
    2
    I see many companies having a R&D department in the organization chart but no real procedure for that and no inclusion in the quality manual, no management in the ISO 9000 or Q1.

    Do you think it is acceptable from a QMS point of view? How can I properly include R&D activities in the QMS?

    Thanks!!!! Any suggestion is appreciated?
     
    Jennin77, Nov 11, 2023
    #1
    John C. Abnet likes this.
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,109
    Likes Received:
    2,562
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Yes, indeed. R&D is frequently not considered as part of a QMS because it happens before a product is designed. I’m not sure it’s true to say “no management”, but ISO 9001 etc only recognizes the need for the QMS to control product when the organization has decided to put resources into a design. Typically research and development is a “sand box” where concepts etc are “played with” to see if viable. It’s not difficult to define plans, testing, etc for that, however.
     
    Andy Nichols, Nov 11, 2023
    #2
    John C. Abnet likes this.
  3. Jennin77

    Jennin77 New Member

    Joined:
    Nov 11, 2023
    Messages:
    3
    Likes Received:
    2
    Trophy Points:
    2

    Hi, thanks for answering!
    Well this is exactly what I was thinking, but I have somehow some doubts: there is no doubt about the research part, but the development part is somehow linked to the product design, even if at an early stage.

    Basically some product could be designed and validated by R&D as part of New Product Development, not linked to any specific job or customer. Prototypes are built, tested, validated. The interesting stuff is that the official design department (with rigorous procedure, 100% under the QMS) can take the new R&D products once they are ready, starting again the design validation with the new rules of this department.

    Can I skip for example ISO 9001 7.3 for R&D assuming that their unregulated development part is somehow not risky because the ISO process will start with the design department later if and when sold?
     
    Jennin77, Nov 12, 2023
    #3
    John C. Abnet likes this.
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,109
    Likes Received:
    2,562
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Basically, yes. Don’t let the word “development” throw you off. I worked in an organization which did what you describe. Concepts were played with and when one looked promising, “development” honed the results. It was this concept model which the detailed design was developed from to production.
     
    Andy Nichols, Nov 12, 2023
    #4
  5. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,350
    Likes Received:
    1,055
    Trophy Points:
    112
    Location:
    Laguna Philippines
    From the definitions given by ISO 9000:2015, a QMS is a set of interrelated/interacting elements of an organization that establish policies and processes to achieve quality objectives. ISO 9001 Clause 4.4.1 states “The organization shall determine the processes needed for the QMS and their application throughout the organization…”

    Question: Does the R&D process not needed to achieve quality objectives?
     
    tony s, Nov 15, 2023
    #5
  6. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    710
    Likes Received:
    510
    Trophy Points:
    92
    Location:
    Upper Midwest- USA
    Good day @Jennin77 and welcome to the site.
    One question that has not been raised is in regard to the scope of your organization's QMS. IS "R&D" included in your organization's scope of certification? (Remember, there is ...
    1- SCOPE of ISO 9001 (identified in ISO 90001 clause 1).
    2- SCOPE of your organization's QMS (what all aspects of your organization you are going to control as part of the QMS.
    3- SCOPE of certification. Often same as "2" above, but not always and not necessarily. For example, your organization may determine to internally maintain R&D as
    consistent with/part of your QMS, but may choose NOT to include in your organization's scope of certification.

    Remember, ...
    "The organization shall determine the boundaries and applicability of the quality management system
    to establish its scope."

    Hope this helps.
    Be well.
     
    John C. Abnet, Nov 15, 2023
    #6