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.

Review of System Policies

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by rpongrance, May 29, 2020.

Tags:
  1. rpongrance

    rpongrance New Member

    Joined:
    May 29, 2020
    Messages:
    3
    Likes Received:
    0
    Trophy Points:
    1
    The site i'm working at is ISO 9001:2015 certified, but is part of a healthcare system that is not certified. Policies are issued to our site at a system level and are reviewed at a system level on a biannual basis. Do we need to review the policies locally as well? Under 7.5.2 C we must review and approval for suitability and adequacy - if that is done by a party outside of the scope of our certification is that sufficient? If it is then considered documentation of external origin? If we have a statement in our quality manual that says the approval process at a system level has been identified as appropriate and sufficient control would we still be compliant?
     
    rpongrance, May 29, 2020
    #1
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,104
    Likes Received:
    2,560
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Welcome! From what you've posted, can I ask what these policies deal with. As simple compliance to the standard, only ONE policy is required to be a) documented and b) reviewed periodically for suitability. The simple and most dangerous answer would be to say, no (or yes), but it's better to understand the context these policies sit inside.
     
    Andy Nichols, May 29, 2020
    #2
  3. rpongrance

    rpongrance New Member

    Joined:
    May 29, 2020
    Messages:
    3
    Likes Received:
    0
    Trophy Points:
    1
    So the system level policies range from administrative policies, IT policies, finance, Marketing, Materials and patient care. Our quality policy is reviewed and documented annually on a local level.

    The patient care policies are our "primary policies" and do include specific procedures that are done at our hospital.
     
    rpongrance, May 29, 2020
    #3
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,104
    Likes Received:
    2,560
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    I think you are dealing with what often happens with a QMS which was poorly conceived and to obtain a certificate. The simple answer is that as long at the Quality Policy meets the requirements then your certificate is assured. The other policies and procedures - if they are not pithing the scope of the local QMS can be dealt with as your are a) dictated to or b) wish to (if you have autonomy in that situation) and neither will affect the QMS. "Quality" is defined within your QMS scope and IT etc polices usually don't impinge on that.
     
    Andy Nichols, May 29, 2020
    #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
    The standard says "When creating and updating..." Are you creating or revising an internal document using references provided externally? You will need to demonstrate appropriate review and approval of documents created internally. Clause 7.5.2 does not cover documents of external origin.
     
    tony s, May 31, 2020
    #5