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Requirements for products and services in 8.2.2 and 8.2.3

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by judegu, Oct 12, 2018.

  1. judegu

    judegu Active Member

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    Hello guy. It is me, again.;)

    When reading the 8.2.2 and 8.2.3, I found another strange thing I can`t figure it out.

    In 8.2.2, there are two bullets:

    "a) the requirements for the products and services are defined, including:
    1) any applicable statutory and regulatory requirements;
    2) those considered necessary by the organization;
    b) the organization can meet the claims for the products and services it offers
    ."

    In 8.2.3, there are four bullets:

    "a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;
    b) requirements not stated by the customer, but necessary for the specified or intended use, when known;
    c) requirements specified by the organization;
    d) statutory and regulatory requirements applicable to the products and services;
    e) contract or order requirements differing from those previously expressed
    ."

    In 8.2.2, we determine the requirements for products and services and in 8.2.3, we review them. Put it in another way, the requirements for products and services are determined by 8.2.2, and reviewed by 8.2.3. Logically, the requirments for products and servcies should be the same things.

    However obviously, the content in these two subclauses don`t match with each other completely. Bullet a) in 8.2.2 has bullet c) and d) in 8.2.3 as the counterparts. But there is no relevant content in 8.2.2 corresponding to bullet a) and b) in 8.2.3. In fact, customer relevant requirements aren`t mentioned in 8.2.2 at all.

    Why? I can understand there may be no need to determine the requirements SPECIFIED by the customer. But What about the requirements in bullet b) of 8.2.3?
    Or maybe the requirements of a) 2) in 8.2.2 includes requirements in bullet b)?

    Looking forwards to your valuable insights on this matter.
     
  2. tony s

    tony s Well-Known Member

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    A nonconformity against 8.2.3.1b was raised by a CB to a government hospital due to unavailability of isolation room intended for those outpatients with communicable diseases. The CB auditor here observed that patients with TB cases share the emergency room with the other patients. Patients may not demand or require an isolation room but the hospital should know the importance of having such and must demonstrate compliance with the national standards in infection control for healthcare facilities.
     
    Last edited: Oct 12, 2018
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Part of the issue with the way this section is worded is based on a) sometimes the customer knows pretty much what they want and it's in their specification, b) sometimes the customer knows "enough to be dangerous" and needs feedback from the (potential) supplier on those requirements and lastly, c) the supplier owns the specification for what the customer wants to buy. Since what the supplier can do and what the customer wants to buy are sometimes at odds, the supplier must perform a review or reviews at times to minimize the risk of not understanding which of the above scenarios is in play.
     
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  4. BufferMess

    BufferMess Member

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    The 8.2.2 a) 2) pretty much covers all others, including 8.2.3 b). I'd pay less attention to the subclause consistency. They don't have to be structured in a same way.
     
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  5. judegu

    judegu Active Member

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    @tony s

    A good example of 8.2.3.1d. It makes it more convincing that the requirements of 8.2.2a 2) includes requirements of 8.2.3.1d.
    And out of curiosity, I have three follow-up questions.

    1) Which kind of disease is TS? (Just want to know a new abbrev.;))
    2) Regarding this nonconformity, it should be categorized into the Major or Minor? Major, I suppose.
    3) And ISO 9001 is not a mandatory standard. IF this govenment hospital chose to ignore this nonconformity, which kind of body should be there to correct this nonconformity?
    (I know this is far beyond the quality realm, however I am quite curious about it.)
     
  6. judegu

    judegu Active Member

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    @BufferMess

    Hi man. If the consistency is good enough, it will be a great help for me to memorize the whole standard.;)
     
  7. tony s

    tony s Well-Known Member

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    TB - tuberculosis
    The CB only raised a Minor NC.
    Any organization who subscribe to the requirements of ISO 9001 must demonstrate compliance with applicable requirements. Who will correct the NC? Obviously, the hospital.
     
  8. judegu

    judegu Active Member

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    I didn`t express it correctly. IF the hospital didn`t subscribe to the requriements of ISO 9001, who would be responsible to identify this issue and supervise the hospital to correct it since ISO 9001 is not mandatory. Some goverment body?
     
  9. tony s

    tony s Well-Known Member

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    Hospitals in all countries are mandated to comply with national standards created by their government's department of health.
     

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