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8.3 Design and Development

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Sonita, Jan 20, 2016.

  1. Sonita

    Sonita Member

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    Just need some advice or clarification. Our company do not have a QMS as of yet - ( we want to be certified by end of 2016). With the new ISO 9001:2015 - to what extend can we exclude D&D?
    We do not design or develop our own product (training material) we buy it from developer which already include all statutory and legal requirements etc. in for us and we just transfer it into our own layout. The developer is an outsourced supplier that we have an SLA with. 8.3.4 I am sure we will not exclude because we have controls in place to ensure that the product we receive from her is up to standard before taking it to our customers.
     
  2. MCW8888

    MCW8888 Well-Known Member

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    Exclude Design if it is defined as an external party in the Context of the Organization. 8.4 requires the control of externally provided products and services.
    8.4.2 Extends and amends the requirements of meeting specification found in ISO9001-2008 to include the potential impact to consistently meet customer requirements and to include measurement that could adversely affect the ability to deliver conforming products or services.
    8.4.3 Communicate to external providers the applicable requirements . Include necessary competencies and qualification of external provider's personnel. Example: if you need certified Engineer it should be included in the SLA.

    I am new to this standard as well, so I appreciate everyone else comment. Thank you.
     
  3. Leonid

    Leonid Active Member

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    Sonita, you are right. Once training is your product under the scope of QMS then performance of the external supplier which provides to you training material is a part of your QMS.
     
  4. Sonita

    Sonita Member

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    Thanks guys
     
  5. tony s

    tony s Well-Known Member

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    The training materials obtained from your developer are just part of the inputs necessary to design and develop your product/service (see 8.3.3 c and d). (This is in the assumption that your company is a training provider like consultancy firms or schools). When you transfer them to your own layout and eventually become part of the training handouts, these are considered part of your products/services.

    In a training organization, the output of the design and development process is usually called training program, syllabus, curriculum or training course plan. The delivery of the program or curriculum to trainees or students is their product and service.
     
  6. Leonid

    Leonid Active Member

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    Please refer to 8.4.1 a: The organization shall determine the controls to be applied to externally provided processes, products and services when: a) products and services from external providers are intended for incorporation into the organization’s own products and services. If the organization purchases a training course from external provider and incorporates it in own products/service it shall do all this in conformity with 8.4.







     
  7. charanjit singh

    charanjit singh Member

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    Even though you outsource the process (design & development of training material) you still are responsible for the effective controls over that process. To my mind you cannot exclude 'design & development' Your product and service providers have to figure in the "Context" of your organistion.

    There are cases wherein an organisation gets the design from a customer and after processing, supplies the finished product back to the same customer. That is a clear case of excluding the design process from its scope. But your case does not seem to fall in this category.
     

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