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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 Well-Known 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 Well-Known 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.
     
  8. Zhedd

    Zhedd New Member

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    Hi , May I know what type of customer/organization who provides design and after processing you, you supply them back the finished product. Are they also training institutions? anybody can answer.... thanks
     
  9. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Zhedd and welcome to the forum.
    Many of automotive tier supply manufactures receive a drawing (design) from the OEM (i.e. Ford, Toyota, etc..etc...) . These organizations then simply "build to print" and provide the finished product to the OEM.

    Hope this helps.
    Be well (and safe)
     
  10. Guy Léger

    Guy Léger Member

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    If I can express myself, I think the company of @Sonita should first communicate to their developer the functional and performance requirement of the products they need, and should agree with standards or codes to be used, and also with verification or validation activities that Sonita company should perform at the developer organization...(8.3.3)
    Indeed, the type of external control or inspection to apply at the developer company should be determined and realized to the developer company during D&D processed and also during change made, to ensure that final product meet requirements and do not affect @Sonita company ability to deliver conforming products to their own customers...the effectiveness of the review, verification and controls applied by the developers should be taken into consideration...

    The receiption of the final product should be made under controlled conditions, which include documented information defined in 8.5.1...(documented information should be retained to enable traceability)...

    Requirement for post delivery activities should be defined and I think this is where warranty provisions, contractual obligation such as maintenance services, and services such as recycling and sometimes training are included...

    Honestly, I think clause 8.2 to 8.6 should be taken into consideration...May be just Design operation itself can be excluded but all the control, verification and validation activities described in clause 8.2 to 8.6 should be taken into consideration...with relevant documented information...

    Sincerely
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Guy: The post is now nearly 4 years old. Apart from the post by Zhedd, it has been answered and has probably been considered closed.
     
  12. Guy Léger

    Guy Léger Member

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    Indeed, I said it because @Zhedd said that anyone can answer only two days ago... And I just wanted to said that according to ISO 9001: 2015, in 8.5.5 (post delivery activities), developer company or product provider do not have to also be a training institution to deliver their product...but it can be a contractual obligation, a supplementary service, according to ISO 9001: 2015, 8.5.5

    Sincerely
     

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