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.