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There must also be methods for ensuring that both design inputs and outputs have traceability. Organizations are now responsible for maintaining design and development planning documents and updating them as feedback flows into them. This means there should also be documented arrangements for communicating with regulatory authorities.ĭesign and development (13485:2016 Section 7.3) There is also the added statement that the organization must communicate with regulatory authorities in accordance to applicable regulatory requirements. The new 2016 version states that the organization shall PLAN and DOCUMENT arrangements for communication with customers. Section 7.2.3 is now listed as “Communication”, instead of “Customer Communication”. Where 7.2.2 just points to the requirement stated in 7.2.1. In sections 7.2.1 Determination of requirements related to product & 7.2.2 Review of requirements related to product, there is the additional requirement that “any user training needed to ensure specified performance and safe use of the medical device”. During product realization, infrastructure and work environment (along with handling, storage, distribution and traceability) have all been added and must be taken into consideration.Ĭustomer-related processes (13485:2016 Section 7.2) As they use ‘shall’, they are mandatory requirements. Records of risk management activities shall be maintained.” have been added to the standard. Two new sentences “The organization shall document one or more processes for risk management in product realization. Planning of product realization (13485:2016 Section 7.1) They are also two of the core differences in section 7, “Product Realization”.ġ3485:2016 Section 7- Product Realization In my previous blog I stated that the two major themes in changes to the ISO 13485 standard are taking a risk based approach and documenting everything. Michael May in Quality, Regulatory | 14 comments How ISO 13485:2016 section 7 changes impact your QMS There is no question whether ISO 13485:2016 section 7 changes will impact your Quality Management System (QMS).