Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,
  We are trying to redesign our Design Controls procedure to be more consistent with ISO 13485:2016 and really nailing down exactly what documentation should be generated and approved when. Our current model for design inputs is as follows:

Step 1) Define & document user needs and intended uses
Step 2) Write more comprehensive, high-level Design Input Requirements document (including all content required in ISO 13485:2016 section 7.3.3)
Step 3) Break DIR down into subsystem level requirement specifications with engineering level of detail (e.g. software, hardware, accessories, etc.)

I'm getting confused by the relationship of 13485:2016 section 7.2.1 "Determination of requirements related to the product" to section 7.3.3 "Design and development inputs." It seems like in our model, parts of 7.2.1. (the user needs) would be defined in our step one, while the remaining requirements would be addressed in our step 2. Am I missing something? The relationship between 7.2.1 and 7.3.3 is very confusing to me. Any help would be greatly appreciated.
  Thanks!

One thing to keep in mind here is that the requirements outlined in 7.2.1 are related to overall product realization and the customer related QMS processes while the requirements for design and development inputs in 7.3.3 are only related to the design and development of the product.

Therefore the requirements outlined in 7.2.1 are intended to set a framework for gathering the information required in 7.3.3. Hopefully this provides the needed clarification.

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Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
Becker MN
United States
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Original Message:
Sent: 24-Jul-2017 16:31
From: Anonymous Member
Subject: ISO 13485:2016 Product realization requirements/inputs

This message was posted by a user wishing to remain anonymous

Hi all,
  We are trying to redesign our Design Controls procedure to be more consistent with ISO 13485:2016 and really nailing down exactly what documentation should be generated and approved when. Our current model for design inputs is as follows:

Step 1) Define & document user needs and intended uses
Step 2) Write more comprehensive, high-level Design Input Requirements document (including all content required in ISO 13485:2016 section 7.3.3)
Step 3) Break DIR down into subsystem level requirement specifications with engineering level of detail (e.g. software, hardware, accessories, etc.)

I'm getting confused by the relationship of 13485:2016 section 7.2.1 "Determination of requirements related to the product" to section 7.3.3 "Design and development inputs." It seems like in our model, parts of 7.2.1. (the user needs) would be defined in our step one, while the remaining requirements would be addressed in our step 2. Am I missing something? The relationship between 7.2.1 and 7.3.3 is very confusing to me. Any help would be greatly appreciated.
  Thanks!