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Old 13th January 2018, 05:07 AM

Total Posts: 3
Re: ISO 9001 2015 Documentation for Engineering and Design

Hello Guys,

These are very insightful explanations. Thanks you very much!

Coincidently, I haven’t been able to stop thinking about this so in the mean time I was brainstorming and wrote a few things down so I thought I would share it.

Mechanical Design:
  • Drawings and 3D Model --> drafts for design review, not controlled
  • Drawings and 3D model finalized --> production planning and assembly instructions
  • Drawings red-lined from assembly --> ??
  • Corrected drawings and 3D model --> Final system documentation, i.e. as-built records

Electrical Design: Similar as mech. Design

Systems Engineering:
  • Hardware Design concepts --> production planning documents
  • Communications and interfaces design notes --> production planning documents
  • Engineering calculations and dimensioning decisions --> internal to systems engineering, not passed down. Is this a record?
  • First-draft PLC Programs, state machines, operating concepts --> I guess same as above
  • Parametrizing/Configuration data --> I guess it is like an appendix to a work instruction
  • Final system performance and hardward configuration compendium --> I guess what one would normally call the system specification (perhaps a record)

R&D (knowledge-base, not controlled):
  • Project reviews and technical Lessons learned
  • Sizing and calculation guidelines
  • Design Guidelines
  • Technical Descriptions
  • Product or replacement Investigations
  • Market or technology research
  • Product benchmarks

I guess the collection of all records from each of these departments is what the medical device industry would normally refer to as "Design History File" (DHF), correct?

However, I am starting to realize that I just have to „think outside the box“ more and think in tags in today’s dynamic and multidimentional environment.

I guess my real questions are:

Are our engineering documents percieved and treated correctly?

Which engineering documents do I really want/need to control as a small company ?

What is the best strategy for a small company to achieve design (quality) assurance without making the mistake of controlling too much and thus exposing too much in case of an audit?

Any thoughts?

Last edited by cferrer; 13th January 2018 at 05:12 AM. Reason: forgot a comment

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