ISO9001 in 2021 - Week by Week - Week 29 - 8.3 Design and development

This is a 52 week discussion of ISO9001:2015. Each week, we discuss a specific clause of the ISO9001:2015 standard in detail and look for ways to trim the fat. (As a member of TAG/TC176, the committee responsible for review and revision of ISO9001, (possible revision in 2023), I’ll keep you posted on what I learn all year!)

(It is strongly recommended that you purchase a copy of ISO9001:2015  for reference).  And, be sure to do your homework!

8.3 Design and development of products and services

8.3.  8.3.1 General states:

The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.

This week, we’ll merely evaluate the applicability of this section as part of the quality management system. 

Traditionally, design and development was limited to the actual act of designing and engineering product and service solutions.  And those companies whose business model was to simply “make to print” or contract manufacture, excluded 8.3 from their quality systems.

The language in this section is lengthy, but it is also very specific, which in my opinion is helpful.  The steps are carefully listed with painstaking detail.  And, if followed, can help to create very robust processes with the right gateways to reduce risk and set up the best odds for success.

THIS WEEK’S HOMEWORK

Evaluate the structure of your current QMS.  If you previously excluded “design”, you’ll need to incorporate it somewhere.  In the beginning, your organization identified the necessary processes and perhaps even described them as process flow diagrams with inputs and outputs and their interaction was clearly defined.  It’s a little awkward that now they tell us more about the requirements of design of the processes, but there has been discussion right along and there will continue to be more discussion about this topic.  Because, after all, the focus of the standard is to be process focused. 

This is an opportunity to simplify how your QMS is designed.  The requirements in this section include Planning, Inputs, Controls and Outputs.  Take a moment to use these steps to design a simply QMS that works for your organization.  Remember, it’s your organization’s QMS and it should work for you!

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For more information about 8.3 Design and development (and all the clauses of ISO9001, subscribe to my video series.  Watch this 3-minute video about this great self-directed, on demand, online learning series  ISO9001 in Plain English, today and you'll get:

• A clear understanding of the requirements of ISO9001:2015
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• Ways to reduce documentation and paperwork (yes, really!!)

Each video is about 15 minutes and targets a specific element of ISO9001, (with over 6 hours of total content!).  We translate all the gobbledegoop into Plain English you can understand and leverage the requirements to get maximum VALUE from your quality efforts. 

For a deeper dive into the process side of your quality system, get Tribal Knowledge - The Practical Use of ISO, Lean and Six Sigma Together, a simple guide to UNITE ISO9001, lean and Six Sigma to create a robust quality system with better results.  Read what ASQ American Society for Quality – Quality Progress Magazine  had to say about it. 

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