Question
We are service providers in NDT and inspection field. I want to know how to implement the design and development clause from ISO 9001: 2015.
Answer
There are two ways to approach this:
One is to use the process developed in ISO 9001:2008, 7.1 where you probably have a “quality plan” for the execution of the service delivery (ISO 9001:2015, 8.1).
The second approach is to design the process itself (ISO 9001:2015, 8.3). That involves these activities:
INPUT
• Development of a design plan
Who will do what when with what?
Necessary control points
• Identification of customer requirements as inputs, along with inputs from similar previous service offerings
• Identify any special service characteristics, such as safety issues, regulatory compliance
Consequences of failure
• Identify products/services to be purchased/outsourced
THROUGHPUT
• Documentation of these inputs
• Preparation of an output in a format appropriate to the organization
OUTPUT
• A comparison of the outputs with the input requirements and an approval, if required
Outputs should include process monitoring and measuring requirements
• Outputs can include verification, design review and validation*
• A mechanism to handle process design changes
George Hummel
Voting member of the U.S. TAG to ISO/TC 176 – Quality Management and Quality Assurance
Managing Partner
Global Certification-USA
http://www.globalcert-usa.com/
Dayton, OH
For more information on this topic, please visit ASQ’s website.