Use promo code:
CTA20

Expert Advice Community

Guest

Requirements of the clause 8.3.2 in ISO 9001

  Quote
Guest
Guest user Created:   Jun 04, 2017 Last commented:   Jun 04, 2017

Requirements of the clause 8.3.2 in ISO 9001

What is the actual requirement for the documentation from 8.3.2.j? Does it include the rest of the letter section in 8.3.2? Does it mean somehow showing that the requirements from 8.2.3 have been incorporated into the design output?
0 0

Assign topic to the user

ISO 9001 PROCEDURE FOR DESIGN AND DEVELOPMENT

Define the design & development process for smaller companies.

ISO 9001 PROCEDURE FOR DESIGN AND DEVELOPMENT

Define the design & development process for smaller companies.

Expert
Strahinja Stojanovic Jun 04, 2017

Answer:

The clause 8.3.2 j) requires that during design an development planning the organization to consider documented information needed to demonstrate that design and development requirements have been met. This doesn't mean that you need to provide these documented information during the planning phase but to define what documented information must exist at the end of the design and development process to demonstrate that the requirements have been met. For example, in the project plan or project task you will define what documented information will be created as the design and development output, e.g. CAD drawings.

For more information, see: Specific use of ISO 9001 design and development in the machining process https://advisera.com/9001academy/blog/2017/03/14/specific-use-of-iso-9001-design-and-development-in-the-machining-process/

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Jun 03, 2017

Jun 03, 2017

Suggested Topics

Guest user Created:   May 14, 2019 ISO 9001
Replies: 1
0 0

Changes & exclusions in ISO 9001

Guest user Created:   Oct 27, 2023 ISO 9001
Replies: 1
0 0

Implementing Clause 8.4