Expert Advice Community

Guest

Design & Development

  Quote
Guest
Guest user Created:   Oct 26, 2022 Last commented:   Oct 29, 2022

Design & Development

I communicated earlier with you regarding the implementation of ISO 9001 for our Laboratory. We are accredited ISO 17025. 

For ISO 9001, do I include Design & Development, since method development is done by our Lab? 

Your view and insight is highly appreciated

0 1

Assign topic to the user

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Tracey Evans Oct 29, 2022

You may have all or most “Design and development” elements documented in your ISO 17025 QMS already, however you need to do a gap assessment (what you need versus what is in place) as there are specific requirements for ISO 9001:2015. Why I say “may” is it depends on what you have in place. Just because a laboratory is accredited to ISO 17025 does not automatically mean all the elements of ISO 9001 are there. The extent of implemented process, documentation and records varies from laboratory to laboratory.

You need to look at the ISO 9001:2015 requirements as per the standard and or a checklist, including the mandatory documents (procedures and records). Confirm is the requirements are implemented, in which procedures the processes are documented and if the records you have include all the information required. If fully covered in your system, then you know clearly where they are. If not, either modify your ISO 17025 documents to add elements required by ISO 9001, or create additional documents.

For more information, look at the resources available at the Advisera ISO 9001 Academy at https://advisera.com/9001academy/ Have a look at the Checklist of Mandatory Documentation Required by ISO 9001:2015 at https://info.advisera.com/9001academy/free-download/checklist-of-mandatory-documentation-required-by-iso-90012015

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Oct 26, 2022

Oct 29, 2022

Suggested Topics

Guest user Created:   Nov 29, 2022 ISO 17025
Replies: 1
0 0

Implemention of ISO 17025

YT Created:   Jul 06, 2022 ISO 17025
Replies: 1
0 0

Evaluating measurement uncertainty frequency