Design & Development

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