Effective Control of Processes - ISO 13485 Clause 4.2.1 (d)

[delaney]

Hello All,

I have been "lurking" for several months here, gathering much information and learning lots. I thank you all for allowing me that and sharing your knowledge!

As I plunge into my new position as an internal auditor with a medical software company, I have been tasked with reviewing some of the open non-conformances from the ISO auditor and resolving them prior to our next audit.

With that said, I have one non-conformance that states in part that the QMS documentation shall include documents needed by the organization to ensure the effective control of its processes (4.2.1 (d)) This non-conformance was specific to the Quality Manual. Our Manual has process maps to show the different processes used here at site for the creation of the software. It also references the various procedures that are followed.

The Quality Manual is in the format of the sections of ISO 13485.

How can I show that there is documentation of control of processes?

Thank you for any and all assistance.

~ newbie in the field~

[pilchard]

Can you show a file for each type or
model of medical device software containing or
identifying documents with product
specifications and QMS requirements?

These documents shall define the complete
process and, if applicable, installation and servicing.

(Review documents to verify they define the
complete process, installation and servicing)

[Rob Nix]

In Reply to Parent Post by delaney

...the QMS documentation shall include documents needed by the organization to ensure the effective control of its processes (4.2.1 (d))

That is an awfully general statement to make. What specifically did the auditor find (what evidence) that prompted him/her to write up the NC?

4.2.1.d usually refers to forms, records, flowcharts, specs, etc. that are used to ensure that requirements are met consistently and are traceable.

Oh, and Welcome To The Cove! Nice first post.