Guest user Created: Feb 28, 2016 Last commented: Feb 28, 2016

ISO 20000 / ISO 27001 in pharmaceutical industry

ITIL & ISO 20000

I am the IT person for a biotech company. I am attempting to implement ISO 20000-1 and 27000. QA is in charge of medical devices and pharmaceuticals. They only adhere to crc 1345. They are trying to take over the SMS and ISMS system and its implementation. They have no idea about IT. What are your suggestions? I think the IT Department and IT director should manage and implement this system not QA.

0 0

Assign topic to the user

Select user

Expert

Branimir Valentic Feb 28, 2016

Answer:
I think that the solution is (almost) in the middle. Namely, ISO 13485 is based on ISO 9001 and provides good foundation for some parts of the SMS and ISMS. But, majority of work (during implementation and afterwards) should be made by someone involved in respective activities, like you suggested – head of IT. But, all systems should be integrated, so there should be close cooperation between QA and IT.

Quote

0 0

Comment as guest or Sign in

HTML tags are not allowed

Name *

Email *

I accept the Privacy and Terms

Notify me when someone replies

Feb 28, 2016

Expert Advice Community