AnaMariaVR2
Trusted Information Resource
Could anybody share your experience about what kind of calibration, maintenance and inspection is required for laboratory equipment for a small biotech company.
under ISO 9001:2008 clause 7.6 "Control of monitoring and measuring equipment".
What quality systems should I develop, evaluate, apply and/or monitor in order to have a robust quality system that controls equipment in our facility?
Does anybody have any ideas or experience on this area? I'm doing this from scratch. I started with the equipment database, wrote a general equipment SOP and now writing specific equipment/instrumentation SOPs. Now, what else?
What approach would Elsmar Cove recommend?
Should I develop this system based on the 6 activities that ISO must document? As it follows:
Thanks in advance to all!
Ana
under ISO 9001:2008 clause 7.6 "Control of monitoring and measuring equipment".
What quality systems should I develop, evaluate, apply and/or monitor in order to have a robust quality system that controls equipment in our facility?
Does anybody have any ideas or experience on this area? I'm doing this from scratch. I started with the equipment database, wrote a general equipment SOP and now writing specific equipment/instrumentation SOPs. Now, what else?
What approach would Elsmar Cove recommend?
Should I develop this system based on the 6 activities that ISO must document? As it follows:
4.2.3 Control of Documents
4.2.4 Control of Records
8.2.2 Internal Audits
8.3 Control of NC products
8.5.2 Corrective Action
8.5.3 Preventive Action
4.2.4 Control of Records
8.2.2 Internal Audits
8.3 Control of NC products
8.5.2 Corrective Action
8.5.3 Preventive Action
Thanks in advance to all!
Ana