Auditing Biomedical service providers
I am the Regional Quality Director for Intl SOS in Africa. Lot's of our clients want to use service providers in Africa for servicing and calibration of Biomedical equipment. What are the minimum criteria I should ask for when auditing them?
Qualification of Bio-technicians?
Against which standard they are performing their calibrations? And btw, should this not be stipulated in the calibration certificates?
Against which standards are their measuring and calibration equipment calibrated/standardized?
This is but a few I can think of - can you please assist me with this as I want to create a procedure for verification of Service Providers for the region.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
If I understand correctly, you are asking about biomedical equipment that are used in production and/or service of medical devices. If that is so, the minimum and mandatory criteria according to both Medical device directive (MDD 93/442/EEC) and Medical device regulation (MDR 2017/745) are that any laboratory used to prove compliance of the medical device to a certain requirement must be accredited. So, you need to ask for an accreditation certificate of that company and check is your equipment test is on the method list.
For more information what is EU MDR (EU MDR – Easy-to-understand basics), please read the following article: https://advisera.com/13485academy/what-is-eu-mdr/
According to the ISO 134985:2016, companies that provide service of medical devices also need to be certified according to the ISO 13485:2016.
On this link you can find Clause-by-clause explanation of ISO 13485:2016: https://info.advisera.com/13485academy/free-download/clause-by-clause-explanation-of-iso-13485
Qualification of the personel who performed and signed the calibration certificate is covered and reviewed during the accreditation audit. Usually, companies that perform calibration services are accredited by ISO 17025:2017 for a particular method, so a Certificate of accreditation is also necessary as proof that the calibration process is done properly.
What is ISO 17025? you can find on the following link: https://advisera.com/17025academy/what-is-iso-17025/
Each equipment has its own standard under which they should be calibrated. There are different standards for scales, for thermometers, for hygrometers, pressure and so on. Standard under which calibration equipment needs to be calibrated must be stated on the calibration certificate. Annex to each calibration certificate is a certificate of the standard gauge with which calibration is done.
For more information about calibration requirements in ISO 13485, please read the following article:
Calibration requirements in ISO 13485 https://advisera.com/13485academy/blog/2019/03/08/calibration-requirements-in-iso-13485/
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Apr 08, 2020