Food Packaging Testing
We are a Transport Packaging Testing Laboratory. We are looking to grow our business in the Medical Device Packaging Testing portion of our industry. We see that SIO standards are geared towards manufacturing and product based businesses. We are looking to adapt a current Medical Device Manufacturer's QM to ours as a service based QM. Mainly need to know how deep do we need to go with process and procedure from the quality side. there's only 2 of us
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ISO 17025 is applicable for calibration and testing laboratories. If you seek ISO 17025 accreditation as a testing laboratory, the laboratory needs to meet all the mandatory requirements for the Standard. The processes and procedures that would be part of the scope relate to all general quality management and technical requirements.
I suggest you become familiar with ISO 17025 and perform a gap assessment (internal audit) of the requirements of ISO 17025 against what you already have in place for your Medical Device Manufacturer QMS.
For more information on ISO 17025 and the processes and documents, to put in place start here https://advisera.com/iso-17025 and the available resources, including the Checklist of mandatory documents required by ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/checklist-of-mandatory-documents-required-by-iso-17025 Then have a look at what the toolkit can offer to assist with requirements of internal audits https://advisera.co/ISO17025Toolkit
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Oct 11, 2023