Audits & Inspections
What We Offer
auditing of management systems acc. to
= EN ISO 9001
= EN ISO 14001
= EN ISO 13485
= 21 CFR 820
= international GMP requirements
preparation, support, and wrap-up of certification, re-certification and surveillance audits as well as
= country specific FDA inspections (USFDA, CFDA, SFDA, KFDA etc.)
= ANVISA inspections
= Health Canada inspections
= 21 CFR 820
= international GMP requirements
2 Process analysis with recommendations for corrections and corrective actions (CAPAs)
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The Inspection Loops - process analysis at its best
We support you in every phase of your inspection: Preparation, performance and reporting of internal audits and supplier audits according to EN ISO 19011
Our Services
Just Blogging
Using an environmental management system generates significantly added value in case legal applicable safety at work requirements are defined as quality objectives...
Welcome to our new website!
The QC Loop team is creating a new approach on process-oriented control loops to ensure full compliance for medical device...
NEWS
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Following the first reading vote of the Parliament in April 2014 and a Council's informal position in October 2015, the Council and the Parliament agreed on a final text on 15 June 2016. At this moment in time, work is ongoing to translate the final texts in all the EU official languages and to correct technical inconsistencies. Final formal adoption is expected both on the Council and the Parliament sides during the first semester 2017. - http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_de
European Commission
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ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. - http://www.iso.org/iso/catalogue_detail?csnumber=59752
ISO org
