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Gap analysis of a QM process landscape for an audit according ISO 13485:2016
Project duration: 2 months
Brief description
The customer is facing a surveillance audit by his notified body. In a previous audit, it was criticized that the process descriptions and references of the customer's QM process landscape are in part outdated and do not meet the requirements of ISO 13485:2016. Based on this nonconformity, PTA analyzes the documentation of the process area Production, documents gaps and suggests measures to remedy them. PTA coordinates the measures with the customer, implements them and documents them for submission to the notified body.
Supplement
Main objective of the gap analyses is, to find out which document versions are still relevant and to ensure their correct referencing throughout the production documentation.
Subject description
The analysis of the documentation gaps in process area Production comprises the following document types: process descriptions, work instructions, assembly instructions and production checklists.
Overview
- Industries medical technology
- Specialist tasks Audit, BPM: process realization, documentation, ISO 13485, quality management
- DV tasks IT consulting
- System environment organizational consulting
- Procedure model customer standard
Project period06.08.2018 - 28.09.2018
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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