Does your ISO 13485:2016 upgrade project need a power-boost?
This year I have been focused on helping my existing clients and others to upgrade their medical device quality management systems (QMS) for compliance with ISO 13485:2016 (EN ISO 13485:2016).
In doing so, I have developed two tools (templates) that you may find useful to help guide your own organization’s upgrade work.
ISO 13485:2016 Change Impact Analysis (MS Word, 34 pages)
– Clause Title Comparisons: ISO 13485:2003 versus ISO 13485:2016
– Clause By Clause Comparison and Gap Analysis Planning Matrix
– Detailed ISO 13485:2016 Impact Assessment (placeholder section)
Clause By Clause Comparison and Gap Analysis Planning Matrix
– Fields 1 and 2: Side-by-side, clause-by-clause, word-for-word comparison between 2003 and 2016 version
– Keyword color coding: document, procedure, record, regulatory, risk
– Highlighting for key differences/additions, to aid understanding of the changes
– Field 3: Comparison (from ISO 13485:2016 Annex A)
– Field 4: Impacted Quality System Documents (placeholder content)
NOTE: To avoid copyright concerns, before purchasing this tool you must provide evidence that your organization owns both standards.
Quality Plan & Report, ISO 13485:2016 Quality System Upgrade (MS Word, 7 pages)
– Purpose & Scope
– Responsible Functional Group Management
– Change Summary
– Change Impact Analysis
– Applicable Documents
– Quality System Document Change Requirements and Tracking
– Regulatory Compliance
– Schedule of Key Events
Lazzara ISO 13485:2016 Power Tools and 30-minute Consultation
Two Templates – ISO 13485:2016 Change Impact Analysis + Quality Plan & Report, ISO 13485:2016 Quality System Upgrade (both documents will be delivered soon after payment is received – please contact Sam@MDQC.com if you have any questions). After delivery, we will schedule a 30 minute consultation to discuss the templates and answer questions.