Expert Advice Community

Guest

Gap analysis and key performance indicators

  Quote
Guest
Guest user Created:   Jul 14, 2021 Last commented:   Jul 21, 2021

Gap analysis and key performance indicators

1. How to conduct gap analysis for ISO 13485?
2. How to determine key performance indicators?

0 0

Assign topic to the user

Assign

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Jul 21, 2021
1. How to conduct gap analysis for ISO 13485?

You did not specify in your question what kind of GAP analysis you need. Gap analysis is about comparing the current situation of a company with standard requirements. 

So please check the following link about performing gap analysis regarding the ISO 13485: https://advisera.com/13485academy/iso-13485-gap-analysis-tool/

You can make also a GAP analysis between ISO 9001 and ISO 13485 if you have implemented a quality management system according to the ISO 9001:2015 and you need now to implement ISO 13485:2016. The best way to conduct this GAP analysis is to take a cross-references table at the end of the ISO 13485:2016 standard (Annex B).

2. How to determine key performance indicators?

The term Key Performance Indicator refers to measurements you used to determine the performance and effectiveness of the QMS. This is completely up to you, but the main question you need to ask yourself is "What do I need to measure to know that my QMS processes are performing as expected and that they are effective?". KPIs also depend on what is a company’s strategy and competitive advantage. KPIs for a manufacturer of commodities are different from a manufacturer of innovative or differentiated stuff.

For more information regarding the KPI, please see the following article, regardless of what is their mention of the ISO 9001 standard:

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Jul 14, 2021

Jul 21, 2021

Suggested Topics

Guest user Created:   Sep 01, 2020 ISO 13485 & EU MDR
Replies: 1
1 0

Gap analysis for ISO 13485

Guest user Created:   Feb 13, 2020 ISO 13485 & EU MDR
Replies: 1
0 0

Risk Analysis

Guest user Created:   May 25, 2021 ISO 13485 & EU MDR
Replies: 1
0 0

Question about requirements