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Effectiveness of QMS and Product Recall

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Guest user Created:   Nov 06, 2019 Last commented:   Nov 08, 2019

Effectiveness of QMS and Product Recall

1. How can you measure the effectiveness of QMS? 2. Do every product recall will require an advisory notice? Is there any advisory notice which will not required a product recall?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Nov 08, 2019

1. How can you measure the effectiveness of QMS?

Measuring effectiveness of QMS depends on the organization's processes as well as Policy/quality objectives. Most companies compared results to the goals for the KPI (Key Performance Indicators) defined for the organization. For example, it can be:- Number of major non-conformities coming from second/third party audit- Customer satisfaction improvement- Confirmed certification from Registrar- Obtain new certifications to improve your business- Increasing the number of orders from Customers- Cost reduction improvement ( including cost of poor quality)- Time to market reduction for new products- Zero defects achievement- Compliance to law and regulation

 For more information please read the following article: 

Practical tips for measuring your QMS according to ISO 9001:2015 clause 9.1: https://advisera.com/9001academy/blog/2017/08/29/practical-tips-for-measuring-your-qms-according-to-iso-90012015-clause-9-1/

2. Do every product recall will require an advisory notice? Is there any advisory notice which will not required a product recall?

No, every product recall does not require an advisory notice. Removals from the market for purely commercial non-safety related reasons do not require advisory notice.

For more information on how to handle recalls, what are the synonyms and meaning of wording iin EU market, please find MEDDEV 2.12/1, revision 8 (January 2013) and Additional guidelines for MEDDEV 2.12/1 (published July 2019). Both documents can be found on the following link in section 2.12 PostMarket surveillance: https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en 

For more information on recalls, corrections and removals under FDA, please look in the following link: https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

For more information on recalls and advisory notices for medical devices, please read the following article:

How to manage recalls and advisory notices for medical devices according to ISO 13485 https://advisera.com/13485academy/blog/2017/08/31/how-to-manage-recalls-and-advisory-notices-for-medical-devices-according-to-iso-13485/

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Nov 06, 2019

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