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QMS for medical devices

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Guest user Created:   Oct 07, 2019 Last commented:   Oct 08, 2019

QMS for medical devices

Hi,

I just wanted to get the exact definitions of the following terms as per medical devices QMS:

Disposition
Containment,
immediate correction.

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Carlos Pereira da Cruz Oct 08, 2019

I cannot give you an authoritative answer because ISO 9000:2015 does not define those words. What I can give you is my interpretation of the meaning of those words:

- Disposition – when an organization decides that a product with defects cannot be reworked and should be destroyed to avoid unintended use. So, disposition is the final destiny of that product with defects
- Containment – when a non-conformity is detected and there are suspicions that there may be more items with defects. To avoid unintended use or delivery to the customer, the product lot should be contained until a full control is done.
- Immediate correction – when a defect is detected and can be immediately corrected. For example, when in a bottling line a bottle with label defect is found, it can be removed and sent back to the beginning of line to get a new label.
 

The following material will provide you more information about those words:

- Five Steps for ISO 9001 Non-conforming Products - https://advisera.com/9001academy/blog/2014/01/13/five-steps-iso-9001-nonconforming-products/
- ISO 9001 – Difference between correction and corrective action - https://advisera.com/9001academy/blog/2016/02/09/iso-9001-difference-between-correction-and-corrective-action/
- Enroll for free course - ISO 9001:2015 Foundations Course - https://training.advisera.com/course/iso-9001-foundations-course/
- book – Discover ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

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G.Gomes Oct 08, 2019

Thanks, Carlos

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