Control of Nonconforming Product

[ISO 13485 Cl 8.3]

Control of Nonconforming - Explanation

ISO 13485 encompasses all stages of the medical device lifecycle, including controlling nonconforming products. The word nonconforming products men’s devices/components/accessories or medical devices that fail to meet specified requirements, such as those set by inhouse standards, customers or regulations. Prompt identification of such nonconformities is essential. Additionally, ISO 13485:2016 outlines the procedures for managing non-conformities in a medical device, even post-use or delivery.

The goal is to identify, segregate and move to other dedicated areas before they get mixed up with good items

INTERNAL AUDIT TOOL

1. IMPORTANT INFORMATION - Step 1 of 6

Certainly, we will be happy to provide you with a detailed service proposal for European Authorized Representative and allied services. To do so, please provide us with the following information:

Manufacturer Name *

Address *

Address Line 1

Address Line 2

City

State / Province / Region

Postal Code

Country

Website / URL

ISO 13485 PRICING

ISO 13485 COST CALCULATOR

ISO 13485 PROPOSAL REQUEST

Frequently Asked Questions

Should a manufacturer maintain single procedure for purchasing and outsourcing ?

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