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CAPA Procedure Template (ISO 13485, Medical Device)

CAPA Procedure Template (ISO 13485, Medical Device)

99 € (excl. GST/VAT)

This template will provide you with standard operating procedure (SOP) for CAPA to document a process for corrective actions and preventive actions according to 8.5.2 and 8.5.3 of ISO 13485:2016.
SKU PT-CAPA Category Tags , , , ,

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Note: Quality management templates are included in the blended course.

Description

Why it is useful

The purpose of the supplier evaluation process is to ensure that the selected suppliers can deliver according to the Company’s requirements. This procedure refers to a supplier evaluation form that will work well with this procedure.

How to use it

1. You may use this procedure template in your quality management system after adapting it to your needs and removing the informative text.
2. Use the template as an inspiration while authoring your own procedure.
3. Use the template as a benchmark to check your own existing procedure.
In general, you can change who is responsible for what throughout this procedure.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before the review of the document.
All texts that are not blue are example texts that can and should be edited by you and tailored to your situation.
Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text updated to suit your situation.

 

Support

If you have questions about the content of the template, you may ask questions in the support forum. The support forum is accessible on this link when you are logged into your Medical Device HQ account.

Need quality management training and a course certificate?

Should want to learn more about using the template or quality management in general, it is covered in two of our public training courses: Introduction to Quality Management for Medical Devices and ISO 13485 and Quality Management for Medical Devices and ISO 13485 blended course. Our blended courses combine a self-paced online course first followed by a live virtual classroom session.

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Would you like to learn more about risk management or design control?

Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course. These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.

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