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Matrix for Requirements against Process/Department

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Guest user Created:   Nov 19, 2020 Last commented:   Nov 20, 2020

Matrix for Requirements against Process/Department

May I request the matrix for ISO13485:2016 Requirement against process/ department for Gloves Manufacturing (Non-Sterile Examination Gloves) is for the guide for Internal Audit.

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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 20, 2020

For internal audit you can definitively use our Internal audit checklist from our ISO 13485:2016 Documentation toolkit. The Internal Audit Checklist is the list of questions required to ensure the management system is implemented and maintained. The listing includes more than 100 questions to ensure each requirement of the ISO 13485 standard is implemented and maintained within the Quality Management System and includes the ability for the company to add additional questions to suit individual needs. Of course within these 100 questions are questions regarding production, warehouse, quality control, and so on. Therefore, you can find questions applicable to your medical devices.

Here is the link for the Internal audit checklist: https://advisera.com/13485academy/documentation/internal-audit-checklist-iso-13485-2016/

For more information about conducting the internal audit, please see the following links:

On following link you can see which documents and records our ISO 13485:2016 Internal audit toolkit has: https://advisera.com/13485academy/iso-13485-internal-audit-toolkit/

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Nov 19, 2020

Nov 20, 2020